docγενικο προξενειο της ελλα∆ος στο σικαγο γραφειο οικονομικων και εμπ
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γενικο προξενειο της ελλα∆ος στο σικαγο γραφειο οικονομικων και εμπ
ΓΕΝΙΚΟ ΠΡΟΞΕΝΕΙΟ ΤΗΣ ΕΛΛΑ∆ΟΣ ΣΤΟ ΣΙΚΑΓΟ ΓΡΑΦΕΙΟ ΟΙΚΟΝΟΜΙΚΩΝ ΚΑΙ ΕΜΠΟΡΙΚΩΝ ΥΠΟΘΕΣΕΩΝ Σικάγο, 15 Ιουνίου 2010 ΑΠ.Φ. 1541/1/ΑΣ 114 Ο κλάδος παραγωγής φαρμάκων στις ΗΠΑ Η παραγωγή φαρμάκων στις ΗΠΑ έχει αναπτυχθεί σε επίπεδο να θεωρείται πλέον από τις σημαντικότερες βιομηχανίες που στηρίζουν την οικονομική δραστηριότητα σε τούτη την δυσμενή συγκυρία. Σύμφωνα με στοιχεία της IMS Health, η μεγαλύτερη και πλέον εξειδικευμένη εταιρεία σε θέματα έρευνας αγοράς και μελετών στον χώρο των φαρμάκων, το 2008 το διεθνές περιβάλλον της φαρμακευτικής αγοράς σημείωσε οριακή βελτίωση. Οι συνολικές πωλήσεις στην παγκόσμια φαρμακευτική αγορά έφτασαν τα $773 δισ. σημειώνοντας αύξηση κατά $58 δισ. σε σύγκριση με το 2007, εντούτοις ο ρυθμός μεταβολής μειώθηκε στο 4,8% από 6,6% το 2007. Το μεγαλύτερο μερίδιο των πωλήσεων (40,3%) στην παγκόσμια φαρμακευτική αγορά το 2008 αφορούσε σε πωλήσεις στη Βόρεια Αμερική (ΗΠΑ και Καναδάς), το 32% σε πωλήσεις στην ευρωπαϊκή αγορά και το 11,7% σε πωλήσεις στην Ασία, την Αφρική και την Αυστραλία. Ο υψηλότερος ρυθμός αύξησης σημειώθηκε επίσης στην Ασία, την Αφρική και την Αυστραλία (15,3%), ενώ η Λατινική Αμερική αν και αποτελεί την αγορά με το χαμηλότερο μερίδιο επί των παγκόσμιων πωλήσεων (6%), χαρακτηρίζεται επίσης από υψηλό ρυθμό αύξησης (12,6%). Στην παγκόσμια φαρμακευτική αγορά, παρατηρείται σημαντική μετατόπιση της ζήτησης από τις ώριμες προς τις αναπτυσσόμενες αγορές καθώς οι ρυθμοί ανάπτυξης στις ώριμες αγορές σταδιακά μετριάζονται, ενώ αντίθετα οι αναπτυσσόμενες αγορές με χαμηλά μερίδια πωλήσεων παρουσιάζουν διψήφιο ρυθμό ανάπτυξης. Το γεγονός ότι η παγκόσμια φαρμακευτική αγορά -αν και σε μικρότερο βαθμό σε σύγκριση με άλλους κλάδους της βιομηχανίας- επηρεάζεται από τις εξελίξεις που σηματοδοτεί η διεθνής οικονομική κρίση, καθιστά τις προοπτικές για τα επόμενα χρόνια ιδιαίτερα ανησυχητικές (IMS Market Prognosis). Το 2009 η αγορά εκτιμάται ότι παρουσίασε ετήσιο ρυθμό αύξησης μόλις 2,5%- 3,5%, κάτι που προβλέπεται ότι θα συνεχιστεί και το 2010, με προοπτική ανάκαμψης το 2012. Επίσης, εκτός από τις επιπτώσεις της οικονομικής κρίσης, η φαρμακευτική αγορά πρόκειται να αντιμετωπίσει μεγάλο αριθμό πατεντών για εξαιρετικά κερδοφόρα φάρμακα που πρόκειται να λήξουν έως το 2012. Οι δαπάνες υγείας στις ΗΠΑ θα αυξηθούν αυτή τη δεκαετία ταχύτερα από ό,τι η συνολική οικονομία και έως το 2019 σχεδόν 20 σεντς για κάθε δολάριο που δαπανάται στις ΗΠΑ θα πηγαίνει στην υγεία, εκτιμούν αναλυτές της παρούσας κυβέρνησης σε μελέτες που κατέθεσαν στο Καπιτώλειο. Οικονομολόγοι του Κέντρου Υπηρεσιών Medicare και Medicaid (CMS) δήλωσαν σε πρόσφατη έκθεσή τους ότι οι εθνικές δαπάνες υγείας θα αυξηθούν με ρυθμό κατά μέσον όρο 6,1% το χρόνο επί μία δεκαετία, φθάνοντας τα 4,5 τρισεκατομμύρια δολάρια το 2019 - η αύξησή τους, δηλαδή, θα είναι περίπου 1,7% ταχύτερη από ό,τι για τη συνολική οικονομία. Οι δαπάνες υγείας θα αντιπροσωπεύουν το 19,3% της οικονομίας το 2019, αναφέρει η έκθεση. Πέρυσι, εκτιμάται ότι 2,5 τρισ. δολάρια δαπανήθηκαν για την υγεία στις ΗΠΑ, αντιπροσωπεύοντας περίπου το 17,3% της οικονομίας. Οι ΗΠΑ δαπανούν περισσότερα στην περίθαλψη από οποιαδήποτε άλλη χώρα, παρόλο που περίπου 46 εκατομμύρια άτομα δεν έχουν ασφάλιση υγείας. Η προσπάθεια του Προέδρου Μπάρακ Ομπάμα να επεκτείνει την ασφαλιστική κάλυψη και να ελέγξει τα αυξανόμενα κόστη πάγωσε αρχικώς στο Αμερικανικό Κογκρέσο, όταν το κόμμα των ∆ημοκρατικών έχασε την απόλυτη πλειοψηφία στη Γερουσία, μετά την εκλογή Ρεπουμπλικάνου στη θέση του εκλιπόντος ∆ημοκρατικού Έντουαρντ Κένεντι (και σταθερού εισηγητή της επέκτασης της περίθαλψης σε μη ασφαλισμένους) στη Μασαχουσέτη. Η έκθεση της έγκυρης εταιρείας μελετών CMS δείχνει ότι οι ιατρικές δαπάνες και ο αριθμός των ανασφάλιστων θα συνεχίσουν να αυξάνονται ανεξέλγκτα με την απουσία δομικής αναθεώρησης του συστήματος. «Η έκθεση αυτή βασικά δείχνει ότι τίποτα δεν έχει αλλάξει ουσιαστικά» δήλωσε ο Richard Foster, επικεφαλής της αναλογιστικής υπηρεσίας του CMS. Έως το 2019, οι ΗΠΑ θα δαπανούν περίπου 13.387 δολάρια/άτομο το έτος για την υγεία. Το ποσό αυτό ήταν 8.047 το 2009 και προβλέπεται ότι θα είναι 8.290 το 2010, αναφέρεται στην έκθεση. Η οικονομική ύφεση είχε μεγάλη επίδραση στην επιβράδυνση της αύξησης των ιδιωτικών δαπανών υγείας, καθώς οι απολυμένοι εργαζόμενοι έχασαν την παρεχόμενη από τον εργοδότη ασφάλιση υγείας. Συγχρόνως, αυξήθηκαν οι δαπάνες για το κρατικό πρόγραμμα υγείας Medicaid για τους φτωχούς . Οι κρατικές πληρωμές θα αποτελούν το ήμισυ του συνόλου των δαπανών υγείας στις ΗΠΑ το 2012 και θα φθάσουν το 52% έως το 2019, καθώς αυξάνεται ο αριθμός αυτών που ασφαλίζονται στο κρατικό πρόγραμμα Medicare για τους ηλικιωμένους. Η έκθεση αναφέρει επίσης ότι οι δαπάνες για συνταγογραφούμενα φάρμακα αυξήθηκαν κατά 5,2% το 2009, κυρίως λόγω των υψηλότερων τιμών για τα επώνυμα φάρμακα. Η βελτίωση της οικονομίας θα επιταχύνει την αύξηση των δαπανών για συνταγογραφούμενα φάρμακα σε 5,6% έως το 2011. Ωστόσο, η αύξηση των δαπανών τους θα επιβραδυνθεί το 2012 και το 2013, καθώς θα λήγουν οι πατέντες πολλών επώνυμων φαρμάκων με υψηλές πωλήσεις. Μετά από αυτό, η αύξηση στις φαρμακευτικές δαπάνες θα επιταχυνθεί ξανά, φθάνοντας το 7,7% το 2019, λόγω των αυξανόμενων τιμών των φαρμάκων και των εγκρίσεων νέων φαρμάκων, καθώς και λόγω του αυξανόμενου ποσοστού που θα αντιπροσωπεύουν τα πιο εξειδικευμένα και ακριβά φάρμακα. Η αναφορά στον κλάδο της φαρμακοβιομηχανίας στις ΗΠΑ πρέπει να περιλάβει αναγκαστικά αναφορές : α) στα είδη φαρμάκων και στις εταιρείες παραγωγής φαρμάκων, β) στα λεγόμενα generics φάρμακα, γ) στα νοσοκομειακά συγκροτήματα, δ) στον κλάδο παροχής ασφάλισης υγείας, ε) στις αλυσίδες φαρμακείων, στ) στα κανάλια διανομής και ζ) στον κλάδο της Βιοτεχνολογίας. Α. Οι εταιρείες παραγωγής και τα είδη των φαρμάκων : Ο κλάδος στις ΗΠΑ περιλαμβάνει 1500 εταιρείες με συνολικό εισόδημα περίπου 200 δις δολ. το 2009. Οι φαρμακοβιομηχανίες αποτελούν ορισμένες από της μεγαλύτερες εταιρείες στις ΗΠΑ, όπως Abbot, Bristol-Myers Squibb, Eli Lilly, 2 Johnson & Johnson και Pfizer. Ο κλάδος είναι ιδιαίτερα συγκεντρωτικός καθώς οι 50 μεγαλύτερες εταιρείες κατέχουν περισσότερο του 80% της αγοράς. Επίσης πρόκειται για κλάδο που σαφώς εντάσσεται σε κατηγορία, οι επιχειρήσεις των οποίων πρέπει να έχουν υψηλή κεφαλαιοποίηση και υψηλό μέσο όρο εισοδηματικής απόδοσης των υπαλλήλων τους1. H παραδοσιακή φαρμακοβιομηχανία, έχει να αντιμετωπίσει πλέον δυο μεγάλες προκλήσεις : την είσοδο των generics φαρμακευτικών σκευασμάτων και την αναμόρφωση της έρευνας με τα επιστημονικά δεδομένα της βιοτεχνολογίας. Η κερδοφορία των επιχειρήσεων αυτών είναι ευθέως ανάλογη της αποτελεσματικότητας των φαρμακευτικών σκευασμάτων που παράγουν. Ο Πρόεδρος Μπάρακ Ομπάμα υπέγραψε, τον Απρίλιο 2010, μέσα σε κλίμα ευφορίας, το νομοσχέδιο για την αναθεώρηση του συστήματος υγείας στις ΗΠΑ, κάνοντάς το νόμο. «Το νομοσχέδιο που υπογράφω θα θέσει σε κίνηση τις μεταρρυθμίσεις για τις οποίες γενιές ολόκληρες Αμερικανών έχουν παλέψει, διαδηλώσει και πεινάσει έως ότου τις δουν» δήλωσε κάτι που οι φαρμακοβιομηχανίες βέβαια δεν συμμερίζονται ούτε ως στόχο, ούτε ως διαδικασία. Με κόστος που εκτιμάται ότι θα φθάσει τα 940 δισ. δολάρια, ο νέος νόμος πρόκειται να αναμορφώσει τον τομέα της υγείας στις ΗΠΑ (έναν τομέα το ύψος του οποίου ανέρχεται στα 2,5 τρισ. δολάρια), παρέχοντας τις μεγαλύτερες αλλαγές κοινωνικής πολιτικής εδώ και δεκαετίες. Ο νόμος επεκτείνει την ασφάλιση υγείας σε 32 εκατομμύρια Αμερικανούς που σήμερα είναι ανασφάλιστοι, απαγορεύει διάφορες πρακτικές των ιδιωτικών ασφαλιστικών εταιρειών, όπως να αρνούνται κάλυψη σε άτομα με προϋπάρχοντα ιατρικά προβλήματα ή να διακόπτουν τα συμβόλαια για άτομα που στην πορεία αναπτύσσουν σοβαρά προβλήματα, επεκτείνει το κρατικό ασφαλιστικό πρόγραμμα Medicaid για τους φτωχούς και επιβάλλει νέους φόρους στα υψηλά εισοδήματα. Οι Ρεπουμπλικάνοι αντιτάχθηκαν με όλες τους τις δυνάμεις επί ένα έτος, αλλά απέτυχαν να εμποδίσουν την ψήφιση του νομοσχεδίου από τους ∆ημοκρατικούς στη Βουλή των Αντιπροσώπων. Ο Πρόεδρος Μπάρακ Ομπάμα δήλωσε, μεταξύ άλλων, μετά την υπογραφή του νομοσχεδίου: «Άκουσα κάποιον από τους ηγέτες των Ρεπουμπλικάνων να λέει ότι ο νόμος αυτός θα αποδειχθεί Αρμαγεδδών. Λοιπόν, σε δύο μήνες από τώρα, σε έξι μήνες από τώρα, θα μπορείτε να δείτε και μόνοι σας. Θα περιμένουμε και θα δούμε». Λιγότερο από ένα 24ωρο μετά την ψήφιση του νομοσχεδίου στη Βουλή των Αντιπροσώπων, οι γενικοί εισαγγελείς από αρκετές πολιτείες των ΗΠΑ δήλωναν ήδη τη ότι θα μπλοκάρουν την εφαρμογή του νόμου, θεωρώντας τον αντισυνταγματικό. Έως τώρα, 14 πολιτείες έχουν καταθέσει αγωγές σε ομοσπονδιακά δικαστήρια, υποστηρίζοντας ότι ο νέος νόμος καταπατά τα δικαιώματα των πολιτειών. Όλοι οι πολιτειακοί αξιωματούχοι που προχώρησαν στις αγωγές, εκτός από έναν, είναι Ρεπουμπλικάνοι. Οι πολιτείες ισχυρίζονται ότι ο νόμος παραβιάζει τα δικαιώματά τους, όπως αυτά καθορίζονται στο Σύνταγμα. Υποστηρίζουν ότι το Αμερικανικό Κογκρέσο δεν έχει δικαιοδοσία να υποχρεώνει τους Αμερικανούς να αγοράσουν ασφάλιση υγείας. Ο Λευκός Οίκος δήλωσε ότι δεν περιμένει ότι οι αγωγές αυτές θα στεφθούν με επιτυχία. Στα χαρακτηριστικά του νόμου στα οποία αντιτίθενται έντονα οι φαρμακευτικές εταιρείες περιλαμβάνεται η απαίτηση προς αυτές να παρέχουν, εκπτώσεις στα φάρμακα για τα άτομα που είναι εγγεγραμμένα στα προγράμματα 1 Ο μέσος όρος της ετήσιας εισοδηματικής απόδοσης των εργαζομένων είναι 700.000 δολ. (Bloomberg) 3 Medicare και Medicaid, καθώς και η δυνατότητα της ομοσπονδιακής κυβέρνησης να διαπραγματεύεται για τις τιμές των συνταγογραφούμενων φαρμάκων που παρέχονται από το Medicare. Αναλυτές πιστεύουν ότι τα μέτρα αυτά θα μπορούσαν να κοστίσουν στη φαρμακοβιομηχανία έως και 150 δις δολάρια σε ένα διάστημα δέκα ετών, ποσό σχεδόν διπλάσιο από τα 80 δις δολάρια που υποσχέθηκε η φαρμακοβιομηχανία να παρέχει στο κράτος ως εξοικονόμηση κατά τη συμφωνία που επιτεύχθηκε τον Ιούνιο με τον Γερουσιαστή Max Baucus, πρόεδρο της Επιτροπής Οικονομικών, η οποία έλαβε την έγκριση του Λευκού Οίκου. Ο κ. Johnson της PhRMA (Ένωση Φαρμακευτικών Εταιρειών) δήλωσε ότι, αν και το νομοσχέδιο της Βουλής των Αντιπροσώπων ήταν «καλοπροαίρετο», θα μπορούσε να έχει «τη μη σκόπιμη συνέπεια του να εξαφανίσει δεκάδες χιλιάδες θέσεις εργασίας στη φαρμακοβιομηχανία, σε μια εποχή που η αμερικανική οικονομία αγκομαχά και η ανεργία έχει ξεπεράσει το 10%». «Παραμένουμε πεπεισμένοι ότι η προσέγγιση της Επιτροπής Οικονομικών της Γερουσίας παρέχει την καλύτερη οδό για μια ολοκληρωμένη αναθεώρηση» πρόσθεσε ο κ. Johnson. Πριν την ψηφοφορία, η ASMC (Εταιρείες Ειδικών Φαρμάκων Αμερικής), μια νέα ένωση καινοτόμων φαρμακευτικών εταιρειών μικρού μεγέθους, προειδοποίησε ότι οι εκπτώσεις που απαιτούσε το νομοσχέδιο της Βουλής των Αντιπροσώπων θα δημιουργούσαν νέα εμπόδια για τις μικρές εταιρείες που αναζητούν χρηματοδότηση για έρευνες που μπορούν να σώσουν ζωές. Σύμφωνα με εκτιμήσεις της ASMC οι μικρές φαρμακευτικές εταιρείες συχνά φέρνουν στην αγορά απαραίτητα εξειδικευμένα φάρμακα, τα οποία κανένας άλλος δεν τα φέρνει, δυστυχώς, με τον νέο νόμο θα απειλείται η καινοτομία και θα δημιουργηθούν εμπόδια για παρόμοιες νέες προσπάθειες. “Τελικά, οι ασθενείς που χρειάζονται αυτά τα φάρμακα είναι αυτοί που θα υποφέρουν περισσότερο” δήλωσε εκπρόσωπος της ASMC.2 Ο κλάδος της φαρμακοβιομηχανίας είναι τόσο μεγάλος και η διαδικασία παρασκευής ενός φαρμάκου τόσο δαιδαλώδης που είναι δύσκολο να υπάρχει απόλυτος έλεγχος. Στις ΗΠΑ, πάντως η Υπηρεσία Φαρμάκων και Τροφίμων (Foods & Drugs Administration/FDA) κάνει αρκετά καλή δουλειά.3 2 Υπάρχει πολύ καλύτερος τρόπος να αναπτύσσουμε φάρμακα, αρκεί να τον υιοθετήσουμε, όπως προτάθηκε από τον Τζόζεφ Στίγκλιτζ, κάτοχο του Νομπέλ Οικονομίας, και είναι απλός. Οι κυβερνήσεις του δυτικού κόσμου θα πρέπει να θεσπίσουν ένα Ταμείο με απόθεμα πολλών δισ. δολαρίων το οποίο θα χορηγεί χρηματικά βραβεία στους επιστήμονες που θα αναπτύσσουν θεραπείες ή εμβόλια. Τα μεγαλύτερα βραβεία θα αποδίδονται σε εκείνους οι οποίοι θα ανακαλύψουν θεραπείες για ασθένειες που σκοτώνουν εκατομμύρια ανθρώπους. Μετά την απόδοση του βραβείου, τα δικαιώματα χρήσης της θεραπείας θα είναι δημόσια. Οποιοσδήποτε, οπουδήποτε στον κόσμο, θα μπορεί να παρασκευάζει το φάρμακο και να σώζει ζωές. ∆εν είναι φθηνή λύση- θα κόστιζε το 0,6% του ΑΕΠ- αλλά μεσοπρόθεσμα θα γλιτώναμε μια περιουσία, διότι τα συστήματα περίθαλψης δεν θα ήταν πλέον αναγκασμένα να καταβάλλουν τεράστια χρηματικά ποσά στις φαρμακοβιομηχανίες. Στο μεταξύ το κόστος των φαρμάκων θα μειωνόταν δραστικά για τους φτωχούς και θα τα έκανε για πρώτη φορά προσιτά σε δεκάδες εκατ. από αυτούς. 3 Πρόστιμο μαμούθ – ύψους 2,3 δισ επέβαλε η αμερικανική ∆ικαιοσύνη στη φαρμακοβιομηχανία Pfizer, για την επίτευξη συμβιβασμού με την κυβέρνηση των ΗΠΑ. Το πρόστιμο επιβλήθηκε επειδή η γνωστή φαρμακοβιομηχανία προώθησε τέσσερα φάρμακα, τα οποία ο Οργανισμός Τροφίμων και Φαρμάκων (FDA) είχε αρνηθεί να πιστοποιήσει. Η δικογραφία περιλαμβάνει επίσης καταγγελίες , σύμφωνα με τις οποίες η Pfizer δωροδόκησε γιατρούς προκειμένου να συνταγογραφούν τα τέσσερα από τα φάρμακα της εταιρείας. Η Pfizer που καταδικάστηκε για δόλιες εμπορικές πρακτικές καλείται να καταβάλει πρόστιμο ύψους 2, 195 δισεκατομμυρίων δολαρίων. Η θυγατρική της Pfizer που καταδικάστηκε για απάτη και παραπλάνηση, καλείται να καταβάλει πρόστιμο ύψους 105 εκατομμυρίων δολαρίων. Παρά το γεγονός ότι αυτού του είδους οι έρευνες είναι χρονοβόρες και περίπλοκες, το FDA διασφαλίζει ότι οι φαρμακευτικές εταιρείες λειτουργούν με σύννομο τρόπο. Όπως δήλωσε εκπρόσωπος της μεγάλης φαρμακοβιομηχανίας, η Pfizer θα πληρώσει το πρόστιμο «ώστε να μην χάσει την αξιοπιστία της». Το τελευταίο τέταρτο του 2008 τα κέρδη της Pfizer μειώθηκαν κατά 90% εξαιτίας του συμβιβασμού που χρειάστηκε τελικά να κάνει με την κυβέρνηση των ΗΠΑ. Το γεγονός αυτό αποδεικνύει ότι οι αξιωματούχοι της φαρμακοβιομηχανίας γνώριζαν ότι θα καλούνταν να πληρώσουν το ποσό των 2,3 δις. δολαρίων, πριν καν ανακοινωθεί επίσημα από το αμερικανικό δικαστήριο. 4 Υπάρχει σοβαρό ενδεχόμενο το κόστος των φαρμάκων να συμπιεστεί πριν ακόμη εφαρμοστεί το πολυσυζητημένο μέτρο που προγραμματίζεται στις ΗΠΑ για υποχρεωτική πραγματοποίηση ερευνών συγκριτικής αποτελεσματικότητας. Σύμφωνα με πρόταση της Συμβουλευτικής Επιτροπής Πληρωμών του Medicare (MedPAC), οι τιμές που πληρώνει το κρατικό ασφαλιστικό πρόγραμμα υγείας θα πρέπει να συνδέονται με τις βελτιώσεις της υγείας που παρατηρούνται στους ασθενείς. Η επιτροπή προτείνει επίσης ότι οι τιμές των νέων φαρμάκων δεν θα πρέπει να είναι υψηλότερες από αυτές των διαθέσιμων θεραπειών, εκτός και αν υπάρχουν στοιχεία που να αποδεικνύουν ότι τα νέα φάρμακα είναι πιο αποτελεσματικά. Η σχετική έκθεση δημοσιεύθηκε μετά την ανακοίνωση του Προέδρου Μπάρακ Ομπάμα για περαιτέρω μειώσεις στη χρηματοδότηση του Medicare. Ο Πρόεδρος Ομπάμα πρότεινε και τελικώς το Κογκρέσο υιοθέτησε περικοπές ύψους 500-600 δισεκατομμυρίων δολαρίων σε διάστημα 10 ετών για το Medicare και το Medicaid, καθώς και μείωση των εκπτώσεων (φορολογικά κίνητρα) προς τις φαρμακευτικές εταιρείες. Ο Πρόεδρος σκέφτεται επίσης να δώσει μεγαλύτερη δύναμη και πιο ενεργό ρόλο στην επιτροπή MedPAC. Οι φαρμακευτικές εταιρείες προσφέρουν περίπου 80 δισεκατομμύρια δολάρια σε μορφή εκπτώσεων σε συνταγογραφούμενα φάρμακα στους ασφαλισμένους του Medicare, κατόπιν συμφωνίας που ανακοινώθηκε. Η συμφωνία αυτή ενισχύει το σχέδιο του Προέδρου Μπάρακ Ομπάμα για αναθεώρηση του συστήματος υγείας στις ΗΠΑ, το οποίο αναμένεται να κοστίσει γύρω στα 2,5 τρις δολάρια. Οι φαρμακευτικές εταιρείες συμφώνησαν να παρέχουν για την επόμενη δεκαετία 50% έκπτωση στους ηλικιωμένους και ανάπηρους Αμερικανούς που εμπίπτουν στη λεγόμενη «τρύπα ντόνατ», ένα κενό στην ασφαλιστική κάλυψη του προγράμματος Medicare, «η ύπαρξη αυτού του ασφαλιστικού κενού ήταν μια διαρκής αδικία, η οποία έχει προκαλέσει μεγάλη επιβάρυνση σε πολλούς ηλικιωμένους» δήλωσε ο Πρόεδρος Ομπάμα, καθώς αυτή δεν παρέχει κάλυψη του Medicare για φαρμακευτικές δαπάνες μεταξύ 2.700 και 6.154 δολαρίων. Καθώς το κόστος της περίθαλψης στις ΗΠΑ αυξάνεται ταχύτερα από ό,τι ο πληθωρισμός, ο Πρόεδρος Ομπάμα έχει δεσμευτεί να μειώσει αυτά τα κόστη, αλλά και παράλληλα να βρει τρόπο να παρέχει ασφάλιση υγείας στα 46 εκατομμύρια ανασφάλιστων Αμερικανών. Ο νέος νόμος προβλέπει ότι όλοι οι πολίτες θα μπορούν να έχουν ασφάλιση, ανεξάρτητα από το ιατρικό τους ιστορικό, και ότι η κάλυψη αυτή θα είναι υποχρεωτική για τα άτομα και τις επιχειρήσεις. Καί η πρόνοια αυτή συναντησε αντίσταση από τους Ρεπουμπλικάνους, αλλά και από ορισμένους κεντρώους ∆ημοκρατικούς, οι οποίοι φοβούνται ότι θα εξουθενώσει τις ιδιωτικές ασφαλιστικές εταιρείες και ότι θα απαιτεί τεράστια κρατική χρηματοδότηση. Ανάμεσα στα θέματα που ανέκυψαν ήταν και οι επανεισαγωγές αμερικανικών φαρμάκων, με αρκετά χαμηλότερες τιμές (που κατά κανόνα πωλούνται σε τρίτες χώρες) που ούτως ή άλλως απασχολούσε τις φαρμακοβιομηχανίες. Ως υποψήφιος για την προεδρία, ο Πρόεδρος Μπάρακ Ομπάμα είχε υποστηρίξει τις επανεισαγωγές φαρμάκων, μια ιδέα στην οποία αντιτίθεται η φαρμακοβιομηχανία. Αξιωματούχοι του Λευκού Οίκου καθησύχασαν τις εταιρείες ότι με νέο νόμο για την υγεία, οι εξοικονομήσεις κόστους θα είναι τόσο μεγάλες που δεν θα είναι απαραίτητες οι επανεισαγωγές, κάτι που δήλωσε αρχικώς και ο Billy Tauzin, πρόεδρος της ένωσης φαρμακευτικών εταιρειών των ΗΠΑ (PhRMA). Εκτιμάται ότι 22% των ενηλίκων ασφαλισμένων δεν μπορεί να καλύψει τις δαπάνες των φαρμάκων του, καθώς 5 μάλιστα δεν περιλαμβάνονται στην κύρια ασφαλιστική κάλυψη που έχουν και για αυτό αγοράζουν τα φάρμακα μέσω Καναδά ή Μεξικό. Επίσης έχουν αυξηθεί σημαντικά οι πωλήσεις μέσω του διαδικτύου, για τις οποίες πλέον το FDA υιοθετεί τις ρυθμίσεις που ισχύουν για την πρόληψη ξεπλύματος βρώμικου χρήματος. Η διαδικασία των επανεισαγωγών μετά και από αυτές τις εξελίξεις αποτελεί σημαντικό κεφάλαιο διαβούλευσης. Ωστόσο, ο γερουσιαστής Bernie Sanders, ανεξάρτητος από την πολιτεία του Vermont, δήλωσε ότι διαφωνεί με οποιαδήποτε κίνηση εγκατάλειψης της ιδέας των επανεισαγωγών. Ο γερουσιαστής Sanders έχει προωθήσει τις επανεισαγωγές φαρμάκων από τον Καναδά, όπου τα φάρμακα είναι φθηνότερα χάρη στους ελέγχους τιμών. Η έκθεση της IMS Health, καταγράφει αύξηση των συνταγών φαρμάκων στις ΗΠΑ κατά 3,8% το 2007, σε σύγκριση με το 8% το 2006. Μερικές διαπιστώσεις της έρευνας αυτής είναι ότι ο τζίρος των συνταγογραφούμενων φαρμάκων ανήλθε στο ποσό των $286.5 δισεκατομμυρίων, με μειωμένη αύξηση των πωλήσεων στα επώνυμα φάρμακα, η μείωση των εγκρίσεων για νέα προϊόντα, η «ισοπέδωση», χρόνο με τον χρόνο της αύξησης που προέρχεται από το πρόγραμμα Medicare D και τα προβλήματα ασφάλειας των φαρμάκων. Ο συνολικός όγκος των συνταγών στις ΗΠΑ αυξήθηκε με ένα ρυθμό 2.8%, έναντι 4.6% το 2006. Τα αντικαταθλιπτικά χάπια κατατάχτηκαν σαν η κύρια κατηγορία θεραπείας, σε όρους όγκου συνταγών το 2007. Συνολικά, οι κορυφαίες πέντε θεραπευτικές κατηγορίες -- αντικαταθλιπτικά, υπολιπιδαιμικά, κωδεϊνούχα φάρμακα & συνδυασμοί φαρμάκων κατά του πόνου, αναστολείς του ενζύμου ACE και βήτα blockers – συνεχίζουν να ηγούνται στην αγορά σε όρους όγκου συνταγών. «Το 2007, η φαρμακευτική αγορά στις ΗΠΑ έφτασε στο χαμηλότερο ποσοστό αύξησής της από το 1961,» δήλωσε η Murray Aitken, αντιπρόεδρος της IMS. Η μέτρια τάση αύξησης που άρχισε το 2001 επαναλήφθηκε το 2007 μετά από τον αντίκτυπο που είχε στην αύξηση της αγοράς το 2006 από την εφαρμογή του Medicare Part D. Το 2008 σημειώθηκε μια συνεχή μετατόπιση, μακριά από τις κύριες θεραπευτικές κατηγορίες και προς την κατεύθυνση των εξειδικευμένων προϊόντων και των προϊόντων βιοτεχνολογίας (βλ. παρακάτω τμήμα –δ- σχετικά), τα οποία αυξήθηκαν με ένα ρυθμό της τάξης του 9% και 10%, αντίστοιχα. Μεταξύ των κυριότερων θεραπευτικών κατηγοριών, τα φάρμακα ογκολογίας συνέχισαν την ταχεία ανάπτυξή τους, με ρυθμούς της τάξης του 14% -- που είναι αποτέλεσμα των νέων και καινοτόμων φαρμάκων, των επεκταθεισών ενδείξεων και της επιταχυνόμενης λήψης προϊόντων προκειμένου να καλυφθούν ανικανοποίητες ανάγκες4. Με τις πωλήσεις που φτάνουν $18.4 δισεκατομμύρια, στα συνταγογραφούμενα φάρμακα, τα υπολιπιδαιμικά συνεχίζουν να είναι η μεγαλύτερη θεραπευτική κατηγορία στις ΗΠΑ, παρά την πτώση του 15.4% των πωλήσεων από χρόνο σε χρόνο. Οι αναστολείς των αντλιών πρωτονίων (H2 Inhibitors) ταξινομούνται στην 2η θέση, με πωλήσεις που φτάνουν τα $14.1 δισεκατομμύρια και αύξηση της τάξης του 2.8%. Τα αντιψυχωτικά φάρμακα αντικατέστησαν τα αντικαταθλιπτικά ως η τρίτη μεγαλύτερη θεραπευτική κατηγορία το 2007, με την αύξηση των πωλήσεων της τάξης του 12.1% και τζίρο $13.1 δισεκατομμύρια. Οι κύριες παράμετροι που συμβάλλουν σε αυτή την επιβράδυνση της αγοράς το 2007 είναι: 4 http://www.whitehousedrugpolicy.gov/publications/policy/11budget/fy11budget.pdf 6 - η απώλεια της αποκλειστικότητας : τα επώνυμα φάρμακα αντιπροσωπεύουν τζίρο ύψους $17 δισεκατομμυρίων σε «χαμένες» πωλήσεις μέσα στο 2007, κάτι που οδηγεί στην αύξηση του όγκου των συνταγών κατά 10% για τα μη επώνυμα γενόσημα ( generics) (βλ. τμήμα –γ- σχετικά). Το 2007 τα generics συνέχισαν να αντικαθιστούν τις συνταγές των επωνύμων φαρμάκων στις σημαντικότερες θεραπευτικές κατηγορίες, αυξάνοντας το συνολικό τους μερίδιο, στον όγκο συνταγών συνταγογραφούμενων φαρμάκων, στο 67.3%. - Η λήψη νέων φαρμακευτικών προϊόντων : η λήψη νέων και καινοτόμων φαρμάκων αντιπροσωπεύει πλέον, σε τζίρο, $441 εκατομμύρια στις συνολικές πωλήσεις το 2007, που απεικονίζουν και τις μικρότερες πωλήσεις νέο-εισηγμένων προϊόντων στην αγορά τις τελευταίες τρεις δεκαετίες και την πιο αργή υιοθέτηση τους (των νέων προϊόντων) από τους παθολόγους. - Η συνεισφορά του Medicare D : τα συνταγογραφούμενα φάρμακα που διανέμονται μέσω του προγράμματος Medicare D και αποτελούν το 19% του συνολικού όγκου των συνταγών, παρουσίασαν μια μέτρια αύξηση κατά το 2006. Θα πρέπει να λάβουμε υπόψη μας οτι μέχρι την πρόσφατη μεταρρύθμιση Ομπάμα το 65% των Αμερικανών πολιτών που υπερβαίνουν το 65 της ηλικίας τους εντάσσονται στο πρόγραμμα Medicare D. - Ζητήματα ασφάλειας : η αύξηση πωλήσεων κατά την διάρκεια του 2007 επηρεάστηκε επίσης, από έναν σημαντικό αριθμό αρνητικών προειδοποιήσεων και αποσύρσεων προϊόντων, καθώς επίσης και τις ανησυχίες για την ασφάλεια προϊόντων στις κατηγορίες των ερυθροποιητινών, του διαβήτη και των αντικαταθλιπτικών, που προκλήθηκαν από την πλευρά του FDA. Τα ζητήματα ασφάλειας συνέβαλαν σημαντικά στην μεγαλύτερη από το αναμενόμενο μείωση των πωλήσεων για προϊόντα που αποτελούν περίπου το 10% της συνολικής αγοράς συνταγών. Το 2010, η αναμενόμενη εισαγωγή νέων φαρμάκων βιοτεχνολογίας και εμβολίων, καθώς επίσης και η είσοδος στην αγορά πέντε έως οκτώ νέων και δυναμικών προϊόντων παγκόσμιας εμβέλειας (κυρίως αντιθρομβωτικά και αντικαρκινικά), αναμένεται ότι θα βοηθήσουν στο να αντισταθμιστεί ο αντίκτυπος από τις χαμηλότερες τιμές και την άνοδο πωλήσεων των generics. Επιπλέον θα πρέπει να ληφθή υπόψη ότι, επώνυμα προϊόντα των οποίων ο τζίρος ανέρχεται στα $13 δισεκατομμύρια, αναμένεται να εκτεθούν στον ανταγωνισμό των generics το 2010 και 2011. Στις ΗΠΑ, το IMS προβλέπει μικτή ετήσια αύξηση των φαρμακευτικών πωλήσεων έως το 2012, της τάξης του 3 έως 6%. Η δυναμική που θα διαμορφώσει την αγορά κατά τη διάρκεια των επόμενων πέντε ετών περιλαμβάνει: (α) τη συνέχιση της απώλεια της αποκλειστικότητας (πατέντας) φαρμάκων σε σημαντικές θεραπευτικές κατηγορίες, (β) την είσοδο στην αγορά νέων εξειδικευμένων και ακριβότερων προϊόντων, (γ) αύξηση της έντασης θεραπευτικής αντικατάστασης προϊόντων σε συνδυασμό με τη μεγαλύτερη συνειδητοποίηση και εστίαση στα θέματα ασφάλειας φαρμάκων. Είναι σαφές ότι η φαρμακευτική αγορά των ΗΠΑ έχει μπει σε μια νέα εποχή, όπως επισημαίνουν και κορυφαία στελέχη της IMS. Η μια παράμετρος που επηρεάζει αυτή την νέα εποχή, είναι τα γενόσημα προϊόντα και η «επιβραδυντική» τους δράση στην αύξηση του τζίρου (αξίες) της φαρμακευτικής αγοράς. Τα νέα και ακριβότερα φάρμακα θα παρέχονται σε ειδικές ομάδες ασθενών, όπως οι καρκινοπαθείς. Μια άλλη παράμετρος θα είναι οι λιγότερες και πιο «προσεγμένες» εισαγωγές νέων φαρμάκων που επηρεάζεται κυρίως από θέματα ασφάλειας. 7 Τα φάρμακα ως χημικά προϊόντα με ευεργετική βιολογική επίδραση στον οργανισμό έχουν πλέον σημαντικές διαφοροποιήσεις στην ανάπτυξή τους σε σχέση με το παρελθόν, καθώς πλέον τόσο οι θεραπείες των ασθενειών έχουν μετεξελιχθεί, όσο και η προώθηση των φαρμάκων γίνεται πλέον με κανόνες του εμπορικού κυκλώματος, χρησιμοποιώντας και τους σύγχρονους κανόνες της διαφήμισης απ΄ευθείας τόσο στον καταναλωτή, όσο και στους ιατρούς. Είναι χαρακτηριστικό ότι στη δεκαετία 1990 η διαφημιστική δαπάνη αυξήθηκε κατά 35%, εκτοξεύοντας και το κόστος των φαρμακευτικών εταιρειών, δημιουργώντας ουσιαστικά μια νέα αγορά για τον κλάδο μάρκετινγκ (βλ. πίνακες 4 & 5). Μέχρι την δεκαετία του 1990 οι φαρμακευτικές εταιρείες προωθούσαν τα προϊόντα τους στους ιατρούς. Η παροχή εκ μέρους των εταιρειών δωρεάν δειγμάτων φαρμάκων είναι μια ενέργεια που σαφώς έχει προωθητικό χαρακτήρα. Είναι φανερό όμως πλέον ότι το ενδιαφέρον στρέφεται στον καταναλωτή (βλ. πίνακες 4 & 5). Βεβαίως το τμήμα έρευνας και τεχνολογίας (R&D) βρίσκεται στην καρδιά των εταιρειών αυτών και μάλιστα απορροφά τους σημαντικότερους πόρους. Καθώς τα περισσότερα φάρμακα μπορούν να σχεδιαστούν από μηδενική βάση ώστε να ικανοποιήσουν συγκεκριμένα βιολογικά πρότυπα που προεπιλέγονται, είναι αναγκαίο ακολούθως να υπάρξει η διαδικασία δοκιμαστικής χρήσης του φαρμάκου (trials). Η πλειοψηφία των συστατικών-πρώτων υλών της φαρμακευτικής βιομηχανίας είναι τα φυτικά προϊόντα. Κάθε εταιρεία δοκιμάζει και τα διαφορετικά υλικά σε διαφορετικά στάδια επεξεργασίας, για να διαγνώσει την χημική τους συμπεριφορά. Υπολογίζεται ότι συνολικά η φαρμακοβιομηχανία χρησιμοποιεί περίπου 2.700 διαφορετικά υλικά στις φάσεις παραγωγής φαρμάκου. Η εξέλιξη ενός φαρμάκου από τα συστατικά μέχρι την προώθησή του στην αγορά μπορεί να διαρκέσει αρκετά χρόνια και τούτο γιατί η τελική δοκιμασία θα γίνει σε εθελοντές ασθενείς ή όχι αναλόγως το φάρμακο, ώστε να συνταχθούν τα λεγόμενα επιστημονικά πρωτόκολλα, που θα ανακοινωθούν σε επιστημονικά συνέδρια, ώστε να υποστούν την βάσανο της επιστημονικής κριτικής και διασταύρωσης εμπειρικών και θεωρητικών μελετών. Μάλιστα καθώς η κατάθεση της συγκεκριμένης πατέντας στο αρμόδιο Γραφείο Πνευματικών ∆ικαιωμάτων, είναι άμεση όταν η εταιρεία ξεκινά την ανάπτυξη του φαρμάκου, ο χρόνος αυτός συμπεριλαμβάνεται συνολικά μέχρι την λήξη της αποκλειστικής χρήσης του τελικού προϊόντος. Έτσι οι εταιρείες αναγκάζονται να συρρικνώνουν τον χρόνο που μπορούν να εκμεταλλευτούν εμπορικά το φάρμακο και να αυξάνουν την τιμή πωλήσεως για να διασφαλίσουν την οικονομική επιτυχία της παραγωγής του φαρμάκου. Γ. Τα generics φάρμακα: Πρόκειται για φάρμακα που παράγονται και διακινούνται χωρίς να έχει κατατεθεί δίπλωμα διασφάλισης δικαιωμάτων αποκλειστικής εμπορικής χρήσης. Ενδεχομένως βέβαια σε μερικές περιπτώσεις να έχουν και τέτοιο, αλλά όχι σε ότι αφορά αυτό που ονομάζεται κύριο ενεργό συστατικό (active ingredient). Μάλιστα ένα φάρμακο generic οφείλει να χρησιμοποιεί το ίδιο ενεργό συστατικό, με το φάρμακο που είχε την πρωτότυπη σύνθεση κατατεθειμένη στο Γραφείο Ευρεσιτεχνίας μέχρι την λήξη της μετά από 20 έτη5. Το 1994, στο πλαίσιο του Παγκόσμιου Οργανισμού 5 Από το 1984 τέθηκε σε ισχύ ο νόμος Hatch & Waxman, (U.S. Drug Price Competition and Patent Term Restoration Act) που συστηματοποίησε τους κανόνες για την παραγωγή των Generics. Μια εταιρεία οφείλει να υποβάλλει την αίτησή της (Abbreviated New Drug Application ANDA) η οποία οφείλει να εγκριθεί από το FDA, το 8 Εμπορίου (ΠΟΕ) υπογράφτηκε η συμφωνία TRIPS (Trade Related Aspects of Intellectual Property Rights), η οποία προέβλεπε 20ετή εξασφάλιση πνευματικής ιδιοκτησίας για την εταιρεία που ανακάλυπτε ένα φάρμακο. Ωστόσο, η TRIPS έδινε τη δυνατότητα στις χώρες που αντιμετωπίζουν κρίση δημόσιας υγείας να αγνοούν τις πατέντες και να παράγουν τα απαιτούμενα φάρμακα (δικαίωμα υποχρεωτικής άδειας) καθώς και να εισάγουν αντίγραφα φάρμακα από άλλες χώρες (παράλληλη εισαγωγή). Την πρωτοκαθεδρία στην παγκόσμια αγορά φθηνών αντιγράφων φαρμάκων διεκδικεί από την ισραηλινή Teva Pharmaceuticals η ελβετική Novartis, καθώς προχώρησε ήδη από το 2008 σε μια πολύ ακριβή, κατά τις εκτιμήσεις αναλυτών, εξαγορά του 100% της γερμανικής Hexal και του 67,7% της αμερικανικής Eon Labs. Η Glaxo, η Sanofi, η Pfizer και άλλες φαρμακοβιομηχανίες που αντιμετωπίζουν τον ανταγωνισμό από αντίγραφα σκευάσματα που είναι φθηνότερα, ήδη αντιμετωπίζουν σοβαρά προβλήματα ανάπτυξης των ερευνητικών δράσεών τους. Τα φάρμακα που παράγουν συνολικά ανέρχονται σε 23 δισ. δολάρια σε ετήσιες πωλήσεις, περίπου το 19 % της αγοράς των ΗΠΑ, έχασαν την προστασία της πατέντας τους το 2009. Τα φθηνότερα αντίγραφα μπορούν να οδηγήσουν χαμηλότερα τις τιμές σε ποσοστό έως 80%. Συνολικά το 2009 ο κλάδος generics έφτασε εισόδημα 63 δις δολ. όταν το 1985 ήταν 1 δις δολ. Σημειώνεται ότι η Pfizer και άλλες φαρμακοβιομηχανίες, συμπεριλαμβανομένης της Eli Lilly, μείωσαν πέρυσι τις θέσεις εργασίας κατά 10.000. Μόνη της η Pfizer ανακοίνωσε ότι κατήργησε 8.000 θέσεις εργασίας το 2008. Σημειώνεται ότι η Eli Lilly προκειμένου να προσαρμοστεί στις ανάγκες της αγοράς, ήδη έχει προβεί στην παραγωγή φαρμάκων συνδυαστικού οφέλους, με βάση φαρμακευτικά σκευάσματα που απώλεσε την αποκλειστική πατέντα. ∆. Τα νοσοκομειακά συγκροτήματα – οι ιατροί: Οι παθολόγοι είναι ίσως οι σημαντικότεροι φορείς στις φαρμακευτικές πωλήσεις, επειδή γράφουν τις συνταγές που καθορίζουν ποια φάρμακα θα χρησιμοποιηθούν από τον ασθενή. Ο επηρεασμός του παθολόγου θεωρείται συχνά ως κλειδί για τις φαρμακευτικές εταιρείες και τις “πωλήσεις συνταγών” όπως αναφέρεται το μέγεθος μεγέθυνσης του κύκλου εργασιών του κλάδου αυτού. Μια μέσου μεγέθους φαρμακοβιομηχανία απασχολεί 1000 αντιπροσώπους. Οι μεγαλύτερες επιχειρήσεις έχουν τη δυνατότητα να απασχολούν δεκάδες χιλιάδες αντιπροσώπους. Εκτιμάται ότι το 2009 περίπου 100.000 φαρμακευτικοί αντιπρόσωποι (ιατρικοί επισκέπτες) προωθούσαν πωλήσεις φαρμάκων στις ΗΠΑ, ενώ ακολουθούν επηρρεάζοντας 120.000 επαγγελματίες του κλάδου που είναι εξουσιοδοτημένοι να συνταγογραφούν. Ο αριθμός διπλασιάστηκε στα τέσσερα έτη από το 1999 ως το 2003 και ακολούθως η αύξηση είναι σταθερή κάθε έτος. Οι επιχειρήσεις φαρμάκων ξοδεύουν $5 δισεκατομμύρια ετησίως στέλνοντας τους αντιπροσώπους στα γραφεία παθολόγων. Περίπου 820.000 νοσοκομειακά ιδρύματα, γραφεία ιατρών, μονάδες παροχής πρώτων βοηθειών, οίκοι νοσηλευτικής υποστήριξης (ιδιωτικοί ή κοινωνικής πρόνοιας), συναποτελούν το σύνολο όπου οι ασθενείς προσφεύγουν για να τύχουν κάθε επιπέδου περίθαλψης. Σύμφωνα με την βάση δεδομένων Hoover’s το συνολικό εισόδημα αυτών των οργανισμών περίθαλψης είναι πλέον του 1 τρις δολ. Οι 50 οποίο θα προβεί στην εγγραφή του generic φαρμάκου στην σχετική λίστα ελεύθερης κυκλοφορίας και εμπορίας που ονομάζεται “Orange Book”. 9 μεγλύτεροι οργανισμοί εισπράτουν το 15% του εισοδήματος. Αντιθέτως τα 50 μεγαλύτερα νοσοκομειακά ιδρύματα γίνονται αποδέκτες του 30% του εισοδήματος. Η βιομηχανία αυτή περιλαμβάνει 6.500 γενικά νοσοκομεία, 20.000 οίκους νοσηλευτικής περίθαλψης, 15.000 διαγνωστικά κέντρα, 30.000 κλινικές εξωνοσοκομειακής περίθαλψης, 120.000 οδοντριατρικά κέντρα, 200.000 γραφεία ιατρών πρωτοβάθμιας περίθαλψης, 75.000 νοσοκομειακές μονάδες ημερήσιας περίθαλψης και 50.000 υπηρεσίες παροχής οικογενειακών κοινωνικών υπηρεσιών. Στον κλάδο υγείας δεν περιλαμβάνονται οι εταιρείες διαχείρισης-διοίκησης των επιχειρήσεων αυτών, τα κέντρα φυσιοθεραπείας και απώλειας βάρους τα οποία αποτελούν διαφορετικό κλάδο της ευρύτερης βιομηχανίας υγείας. Ο μέσος όρος ετησίου ατομικού εισοδήματος είναι 80.000 δολ. Το 40% του εισοδήματος του κλάδου προέρχεται από τις νοσοκομειακές υπηρεσίες και 20% από τα ιατρεία. Το 75% των 6.000 νοσοκομείων στις ΗΠΑ είναι μη κερδοσκοπικού χαρακτήρα επιχειρήσεις. Συνολικά 60% των αμερικανών είναι ασφαλισμένοι μέσω εργοδοτικών εισφορών και δικής τους συμβολής (μέσω κρατήσεων στο μισθό υπέρ του Medicare), διότι κατά 85% η παρεχόμενη ασφάλιση δεν είναι πλήρης. Συνολικά η κρατική ενίσχυση ανέρχεται στο 45% της συνολικής δαπάνης ασφαλιστικών καλύψεων. Το 1.5 τρις δολ. που δαπανάται ετησίως για ασφαλιστικές καλύψεις είναι το 15% του ΑΕΠ στις ΗΠΑ, το υψηλότερο από όλες τις βιομηχανικές χώρες. Υπολογίζεται ότι οι αμερικανοί δαπανούν κατά μέσο όρο 6000 δολ. ετησίως για την ασφαλιστική τους κάλυψη. Ε. Οι αλυσίδες φαρμακείων: Ο κλάδος των επιχειρήσεων που παρέχουν υπηρεσίες φαρμακείου, περιλαμβάνει 20.000 εταιρείες με συνολικό εισόδημα 200 δις. δολ. Οι κυρίαρχοι του κλάδου είναι οι εταιρείες Walgreens, CVS και Rite Aid. Ο κλάδος είναι σημαντικά συγκενρωτικός, καθώς οι 50 μεγαλύτερες επιχειρήσεις κατέχουν το 70% της αγοράς. Σημαντικό χαρακτηριστικό της αγοράς είναι η ύπαρξη φαρμακείων εντός μεγάλων υπεραγορών (αλυσίδες καταστημάτων χονδρικής και λιανικής όπως Wallmart, Target, Safeway, Super Value, Kroger κ.α.). Στα φαρμακεία πωλούνται είτε συνταγογραφούμενα φάρμακα, είτε χωρίς συνταγή (front store, over-the-counter OTC) και μια σειρά άλλων προϊόντων. Τα φαρμακεία αγοράζουν φάρμακα συνήθως από τις φαρμακοβιομηχανίες ή απο τους χονδρεμπόρους του κλάδου όπως π.χ. Cardinal Health και McKesson και τα προωθούν στα υποκαταστήματά τους. Οι επιχειρήσεις αυτές συνάπτουν απευθείας συμβάσεις και με ομάδες που χρειάζονται σταθερά πρόσβαση σε προμήθειες φαρμάκων, όπως οίκοι κοινωνικής πρόνοιας και νοσοκομεία μικρομεσαίου μεγέθους. Η ηλεκτρονική συνταγή είναι ευρέως διαδεδομένη καθώς μάλιστα 30% των ιατρών στις ΗΠΑ διατηρούν πλήρως ηλεκτρονικό αρχείο των ασθενών τους. Όλες αυτές οι εταιρείες (οι λεγόμενες pharmacy benefit management companies - PBMs) προσφέρουν εταιρικές κάρτες με εκπτωτικές και άλλες προσφορές (loyalty cards) ενώ σημαντικό είναι το ότι συνάπτουν συμβάσεις με εταιρείες διαχείρισης υπηρεσιών υγείας με σκοπό την ανάληψη της υποχρέωσης είσπραξης των οφειλών είτε των μικρών πελατών, αλλά κυρίως των μεγάλων πελατών. Οι εταιρείες αυτές ουσιαστικά διαχειρίζονται την είσπραξη εκτελεσμένων συνταγών για λογαριασμό φαρμακείων, λιανοπωλητών και νοσοκομείων. Για παράδειγμα μια από τις μεγαλύτερες εταιρείες η Medco Health 10 Solutions, Inc. (όπως AmerisourceBergen) διαχειρίζεται ετησίως 700 εκ. συνταγές. Η λειτουργία τους είναι σημαντική και ο ρόλος τους είναι κατεξοχήν ρυθμιστικός μεταξύ των φαρμακοβιομηχανιών και των χρηστών των υπηρεσιών υγείας σχετικά με το φάρμακο. Η σημαντική τους συμβολή στην λειτουργία του συστήματος ασφάλισης έγκειται στον περιορισμό της απώλειας εσόδων και τον εξορθολογισμό των δαπανών σε κάθε επίπεδο που επεκτείνεται μάλιστα μέχρι την επιλογή της γραμμής των φαρμακευτικών προϊόντων, που χρησιμοποιούν οι αλυσίδες φαρμακείων. Μάλιστα διατηρούν και οι ίδιες αλυσίδες φαρμακείων σε διαφορετικές Πολιτείες των ΗΠΑ καθώς και κέντρα ταχυδρομικών πωλήσεων. ΣΤ. Τα κανάλια διανομής (distributors): Οι εταιρείες που διακινούν τα προϊόντα της φαρμακοβιομηχανίας έχουν σημαντικά μεγέθη. Ειδικότερα, όπως και στον σχετικό πίνακα του παραρτήματος καταγράφεται, οι εταιρείες αυτές έχουν ετήσιες πωλήσεις, στοιχεία του 2009, άνω των 60 δις. δολ. όταν γενικά αντίστοιχες εταιρείες σε άλλους κλάδους έχουν σημαντικά μικρότερα έσοδα. Σημειώνεται ενδεικτικά ότι η εταιρεία McKesson Corp. , με έδρα το San Francisco, ο μεγαλύτερος διανομέας φαρμάκων στην Β. Αμερική, απασχολεί 32.000 υπαλλήλους και είχε ετήσια έσοδα το 2009 108,7 δις. δολ. . Επίσης η Cardinal Health Inc. (99,5 δις. δολ. εισόδημα), η Omnicare Inc. (6,2 δις. δολ.), η Express Scripts Inc. (24,5 δις. δολ.), η Amerisourcebergen Corp. (71,2 δις. δολ.) είναι μερικές από τις εταιρείες που είναι σημείο αναφοράς στον συγκεκριμένο κλάδο και η λειτουργία τους διαρθρώνει σε αποφασιστικό βαθμό όλο τον κλάδο φαρμάκου, σε βαθμό που ακόμα και η εκπόνηση κεντρικής πολιτικής από την Γερουσία να τις θέτει στο επίκεντρο των συζητήσεων μαζί με τις φαρμακοβιομηχανίες, ως διαμορφωτές του κόστους και της συνεργασίας τους με τις ασφαλιστικές εταιρείες (βλ. σχετ. πίνακα). Z. Κλάδος Βιοτεχνολογίας: Η κλινική έρευνα γίνεται ολοένα και πιο δαπανηρή με αποτέλεσμα η συνεργασία με τη φαρμακευτική βιομηχανία να είναι αναγκαία. Η φαρμακευτική βιομηχανία αποτελεί τον κύριο χορηγό της ιατρικής έρευνας (από το 1970) και μέσω αυτής συνέβαλε σε σημαντικό βαθμό στην επιστημονική πρόοδο τα δε οφέλη για τους ασθενείς που προέκυψαν από την ανάληψη της συντριπτικής πλειοψηφίας των συγχρόνων φαρμακευτικών ουσιών μέσα από τις διαδικασίες έρευνας της φαρμακοβιομηχανίας είναι αναμφίβολα. Αν και οι αναλύσεις αλλά και οι πράξη καταδεικνύουν ότι πλέον η εμφάνιση πραγματικά καινοτόμων δραστικών ουσιών είναι ιδιαίτερα σπάνιο στο πλαίσιο των συμβατικών φαρμάκων, η φαρμακευτική βιομηχανία συνεχίζει να επανεπενδύει τους πόρους από τις επιτυχημένες προσπάθειες ανάπτυξης και κυκλοφορίας καινούριων θεραπευτικών παραγόντων στην συνεχιζόμενη έρευνα και ανάπτυξη. Πιο ελπιδοφόρος αναδεικνύεται τα τελευταία χρόνια η έρευνα στο χώρο της βιοτεχνολογίας, όπου οι νεώτεροι βιολογικοί παράγοντες αποτελούν σημαντική προσθήκη στις θεραπευτικές επιλογές. Η φαρμακευτική βιομηχανία που βασίζεται στην Έρευνα και την Ανάπτυξη (R&D) αποτελεί τον κύριο χορηγό της βιοϊατρικής έρευνας, ειδικώς δε η έρευνα που βασίζεται στα νέα επιστημονικά δεδομένα που η Βιοτεχνολογία παρέχει οδήγησε σε σημαντικό βαθμό στην ανακάλυψη και ανάπτυξη σε ποσοστό 90% την τελευταία 11 10ετία των νέων και καινοτόμων φαρμάκων. Στις ΗΠΑ έχουν αναπτυχθεί ερευνητικά κέντρα και εταιρείες βιοτεχνολογίας6 που πλεόν συνεργάζονται με τις μεγάλες φαρμακευτικές εταιρείς. Μέχρι το 2006 είχαν υπήρχαν 1452 εταιρείες βιοταχνολογίας από τις οποίες οι 336 ανήκαν σε φορείς του δημοσίου. Η συνολική κεφαλαιοποίησή τους έφτανε τα 360 δις δολ. και απασχολούσαν 190.000 υπαλλήλους. Οι περισσότερες εταιρείες έχουν ζωή μικρότερη των πέντε ετών και στηρίζουν την κεφαλαιακή τους υπόσταση σε επιχειρήσεις venture capital ή επενδυτικές εταιρείες γενικώς. Ο κλάδος έχει καταγράψει μέχρι τώρα 126 συγχωνεύσεις και εξαγορές, ενώ ήδη έχουν καταγραφεί την τελευταία 10ετία 650 πατέντες. Η βιοτεχνολογία στηρίζεται στην διαχείριση ζωντανών κυττάρων και των συστατικών τους, για την παραγωγή νέων προϊόντων, προσανατολισμένα στο γενετικό τύπο της ασθένειας και του ασθενούς. Ουσιαστικά η εν λόγω επιστήμη αναπτύσσει ένα βιολογικό προϊόν (μέσω μεθόδων εργαστηρίου) και κατόπιν εφαρμόζει την ίδια μέθοδο/τεχνολογία για τη δημιουργία παρόμοιων προϊόντων. Καθώς ορισμένες εταιρείες παράγουν οι ίδιες τεχνολογία ανάπτυξης φαρμακευτικών σκευασμάτων, είναι συνήθης η πρακτική στις επιχειρήσεις βιοτεχνολογίας ή η με αμοιβή εξασφάλιση (technology licensing), τεχνολογικών μεθόδων (patterns), προκειμένου να αναπτυχθεί κάποιο προϊόν. Ζ. Εισαγωγές και εξαγωγές φαρμάκων στις ΗΠΑ: Σύμφωνα με την τελευταία έκθεση της ΕΕ7 αναφορικά με τις εμπορικές σχέσεις με τις ΗΠΑ, ο κλάδος φαρμάκου εξακολουθεί και είναι στην κορυφή της αντζέντας στις διμερείς διαπραγματεύσεις, ώστε να μειωθούν τα εμπόδια στις εισαγωγές των φαρμάκων στις ΗΠΑ, καθώς η υπηρεσία FDA έχει επιβάλλει μια εξαιρετικά βραδυκίνητη και πολλαπλώς γραφειοκρατική διαδικασία8 μέσω ποικίλων προδιαγραφών ασφαλείας που έχει επιβάλλει. Ο χρόνος που απαιτείται για να ληφθεί η σχετική έγκριση για κυκλοφορία ενός φαρμάκου που παρασκευάστηκε από αμερικανική εταιρεία, εκτιμάται ότι είναι σημαντικά μικρότερος από εκείνον για ευρωπαϊκές εταιρείες (έως και διπλάσιος). Η μόνη θετική εξέλιξη είναι η εναρμόνιση για τα λεγόμενα φάρμακα της κατηγορίας OTC (over-the-counter) τα οποία δεν χρειάζονται συνταγογράφιση και συμφωνήθηκε να εξαιρεθούν από την αργόσυρτη διαδικασία έγκρισης (Monograph system). Το ενεργό συστατικό είναι σημαντικό, σε αυτά τα φάρμακα, να μην χρησιμοποείται σε άλλα μη generic ώστε να μην νοθεύεται το σύστημα αξιολογήσης της FDA. Εσχάτως ολοένα και περισσότερες ευρωπαϊκές φαρμακευτικές επιχειρήσεις υποβάλλουν αιτήσεις για ένταξη των προϊόντων τους στη διαδικασία OTC για αυτονόητους λόγους. Η Γερμανία με 2.29 δις, η Ολλανδία με 1.44 δις, ο Καναδάς με 1.745 δις και η Μ. Βρετανία με 1.5 δις είναι κατά σειρά οι μεγαλύτεροι εξαγωγικοί προορισμοί των προϊόντων της φαρμακευτικής βιομηχανίας των ΗΠΑ. Επίσης η Γαλλία, το Βέλγιο και η Βραζιλία την τελευταία διετία ανέβασαν σημαντικά τα ποσοστά εισαγωγής φαρμακευτικών προϊόντων από τις ΗΠΑ. Συνολικά οι εξαγωγές σημείωσαν αύξηση 18% το 2009 (40,66) σε σχέση με το 2008 (34,1 δις). Οι ΗΠΑ εισήγαγαν συνολικά 56 δις δολ. το 2009 (52 δις το 2008), αυξάνοντας το αρνητικό ισοζύγιο του κλάδου κατά 5.4%, σχεδόν σταθερά την τελευταία 6 http://www.lead411.com/biotechpharmacompanylist.taf http://trade.ec.europa.eu/doclib/docs/2009/july/tradoc_144160.pdf 8 http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm 7 12 πενταετία, καταδεικνύοντας την υστέρηση στην προσαρμογή κυρίως στον κλάδο των generics φαρμάκων. Κυριότεροι εξαγωγείς είναι η Γερμανία, Ιρλανδία, Μ. Βρετανία, Καναδάς, Γαλλία, Ελβετία, Ισραήλ και Βέλγιο. Η Ελλάδα το 2009 εισήγαγε περίπου 33 εκ. δολ. σε φάρμακα ενώ οι εξαγωγές γνώρισαν ένα υψηλό επίπεδο μονάχα το 2007 (1,9 εκ. δολ.) για να προσγειωθούν ανώμαλα το 2009 σε μόλις 8.000 δολ. (βλ. Πίνακες 6 & 7). Αντίθετα παρατηρούμε ότι άλλες χώρες της ΕΕ και μάλιστα νέες έχουν φτάσει σε αρκετά υψηλά επίπεδα, όπως η Πολωνία, η Μάλτα και η Τσεχία με εξαγωγές άνω των 20 εκ. δολ. το 2009. Επίσης προωθούμε συνημμένα (μέσω ηλεκτρονικού ταχυδρομείου) καταστάσεις δεδομένων επεξεργασμένες από το Γραφείο μας, των σημαντικότερων φαρμακευτικών εταιρειών, generic εταιρειών αλλά και μεγάλων χονδρεμπόρων διανομέων φαρμάκου και PBMs στις ΗΠΑ. Επίσης, προς υπογράμμιση των οικονομιών κλίμακας, αλλά και της προώθησης εν γένει στην αγορά του φαρμάκου, το Γραφείο μας έχει επεξεργαστεί πληροφορίες για τις πενήντα μεγαλύτερες αλυσίδες ιδιωτικών ή μη κερδοσκοπικού χαρακτήρα φαρμακείων ή εταιρειών λιανικής που διαθέτουν φαρμακεία, αλλά και τις πενήντα μεγαλύτερες αλυσίδες ιδιοκτητών νοσοκομειακών κλινικών. Παρακαλούμε να ενημερώσετε τα μέλη σας για το σύνολο της παρούσας έρευνας, η οποία ευρίσκεται επίσης ανηρτημένη στο δικτυακό ιστοχώρο www.agora.mfa.gr/us69. Τέλος παρακαλούμε να ενημερώσετε τα ενδιαφερόμενα μέλη σας ότι το Γραφείο μας διαθέτει καταστάσεις εισαγωγέων, κυρίως generic φαρμάκων από τις Μεσοδυτικές και Νότιες-Κεντρικές Πολιτείες των ΗΠΑ (περιοχή αρμοδιότητός μας). Ο Προϊστάμενος Χρήστος Λελεμψής Σύμβουλος ΟΕΥ Α΄ 13 Πίνακας 1 : Παγκόσμιες Πωλήσεις Φαρμακευτικών Προϊόντων ανά γεωγραφική περιοχή 2009 Περιοχή Πωλήσεις δις Μερίδιο % ΗΠΑ Μεταβολές σε σταθερές τιμές δολ. ΗΠΑ Β. Αμερική 311,8 40,3% 1,4% Ευρώπη 247,5 32,0% 5,8% Ασία, Αφρική, 90,8 11,7% 15,3% Ιαπωνία 76,6 9,9% 2,1% Λατινική Αμερική 46,5 6,0% 12,6% Σύνολο Αγοράς 773,1 100% 4,8% Αυστραλία USITC United States International Trade Commission 14 Drugs: FAS Value by FAS Value for ALL Countries U.S. Total Exports Annual + Year‐To‐Date Data from Jan ‐ Apr 2002 2,297,918 1,446,886 1,745,810 1,525,696 713,165 698,812 673,640 1,057,653 415,242 339,523 463,257 431,150 347,892 521,869 90,023 176,477 181,898 94,054 81,979 44,443 90,277 61,920 47,561 39,225 57,703 60,636 46,219 34,413 33,193 29,557 Percent Change YTD2009 ‐ YTD2010 21.70% ‐29.90% 31.10% ‐10.40% 2.40% ‐28.30% ‐4.10% 62.10% ‐24.00% ‐16.70% 41.50% 43.20% 27.40% 125.80% ‐38.40% 32.60% 19.50% ‐46.00% 6.00% ‐42.40% 14.40% 5.60% 17.50% ‐9.80% 14.70% 64.90% 13.40% ‐23.90% 43.50% 55.40% Subtotal : 12,409,225 15,135,457 18,620,442 20,666,787 24,168,295 27,922,872 32,879,307 39,239,890 13,295,443 13,848,089 All Other: 664,227 803,901 876,960 1,063,826 1,067,985 1,176,836 1,234,056 1,428,676 407,663 515,810 Total 13,073,452 15,939,359 19,497,401 21,730,613 25,236,280 29,099,708 34,113,362 40,668,566 13,703,106 14,363,900 4.20% 26.50% 4.80% Country Germany Netherlands Canada United Kingdom Switzerland Spain Belgium Japan France Australia Italy Mexico Ireland Brazil Sweden Korea China Austria Taiwan Hong Kong Argentina Colombia Venezuela Israel Saudi Arabia Singapore India Turkey Thailand Denmark 2003 2004 2005 2006 2007 2008 2009 2009 YTD 2010 YTD In 1,000 Dollars 547,675 1,066,670 2,177,217 1,784,106 536,995 188,735 1,293,743 911,725 621,217 380,377 632,368 374,570 467,508 258,825 115,768 126,371 79,753 199,501 139,962 56,042 59,338 36,141 36,035 75,680 63,735 36,782 24,568 48,471 35,890 33,455 671,854 1,670,354 2,539,835 1,784,935 1,013,507 267,202 1,493,465 918,208 1,090,663 448,693 843,557 422,010 532,991 257,239 122,842 141,682 89,435 152,904 147,749 47,691 68,385 37,569 23,851 63,869 66,645 49,863 20,905 58,343 37,050 52,159 633,323 3,222,302 2,643,816 2,195,733 1,305,184 467,296 1,726,227 1,039,090 1,148,481 534,032 772,440 547,008 634,065 315,909 106,465 174,446 98,507 156,840 141,416 56,997 103,898 60,830 42,751 99,792 70,147 28,912 27,639 102,326 41,505 123,065 805,062 3,496,545 2,778,312 2,770,623 1,438,661 252,963 1,582,917 1,181,776 1,222,638 617,840 888,958 613,346 687,640 415,918 100,683 213,044 175,368 204,665 133,905 74,936 114,601 84,138 54,435 85,021 64,586 280,017 37,017 96,468 54,980 139,723 1,357,513 4,211,329 3,241,746 3,604,488 1,805,046 231,037 1,870,592 1,379,635 1,265,679 635,743 910,336 698,274 488,220 526,557 142,330 264,203 238,368 269,043 157,241 94,947 122,790 110,175 64,692 119,625 67,379 38,649 52,216 82,580 62,907 54,956 3,396,560 3,628,171 3,187,279 3,683,770 2,243,744 1,004,270 2,001,717 1,422,050 1,207,534 805,560 985,975 609,797 815,909 576,348 94,806 313,892 355,169 338,830 188,944 118,344 153,435 116,334 104,436 155,885 75,323 83,040 58,965 77,239 57,924 61,622 4,666,402 4,235,018 3,014,965 3,936,748 2,449,143 2,136,847 2,331,634 1,630,790 1,386,563 797,408 1,141,380 863,997 816,766 711,910 134,015 357,575 392,478 381,423 183,853 124,654 179,261 160,378 152,334 156,575 121,913 89,311 87,478 87,532 75,926 75,032 6,107,183 4,817,187 4,367,669 4,264,500 2,428,118 2,345,926 2,302,470 2,279,119 1,467,507 1,177,333 1,157,835 1,146,020 843,129 746,992 535,622 501,910 478,390 469,834 235,410 202,255 193,107 188,013 150,442 147,232 145,323 137,903 126,405 118,316 79,655 79,085 1,887,512 2,064,648 1,331,812 1,702,087 696,420 974,301 702,203 652,599 546,708 407,646 327,451 301,161 273,042 231,117 146,099 133,057 152,229 174,167 77,321 77,105 78,929 58,652 40,472 43,504 50,299 36,761 40,750 45,248 23,126 19,018 Drugs: Customs Value by Customs Value for ALL Countries U.S. Imports for Consumption Annual + Year‐To‐Date Data from Jan ‐ Apr Country Germany 2,631,429 3,266,950 3,996,684 4,268,585 In 1,000 Dollars 5,251,275 6,992,115 6,305,528 7,593,072 2,356,612 2,079,338 Percent Change YTD2009 ‐ YTD2010 ‐11.80% Ireland 5,267,406 5,629,509 6,019,571 6,406,560 6,556,043 6,908,671 7,108,286 7,310,003 2,539,487 3,003,291 18.30% United Kingdom 3,150,283 4,534,566 4,905,154 4,202,833 5,049,377 6,458,148 7,609,464 7,136,539 2,230,825 1,670,622 ‐25.10% Canada 1,213,466 1,842,948 2,115,266 2,376,477 3,467,804 4,759,684 4,617,295 4,834,338 1,506,263 1,473,770 ‐2.20% France 1,883,969 2,488,465 3,260,839 3,892,982 3,996,149 4,426,679 5,221,009 4,313,634 1,394,252 1,570,932 12.70% Switzerland 1,135,961 1,331,886 1,290,786 1,507,185 2,204,050 2,304,765 3,020,074 3,907,112 914,926 1,555,019 70.00% Israel 541,366 713,985 854,761 1,454,902 2,496,364 2,593,992 3,738,067 3,767,744 1,283,260 1,338,195 4.30% Belgium 619,596 671,090 615,639 812,799 1,108,158 1,083,437 1,537,830 2,484,043 423,490 1,133,025 167.50% Singapore 151,991 1,078,193 1,323,810 1,336,204 2,427,199 3,047,012 1,912,644 1,993,478 721,470 569,945 ‐21.00% Italy 604,213 693,449 982,699 1,511,973 1,355,402 1,417,756 2,032,980 1,887,602 534,871 670,904 25.40% 1,596,057 2,163,021 2,047,869 1,790,403 1,325,935 1,388,265 1,390,471 1,773,492 513,374 585,287 14.00% India 222,964 358,506 255,127 291,142 437,608 841,877 1,479,267 1,657,044 442,842 657,929 48.60% Denmark 307,520 437,629 524,306 1,085,131 1,005,711 987,651 1,037,845 1,111,904 363,842 502,577 38.10% Sweden 747,332 1,394,637 1,659,277 1,577,204 2,287,340 1,372,396 1,305,537 1,111,610 525,867 298,317 ‐43.30% Austria 559,924 570,588 505,838 506,581 581,966 839,512 816,728 884,244 279,530 282,557 1.10% Spain 148,903 295,271 438,317 961,848 693,992 867,082 923,584 811,563 280,918 268,293 ‐4.50% China 87,139 113,690 142,537 288,637 343,071 428,859 656,385 758,908 219,390 266,764 21.60% Netherlands 289,596 235,155 273,160 257,883 389,960 313,354 299,435 543,851 98,387 253,200 157.40% Australia 135,683 143,540 161,837 195,654 251,321 226,666 356,441 405,722 138,639 162,261 17.00% 91,480 140,847 135,409 162,036 200,908 240,793 320,747 405,022 122,026 140,012 14.70% 2002 Japan Finland 2003 2004 2005 2006 2007 2008 2009 2009 YTD 2010 YTD Norway 74,592 75,969 97,697 129,044 199,598 257,929 291,780 348,915 119,999 145,857 21.50% Mexico 176,322 242,298 447,133 335,361 331,824 173,239 196,903 238,387 67,388 76,625 13.70% Brazil 3,454 3,356 23,207 65,654 65,623 92,440 112,019 103,771 36,383 42,588 17.10% Slovenia 1,454 47,005 75,389 23,114 47,426 74,165 46,924 102,985 25,676 36,134 40.70% Hungary 2,192 2,395 1,569 740 64,706 35,054 63,431 99,299 27,361 46,231 69.00% 11,061 13,179 15,881 17,805 30,461 66,992 95,153 96,069 41,133 5,273 ‐87.20% 32 0 884 28,053 88,897 77,128 72,020 75,971 24,407 32,606 33.60% 1,749 1,907 1,900 3,159 4,051 13,650 23,834 35,108 9,093 10,944 20.40% Poland 473 447 221 233 15,188 28,196 29,880 31,759 10,155 11,806 16.30% Czech Republic 207 301 1,843 5,547 5,346 13,070 12,041 25,929 4,920 6,729 36.80% 10,386 14,981 16,589 18,866 19,693 15,907 27,980 22,822 5,801 7,872 35.70% 14 33 6 0 0 14,595 33,262 21,929 7,766 7,533 ‐3.00% Portugal 499 676 543 4,449 12,736 11,492 12,410 21,407 1,325 3,998 201.80% Liechtenstein 643 635 571 477 281 3,961 16,016 15,071 4,343 4,518 4.00% South Africa 415 5,260 6,479 7,658 7,792 8,811 9,459 14,013 2,148 6,006 179.60% Jordan 601 0 1,001 465 2,830 3,959 3,129 13,096 5,258 2,745 ‐47.80% Thailand 3,734 8,561 8,829 9,215 10,381 10,654 15,553 13,053 4,619 6,318 36.80% Taiwan 1,505 5,648 10,459 11,322 7,887 5,060 4,678 11,173 2,653 5,670 113.70% Argentina 2,943 3,407 3,332 2,443 3,306 3,456 9,556 9,655 3,055 2,895 ‐5.20% 361 1,452 1,715 1,089 2,742 3,285 3,755 4,588 1,477 996 ‐32.60% Serbia 0 0 0 0 0 0 0 3,750 0 2,351 N/A Turkey 0 0 1 17 0 1,686 2,012 3,660 667 1,202 80.10% Hong Kong 4,138 3,331 4,796 4,333 5,872 6,203 6,263 3,492 1,331 1,810 36.10% Colombia 4,509 4,555 4,206 3,837 4,530 4,926 4,136 3,387 1,228 1,434 16.80% Romania 0 0 0 0 0 1,284 4,989 3,091 116 670 477.30% Egypt 7 90 168 817 1,554 1,690 908 2,499 598 1,176 96.70% 576 461 1,466 1,818 1,746 1,418 1,624 1,536 418 449 7.40% Korea Croatia Dominican Rep New Zealand Malta Malaysia Guatemala 17 Philippines 2,197 1,853 2,594 3,102 2,613 2,273 2,500 1,278 310 608 95.90% Panama 2,341 2,671 2,621 3,026 1,689 1,640 1,686 1,233 551 443 ‐19.60% Kyrgystan 0 49 0 0 23 0 47 1,173 0 40 N/A Costa Rica 1,483 1,734 1,663 1,032 1,125 1,000 722 1,023 50 213 328.50% Indonesia 198 24 61 44 840 658 1,174 778 189 240 27.20% Barbados 0 46 0 0 0 285 883 744 183 180 ‐1.40% El Salvador 304 446 270 538 657 973 836 706 167 287 71.40% Nicaragua 784 1,001 1,247 1,088 848 968 578 343 97 175 80.50% Mauritius 0 32 0 0 3 0 36 319 124 326 162.30% Vietnam 3 8 10 0 22 224 308 277 96 102 6.30% Peru 167 57 46 16 70 211 157 234 43 87 105.40% Honduras 540 846 571 603 472 472 328 233 91 90 ‐1.60% Russia 450 12 6 150 28 45 44 214 59 31 ‐48.40% Chile 923 541 139 16 135 183 591 167 27 240 803.40% Pakistan 147 238 207 158 82 207 136 144 19 63 231.40% 4 5 10 8 74 483 437 77 57 77 36.00% 87 14 49 23 328 55 388 70 70 0 ‐100.00% 0 0 29 82 157 79 36 70 33 0 ‐100.00% 119 125 85 110 51 73 16 60 5 8 83.30% Ukraine 5 60 13 59 20 1,237 49 52 18 3 ‐83.10% Nigeria 0 0 0 2 8 26 4 50 34 0 ‐100.00% Estonia 74 64 10 25 230 41 76 47 47 58 23.00% Cyprus 0 7 0 21 0 0 36 39 0 0 N/A Iceland United Arab Em Bulgaria Trin & Tobago Greece Total 2 4 8 8 179 1,929 713 8 0 5 N/A 21,701,948 28,553,043 32,245,276 35,573,714 42,375,158 48,442,373 52,801,397 56,026,980 17,301,873 18,958,724 9.60% 18 ΠΙΝΑΚΑΣ 4 : ∆ιαφημιστική δαπάνη στις ΗΠΑ για προώθηση φαρμάκων δις δολ. ΕΤΟΣ Ποσό διαφημιστικής δαπάνης Ποσοστό αύξησης νέων φαρμάκων (ετήσια βάση) 1996 0.791 5.5% 1997 1.07 5.9% 1998 1.32 6.4% 1999 1.85 7.5% 2000 2.1 8.5% 2001 2.2 5.2% 2002 3.2 8.5% 2003 3.5 11.3% 2004 4.2 9% 2005 4.8 8.3% 2006 5.3 12% 2007 5.9 17% 2008 6.7 19% IMS Health, Competitive Media Reporting ΠΙΝΑΚΑΣ 5 : Κατανομή της Συνολικής ∆απάνης Προώθησης ∆ιαφημιστικής ∆απάνης το 2003 στις ΗΠΑ (εκ. δολ.) Κατηγορία ∆απάνης Ποσά ∆απάνης Ποσοστά DTC διαφήμιση 3.500 15.9 ∆ωρεάν δείγματα 7.900 50.5 Ειδικός Τύπος 484 3.1 Επισκέψεις σε κλινικές 765 4.9 Επισκέψεις σε ιατρεία 4.000 25.6 Σύνολο 16.649 100 IMS Health, Competitive Media Reporting Πίνακας 6 : Εισαγωγές στην Ελλάδα (χιλ. δολ.) 2009 2009 YTD 2010 YTD Country In 1,000 Dollars Greece 17,063 22,901 21,418 28,002 20,478 27,472 24,823 36,622 Total 17,063 22,901 21,418 28,002 20,478 27,472 24,823 36,622 18,522 18,522 4,521 4,521 2002 2003 2004 2005 2006 2007 2008 Percent Change YTD2009 ‐ YTD2010 ‐75.60% ‐75.60% USITC United States International Trade Commission Πίνακας 7 : Εξαγωγές στις ΗΠΑ από την Ελλάδα (χιλ. δολ) 2002 2003 2004 2005 2006 Country Greece Total 2007 2008 2009 2009 YTD 2010 YTD 0 0 5 5 In 1,000 Dollars 2 2 4 4 8 8 8 8 179 1,929 179 1,929 USITC United States International Trade Commission 713 713 8 8 Percent Change YTD2009 ‐ YTD2010 N/A % ΚΑΤΑΣΤΑΣΗ ΤΩΝ ΜΕΓΑΛΥΤΕΡΩΝ ΒΙΟΜΗΧΑΝΙΩΝ ΦΑΡΜΑΚΩΝ ΣΤΙΣ ΗΠΑ A/A COMPANY NAME, ADDRESS, PHONE, FAX 1. Pfizer Inc. 235 E. 42nd St. New York, NY 10017-5755 United States Phone: 212-733-2323 www.pfizer.com 2009 SALES (MIL. $) 50,009 .5 EMPLO YEES OVERVIEW CONTACT 116,50 0 Pfizer pfabricates pfarmaceuticals pfor quite a pfew inpfirmities. The company is the world's largest research-based pharmaceuticals firm. Its best-known products include cholesterol-lowering Lipitor, pain management drugs Celebrex and Lyrica, pneumonia vaccine Prevnar, highblood-pressure therapy Norvasc, and erectile dysfunction treatment Viagra. Pfizer also keeps Fluffy and Fido in mind with its animal health products, including Revolution (antiparasitic). The company markets its pharmaceuticals directly to health care providers and patients; most of its sales are conducted through wholesalers including McKesson and Cardinal Health. Pfizer acquired pharma rival Wyeth in a $68 billion deal in 2009. Mikael Dolsten SVP; President, Pfizer Worldwide Research and Development The combination of the two drug giants -the largest pharmaceuticals merger in nearly a decade -- was designed to help both companies deal with upcoming patent losses on top-selling drugs. The acquisition of Wyeth broadened Pfizer's traditional and biological product offerings in areas including vaccines, antibiotics, women's health, inflammatory and cardiovascular conditions, and gastroenterology. The combined company, which continues to operate under the Pfizer moniker, also has an expanded development pipeline for 22 targets including Alzheimer's disease, cancer, pain, and psychosis. Pfizer is working to cut costs by integrating overlapping operations between the two organizations, including administration, sales, research and development, and manufacturing. The company launched a 10% workforce reduction to prepare for the transaction, and it estimates that the integration efforts will eventually result in an overall 15% reduction of the combined workforce. The company is also closing eight manufacturing plants at Caguas and Carolina, Puerto Rico; Dublin, Loughbeg and Shanbally, Ireland; Rouses Point and Pearl River, NY, and Richmond, Va. The acquisition of Wyeth brought Pfizer back into the consumer health arena, adding products such as analgesic Advil and cough medicine Robitussin. (Pfizer sold its consumer unit -- which made such sniffleand-sneeze treatments as Benadryl and Sudafed -- to Johnson & Johnson in 2006 to focus on the prescription pharmaceutical market.) The Wyeth deal also expanded Pfizer's animal health business, even after the companies sold some animal health assets (primarily from Wyeth's Fort Dodge Animal Health unit) to Boehringer Ingelheim and Eli Lilly to meet regulatory approval requirements. Pfizer had three drugs topping $2 billion in sales in 2009: Lipitor, Celebrex, and pain medication Lyrica. (The top three products from the Wyeth acquisition -- Prevnar, antidepressant Effexor, and arthritis Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 23 treatment Enbrel -- also pulled in over $2 billion each in 2008.) Six more Pfizer drugs pulled in over $1 billion in 2009, including Norvasc, Viagra, and glaucoma treatment Xalatan. However, Pfizer's revenues from established blockbusters continue to slide due to one of the pitfalls of the drug game: patent expiration. Former bestselling allergy medication Zyrtec (which the company has since divested), cancer treatment Camptosar, and Wyeth's acid reflux treatment Protonix faced generic competition starting in 2008. Knockoff versions of the top-selling Wyeth-acquired drug, Effexor, have been on the market since 2008 as well, though Effexor XR (extended release) is still protected. Pfizer's largest patent threat has been over cash cow Lipitor, the world's top-selling drug that brings Pfizer over $12 billion in annual sales. After a years-long court battle over a proposed generic equivalent release by Ranbaxy, Pfizer reached a settlement agreement with the generics maker in 2008 allowing Ranbaxy to sell a generic Lipitor version in the US after November 30, 2011. The drug giant claims that it will be able to launch new blockbusters from its robust pipeline to make up for the off-patent losses and return to revenue growth. Pfizer spends about $8 billion annually on R&D in order to bolster its pipeline, which includes about 130 projects in clinical stages of development, including drugs for diabetes, breast cancer, epilepsy, pain, and anxiety disorders. Pfizer has increasingly relied on acquisitions and Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 24 partnerships to build its R&D activities. In 2008 the company released overactivebladder treatment Toviaz, and in 2009 schizophrenia drug Geodon received FDA approval for the treatment of bipolar mania. In early 2010 the Prevnar 13 pneumonia vaccine was approved for marketing by the FDA. The company seems to have an awareness that it's not the only company in the pipeline bind, it has begun to work with its competition on developing replacement blockbusters. For example, the company is collaborating with Bristol-Myers Squibb on cardiovascular and metabolic candidates. Pfizer has additional partnerships with GlaxoSmithKline (HIV), Bausch & Lomb (ophthalmic ailments), and a number of smaller drug companies. Vaccines have taken on a new luster for many large drugmakers looking for the next big therapeutic treatment. The company's 2009 acquisition of Wyeth gained it a strong foothold in the vaccines market; Pfizer also purchased Coley Pharmaceutical in early 2008 to gain access to Coley's vaccine technologies. Through additional 2008 purchases, Pfizer expanded in key growth areas including oncology (Serenex), cardiovascular therapies (Encysive Pharmaceuticals), and animal health (Embrex and several European products of the former Schering-Plough, which is now part of Merck). Pfizer is also looking to establish a presence in the generic drug business by licensing rights to off-patent Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 25 pharmaceuticals from other manufacturers. CEO Jeffrey Kindler has been broadening the company's restructuring initiatives to make its operations more nimble. A major program to tighten the company financially and operationally was launched in early 2007; the program cut costs by about $2.8 billion by the end of 2008 through workforce reductions, asset divestitures, and the closure of numerous research and manufacturing facilities. In early 2009 Kindler announced an additional restructuring initiative aiming to reduce costs by another $3 billion by the end of 2010; the company expects to save another $4 billion from the Wyeth integration programs by 2012. During 2008 Kindler outlined a strategy to increase the number of drug candidates in late-stage trials in select targeted areas such as oncology, pain, inflammation, neurology, vaccines, and biotechnology. As a result, the company cut some early-stage development projects and reduced the overall number of drug candidates by nearly half. Pfizer has since been focusing R&D growth on latestage candidates in key therapeutic areas, while continuing to streamline operations at its research facilities. Pfizer took a financial hit, however, in 2009 when it agreed to pay $2.3 billion to settle allegations that it improperly marketed several drugs, including discontinued painkiller Bextra. In a recent crackdown effort against pharmaceutical marketing fraud (promoting drugs for unapproved Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 26 uses), the federal government has reached several settlement agreements with large pharmaceutical companies (including smaller deals with Pfizer); however, Pfizer's 2009 settlement was the largest to date 2. Johnson & Johnson 1 Johnson & Johnson Plaza New Brunswick, NJ 08933 United States Phone: 732-524-0400 Fax: 732-214-0332 www.jnj.com 61,897 .0 115,00 0 It's nearly impossible to get well without Johnson & Johnson (J&J). The diversified health care giant operates in three segments through more than 250 operating companies located in some 60 countries. Its Pharmaceuticals division makes drugs for an array of ailments, such as neurological conditions, blood disorders, autoimmune diseases, and pain. Top sellers are psoriasis drug Remicade and schizophrenia medication Risperdal. J&J's Medical Devices and Diagnostics division offers surgical equipment, monitoring devices, orthopedic products, and contact lenses, among other things. Its Consumer segment makes overthe-counter drugs and products for baby, skin, and oral care, as well as first aid and women's health. J&J prides itself on its decentralized operating structure, with the management teams of its myriad and far-flung operating units having wide latitude to make decisions. Each company belongs to one of J&J's three broad divisions. The company's Pharmaceuticals and Medical Devices segments are the largest, each accounting for more than 35% of sales. Operating companies in the Pharmaceuticals division include Centocor Ortho Biotech, Ortho-McNeil, Janssen, and Noramco. Along Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Jaso n Van Bure n Johnson & Johnson Pharmaceutic al Research & Development, L.L.C 27 with Risperdal and Remicade (which treats Crohn's disease and rheumatoid arthritis in addition to psoriasis), key drugs are anemia treatment Procrit (sold internationally as Eprex), attention deficit drug Concerta, antiinfectives Floxin and Levaquin, and epilepsy medicine Topamax. J&J has confidence that its drug development pipeline will produce some additional winners. J&J aims to launch a number of new investigational compounds in areas including immunology, pain, cardiology, infectious disease, and neurology. The company won FDA approval for HIV drug Intelence in 2008, and in 2009 it launched Stelara for psoriasis, Simponi for rheumatoid arthritis, and Nucynta for pain. The company's push for R&D growth is driven by the drug industry's biggest challenge: patent expiration. Global blockbusters Risperdal and Topamax lost patent protection in 2008 and 2009, respectively, and thus face competition from cheaper generics. The company still has market exclusivity for Risperdal Consta, a long-acting injectable version of the drug that is increasing its market penetration; Risperdal Consta received approval for the expanded application of bipolar disorder treatment in 2009. J&J also hopes a newer schizophrenia medication called Invega will replace Risperdal, but sales have so far been disappointing. Safety concerns and bad publicity have inflicted wounds on a couple of other J&J brands. Its anemia drug Procrit, which is Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 28 prescribed for dialysis and chemotherapy patients, has been under fire after some studies indicated that patients on the drug were at higher risk for cardiovascular events, as well as possible worsening of their cancer. Another product, contraceptive patch Ortho Evra, is facing lawsuits over claims that the product creates a greater risk for blood clots than do birth control pills. To offset losses from the products' shrinking markets, J&J in 2008 consolidated Ortho Biotech (the marketer of Procrit) into Centocor (the successful maker of Remicade), which was then renamed Centocor Ortho Biotech. It also combined administrative functions of its Janssen (neurology) and Ortho-McNeil (birth control) divisions into holding company OrthoMcNeil-Janssen Pharmaceuticals. In its ever-expanding Medical Devices and Diagnostics division, many operating companies -- including surgical supplies companies Ethicon and Ethicon EndoSurgery, orthopedics device maker DePuy, vision care subsidiary Vistakon, and diagnostics unit Ortho-Clinical Diagnostics -have experienced strong sales growth. However, Cordis, a maker of cardiology products such as the Cypher drug-coated stent, has experienced declining sales due to increased competition and safety concerns over blood clotting in the stent market. In response to challenges in its Pharmaceuticals and Medical Device divisions, in late 2009 the company announced restructuring measures, including Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 29 a 6% to 7% workforce reduction that aims to reduce management layers and simplify business structures. The move came on top of previous cost-cutting efforts in 2007 and 2008, including layoffs at Cordis. J&J is focusing its resources on core drug development and commercialization efforts. The restructuring efforts have not precluded expansion efforts in some areas of the business, however. In late 2008, for example, the company acquired biosurgical products maker Omrix Biopharmaceuticals for $438 million, and in early 2009 J&J paid about $1.1 billion for Mentor Corporation, a maker of devices for aesthetic procedures. Omrix and Mentor both became independently operating subsidiaries within the Ethicon business. To further expand in the medical equipment industry, in early 2010 Ethicon expanded through the acquisition of ear, nose, and throat device maker Acclarent for $785 million. In addition, J&J strengthened its Centocor Ortho Biotech division in 2009 through the purchase of Cougar Biotechnology, an oncology research and development firm with a promising prostate cancer candidate, for about $1 billion. Also in 2009 the company paid $885 million for an 18% stake in Irish drug maker Elan. J&J also gained control of Elan's portion of an Alzheimer's disease treatment partnership with Pfizer (gained by Pfizer through it's 2009 acquisition of Wyeth). J&J has incorporated the development program into a new company, Janssen Alzheimer Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 30 Immunotherapy, of which Elan owns a nearly 50% equity interest in (though J&J has the option to acquire the stake from Elan later on). J&J will invest up to $500 million toward further development of the drugs in the program, including lead candidate bapineuzumab, a late-stage antibody (protein) therapy thought to slow the progression of Alzheimer's disease. Later that year J&J broke into the growing flu vaccine development market by making a similar investment in Dutch biotech firm Crucell, buying an 18% stake for $443 million and forming a collaboration with Crucell to develop influenza therapies and vaccines based on Crucell's monoclonal antibody (MAb, or single-source protein) technology. Another bright spot for J&J has been its growing Consumer segment, which has also expanded through acquisitions over the years. The division's offerings include consumer brands Benadryl, Listerine, Lubriderm, Neutrogena, Rolaids, Splenda, Sudafed, Tylenol, and (of course) Johnson's. In 2008 J&J launched an over-the-counter version of Zyrtec, a former Pfizer allergy prescription that had gone off-patent 3. Abbott Laboratories 100 Abbott Park Rd. Abbott Park, IL 600643500 United States Phone: 847-937-6100 Fax: 847-937-9555 30,764 .7 73,000 Filling baby bottles and soothing aching joints are a habit for Abbott. Abbott Laboratories is one of the US's top health care products makers. The company's pharmaceuticals include HIV treatment Norvir, rheumatoid arthritis therapy Humira, and Depakote to treat epilepsy and bipolar Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 William J. Chase VP Licensing and Acquisitions 31 www.abbott.com disorder. Its nutritional products division makes such well-known brands as Similac infant formula and the Ensure line of nutrition supplements. Abbott also makes diagnostic instruments and tests, including the FreeStyle diabetes care line, as well as vascular medical devices such as its Xience drug-eluting stents. The company sells its products in about 130 countries through affiliates and distributors. Abbott's pharmaceuticals division -- which focuses on the therapeutic areas of immunology, oncology, neuroscience, metabolic disorders, and infectious disease - brings in more than half of it annual sales. Humira is the division's big hit and considerable R&D and marketing money is dedicated to expanding uses for the drug, as well as for new cholesterol drugs. One such drug is Trilipix, a cholesterol and lipid fibrate therapy, for which the company received approval in 2008. Like all pharmaceutical giants, the company knows the pains of patent expiration. Abbott is facing the patent expiration of many of its top sellers between 2011 and 2016 (Aluvia, TriCor, Niaspan, Humira) and sales of topseller Depakote have already been hit by generic competition, decreasing nearly 10% between 2008 and 2009. Abbott is hoping new candidates in its R&D pipeline, as well as expanded uses for drugs like Humira, will help make up some of those losses. The company is also looking to make acquisitions and form strategic alliances to bolster its pharmaceuticals business. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 32 In early 2010 Abbott made a bold move for growth by paying some €4.5 billion ($6.2 billion) in cash, plus potential milestone payments, to acquire the pharmaceuticals business of Belgian chemical group Solvay. The purchase of the global Solvay Pharmaceuticals division (which has since been absorbed into the Abbott pharmaceuticals division) added therapies for cardiovascular, gastrointestinal, and neurological ailments, as well as vaccines and hormone therapies. The acquisition also bolstered Abbott's position in emerging geographic markets, especially in the field of branded generic drug sales, and it expanded Abbott's pharmaceutical R&D programs. Going forward Abbott intends to use Solvay's presence in emerging markets to further its own efforts to expand in those areas. Customers outside of the United States already account for about half of the company's sales. Despite paying a hefty price tag for Solvay in early 2010, Abbott wasn't finished shelling out big bucks to expand its drug making business. In mid-2010, the company agreed to a deal worth roughly $4 billion to buy Piramal Healthcare's branded genericmedicine unit in India. The buy will make Abbott India's largest drugmaker, giving the company about a 7% share of the market and the rights to some 350 brands. Under terms of the agreement, Abbott will give Piramal an up-front payment of about $2 billion, plus $400 million each year for the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 33 next four years. Piramal has also agreed not to make generic drugs to sell in India and other emerging markets for eight years. On a smaller scale, Abbott paid about $450 million in cash to obtain US drug development firm Facet Biotech. The 2010 buy harnessed Abbott a range of clinicalstage compounds including a treatment for multiple sclerosis and oncology candidates in early- to-mid-stages development. The company then said it would spend another $575 million to help develop and commercialize Neurocrine Biosciences' clinical stage endometriosis treatment. Under the agreement, Abbott will receive worldwide exclusive rights to develop and commercialize the drug. It will pay Neurocrine $75 million up front and fund future development activities. Neurocrine is also eligible for eight additional milestone payments of about $500 million combined as well as royalties from any product sales. To keep drug development focused on its core areas (immunology, oncology, neuroscience, metabolic disorders, and infectious disease) Abbott sold its share of TAP Pharmaceutical Products to Takeda Pharmaceutical in 2008. Abbott and Takeda had formed the joint venture in 1977 to market Takeda's drugs in the US. Takeda paid more than $1.5 billion for Abbott's share in TAP, which was broken up through the deal, taking home best-selling acidreflux treatment Prevacid and the TAP development. Abbott retained rights to oncology drug Lupron and will continue to Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 34 receive payments on current and future TAP products. Despite the fact that pharmaceuticals account for roughly half of its yearly sales, Abbott is still intent on pursuing growth in its non-pharmaceutical divisions. The company formed a partnership with Ibis Biosciences, a subsidiary of Isis Pharmaceuticals, to develop a genetic identification system for the clinical diagnostics market. Then, in 2009, Abbott purchased Ibis Biosciences for $215 million and turned the company into one of its subsidiaries. Abbott grew its health care informatics operations when it acquired Israeli firm STARLIMS Technologies, which makes information management systems for diagnostic laboratories, for $123 million in 2010. Its medical device operations got a boost with the 2009 purchase of Advanced Medical Optics for about $2.8 billion (plus debt assumptions). The company, renamed Abbott Medical Optics, is a leading provider of surgical equipment and products for cataract and vision correction procedures (including LASIK equipment), as well as contact lens care products. Abbott Medical Optics was combined with the vascular products unit, which makes stents and catheters, to create a new medical devices division. Later in 2009 Abbott moved further into the ophthalmic arena by purchasing implantable intraocular lens maker Visiogen for $400 million. Also in the medical devices division, the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 35 drug-coated stent Xience received FDA approval in 2008 and has since become one of the company's key products in that segment. The vascular device has been able to penetrate the market to the point that it poses a challenge to the leading drug-coated stent made by Boston Scientific. Given that success, the next logical step for Abbott was to grow its vascular business further, and it did just that with the acquisition of Evalve, a maker of minimally invasive heart-valve repair devices, in a $410 million deal in late 2009. It is also in the process of introducing a next-generation Xience product (which has already been launched in Europe and Japan). Abbott continues to be on the look-out for medical technology acquisitions as the global economic downturn has put many smaller companies in financial difficulty. Until mid-2009 Abbott was embroiled in a decade-long intellectual property rights lawsuit with Medtronic over certain patents related to coronary stent and stent-delivery systems. Medtronic eventually agreed to pay $400 million to Abbott to settle the lawsuit. Also under terms of the agreement, both parties have agreed not to sue the other in the field of coronary stents for at least 10 years 4. Merck & Co., Inc. 1 Merck Dr. Whitehouse Station, NJ 08889-0100 United States 18,502 .0 51,000 The new Merck (formerly Schering-Plough) makes medicines for a number of ailments, from stuffy noses and asthma to hypertension and arthritis. The pharmaceutical giant's top prescription drugs Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Didier Colombeen SVP External Manufacturing 36 Phone: 908-423-1000 Fax: 908-735-1253 www.merc.com include asthma medication Singulair, antiinflammatory Remicade, hypertension fighters Cozaar and Hyzaar, and cholesterol combatants Vytorin, Zetia, and Zocor. The company also makes animal health pharmaceuticals, as well as childhood and adult vaccines for such diseases as measles, mumps, hepatitis, and shingles. Its OTC drug and personal care offerings include Claritin allergy pills and Dr. Scholl's foot care products. The company completed a reverse merger with the old Merck in 2009 and took on the Merck name. The predecessor Merck entity paid $41.1 billion to acquire Schering-Plough's operations in November 2009 through a reverse-merger transaction. The combined entity, which began operating under the Merck name immediately following the transaction, became the second-largest global pharmaceuticals manufacturer (behind Pfizer). Former Schering-Plough shareholders own nearly a third of the new Merck. Merck is conducting integration efforts to combine the two organizations, which will result in an estimated 15% reduction in the combined workforce by the end of 2012. The existing Merck CEO, Dick Clark, took the helm at the new Merck, while former Schering-Plough CEO Fred Hassan retired. The two companies, which had already worked together on several drug development projects and have been weathering some backlash over their comarketed cholesterol drug Vytorin, took the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 37 logical step of marriage to further combine their respective drug caches and strengthen their defenses against future competitive challenges. The merger created a stronger portfolio of marketed and developmentstage pharmaceuticals in areas including cardiovascular, oncology, respiratory, neurology, inflammatory ailments, infectious disease, vaccines, and women's health. The new Merck has three core growth initiatives -- biologics, vaccines, and emerging markets -- that are part of the main Global Human Health prescription division. The new structure includes four additional divisions: Animal Health, Consumer Health Care, Merck Manufacturing, and Merck Research Laboratories. Merck especially boosted its presence in the growing biotech drug business through the transaction by gaining access to ScheringPlough's biologics pipeline. The purchase also greatly expanded Merck's operations in the animal health and consumer health arenas, although Merck had to sell its stake in veterinary joint venture Merial to partner Sanofi-Aventis for about $4 billion to avoid anti-trust issues. However, Merck and Sanofi-Aventis exercised an option to strike a fresh veterinary medicine joint venture in early 2010 by announcing plans to combine Merial with Intervet, the acquired ScheringPlough animal health business. SanofiAventis will pay about $1 billion to Merck to establish the 50/50 joint venture, which will create one of the largest animal health companies in the world. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 38 The new Merck markets its products in over 140 countries through direct sales forces and international distributors, though it gets more than half of its revenues from sales in the US market. The company plans to simplify its global branding under the Merck and MSD names, and is phasing out the Schering-Plough moniker. (MSD is short for Merck Sharp & Dohme and is an existing Merck brand in certain international markets.) Merck hopes to realize cost savings through synergies in the merged organization, as well as expanded avenues for revenue growth as the ever-present threats of patent expiration and generic competition require Merck to push new products through its development pipeline. Best selling drugs carried over from the old Merck include Singulair (topping $4 billion in annual sales), Cozaar/Hyzarr, diabetes drug Januvia, osteoporosis therapy Fosamax, and infant vaccines ProQuad and Varivax. The former Schering-Plough contributed Remicade, a treatment for rheumatoid arthritis and Crohn's disease earning over $2 billion in annual revenues, as well as allergy drugs Nasonex and Clarinex and cancer therapy Temodar. Remicade is marketed outside the US under a licensing agreement with Johnson & Johnson subsidiary Centocor. However, Johnson & Johnson is seeking to regain control of the non-domestic Remicade rights in response to Schering-Plough's acquisition by Merck. (The new Merck hopes to hold on to its Remicade rights, which is reportedly the reason the Schering-Plough acquisition was structured as a reverse Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 39 merger.) As part of the merger integration efforts, the new Merck is focused on bringing its most promising late-stage development candidates to market. It is also increasingly seeking out collaboration, licensing, and outsourcing agreements in the R&D arena to cut costs. The research and development programs of the combined entities are focused on ailments in field such as cancer, cardiology, women's health, immunology, infectious disease, metabolism, ophthalmology, respiratory ailments, and neurological conditions. Successful drug launches in recent years include the predecessor Merck's Emend for chemotherapy side-effects in 2008, and Schering-Plough's Saphris, which received FDA approval as a treatment for schizophrenia and bipolar disorder in 2009. Biotech R&D includes programs in areas such as monoclonal antibodies (singlesource proteins) and RNA interference (RNAi, a gene silencing process); in addition, the Merck BioVentures division is focused on developing follow-on (generic) biologics. The controversial drug Vytorin is a combination of two cholesterol drugs -Schering-Plough's Zetia and Merck's Zocor. Vytorin's success was thwarted in 2008 when study results were released questioning the drug's effectiveness compared to Merck's older medication Zocor. The companies' troubles with Vytorin came to a head in 2009 when they agreed to pay about $42 million to settle class-action Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 40 lawsuits filed by consumers and health plans over Vytorin's efficacy. Controversy over Vytorin, along with some other pipeline setbacks (including the FDA's rejection of a Merck/Schering-Plough combo asthma drug and Merck's Cordaptive cholesterol candidate) led both predecessors Merck and Schering-Plough to announce layoffs and restructuring measures in 2008. Each company reduced its workforce by around 10% that year, with their respective US sales teams bearing the brunt of the cuts 5. Eli Lilly and Company Lilly Corporate Center 893 S. Delaware Indianapolis, IN 46285 United States Phone: 317-276-2000 Fax: 317-276-4878 www.lilly.com 21,836 .0 40,360 Eli Lilly hopes everything will come up roses for you, healthwise. Although best known for its popular antidepressant Prozac, the company develops medicines for a wide variety of ailments. Its top drugs include neurological therapies Zyprexa (schizophrenia and bipolar disorder) and Cymbalta (depression), cancer treatments Gemzar and Alimta, and endocrinology (hormone-related) products such as Humalog insulin and osteoporosis medication Evista. The company also makes cardiovascular therapies and anti-infective agents, as well as animal health products. Lilly sells its products in some 130 countries. The company operates research, manufacturing, and distribution facilities in the US and 20 other countries in Europe, Asia, and the Americas. In the US market, which accounts for more than half of the company's sales, products are promoted through direct sales representatives and are sold through independent distributors Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Robert W. Armstrong VP Global External Research and Development, Lilly Research Laboratories 41 (primarily AmerisourceBergen, Cardinal Health, and McKesson). It also maintains sales forces in many international markets. Eli Lilly knows the value of drug patents: After the company lost its lucrative patent protection for Prozac in August 2001, it saw sales drop dramatically. Lilly's current bestseller Zyprexa, which accounts for about 20% of annual sales, will have patent protection until October 2011, but Eli Lilly is avidly seeking new potential blockbusters and has started making "knockoff" versions of its own drugs so it will be less susceptible to generic competition. The company has some 60 drug candidates in development stages, including treatments for cancer, diabetes, rheumatoid arthritis, depression, atherosclerosis (arterial plaque), and Alzheimer's disease. Its programs are conducted both independently and in concert with research partners. Biotechnology is increasingly important; the firm completed a $1 billion biotech research facility in Indianapolis in 2008. Lilly received FDA approval on a top pipeline candidate, blood thinner Effient (or prasugrel, developed with Daiichi Sankyo), in 2009, though the drug will carry heavy warning labels due to fatal bleeding risks. Another promising development candidate is a once-a-week version of diabetes treatment Byetta; the drug is being co-developed with Amylin and Alkermes. The company is also pursuing additional indications for existing drugs; in 2009 the FDA approved Zyprexa Relprevv, a long-acting injectable version of Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 42 Zyprexa, and bipolar therapy Symbyax was expanded for treatment-resistant depression indications. The company gave its biotech ambitions a big boost through the 2008 acquisition of biotech firm ImClone for about $6.5 billion; ImClone now operates as a research subsidiary of Lilly. ImClone has one approved blockbuster therapy, Erbitux for colorectal and head/neck cancers, and is developing numerous other cancer therapy candidates. Lilly had also expanded its biotech oncology program earlier that year by purchasing development partner SGX Pharmaceuticals for $64 million. SGX was absorbed into Lilly's research operations. Lilly has also been expanding its veterinarian pharmaceuticals division, Elanco Animal Health, through acquisitions, including a 2010 agreement to purchase a European portfolio of animal health products from Pfizer. The deal includes marketing rights to vaccines, parasiticides, and feed additives for pets and livestock. It also expanded the animal health business through the $404 million purchase of dairy cow supplement Posilac from Monsanto in 2008. On the slimming-down side, in 2009 Lilly announced a reorganization plan to cut $1 billion in costs by 2011; the plan includes a 14% workforce reduction and the formation of five core business units (oncology, diabetes, established markets, emerging markets, and animal health). The new restructuring initiatives come on top of ongoing cost-cutting measures to offset Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 43 losses from patent expirations and increased competition, including an employee attrition plan announced in 2007 and a management restructuring in 2008. Also in 2008 the company announced plans to streamline some manufacturing operations, which resulted in the sale of its Indiana pharmaceutical ingredients plant to Evonik Industries in early 2010. Lilly further reduced costs by contracting out the related manufacturing functions to Evonik. The company also increased outsourcing efforts in 2008 by forming partnerships with several contract research organizations (CROs), including firms Quintiles, i3, and Covance. The power of bestseller Zyprexa has been somewhat diminished due to consumer lawsuits alleging that the drug causes sideeffects including diabetes, weight gain, and high cholesterol. In early 2007 Lilly agreed to settle with a large group of patients; total settlement figures have since reached $1.2 billion. In addition, the company agreed in 2009 to pay an additional $1.4 billion in government fines to settle allegations over its marketing tactics for Zyprexa. The Lilly Endowment, a charitable foundation created by the company and the Lilly family in the 1930s, owns 12% of the company 6. Bristol-Myers Squibb Company 345 Park Ave. New York, NY 10154-0037 United States 10,681 .0 28,000 Pharmaceutical giant Bristol-Myers Squibb (BMS) makes big bucks on matters of the heart. The company's blockbuster cardiovascular line-up includes heart disease drug Plavix and Avapro for hypertension. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Brian Daniels SVP Global Development, Medical Affairs, and Research and Development 44 Phone: 212-546-4000 Fax: 212-546-4020 www.bms.com BMS also makes antipsychotic medication Abilify and HIV treatments Reyataz and Sustiva. Most of the company's sales come from products in the therapeutic areas of cardiovascular, immunoscience, metabolics, neuroscience, oncology, and virology. BMS, which has about 20 manufacturing plants worldwide and about 10 R&D centers in five countries, sells its products globally; the US accounts for more than half of sales. BMS' largest international markets are Canada, France, Germany, Italy, Japan, Mexico, and Spain. Its top customers are drug distributors McKesson (25% of sales), Cardinal Health (20%), and AmerisourceBergen (15%). BMS is engaged in a multi-year restructuring effort to focus solely on its biopharmaceutical and specialty drug operations. First announced in 2007, the plan calls for the company to divest its nonpharmaceutical operations, shutter more than half of its manufacturing and packing facilities, and trim its workforce by at least 10%. BMS is also placing less attention on maturing brands to concentrate its efforts on the development and marketing of up-andcoming drug candidates. As part of the restructuring, BMS sold its Medical Imaging unit to private equity firm Avista Capital Partners for $525 million in 2008. Also in 2008 Avista Capital Partners and Nordic Capital paid $4.1 billion to acquire BMS' ConvaTec ostomy and woundcare subsidiary. Then in 2009, the company divested its Mead Johnson subsidiary, which Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 45 sold Enfamil infant formula and other nutritional products for children. While on one hand BMS is busy restructuring and trimming, the company is also anxious to buttress its pharmaceutical pipeline by netting new drug candidates through acquisitions. It acquired cancer therapy developer Kosan Biosciences for $190 million in 2008. Then, in 2009, BMS acquired one of its development collaborators, Medarex, for about $2.4 billion. The companies were already working together on ipilimumab, an antibody candidate in late-stage trials for melanoma and other cancers. The purchase netted BMS a portfolio of other oncology and immunology treatments, as well as access to Medarex's antibody technology, dubbed UltiMAb. Collaborations are also an important part of BMS' development and marketing strategy. French drugmaker Sanofi-Aventis manufactures and distributes several of the company's products, including Plavix and Avapro. Japanese drug firm Otsuka Pharmaceutical co-promotes the schizophrenia treatment Abilify and certain oncology products. BMS also works with Allergan for the development and commercialization of AGN-209323, an earlystage, orally administered small molecule in clinical development for neuropathic pain. Though narrowing its focus will help BMS in its quest to become a pharmaceutical juggernaut, it also increases the company's vulnerability to the loss of patent protection (and thus market exclusivity) on its best Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 46 selling drugs. Most notably Plavix and Avapro, which accounted for about 40% of the company's sales in 2009, will see their patents expire in 2011 and 2012, respectively. The company -- led by CEO Lamberto Andreotti -- is pinning its future on harder to copy biopharmaceuticals, and a pipeline full of chemical compounds in development and newly approved drugs. Lead candidates in the BMS pipeline include Apixaban for blood clots and kidney transplant drug Belatacept. Its Onglyza treatment for type 2 diabetes (developed with AstraZeneca) received FDA approval in mid-2009. Other recently approved drugs in the company's cabinet include Orencia (rheumatoid arthritis), Ixempra (cancer), and Emsam, a treatment for major depressive disorder developed with Somerset Pharmaceuticals (a subsidiary of Mylan Laboratories) 7. Bayer Corporation 100 Bayer Rd. Pittsburgh, PA 152059741 United States Phone: 412-777-2000 Fax: 412-777-3883 www.bayerus.com n/a 17,000 For when you can't "bayer" the pain, Bayer Corporation makes your medicine. The US subsidiary of pharmaceuticals and materials giant Bayer AG (or Bayer Group), the company operates through three divisions and an internal services company. Bayer Corporation handles Bayer Group's US operations in three segments: Bayer HealthCare (pharmaceuticals, animal health, and over-the-counter medicines), MaterialScience (plastics, coatings, and polyurethanes), and Bayer CropScience (herbicides, fungicides, and insecticides). The internal services unit, Bayer Corporate Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 47 and Business Services, handles administrative, technology, human resources, legal, and procurement functions for the Bayer Group's US operations. Overall, North American operations account for about a quarter of Bayer AG's annual sales, and Bayer has around 40 sales and manufacturing locations in the US. As with the parent company's global business, in North America Bayer's largest segment is its health care operations, led especially by prescription pharmaceuticals (including cardiology, cancer, and women's health drugs) and consumer care products (including Aspirin, Alka-Seltzer, and Aleve). The HealthCare division overtook MaterialScience as the largest Bayer division when the group acquired Schering AG (now Bayer Schering Pharma) in 2006. The Bayer Group is focusing on growing in its three core segments (health care, hightech materials, and crop nutrition) by concentrating on markets where it has an existing strong position, as well as by investing in innovative technologies, while at the same time cutting costs and improving efficiencies. The company's MaterialScience division in 2009 formed a strategic partnership with marine cargo container producer Conforce International. The two will produce a polyurethane coating flooring system for marine containers. MaterialScience also entered into a joint development agreement with Ultimate Holographic Reproductions to make holograms. In 2009 the division Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 48 purchased Stepan Company's polyurethane foam business 8. Sanofi-Aventis U.S. LLC 55 Corporate Dr. Bridgewater, NJ 08807 United States n/a 16,000 Phone: 908-231-4000 www.sanofi-aventis.us Yes, Sanofi-Aventis US is "just" a subsidiary, but it's still one of the largest pharmaceutical companies in the country. As the US operations of European drugmaker Sanofi-Aventis, the company develops, manufactures, and markets pharmaceutical products for a range of ailments. Its principal therapeutic areas include cardiovascular disease, central nervous system, internal medicine, metabolic disorders, oncology, and vaccines. Some of its key products include sleep aid Ambien, cancer drug Taxotere, and blood thinner Plavix. Sanofi-Aventis US markets its parent's products in the US through its thousands of field sales professionals. John M. Spinato VP and General Counsel Sanofi-Aventis US also operates four research centers in Arizona, Massachusetts, New Jersey, and Pennsylvania. Its facility in St. Louis, Missouri, offers contract pharmaceutical packaging for other manufacturers. Its services include filling of capsules, gel caps, or tablets in various sizes and shapes, including glass and plastic. Its production facility in Kansas City, Missouri, is one of its parent company's primary manufacturing sites, producing pharmaceuticals not only for sale in the US, but also for its many markets around the world 9. Genzyme Corporation 4,515. 12,000 Genzyme makes big money off uncommon Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Scott Canute 49 500 Kendall St. Cambridge, MA 02142 United States Phone: 617-252-7500 Fax: 617-252-7600 www.genzyme.com 5 diseases. The company's product portfolio focuses on treatments for rare genetic disorders, as well as kidney disease and cancer. One of its main products, Cerezyme, is a leading (and pricey) treatment for Gaucher disease, a rare enzyme-deficiency condition. Founded in 1981, Genzyme also is involved in drug development, genetic testing, and other services. In addition, the company develops gene-based cancer diagnosis and treatment products, renal care and immunological therapies, and orthopedic biosurgery products. Genzyme's products are sold to healthcare professionals in some 100 countries through a specialized marketing force and wholesale distributors. Although Genzyme sells its products worldwide, the US is its primary geographic market accounting for about half of the company's revenues. Cerezyme, the first FDA approved biotech treatment for Gaucher disease, is one of the most expensive drugs in the world and is Genzyme's top-selling product, accounting for about 20% of global sales in 2009. Genzyme is avidly working to diversify its product line to reduce dependence on the radical therapy, in case competition increases or other factors cause the drug to decrease in profitability over the long-term. The company's fears were realized in 2009 when a rash of difficulties at one of the company's main US manufacturing plants in Allston, Massachusetts, caused a shortage in Cerezyme, crimping annual sales of the drug (which fell from $1.2 billion in 2008 to just Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 President, Global Manufacturing and Corporate Operation 50 under $800 million in 2009) and making room for competitors to elbow their way into the market. Genetic disorder drug Fabrazyme for Fabry disease, which accounts for 10% of sales, is also experiencing supply constraints due to the plant troubles. Genzyme is working to reverse the shortage by moving some manufacturing operations to its Ireland facility and correcting contamination issues at the plant. In early 2010 the company also struck a deal through which Hospira will take over some manufacturing functions for Genzyme's products on a contract basis. The company had already been working to expand capacity at its manufacturing facilities in Belgium and Ireland. In addition, it is nearing completion on a new biotech plant in Framingham, Massachusetts, scheduled to open in 2011. Increasing sales of Genzyme's newer therapies went a long ways towards offsetting losses in 2009. For instance sales of Myozyme, a treatment for Pompe disease (another rare genetic disorder caused by an enzyme deficiency) launched in 2006, are being expanded into new global markets. The FDA approved Genzyme's Renvela kidney treatment in late 2007; Renvela is the next generation of its Renagel kidney disease medicine. In 2008 the company received approval for Mozobil, a treatment for cancer patients undergoing stem cell transplants, and in 2009 it launched Synvisc-One, an enhanced version of the Biosurgery division's osteoarthritis Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 51 treatment, in the US market. Genzyme has also been expanding its cancer testing and treatment products in recent years, primarily through acquisitions; in 2009 it acquired full development and commercialization rights for leukemia drug Campath from former partner Bayer. Genzyme's R&D organization is focused on bringing late-stage development candidates to market, as well as on expanding applications for existing drugs. The company's development pipeline includes therapies for the treatment of multiple sclerosis, cystic fibrosis, and cancer tumors, as well as new rare disease treatments. Genzyme is collaborating with Isis Pharmaceuticals on cholesterol treatment mipomersen and with Osiris Therapeutics on cell therapeutics for cardiovascular, inflammatory, and orthopedic ailments. The company is also developing a nextgeneration version of Myozyme (called Lumizyme) and is working to expand indications for drugs including Campath and pediatric leukemia treatment Clolar 10. Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 United States Phone: 650-225-1000 Fax: 650-225-6000 www.gene.com 13,418 .0 11,186 "The few, the proud, the profitable" could be Genentech's motto. One of the world's oldest and most successful biotechs (in an industry full of money-losers), the firm has a number of blockbuster cancer therapies based on its antibody (protein) technologies: Rituxan, which fights non-Hodgkin's lymphoma; Avastin, a treatment for colorectal, breast, and lung cancers; and Herceptin for breast cancer. Lung cancer drug Tarceva rounds Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Brian Kelly VP BioProcess Research and Developmen 52 out its oncology portfolio. Genentech's other marketed drugs include age-related macular degeneration treatment Lucentis, human growth hormone Nutropin, cystic fibrosis drug Pulmozyme, and asthma drug Xolair. The company is a wholly owned subsidiary of Swiss drugmaker Roche. Roche, which previously owned a majority stake in the firm, purchased the 44% of Genentech that it did not already own for about $47 billion in 2009 after making a determined effort to take full ownership that included many volleys back and forth. A $44 billion offer in late 2008 had been rejected by Genentech as undervalued. Roche issued a hostile tender offer of $42 billion early the following year, but after a tepid response from Genentech's shareholders Roche eventually upped the offer to $47 billion, which Genentech accepted. While its majority ownership of Genentech already made up about a quarter Roche's annual sales and gave it access to many of Genentech's development projects (some of which were joint efforts), the takeover placed the larger drugmaker into the fast lane of biopharmaceuticals. Roche anticipates that Genentech's creative and successful research organization will keep its drug pipeline full of promising new biotech drugs, thus relieving stress from patentexpiration pressures in its existing product lineup. Roche is also hoping to cut expenses by combining the two companies' research, marketing, and administrative operations in Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 53 the US, while at the same time maintaining Genentech's innovative identity and culture. Genentech's primary San Francisco, California, location has replaced Hoffman-La Roche's Nutley, New Jersey, office as Roche's US headquarters. While Genentech became the administrative and marketing location for Roche in the US, both Nutley and San Francisco retain major research facilities. Genentech has taken over US marketing efforts for Roche products including Tamiflu (influenza), Pegasys (hepatitis), CellCept (transplants), and Xeloda (colorectal cancer). In addition, former Genentech CEO Arthur Levinson was replaced by Roche executive Pascal Soriot shortly after the transaction's closure in March 2009. In early 2010, however, Genentech veteran Ian Clark took over as CEO of the company when Soriot was promoted to the helm of the entire global Roche pharmaceutical division. Genentech's products are sold through direct marketing efforts and large drug distributors, including AmerisourceBergen, McKesson, and Cardinal Health. In international markets, the company's products are primarily marketed through parent Roche's global sales force and distribution network. Instead of acquisitions, Genentech has traditionally relied on its own internal efforts (sometimes with research partners) to develop and commercialize new drugs. The company's development-stage pharmaceuticals in clinical trials include Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 54 treatments for ailments such as lupus, asthma, diabetes, Alzheimer's disease, and various cancers. In early 2010 the company received FDA approval to market Actemra, a rheumatoid arthritis treatment co-developed with another Roche-controlled entity, Chugai Pharmaceutical. While its long-term success depends on its ability to develop novel compounds (especially as older drugs lose patent protection), Genentech is also seeking shorter-term success in its commercialization efforts for its newer drug releases, including Avastin (launched in 2004) and Lucentis (2006). Avastin has pulled itself up to become the firm's top seller, neck-and-neck with Genentech's long-time blockbuster Rituxan (known internationally as MabThera), while Lucentis is rapidly gaining market share. Additionally, the company is working to expand the number of approved uses of its marketed drugs, such as Avastin and Rituxan. The latter drug was approved as a treatment for leukemia in 2010. Colorectal and lung cancer treatment Avastin was approved for breast cancer treatment in the US in 2008 and for kidney and brain cancers in 2009. Genentech is also testing several combination drug therapies for new cancer applications. The company voluntarily yanked psoriasis treatment Raptiva, which was co-developed with XOMA and marketed internationally with Merck KGaA, from the US market in 2009 after the drug was linked to a fatal Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 55 brain disorder (progressive multifocal leukoencephalopathy, or PML). The move came a month after European Union regulators recommended its withdrawal in that market. Canada has also halted sales of Raptiva. Genentech is expanding its manufacturing capacity by adding on to existing facilities and through new facility construction efforts. For instance, it is constructing a new bulk drug manufacturing facility in Singapore. However, some US expansion efforts have been discontinued due to the integration efforts with Hoffman-La Roche. Through its 33% stake in Roche, Novartis is an indirect shareholder in Genentech. Novartis holds international licensing rights for Lucentis and Xolair 11. Novartis Pharmaceuticals Corporation Health Plaza East Hanover, NJ 079361080 United States Phone: 862-778-8300 Fax: 973-781-8265 www.pharma.uu.novartis. com 9,542. 0 7,000 Novartis Pharmaceuticals holds down the fort on this side of the big pond. As the US pharmaceuticals marketing affiliate of Swiss drug giant Novartis AG, the company helps with the development and sales of its parent company's products in the US. Its product line addresses a range of ailments including cardiovascular and respiratory diseases, gastrointestinal complaints, central nervous system disorders, cancer and blood disorders, bone and joint conditions, and organ transplants. Key products include tumor growth inhibitor Gleevec, high blood pressure drug Diovan, and attention deficit disorder therapies Focalin and Ritalin. The company sells its products through an in- Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Preside nt Keith Boudreau Novartis Institutes For Biomedical Research, Inc 250 Massachusetts Ave Cambridge, MA 021394229 United States Phone: 617-871-8000 56 house sales team. In 2010 the company expanded its portfolio of treatments for mental disorders when it launched schizophrenia treatment Fanapt in the US. Parent company Novartis AG had previously acquired the rights to the drug in North America in late 2009 from Vanda Pharmaceuticals 12. Hoffmann-La Roche Inc 340 Kingsland St. Nutley, NJ 07110-1199 United States Phone: 973-235-5000 Fax: 973-777-3327 www.roche-nutley.com n/a 5,000 Hoffmann-La Roche, also known as Roche Nutley, conducts drug research in the suburban community of Nutley, New Jersey. The company is part of Roche USA and is one of the primary US research facilities for its parent, Swiss drug giant Roche Holdings. It serves as a lead location for Roche's oncology, inflammatory disease, virology, and metabolism R&D programs, developing drugs to treat conditions including tumorous cancers, asthma, rheumatoid arthritis, diabetes, and heart disease. Hoffmann-La Roche also has extensive programs in genebased and protein-based biotechnology research. Parent Roche Holding's $46.8 billion acquisition of the 44% of biotech firm Genentech that it didn't already own in 2009 meant huge changes for Hoffman-La Roche, which had previously served as the manufacturing, sales, and administrative headquarters for Roche in the US. By the end of the year, Roche's integration of Genentech into the Roche USA division was completed and the Roche USA headquarters location was moved from Nutley to the Genentech building in San Francisco. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Ivor MacLeod VP, CFO, and Site Head Nutley 57 Roche's commercial operations (drug sales and marketing) in the US now operate primarily under the Genentech name. As all administrative and drug marketing functions were moved to San Francisco, and the manufacturing operations were closed down, the main Hoffman-La Roche location in Nutley became strictly an R&D operation. Hoffman-La Roche's Palo Alto, California, research group was disassembled and its virology, inflammation, and neurology programs were relocated to San Francisco and Nutley. Genentech and Hoffman-La Roche had already worked together on several drug development efforts, including potential cancer treatments, and continue to partner on some efforts. In addition, Hoffman-La Roche has research collaborations with other pharmaceutical companies, including Synta Pharmaceuticals (for inflammatory disease treatments) and Alnylam (on RNA interference treatments for cancer and metabolic ailments). The company has benefited from other acquisitions made by its parent company, including the 2008 purchase of Piramed, which gave Hoffman-La Roche scientists access to additional cancer treatment technologies. The company takes its name from the parent company's founder, Fritz HoffmannLa Roche. Roche's US presence began in Manhattan in 1905; Hoffmann-La Roche was incorporated in New Jersey in 1929. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 58 Products developed at Hoffmann-La Roche's Nutley research center have included influenza fighter Tamiflu, cancer drug Xeloda, HIV inhibitor Fuzeon (co-marketed with Trimeris), obesity drug Xenical, and hepatitis B and C therapy Pegasys 13. Cephalon, Inc 41 Moores Rd. Malvern, PA 19355 United States Phone: 610-344-0200 www.cephalon.com 2,192. 3 3,026 Cephalon isn't asleep at the wheel. The company sells PROVIGIL, a treatment for the sleep disorder narcolepsy, in the US and select countries around the world. The company's other top sellers are cancer pain medications ACTIQ and FENTORA, epilepsy treatment GABITRIL (licensed from Abbott Labs and Novo Nordisk), cancer drug TREANDA, and narcolepsy treatment NUVIGIL. It sells seven products in the US and has more than a dozen approved drugs on the market in Europe. Cephalon's drug research and development activities focus on central nervous system disorders, cancer, pain, and inflammatory disease. The company focuses its promotional efforts on the US market, where it employs a direct sales force and makes about 80% of its annual revenues. Its two biggest sellers are PROVIGIL and NUVIGIL, which together comprise about half of the company's sales (most of that in the US). Cephalon also has representatives throughout Europe and in other select regions. Wholesale distributors Cardinal Health, McKesson, and AmerisourceBergen are the company's chief customers; collectively the three account for about half of sales. Like most pharmaceutical companies, Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Alain Aragues EVP; President, Cephalon Europe 59 Cephalon depends on new products (and new applications for existing products) to fight off potential operating losses brought on by patent protection and regulatory hurdles. It adds to its product line through internal and collaborative development and through acquisitions. The company's clinical development focus is primarily on developing therapies for neurological disorders and cancer. It is developing potential treatments for hematological cancers, solid tumors, pain, fatigue, and Alzheimer's disease. Development partners include AstraZeneca and Merck. The company formed a codevelopment agreement with Immupharma on a treatment for immune-system disease lupus erythematosus in 2008. One of Cephalon's oncology treatments for chronic lymphocytic leukemia and nonHodgkin's lymphoma, TREANDA, received approval from the FDA in 2008 and was successfully launched later that year. NUVIGIL was launched as a next-generation version of PROVIGIL. The company hopes sales of NUVIGIL will ward off competition when PROVIGIL loses its patent protection in 2012, and so far sales of the drug have not disappointed. Cephalon maintains a steady acquisition pace to keep its pipeline flowing. The company paid $207 million in 2009 to acquire Australian biotech firm Arana Therapeutics, a developer of antibody-based drugs to address cancer and inflammatory Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 60 diseases. In early 2010 Cephalon expanded its development operations further when it exercised an option to acquire privately held Ception Therapeutics, which had candidates in clinical trials for esophagitis and asthma, for $250 million after Ception's lead pipeline candidate passed certain development milestones. Cephalon had inked the deal a year earlier and paid a $100 million upfront payment to secure its option rights. To broaden its product range and geographical footprint, the company also acquired Swiss generic drug maker Mepha in 2010. Cephalon spent some $615 million on the deal to enter into the generics business and double the size of its international business. The company has suffered some grief over its pain medication franchise. The active ingredient in cancer pain medication ACTIQ and its next-generation version FENTORA is fentanyl, which is 80 times stronger than morphine and can be highly addictive. The fentanyl drugs have not been approved for use in any context other than cancer pain, but the company has been under investigation for pushing ACTIQ and FENTORA for off-label uses, including use against migraines. Cephalon reached settlement agreements with several government agencies over the charges in 2007 and 2008. Despite the controversy over FENTORA's use, Cephalon is pursuing FDA approval for the drug's use in noncancer patients with opioid-tolerant chronic Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 61 pain issues. It expects to receive a response from the FDA about expanding the drug's use by the end of 2010. 14. Kolmar Labs Group 20 W. King St. Port Jervis, NY 12771 United States n/a 2,800 Phone: 845-856-2203 Fax: 845-856-2203 www.kolmarlabsgroup.co m If you think beauty is on the outside, perhaps Kolmar Labs Group can help. The company (formerly known as Outsourcing Services Group) is a contract manufacturer of cosmetics and personal care products, as well as over-the-counter pharmaceuticals. It operates through two subsidiaries: Kolmar Laboratories, which makes cosmetics, bath and hair products, and OTC health products; and Acupac Packaging, a specialty manufacturer focused on single-use consumer products, such as moist towelettes, sample packs, and dissolvable thin films (for example, breath strips). Both companies assist clients with the entire product development process, from conceptualization and formulation to testing, packaging, and distribution. Jeffrey Swaine Director Technical Services and Product Development, Kolmar Labarotories In 2007 the company restructured its operations around its Kolmar and Acupac operations, renaming itself Kolmar Labs Group. As part of the restructuring, it sold its facilities in Canada and the US 15. Celgene Corporation 86 Morris Ave. Summit, NJ 07901 United States Phone: 908-673-9000 Fax: 908-673-9001 2,689. 9 2,813 A terror from the past has provided hope in the present. Celgene's flagship products Thalomid and Revlimid are versions of the infamous thalidomide, the morning sickness remedy pulled from shelves in the 1960s after it was linked to birth defects. Both drugs are approved in the US and Europe as a treatment for multiple myeloma (bone Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Kevin Loth Director External Affairs 62 www.celgene.com marrow cancer). Revlimid also is used to treat a malignant blood disease called MDS. Celgene sells each drug under strict risk management plans that ensure they are safely administered. The firm has other drugs in development that combat inflammatory diseases and cancer. Fidelity Management and Research and Janus Capital Management combined hold about 15% of the company's shares. In addition to Revlimid and Thalomid, Celgene's marketed products include Focalin, a relative of ADHD drug Ritalin; and Vidaza, also a treatment for MDS, which affects blood and bone marrow. Focalin is licensed exclusively to Novartis. Celgene also receives royalties on sales of all Novartis' Ritalin products. Revlimid is by far the company's biggest seller, making up about 65% of Celgene's annual sales. Likewise, the US is its biggest market, also accounting for more than 60% of Celgene's sales. Its second biggest seller is Thalomid, coming up far behind Revlimid, accounting for approximately 15% of the company's sales. Celgene's Lifebank USA subsidiary operates a blood bank in which parents may choose to store their newborn's cord and placenta blood as way to combat possible blood diseases the child might contract later. Leukemia, lymphoma, and about 80 other blood diseases can be treated with cord and placenta blood and stem cells. The company's development efforts target Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 63 cancer and inflammatory diseases, and it has a pipeline full of early stage candidates which it continues to expand through internal development, collaborations, and acquisitions. Its Celgene Cellular Therapeutics subsidiary is researching stem cell therapies for diseases such as cancer and multiple sclerosis. In 2008 the company entered a $50 million collaboration with Acceleron for the development and sale of a treatment for chemotherapy induced anemia in breast cancer, bone disease, and renal anemia. Celgene also acquired Gloucester Pharmaceuticals in early 2010 for $340 million to obtain its recently approved cancer drug Istodax. In 2008 Celgene acquired fellow thalidomide resurrector Pharmion for $2.9 billion.The two companies were already familiar with each other: Pharmion had held the right to market Thalomid in Europe, and Celgene already owned a small stake in the company. With the acquisition, Celgene gained worldwide rights to Thalomid, along with another approved blood cancer drug, Vidaza (for which it pays royalties to Pfizer). It also picked up an established sales force in Europe. Though the US is the company's largest market, Celgene is working to expand its global presence through licensing deals and acquisitions (such as the Pharmion buy). Along with the US and Europe, the company operates in Asia, Latin America, and the Middle East. Celgene manufactures some of Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 64 its products at its manufacturing facility in Switzerland 16. MedImmune, L.L.C 1 MedImmune Way Gaithersburg, MD 20878 United States Phone: 301-398-0000 www.medimmune.com n/a 6,000 MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial virus (RSV), a major cause of pneumonia and other respiratory disease in infants and children. Also on the market are FluMist, its nasal spray flu vaccine, and Ethyol, which treats side effects of chemotherapy and radiation. The company is working on dozens of investigational therapies -- including monoclonal antibodies, vaccines, and small molecule drugs -- in the areas of infectious diseases, cancer, and inflammatory conditions. MedImmune is a subsidiary of UK-based pharmaceutical giant AstraZeneca. AstraZeneca acquired MedImmune in 2007 in a more than $15 billion deal, primarily conducted through a public share tender offer. MedImmune had been under pressure from some of its shareholders (including investor Carl Icahn) and began seeking potential buyers earlier that year, reversing its previous determination to remain independent. Following the acquisition, AstraZeneca integrated another of its purchases -- Cambridge Antibody Technology -- into MedImmune to form a larger biologics and vaccines unit. MedImmune has grown as part of AstraZeneca's family, moving more product candidates into its development pipeline and adding new employees to its rolls. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Bahija Hallal SVP Research and Development 65 AstraZeneca also launched a new venture capital subsidiary, MedImmune Ventures, under the MedImmune structure. Also in 2008, David Mott, the CEO who oversaw MedImmune's rapid growth and its acquisition by AstraZeneca, left the company and was replaced by AstraZeneca's head of North American operations Tony Zook. Two years later, in 2010, Peter Greenleaf moved up from within MedImmune and was named president, reporting to Zook who continued as senior executive at AstraZeneca. Synagis, a monoclonal antibody (MAb, or single-source protein) therapy, is MedImmune's top selling drug. The company promotes Synagis independently in the US, while Abbott Labs distributes the product outside the US. Sales of Ethyol slowed in 2008 on the entry of generic versions of the drug into the US market. Schering-Plough (now Merck) had marketed Ethyol internationally, but MedImmune found a new European marketing partner in Pinnacle Biologics in 2008. MedImmune has facilities in the Netherlands, the UK, and the US. MedImmune has pinned a lot of hopes on its flu vaccine FluMist. Sales of the drug doubled in 2008 after the company worked to address certain problems that had plagued FluMist in previous years, including distribution difficulties and a limited target audience. In 2007 it won FDA approval for a refrigerated version of the drug, which had previously required frozen storage (a hardship to many doctors and clinics that had hindered sales). Later that year Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 66 MedImmune received approval for FluMist to be applied to children ages 2 to 5, thus expanding the number of people who can take the vaccine. (It was previously used only on patients between 5 and 49.) Additionally, FluMist received a boost in 2008 when the CDC announced new recommendations that all children ages 2 to 18 receive a flu vaccine. MedImmune is also working to gain approval for FluMist in the European Union and other regions. In addition, MedImmune is working under contracts with the National Institutes of Health and the Department of Health and Human Services (HHS) to develop pandemic flu vaccines, as well as the manufacturing capacity to generate them on short notice. In 2009 the company received contracts totaling over $450 million from the HHS to develop and produce an H1N1 (swine flu) vaccine using its nasal technology. The product was swiftly approved by the FDA during the swine flu outbreak, with distribution of the vaccine beginning in October. MedImmune is striving to broaden its product portfolio through research and development, and it doubled the number of products in its pipeline to about 100 following its acquisition by AstraZeneca. It has also added some products and technologies through acquisitions and partnerships over the years: A 2007 deal with Crucell gives it access to Crucell's MAbstract technology used to develop antibodies for hospital-acquired bacterial Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 67 infections. Other drugs in the pipeline include a second-generation version of Synagis (called motavizumab) for treating RSV, vaccines for RSV and Epstein-Barr virus, and medications for various inflammatory ailments, infectious diseases, and cancer. Other research areas include neurological, cardiovascular, and gastrointestinal ailments. MedImmune has also licensed technology to GlaxoSmithKline and Merck for use in developing vaccines to protect against human papillomavirus (HPV), which causes cervical cancer. Merck's version of the HPV vaccine, Gardasil, got the FDA green light in 2006. In 2007 Novartis licensed the company's reverse genetics technology to use in making influenza vaccines 17. Sanofi Pasteur Inc Discovery Dr. Swiftwater, PA 18370 United States Phone: 570-839-7187 Fax: 570-839-0955 www.sanofipasteur.com n/a 2,200 Sanofi Pasteur helps you guard against getting sick in the first place. The company is the US vaccines division of French drugmaker Sanofi-Aventis. It makes vaccines that protect against such infectious diseases as influenza, polio, and meningitis. Some of its top sellers are flu vaccines, childhood combination vaccines, and adult booster shots. It also makes travelers' vaccines that keep globetrotters safe from typhoid, cholera, yellow fever, and the like. Projects in development include improved vaccines for influenza, preventative vaccines for HIV and dengue fever, and therapeutic vaccines for cancer. While it might seem a bit dark to be betting on a worst-case scenario, Sanofi Pasteur is Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 68 the largest flu vaccine maker in the world and it's working on improving flu vaccines to prepare for a potential influenza pandemic. The company completed construction of a new $150 million flu vaccine manufacturing plant in Pennsylvania in 2009 to double its US production capacity. Sanofi Pasteur supplied about 45% of seasonal vaccines in the US during the 2008-2009 flu season and received FDA approval for its H1N1 (Swine flu) vaccine ahead of the 2009 winter flu season. Sanofi Pasteur is developing vaccines based on new cell culture technology through contracts with the US Department of Health and Human Services. In 2007 the FDA approved its provisional avian flu vaccine, that has shown limited effectiveness in preventing the disease and will be replaced by better versions as they come along. In addition to its influenza research, Sanofi Pasteur has about 20 vaccines in its R&D pipeline, including improvements to its existing vaccines, as well as new vaccines for some forms of cancer, Chlamydia, dengue fever, HIV, malaria, rabies, and West Nile virus. In the US, the company received a shot in the arm from the FDA approvals of 5-in-1 pediatric combination vaccine Pentacel in 2008 and meningitis vaccine Menactra in 2007. On the global front, Sanofi Pasteur operates in about 150 countries, and more than 500 million people around the world receive its vaccines each year. Products in Europe are distributed through Sanofi Pasteur MSD, a Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 69 50/50 joint venture with Merck. It also enjoys alliances with smaller biotech firms including Crucell. Its earlier alliance with Acambis grew cozier when Sanofi Pasteur acquired the UK vaccine maker, netting its approved smallpox vaccine and other vaccines in development. Sanofi Pasteur then integrated Acambis' operations, including three research sites in the US. To reach deeper into emerging international markets, Sanofi Pasteur has announced that it will acquire a majority share of vaccine maker Shantha Biotechnics from Mérieux Alliance. The deal will give Sanofi Pasteur access to new vaccines in development, and Shantha will use the weight of its new parent to bring affordable vaccines to developing countries 18. Amylin Pharmaceuticals, Inc. 9360 Towne Centre Dr. San Diego, CA 92121 United States Phone: 858-552-2200 Fax: 858-552-2212 www.amylin.com 758.4 1,700 Amylin Pharmaceuticals helps diabetics gain the upper hand in their battle with the disease. The company makes and markets two injectable diabetes drugs, Byetta and Symlin, that are approved as adjunct therapies to other diabetes treatments such as metformin and insulin. Byetta is also approved as a stand-alone diabetes therapy. Development partner Eli Lilly markets Byetta worldwide and is responsible for the development of Byetta in international markets. Amylin's US-based sales force copromotes Byetta with Eli Lilly and markets Symlin on its own. The company is working on other diabetes drugs, including a onceweekly version of Byetta, as well as treatments for obesity. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Michael Hanley VP Discovery Research 70 Both Byetta and Symlin have been on the market in the US since 2005. Amylin and Eli Lilly launched Byetta in Europe in 2007 and is expanding sales to other countries. The company is also looking to expand the drugs' uses; and, in 2009 gained approval from the FDA to market Byetta as a monotherapy (stand-alone therapy) for diabetes. Amylin is also developing a weekly version of Byetta (called Bydureon or exenatide once weekly) with Eli Lilly and drug delivery expert Alkermes. Clinical trial results have indicated that the once-weekly version controlled blood sugar better than the existing twice-a-day version; patients using either version of the drug generally have experienced weight loss as well. Amylin has submitted Bydureon to the FDA for approval. The company has experienced continued operating losses its inception in 1987, and as of 2009, had accumulated a deficit of roughly $1.9 billion. Previous to the commercialization of Byetta and Symlin, Amylin derived nearly all of its revenue from development funding, fees and milestone payments under collaborative agreements. Today the company is counting on revenue from sales Byetta and Symlin to help it become profitable in the near term, and on the approval and eventual sale of Bydureon in the future. However, it has hit a few bumps in the road along the way. For example, in 2008 the company saw weak sales of Byetta due to concerns over possible links to pancreatitis Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 71 (a potentially deadly disease of the pancreas), as well as high cash demands of its product in development. In response, Amylin announced corporate restructuring efforts to rein in operating expenses, including a 16% workforce reduction. It announced another 10% workforce reduction strictly consisting of sales positions in 2009. The company has also been facing pressure from shareholders over declining sales and continued unprofitability, including billionaire corporate raider Carl Icahn (9%) and Eastbourne Capital Management, both of which managed to shake up the board of directors in 2009. Eastbourne Capital Management sold off its 12% stake in Amylin later that year. In order to diversify its holdings so as not to be dependent on just a couple of products, Amylin has expanded into therapeutic areas other than diabetes that include obesity and severe lipodystrophy, a rare metabolic condition that causes abnormalities in fat distribution with loss of subcutaneous fat. Amylin has an agreement with Takeda Pharmaceutical to develop obesity therapies using a compound from Amylin's pipeline called pramlintide/metreleptin, which is in early clinical trials 19. Schering-Plough Healthcare Products, Inc. 56 Livingston Ave Roseland, NJ 07068-1733 1,266. 0 n/a MANUFACTURER OF OVER THE COUNTER PRODUCTS SUNCARE AND FOOTCARE Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 72 United States Phone: 973-325-4500 www.sphcp.com 20. Vertex Pharmaceuticals Incorporated 130 Waverly St. Cambridge, MA 021394242 United States Phone: 617-444-6100 Fax: 617-444-6680 www.vpharm.com 101.9 1,432 Vertex Pharmaceuticals represents the convergence of drug discovery technologies. The biotechnology company uses an integrated, multidisciplinary approach -employing biophysics, computer-based modeling, and functional genomics -- to speed up the discovery and development of new drugs. It is focused primarily on the development of its lead candidate, telaprevir, an investigational treatment for hepatitis C. The company has other hepatitis C drugs in development, as well as possible treatments for cystic fibrosis, epilepsy, and inflammatory disease. Vertex, which was formed in 1989, has research facilities in California and Massachusetts, as well as in the UK. The company is hoping that its leading hepatitis candidate telaprevir will be the first approved drug in a new class of antivirals, and it has the drug in concurrent clinical trials worldwide. It has partnered with Johnson & Johnson unit Janssen Pharmaceutica and Mitsubishi Tanabe Pharma to develop the drug in international markets, but has kept North American commercial rights for itself. Vertex plans to expand its sales and marketing capabilities to support the commercial launch of telaprevir once the drug receives FDA approval; if all goes according to plan the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Peter Mueller EVP Global Research and Development and Chief Scientific Officer 73 drug will be launched in the US in 2011. In addition to telaprevir, Vertex is building a pipeline of earlier-stage hepatitis C compounds. It has also partnered with the Cystic Fibrosis Foundation on treatments for cystic fibrosis. In mid-2008 Vertex partnered with non-profit CDHI Foundation to research treatments for Huntington's Disease. The company had also been working with Merck on an early stage anti-cancer compound, but Merck has indicated that it will not pursue further development of the drug. Vertex relies on funding from collaboration and licensing partners to support its research and development efforts, and it seeks to add partners and drug candidates to gain new market opportunities. To expand its development pipeline, the company paid $100 million in early 2009 to acquire privately held ViroChem Pharma. The purchase added two antiviral compounds which will augment Vertex's hepatitis C drug portfolio. The company had also previously received royalty payments on the sales of HIV drug Lexiva (known as Telzir in Europe) from its marketing partner GlaxoSmithKline. Vertex co-discovered Lexiva/Telzir, and an earlier iteration of the compound called Agenerase. In 2008, however, Vertex sold royalty rights for the two drugs to its partner. Founder and CEO Dr. Joshua Boger retired in 2009, but chose to stay on as a company director. Five-year board member (and former head of UK drug firm Shire plc) Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 74 Matthew Emmens stepped up to replace Boger. The two worked together at Merck before Boger founded Vertex ΚΑΤΑΣΤΑΣΗ ΤΩΝ ΜEΓΑΛΥΤΕΡΩΝ ΧΟΝΔΡΕΜΠΟΡΩΝ, ΔΙΑΝΟΜΕΩΝ ΚΑΙ ΠΡΟΜΗΘΕΥΤΩΝ ΦΑΡΜΑΚΩΝ ΣΤΙΣ ΗΠΑ A/A COMPANY NAME, ADDRESS, PHONE, FAX 1. CVS Caremark Corporation 1 CVS Dr. Woonsocket, RI 02895 United States Phone: 401-765-1500 Fax: 401-762-9227 www.cvs.com 2009 SALES (MIL. $) 98,729.0 EMPLOYEE S OVERVIEW 295,000 Size matters to CVS Caremark (formerly CVS), the nation's secondlargest drugstore chain and its thirdlargest pharmacy benefits manager. With about 7,090 retail and specialty drugstores under the CVS and Longs Drug banners, it trails archrival Walgreen by about 400 stores. CVS has grown rapidly through a string of acquisitions that included the Eckerd chain, stores from Albertsons, and most recently Longs Drug Stores (2008). In 2007 CVS purchased prescription benefits management (PBM) firm Caremark Rx for about $26.5 billion. Caremark was combined with CVS's PBM and specialty pharmacy unit PharmaCare Management Services to form Caremark Pharmacy Services. CVS's active acquisition schedule has both greatly expanded the number of retail and specialty pharmacies it operates and the range of services it offers to customers, employers, Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 CONTACT Gener al Manag er Allan Ackro yd 75 insurance companies, unions, managed care organizations, and other clients. The company is betting that size will make it a more convenient and efficient operator and a preferred provider to health benefit plans attempting to better manage their health care costs. Indeed, acquisitions have increased both revenues and profits for the company. In 2009 revenues increased by more than $11 billion and gross profit by more than $2 billion (more than half of each can be attributed to the Longs purchase). While size has its advantages, it can also make a company a target. Indeed, the Federal Trade Commission (FTC), which approved the CVS-Caremark merger, in August 2009 reopened its investigation in response to lawmakers' pleas. In their letter to the FTC, a bipartisan group of eight US congressmen accused CVS Caremark of unfair and deceptive business practices, including arranging to have consumers' prescriptions filled only at CVS pharmacies. CVS is drawing fire from consumer groups and the attorneys general of two major states (California and New York) over the alleged sale of expired over-thecounter products in its stores. The attorney general of New York has also filed suit against the company. The Caremark purchase positioned the company as a leading manager of Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 76 pharmacy benefits in the US. The hardwon deal, launched in late 2006, led to a bidding war between CVS and Caremark rival Express Scripts that forced CVS to raise its offer several times. Combined, CVS and Caremark created a company that's an industry leader in pharmacy and specialty pharmacy sales, PBM lives managed, mail-order pharmacy sales, and retailbased clinics (through its MinuteClinic business). Prior to the Caremark purchase, PharmaCare Management Services had been key to CVS's growth. After more than doubling the number of drugstores it operates in California and adding Hawaii with its Longs purchase and adding about 100 new drugstores in 2009, in 2010 CVS will continue to grow its retail network with the addition of between 250 and 300 new or relocated drugstores and MinuteClinic locations. MinuteClinic (acquired in 2006) operates health clinics inside retail stores. The CVS subsidiary runs about 570 clinics in some 25 states, most of which are located within CVS stores. Continued expansion of its retail network is a key element of the company's growth strategy and essential if CVS is to keep up with ever-expanding Walgreen, which in 2010 acquired the 250-plus Duane Reade drugstore chain based in New York City. (With CVS and Walgreen drugstores carpeting the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 77 nation's suburbs, Walgreen is now seeking to conquer urban America.) In addition to opening new stores, CVS is attempting to increase sales at existing ones. Prescription drugs account for more than two-thirds of sales, and the retailer is attempting to grow revenues from over-the-counter medications and general merchandise through its private-label offering of more than 4,300 products. (CVS brand and proprietary products account for about 15% of front-of-store revenues.) CVS is also doubling the size of grocery sections in about 3,000 stores during 2010, in an effort to capture a wider slice of shoppers' food budgets. Chairman and CEO Thomas Ryan, a 36-year veteran of CVS and its president for the past 16 years, plans to retire as chief executive in May 2011. Larry Merlo, president and COO of the firm, is expected to succeed him. CVS Caremark has formed an office of the chairman to help smooth the transition. The three-man office includes Ryan, Merlo, and the president of Caremark Pharmacy Services 2. McKesson Corporation 1 Post St. San Francisco, CA 94104 United States Phone: 415-983-8300 Fax: 415-983-7160 108,702. 0 32.500 McKesson moves medicine. The largest pharmaceuticals distributor in North America, McKesson delivers prescription and generic drugs, as well as health and beauty care products, to more than 40,000 retail and institutional pharmacies throughout the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Patrick Carter International Operations Group 78 www.mckesson.com US and Canada. The company is also a major medical supplies wholesaler, providing medical and surgical equipment to alternate health care sites, such as doctors' offices, surgery centers, and long-term care facilities. In addition to distribution services, McKesson offers software and technical services that help pharmacies, health care providers, and insurers manage supply chain, clinical, administrative, and financial operations. McKesson's distribution operations bring in most of the company's money. The McKesson Distribution Solutions division primarily provides prescription and over-the-counter pharmaceuticals and other health care items to retailers and health care institutions in the US; it also is a wholesale of drug in Canada and owns about half of Nadro, a Mexican pharma distributor. The distribution division also supplies medical equipment and beauty care items, and it provides consulting and inventory management services. Major US pharmacy operators CVS Caremark and Rite Aid are among the company's key clients, each accounting for more than 10% of sales. Outside of its traditional retail and institutional distribution operations, McKesson provides disease management programs that serve health providers, drug manufacturers, insurers, and employers. Its specialty Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 79 pharmacy solutions unit coordinates the delivery of complex medicines directly to physicians. Additionally, the company supplies automated pharmacy dispensing systems through its minority stake in North Carolinabased Parata Systems, and it provides first aid kits and workplace safety training through subsidiary ZEE Medical. McKesson launched a new Plasma and BioLogics division in 2008; the unit will deliver plasma and plasma-related products to hospital pharmacies. Strategic acquisitions have been important to the growth of the company, both in its core distribution operations and its smaller but growing Technology Solutions (software and data management) division. The company regularly purchases small to midsized regional distributors and distribution support companies, including the 2008 purchase of Midwest pharmacy distributor McQueary Brothers for $190 million. McKesson also widens its product offerings by forming new partnerships with its suppliers. While McKesson seeks to grow its operations to provide a complimentary array of solutions and maintain its leading edge, the company has also trimmed some operations to focus on core drug distribution and technology initiatives. It sold specialty pharmacy Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 80 unit ivpcare to Walgreen in 2008 3. Cardinal Health, Inc 7000 Cardinal Place Dublin, OH 43017 United States Phone: 614-757-5000 Toll Free: 800-234-8701 www.cardinal.com 99,512.4 29,600 Cardinal Health seeks to deliver medicine to all points of the compass. The company is a top distributor of pharmaceuticals and other medical supplies and equipment in the US. Its pharmaceutical division provides supply chain services including prescription and over-the-counter drug distribution, while its medical division parcels out medical, laboratory, and surgical supplies. The divisions also provide logistics, consulting, and data management services. Customers include pharmacies, hospitals, doctor's offices, and other health care businesses. Cardinal Health spun off its medical equipment manufacturing and clinical technologies operations into CareFusion in 2009. Cardinal Health completed the spinoff of about 81% of CareFusion to its shareholders in August 2009 to maximize shareholder and customer value for all of its businesses. It plans to divest its remaining shares in CareFusion within five years of the spinoff. Cardinal Health aimed to increase growth within both Cardinal Health and CareFusion by separating the businesses; it also plans to focus on improving customer relationships across the board. Former Cardinal chairman and CEO Kerry Clark retired at the time of the spinoff, with George Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Gener al Mana ger Enriqu e Espino za 81 Barrett (the former leader of the distribution operations) taking over Clark's roles. Pharmaceutical distribution has historically accounted for about 85% of Cardinal Health's sales, with pharmacies accounting for the largest chunk of Cardinal's customer revenues. CVS and Walgreen each account for about 20% of the company's sales. The Cardinal Health Pharmaceutical division operates distribution facilities and nuclear pharmacy labs (for the distribution of medical imaging agents) across the US; it also has limited operations in Mexico (nuclear labs) and the UK (generic drugs). The division also includes the Cardinal Health Pharmacy Management business, the Medicine Shoppe retail pharmacy subsidiary, and a specialty pharmacy unit that distributes plasma and intensive care therapies. The smaller Cardinal Health Medical distribution division offers branded and private-label supplies, including fluid collection devices, scientific laboratory equipment, and general hospital and physician practice supplies in Canada and the US. It also assembles procedure kits and makes exam gloves and surgical drapes. Cardinal has expanded through acquisitions of companies and products within all of its operating segments. Since 1980 it has acquired more than Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 82 50 companies. In 2007 the company dropped about $1.5 billion on medical equipment manufacturer VIASYS Healthcare, which was integrated and later added to the CareFusion business. The following year the company added to its infection prevention line by acquiring private health care firm Enturia, maker of the ChloraPrep brand line of skin disinfectant products, for $490 million. Enturia also became part of the CareFusion spinoff. In 2010 Cardinal announced it would bolster its specialty pharmaceutical services by purchasing Healthcare Solutions Holding in a deal worth up to roughly $670 million (including an upfront payment of $517 million and another $150 million in milestone payments). Healthcare Solutions Holding is the parent company for a number of subsidiaries, including P4 Pathways and P4 Healthcare. The company provides tools and services that include product data and claims management help for specialty care industry doctors, payers, and drug makers. On the paring side, the company unloaded its healthcare marketing services unit and its UK Intercare distribution business in 2007. Even more significantly, Cardinal Health sold its Pharmaceutical Technologies and Services division, which offered drug delivery systems, packaging services, Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 83 and development services, to The Blackstone Group for $3.3 billion. As part of the deal, Cardinal retained two businesses that complement its generic pharmaceutical operations. In 2008 Cardinal divested two former VIASYS businesses, Tecomet (orthopedic implants) and MedSystems (feeding tubes). It has also announced plans to divest its SpecialtyScripts business, a specialty medication distributor acquired in 2007, and its UK Martindale injectable drug manufacturing unit 4. Medco Health Solutions, Inc 100 Parsons Pond Dr. Franklin Lakes, NJ 07417-2603 United States Phone: 201-269-3400 Fax: 201-269-1109 www.medcohealth.com Administering some 700 million prescriptions each year, Medco Health Solutions is the country's top pharmacy benefits management company and, through its Accredo Health unit, its top specialty pharmacy as well. The company assists health plans in managing drug costs by designing drug formularies, negotiating discounts with pharmaceutical companies, and processing claims. Members may fill their prescriptions through a network of about 60,000 pharmacies, a mailorder program, or the company's callcenter and Internet pharmacies. Medco Health Solutions manages drug benefits for clients that include unions, corporations, HMOs, insurance companies, and federal employees. Customer cost containment is the cornerstone of the company's business Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Laizer D. Kornwasser SVP Channel and Generic Strategy; President, Liberty Medical 84 strategy. Medco Health Solutions is able to control costs through the use of technology to process prescription claims, automation to fill and distribute prescriptions, and volume purchasing of pharmaceuticals. It also encourages the use of its mail order pharmacies and of generic equivalents in place of more expensive brand name drugs. Medco's mail order business is a big part of this cost reduction strategy. With seven order-processing pharmacies and two automated dispensing pharmacies scattered across the country, the company fills more than 100 million prescriptions a year. It uses this scale to get better deals from suppliers and to force stricter compliance with health plan formularies. To expand capacity and improve efficiencies in the division, the company is building a third automated mail-order pharmacy fulfillment center in Indiana, scheduled for completion by the end of 2010. Within its mail order pharmacy segment, Medco has instituted what it calls Medco Therapeutic Resource Centers, which are specialized groups of pharmacists who are focused on certain chronic or complex diseases. One of its largest Therapeutic Resource Centers provides diabetes supplies under the Liberty Medical brand (which it gained through the 2007 purchase of PolyMedica). The company further Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 85 enhanced the Liberty division when it bought the diabetes distribution assets of Owens & Minor subsidiary Access Diabetic Supply for $63 million in 2009. Another key component of the company's strategy is the growth of Accredo Health, which dispenses sensitive biotechnology drugs, usually injectable or infusion drugs, to patients with serious diseases such as cancer and hemophilia. Accredo delivers medications and related supplies either to patient homes or clinical sites from three main distribution centers in Tennessee and Pennsylvania. Within its traditional retail pharmacy operations, Medco has been working to expand its complementary service offerings to help pharmacists, patients, and payers select the the most costefficient and accurate medical regime. To further this goal, in 2010 the company acquired personalized medicine company DNA Direct, a telemedicine provider of advisory services for gene-based and biological medicines. It has also established the Medco Research Institute to pursue discovery efforts in pharmacogenomics, or the study of how a patient's genetic profile can assist in the physician's prescription selection process. Medco has also been trying to take advantage of the Medicare Part D Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 86 prescription drug benefit, by tailoring some services to clients offering Part D programs or other drug coverage to their Medicare-eligible members. It has also contracted with the Centers for Medicare & Medicaid Services to offer a Medicare Part D drug plan of its own. Medco went international in 2008 when it purchased a majority stake in Dutch firm Europa Apotheek Venlo, which provides mail order pharmacy and other health care services in the Netherlands and Germany. Earlier the same year, the company partnered up with Apoteket, the Swedish government agency that oversees retail pharmacy operations in that country, to develop an automated prescription-review system. In 2009 Medco formed a partnership with United Drug to provide specialty pharmacy services in patients homes in the UK 5. Omnicare, Inc 1600 RiverCenter II 100 E. RiverCenter Blvd. Covington, KY 41011 United States Phone: 859-392-3300 Fax: 859-392-3333 www.omnicare.com 6,166.2 15,200 Omnicare strives to be omnipresent in US nursing homes. The firm is the country's largest institutional pharmacy services provider, dispensing drugs to nursing homes, assisted-living centers, and other long-term care facilities in the US and parts of Canada. It also provides clinical and financial software and consulting services to long-term care facilities, as well as infusion and respiratory therapy products and services for nursing home residents Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Deborah Brewer SVP Global Business Development 87 and hospice patients. The company has some 250 pharmacy and distribution locations across the US, and it serves health care facility customers with a combined capacity of some 1.4 million patient beds. The highly acquisitive Omnicare expands its operations by purchasing small, independent institutional pharmacies and integrating them into its organization; it made more than 20 such acquisitions in 2008 and 2009. The company has had to be nimble to absorb its many acquisitions, however, and keep up its level of service without losing customers. It has also struggled against lower reimbursements on drugs from health insurers. Omnicare has responded to these challenges with a number of customer retention efforts and restructuring initiatives aimed at improving quality and efficiency. The company has been reorganizing its operations into a "huband-spoke" model, moving more administrative activities, as well as some routine prescription refilling, to larger regional hubs where scale, centralization, and automation can produce greater efficiency. Smaller local pharmacies (the "spokes") in turn focus on activities requiring direct customer interaction. The company has also been working to divest some small businesses, such as its home health operations, that don't fit in with its Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 88 core operations. Omnicare's Pharmacy Services division, which includes its institutional pharmacy operations, brings in over 95% the company's revenue. Serving nursing homes and their residents, the institutional pharmacy unit fills and dispenses prescriptions to customers, monitors medication safety and process efficiencies, and provides purchasing, billing, and inventory services. In addition, the Pharmacy Services division offers consulting, compliance, and data management services and operates divisions providing specialty pharmacy (infusion and other complex medications), pharmacy benefits management (PBM), and disease management services. Though it primarily serves long-term care facilities, the division also serves some hospitals, hospice organizations, and other health care centers. A second division, CRO Services (operating as Omnicare Clinical Research) provides contract clinical drug research and development services to pharmaceutical, biotech, and medical device companies. Its Clinimetrics unit focuses on biotechnology clients. Another Clinical Research unit specializes in assisting drug companies with the development of new treatments for the elderly. In late 2009 the company agreed to Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 89 pay $98 million to settle allegations from the US Department of Justice that it had accepted kickback payments from drug manufacturers and nursing homes. Omnicare settled the charges without admitting any wrongdoing. Omnicare sued UnitedHealth Group over reimbursement reductions in its Medicare Part D prescription drug coverage in 2006, but a summary judgment by an Illinois federal court dismissed the lawsuit in 2009. Omnicare has appealed the ruling 6. Express Scripts, Inc 1 Express Way St. Louis, MO 63121 United States Phone: 314-996-0900 www.express-scripts.com 24,748.9 14,270 Express Scripts knows that its customers like their drugs fast. One of the largest pharmacy benefits management (PBM) companies in North America, Express Scripts administers the prescription drug benefits of millions of health plan members in the US and Canada. Members have access to a network of about 60,000 retail pharmacies, as well as the company's own mail-order pharmacies. Express Scripts processes claims for about 750 million prescriptions per year, designs drug plans, and offers such services as disease management programs and consumer drug data analysis. Clients include HMOs and other health insurers, self-insured businesses, and union benefit plans. Express Scripts is one of the top three players in the PBM industry, the other Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Agnes Rey-Giraud President, International Operations 90 two being Medco and Caremark Pharmacy Services. The company and the industry have grown rapidly, as the PBMs strive to save money for their customers by negotiating good deals for prescription drugs with networks of retail pharmacies, as well as by encouraging the use of cheaper generic drugs and home-delivered medications. The company grew substantially in 2009 with the acquisition of NextRx, the PBM business of Blue Cross Blue Shield (BCBS) licensee WellPoint, for about $4.7 billion. As part of the acquisition, the company has a 10-year contract to provide PBM services to WellPoint, the nation's largest health insurer. The purchase launched Express Scripts closer to its top two rivals by increasing its claims processing load from 500 million to more than 750 million prescriptions per year. It also enhanced the company's online, generic drug, and mail delivery service offerings. Express Scripts had previously expanded its PBM operations in 2008 by purchasing the pharmacy services division of Medical Services Company for $251 million. The acquired business specialized in managing pharmacy benefits for workers' compensation insurers. In addition, Express Scripts opened a new pharmacy fulfillment center in St. Louis in 2010. The center supports the company's growing home Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 91 delivery business, which is experiencing increased demand from clients and patients seeking to cut costs on traditional maintenance medications through the use of mailorder services. Another element of Express Scripts' PBM business that is experiencing higher consumer demand is specialty pharmacy subsidiary CuraScript. Through its primary operating unit, CuraScript Specialty Pharmacy (or CuraScript SP), the subsidiary provides home distribution of specialty prescriptions (primarily injectable biotech drugs that require special packaging and handling); the unit also delivers to doctors' offices and other health care providers. To focus on its core distribution operations, the company divested its CuraScript Infusion Pharmacy business, which operated infusion therapy centers in six states, to Walgreen's Option Care subsidiary in 2008. In 2009 Express Scripts expanded its contract with the US Department of Defense, adding a number of services beyond its existing management of the pharmacy network of the TRICARE military health care program. The contract now includes home delivery, specialty pharmacy, claims management, and other integrated offerings. While its PBM operations account for Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 92 the lion's share of Express Script's revenues, the company has also been looking to expand into new highgrowth fields of managed care through its Emerging Markets segment. It has added such services as group purchasing for doctors and clinics (through CuraScript Specialty Distribution, or CuraScript SD), fertility drug packaging and delivery (Freedom FP), and third-party administration of consumer-driven health plans (ConnectYourCare). In addition, Express Scripts assists pharmaceutical and biotech companies with activities such as delivering marketing samples to doctors and providing customized packaging and logistics services through its HealthBridge division 7. AmerisourceBergen Corporation 1300 Morris Dr. Chesterbrook, PA 19087-5594 United States Phone: 610-727-7000 Fax: 610-727-3600 www.amerisourcebergen.com 71,760.0 10,300 AmerisourceBergen is the source for many of North America's pharmacies and health care providers. The company serves as a go-between for drugmakers and the pharmacies, doctors' offices, hospitals, and other health care providers who dispense drugs. Operating primarily in the US and Canada, it distributes generic, branded, and over-the-counter pharmaceuticals, as well as some medical supplies and other products, using its network of more than two dozen facilities. Its specialty distribution unit focuses on sensitive and complex biopharmaceuticals, such as cancer drugs, vaccines, and plasma Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Gener al Manag er Mike Hamil ton 93 products. The company also has some pharmaceutical packaging operations. AmerisourceBergen has one division through which it operates a number of business segments. The Pharmaceutical Distribution division is comprised of three operating segments which include AmerisourceBergen Drug Corporation (ABDC), AmerisourceBergen Specialty Group (ABSG), and AmerisourceBergen Packaging Group (ABPG). ABDC is the business arm that distributes generic and brand-name pharmaceuticals, over-the-counter products, and home health care supplies and equipment to medical providers, pharmacies, and the like throughout North America. ABSG, the company's specialty distribution operations, are growing at a fast clip, outpacing the growth experienced by the rest of the business. AmerisourceBergen intends to continue growing the unit that delivers drugs for particular diseases (especially cancer) to the doctors who administer them. The unit also provides marketing and other services to drugmakers, helping them successfully launch new biotech drugs. Other services to pharmaceutical manufacturers include consulting and reimbursement support. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 94 The specialty packaging group (ABPG) provides contracting packaging services to drug manufacturers in North America and the UK. The company sells its products through an in-house sales force that is organized regionally and specialized by healthcare provider type. Acquisitions have helped AmerisourceBergen expand its reach to new customer segments and geographic markets. For example, its $180 million purchase of Bellco Health a few years ago increased its access to independent community pharmacies in the New York City area. (Bellco's operations have since been parceled out to the ABDC and ABPG segments.) AmerisourceBergen expanded into Canada through several key acquisitions that made it that country's second largest drug distributor. AmerisourceBergen further cemented its position in Canada in 2009 by acquiring Innomar Strategies for about $14 million. Innomar is a specialty pharmaceutical services company offering logistics management, patient assistance, and clinical research. AmerisourceBergen tapped into the growing market for electronic health records (EHR) in 2010 when the company by offering consulting services to hospitals and other health care providers looking to go digital with EHRs. The company helps EHR users Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 95 understand how to meet new compliance guidelines set by the Centers for Medicare & Medicaid Services. The company offers the service, which includes a review of clinical operations to help identify gaps in compliance, through its Pharmacy Healthcare Solutions health care consulting business unit. Along with tapping into new markets, the company has also worked to streamline its existing operations by expanding some distribution facilities while closing others. Since 2001, the firm has cut its distribution facility network in half -- from 51 to 26 facilities. It chose to close operations with administrative redundancies and could be easily consolidated into other, existing facilities. AmerisourceBergen spun off its PharMerica subsidiary a couple of years ago, which delivers pharmaceuticals and provides drug dispensing services in nursing homes and other long-term care institutions. It spun off the business as PharMerica Long-term Care and merged it with Kindred Healthcare's institutional pharmacy unit to form the new PharMerica entity. The combined entity became the second-largest institutional pharmacy operator in the US. To further narrow its focus on its core Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 96 pharmaceutical distribution operations, AmerisourceBergen sold its PMSI unit in 2008 for $34 million. PMSI provided workers' compensation services to insurance companies and other health care payers. Institutional clients (health care providers and facilities and mail-order pharmacies) account for about 70% of the Pharmaceutical Distribution division's sales, while retailers (chain drugstores, independent pharmacies, and supermarket and mass merchandiser pharmacies) make up the rest. AmerisourceBergen's top client is pharmacy benefit manager Medco Health Solutions, which accounts for about 15% of revenue 8. PharMerica Corporation 1901 Campus Place Louisville, KY 40299 United States Phone: 502-627-7000 www.pharmerica.com 1,841.2 6,900 PharMerica's former parents were kindred spirits who believe in the power of two. Created through the spinoffs and merger of Kindred Pharmacy Services (from Kindred Healthcare) and PharMerica Long-term Care (from AmerisourceBergen), PharMerica is the country's secondlargest institutional pharmacy operator (behind Omnicare). The publicly-traded company provides purchasing, packaging, and dispensing of prescription and nonprescription drugs to patients at nursing homes, assisted living facilities, and psychiatric hospitals in more than 40 states. PharMerica operates about 100 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Robert Mckay SVP Sales and Marketing 97 institutional pharmacies from which it packages and delivers the medications in unit doses (rather than in bulk) to its customers. PharMerica also provides consulting services to skilled nursing and longterm care facilities in which specialists monitor drug usage in accordance with government regulations. The company also manages on-site pharmacies at more than 80 US hospitals, most of them belonging to the Kindred Healthcare family. Services include patient safety and regulatory compliance, work force optimization, and drug utilization management. Other services include inventory control and budgetary analysis. In the company's 2007 merger, PharMerica Long-term Care contributed some 80 regional pharmacies that served more than 200,000 patients, while the smaller Kindred Pharmacy Services added another 46 pharmacies serving more than 100,000 patients. Also as part of the deal, PharMerica agreed to purchase nearly all (95%) of its prescription pharmaceuticals from AmerisourceBergen for five years, ending in 2012. The company's growth strategy hinges upon developing its business in its existing markets by adding new customers and by using its larger size to grab business away from its competitors in those markets. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 98 PharMerica is also on the lookout for acquisition targets (including snapping up its competitors when it can) particularly among the small, regional providers that abound in the fragmented institutional pharmacy marketplace. It found one such target in early 2010 when it agreed to buy fellow institutional pharmacy provider Integrity Pharmacy Services, which expanded PharMerica's operations further into Florida, Massachusetts, and Pennsylvania. PharMerica receives the nearly half of its annual pharmacy services revenue from government payor, primarily Medicare. Other payors include institutional health care providers, commercial insurance companies, and contracted providers. The company intends to beef up its generic drug dispensing rates as a way to reduce costs and capture more customers. About three-quarters of the prescription drugs PharMerica dispenses are generic, and it expects to increase that number as more pharmaceutical companies lose exclusivity patents and additional generics are introduced to the market 9. Accredo Health, Incorporated 1640 Century Center Pkwy. Memphis, TN 38134 United States n/a 6,530 Accredo Health is one pharmacy where you won't be able to pick up a bottle of aspirin. As the specialty pharmacy Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Michael A. James President CommercialStrateg 99 Phone: 901-385-3688 Fax: 901-385-3689 www.accredo.com segment of pharmacy benefits manager Medco Health, Accredo dispenses high-tech injectable and infusion drugs for chronic and serious illnesses such as cancer, multiple sclerosis, hemophilia, pulmonary arterial hypertension (PAH), and certain autoimmune disorders. Under contracts with managed care organizations and drugmakers, it delivers drugs and related supplies in temperature-controlled packaging to patient homes or clinics. It also provides consulting and monitoring services to make sure patients are complying with their drug regimens, and it files claims on behalf of patients and doctors. The company dispenses drugs from three main pharmacies (located in Pennsylvania and Tennessee) and through a number of satellite facilities across the US. Parent Medco aims to expand Accredo's service offerings to provide patient solutions that simplify administration processes and control drug costs. President CommercialStrategy and Operations The organization's specialty pharmacy services are offered through divisions including Hemophilia Health Services, which specializes in therapeutics for bleeding disorders. Another unit, Critical Care Systems (acquired in 2007), provides patient infusions at outpatient clinics or in patients' homes Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 y and Operations 100 for anti-infective, nutritional, pain management, and chemotherapy treatments, among others. Though most of Accredo's dispensed products are injectable or infusion therapies, it also deals with some complex inhaled and oral medicines that require enhanced patient support services. An affiliated company, Proherant Health (formerly Accredo Clinical Business Solutions), offers support services to pharma, biotech, and medical device companies. Its services -- including doctor and patient education and clinical call center support -- aim to assist clients in successfully launching their products. Accredo Health was acquired by Medco for $2.3 billion in 2005 10. US Oncology, Inc 10101 Woodloch Forest The Woodlands, TX 77380 United States Phone: 281-863-1000 Toll Free: 800-381-2637 www.usoncology.com 3,511.7 9,700 US Oncology has got the backs (and the back offices) of more than 1,300 oncologists across the US. The company, which is majority-owned by investment firm Welsh, Carson, Anderson & Stowe, provides management and support services to some 500 oncology practices and radiation treatment centers throughout the US. Its range of management services includes billing, recruiting, data management, drug purchasing, and accounting. It also offers a separate drug purchasing service, negotiating prices with pharmaceutical and biotech companies for specialty Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Rolando De Cardenas VP, Pharmaceutical Distribution 101 cancer drugs and distributing them to client practices. Additionally, US Oncology helps its affiliate practices expand into full-fledged cancer treatment centers. US Oncology has helped develop more than 80 such cancer centers, and it has ownership stakes in about half of those. It also manages some 15 radiation clinics. The company provides development capital and shepherds its medical practices through the process of negotiating regulatory issues, building the facilities, and setting up operations. For independent practitioners, the company either offers a comprehensive management package or select offerings on a feefor-service basis. Clients can also elect to only participate in the group purchasing and distribution segment. Along with its services aimed at cancer doctors, the company serves pharmaceutical and biotechnology firms by designing and supervising cancer-related clinical trials. It enlists its affiliated physicians in the trials, thus giving them access to the latest available treatments. The company also provides services to insurance companies to help them avoid unnecessary care costs. US Oncology works to steadily expand its network of affiliated practices, which already includes some 1,300 doctors. It has also been expanding its Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 102 drug distribution and mail-order operations, and it plans to grow its offerings for pharmaceutical companies. In early 2008 long-time CEO Dale Ross resigned and was replaced by company president Bruce Broussard. Ross remained with US Oncology for another year as executive chairman. Investment firm Welsh, Carson, Anderson & Stowe (WCAS) owns more than 70% of the company. Directors Scott Mackesy and Russell Carson are general partners of WCAS 11. Watson Pharmaceuticals, Inc 311 Bonnie Cir. Corona, CA 92880-2882 United States Phone: 951-493-5300 Fax: 973-355-8301 www.wstsonpharm.com 2,793.0 5,830 Watson Pharmaceuticals tries to have the best of both worlds, with operations in the US generics market and the higher-profit-margin branded drug business. The company's broad generics portfolio of about 140 products includes treatments for hypertension and pain, as well as smoking cessation products, antidepressants, and oral contraceptives. Its line of about 30 branded drugs focuses on urology and nephrology; it markets its branded products, including treatments for iron deficiency anemia and overactive bladder, to specialist physicians in the US. Additionally, Watson distributes its own and third-party products to independent pharmacies and health care providers through its Anda and Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Andrew Boyer SVP Sales and Marketing, U.S. Generics Division 103 Valmed subsidiaries. Watson Pharmaceuticals' bread and butter is its generics line, accounting for about 60% of sales. An important part of the company's generics business is its generic oral contraceptive line. Watson has a leading position in the US in generic oral contraceptives with roughly two dozen different oral contraceptive products and about a 35% market share. Its top five oral contraceptives TriNessa, Low-Ogestrel, Necon, Lutera, and Microgestin, account for almost 50% of the total Watson oral contraceptives portfolio. The generics business overall has struggled with the loss of a key product and the general decline of generics revenue over time. The big loss came a few years ago when a distribution agreement with Purdue Pharma for oxycodone HCl (generic OxyContin) ended. Name-brand drug companies sometimes authorize an "official" generic form when a drug goes off-patent, in order to recoup some losses that inevitably result from generic competition. Watson had distributed the authorized generic of OxyContin since the drug lost patent protection in 2005, and the drug was a big contributor to the company's revenue. Watson's strategy for combating declining sales (as well as the loss of Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 104 the OxyContin deal) is to develop and acquire new products to beef up its pipeline. In 2009 alone the company launched about a dozen new products including Metoprolol ER to treat angina, emergency contraceptive NextChoice, and Galantamine for the treatment of Alzheimer's disease. The previous year Watson introduced a generic version of Biovail's antidepressant Wellbutrin XL, Johnson & Johnson's Duragesic pain patch and its Alzheimer drug Razadyne, Duramed's Mircette oral contraceptive, and GSK's Nicorette smoking cessation gum. Additionally, the company copromotes AndroGel, a male hormone replacement therapy, with Unimed and distributes an authorized generic of Merck's Fosamax. To pick up a few more products, expand its development pipeline, and broaden its geographic presence, Watson spent about $1.75 billion to acquire privately held Arrow Group in 2009. Arrow develops and manufactures generic pharmaceuticals in Canada, Malta, and Brazil and distributes its products in more than 20 countries. Major products in the company's branded drug segment include prostate therapies Trelstar and Rapaflo. Watson is building its branded product line through several partnerships and joint ventures, as well as through Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 105 acquisitions of later-stage drug candidates. Because it relies on partnerships to augment its product line, the company's bottom line is also vulnerable to the expiration of those deals. For example, Watson lost a key product in 2009 when its license agreement with Sanofi-Aventis for anemia drug Ferrlecit ended. To stave off losses related to losing licenses, Watson has been trimming costs by consolidating some operations and moving some manufacturing operations overseas. It established a plant in Goa, India, for example, and has announced the closures of some US facilities, including the planned closure of a facility in Carmel, New York (it will transfer these operations to Goa). It owns or has invested in plants in China and other parts of India and plans to continue its overseas growth; however, Watson divested its interest in an API (active pharmaceutical ingredient) plant in Taiwan in 2010 after deciding that the operation was not key to the company's long-term growth strategy 12. Prescription Solutions, Inc 2300 Main St. Irvine, CA 92614-9731 United States Phone: 949-442-8081 14,452.0 3,500 Prescription Solutions has the Rx for insurance providers reeling from high drug costs. The company provides pharmacy benefit management (PBM) services to health insurers, managed care organizations, employers, unions, and other clients, representing more Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Brian Solow VP Clinical Services and Senior Medical Director 106 www.prescriptionsolutions.com than 10 million members nationwide. Its services range from formulary management and benefit design to pharmacy network management, online reporting, and claims processing. The company also operates two mail order pharmacies and provides specialty pharmacy services for high-cost biotech drugs. Founded in 1993, Prescription Solutions is a subsidiary of UnitedHealth. Along with its commercial and union members, Prescription Solutions manages the Medicare Part D prescription drug benefits of millions of US seniors. The company works through a network of about 65,000 pharmacies across the US, as well as its two mail order pharmacies located in Carlsbad, California, and Overland Park, Kansas. In order to improve its profit margins, Prescription Solutions has been promoting the use of its mail order pharmacy services and cheaper generic drugs. It encourages the use of generic drugs by offering reduced or no co-pays for generics through mail service; providing a generic sampling program for physicians; and offering a real-time Web tool for Medicare Part D customers that compares retail with mail order pricing and brand with generic pricing. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 107 As part of its strategy to promote the use of its online mail order business, the company has expanded ordering options to include a range of over the counter medications and personal care products such as first aid ointments, pain relievers, and vitamins. In addition to order fulfillment and benefit design consultation, the company's pharmacy management services include drug utilization reviews, disease therapy management, and adherence programs, all designed to help clients keep drug costs manageable by identifying high-usage areas and clients and then determining ways to make their usage more efficient (such as through the use of generic drugs or by disseminating information about how to live healthier lifestyles). In addition to its pharmacy management services, Prescription Solutions operates a consumer health products business that delivers medical supplies, including home respiratory equipment and diabetes testing materials, to patients' in their homes. UnitedHealth gained Prescription Solutions when it acquired PacifiCare Health Systems in 2005, and it established the unit as one of its main reporting segments in late 2007. Prescription Solutions' operations account for about one quarter of its Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 108 parent company's revenues 13. Kinray Inc 152-35 10th Ave. Whitestone, NY 11357 United States Phone: 718-767-1234 Fax: 718-767-4388 www.kinray.com 5,100.0 1,000 Kinray, the US's top private wholesale drug distributor, is nothing if not independent. It provides generic, branded, and repackaged drugs, health and beauty products, medical equipment, vitamins, and diabetescare products. The distributor also offers about 800 private label products under the Preferred Plus Pharmacy brand. It serves more than 4,000 independent pharmacies, long-term care facilities, and specialty pharmacies in states stretching from Maine to Delaware; though Kinray is looking to supply generic drugs to pharmacies nationwide. The firm was founded in 1944 by Joseph Rahr. His son, CEO and president Stewart Rahr, has owned Kinray since 1975. Like its bigger rivals McKesson, Cardinal Health, and AmerisourceBergen, Kinray had depended on speculative buying (the practice of stocking up on drugs it anticipated were about to go up in price) for much of its rapid growth. However, that mode of operation took a hit when Bristol-Myers Squibb was sued by the SEC over the practice several years ago. The company also faces stiff competition from mail-order pharmacies, and in response has stepped up its online ordering Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Jean Kappes VP Generic Sales and Business Development 109 capabilities with its Weblink system. The system allows pharmacies to view real-time pricing information, generate reports, invoices, and statements for inventory management, and order class 2 controlled drugs using Kinray's Controlled Substance Ordering System (CSOS). Kinray is also focused on selling higher-margin generic drugs, a big part of its business, and private-label home health care products. In addition, the company offers merchandising and marketing programs, including retail pricing consultation, shelf-labeling, and promotional materials. The company's stock of goods doesn't stop at medical supplies and prescription drugs. Other products include DVDs, fragrances, and household items (both branded and the private Preferred Plus Pharmacy label). Kinray's billionaire CEO and owner, Rahr also operates an informal lending system in which he finances local pharmacy owners looking to expand through acquisitions or to make up financial shortfalls. Rahr's lending activities have grown to about $30 million, with the tycoon charging prime plus 1% interest on loans of up to about $1 million 14. Stephen L. LaFrance Pharmacy, Inc 3017 N. Midland Dr. 560.0 1,500 Stephen L. LaFrance Pharmacy (dba USA Drug) boasts more than 150 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Frank Muller Manager Sales 110 Pine Bluff, AR 71603 United States Phone: 870-535-2411 Fax: 870-535-5601 www.usadrug.com drugstores in Arkansas, Mississippi, Missouri, Tennessee, and Oklahoma. Besides USA Drug, company banners include Ike's Discount, Super D Drugs, May's Drug Stores, Drug Warehouse, and Med-X Drugs. The pharmacy chain franchises locations and fills prescriptions and sells home health care products online at usadrug.com. It markets its own line of merchandise under the Select Brand name. The firm's wholesale distribution operation, SAJ Distributors, supplies health, beauty, and general merchandise to discount, drug, and grocery stores. Founded in 1968 by pharmacist and chairman Stephen L. LaFrance, the company is still family-owned and operated. The regional drugstore operator provides shoppers an alternative to the megachains, such as Walgreen and CVS, which each number more than 6,000 locations. The company caters to individual markets with a variety of banners. About a third of its stores are USA Drug Express outlets, which measure between 2,000 to 3,500 square feet, and sell only pharmaceuticals and first aid supplies, such as bandages, and nonprescription pain relievers and other medicines. The remaining stores are all full-service outlets with a broad selection of front-end merchandise. Its Ike's stores in the Memphis, Tennessee market, measure about 40,000 square Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 111 feet. Like the bigger chains, some of the firm's pharmacies are opening instore health clinics to provide routine medical and first aid care. In 2007 the company struck a deal with MedBasics to begin opening medical clinics within certain USA Drug stores for a total of 60 within three years. The regional drugstore operator acquired 22 Med-X stores and the 39store May's chain in mid-2004 15. J M Smith Corporation 101 W. St. John St. Ste. 305 Spartanburg, SC 29306 United States 2,367.1 950 Phone: 864-542-9419 Fax: 864-582-6585 www.jmsmith.com 16. Diamond Drugs, Inc 645 Kolter Dr. Indiana, PA 15701-3570 United 240.0 750 J M Smith Corporation has gone from corner drug store to serving drug stores and more. A holding company serving pharmacies and government agencies, the company consists of Smith Drug Company, Integral Solutions Group, QS/1 Data Systems, and Smith Premier Services. Smith Drug Company provides purchasing and distribution services for independent pharmacies, while QS/1 develops computer systems for medical equipment providers, institutional pharmacies, and related businesses. Smith Premier Service offers prescription benefit management services for employers and insurance carriers. Integral Solutions serves local government agencies providing hardware, software, forms and offering data processing services Many of Diamond Drugs' customers are behind bars. The company, through its Diamond Pharmacy Services unit, Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Dave Brown General Manager Barbara Wilson Manager 112 States Phone: 724-349-1111 Fax: 724-349-2945 www.diamondpharmacy.com 17. Quality King Distributors Inc 2060 9th Ave. Ronkonkoma, NY 11779 United States n/a 850 n/a 400 Phone: 631-737-5555 Fax: 631-439-2388 www.qkd.com 18. The Harvard Drug Group, L.L.C 31778 Enterprise Dr. Livonia, MI 48150 United States provides pharmacy services to correctional facilities for adults and juveniles in some 40 states and Puerto Rico. Diamond Pharmacy Services also serves nursing homes across Pennsylvania, offering medical records services, formulary management, and respiratory and intravenous therapies. The company also operates Diamond Drug retail drugstores and a medical supply business in its hometown of Indiana, Pennsylvania. The company is owned and operated by the Zilner family Quality King Distributors rules a gargantuan gray-market empire. It buys US name-brand OTC pharmaceutical and branded personal care products that have been exported to overseas markets, re-imports them, then sells them below suggested retail prices. The practice, deeply disliked by US manufacturers, has been ruled legal by the Supreme Court. Quality King distributes its products to pharmacy and grocery chains, grocery distributors, and wholesale clubs throughout the US. Subsidiary QK Healthcare distributes branded and generic prescription pharmaceuticals. Bernard Nussdorf and his wife Ruth founded Quality King in 1961 in Long Island, New York. The Nussdorf family still owns the company Drugs, not scholars, are what come out of this Harvard. The Harvard Drug Group distributes branded and generic prescription and OTC drugs, vitamins, Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Michael Ross Sales Director Robert Brown SVP Business Development and General Counsel 113 Phone: 734-743-6000 Fax: 734-743-7000 www.theharvarddruggroup.com and consumer products to independent pharmacies, retail pharmacy chains, and buying groups through more than 100 sales representatives and through partnerships with about 35 different vendors. The firm also offers manufacturing services through its partnership with Canadian drugmaker Apotex. Founded as Great Lakes Wholesale Drug in 1967, a steady regimen of acquisitions helped it transform into The Harvard Drug Group in 1997. The company is controlled by investment firm Court Square Capital Partners. In 2010 Court Square acquired Harvard Drug Group from its former controlling shareholder, H.I.G. Capital. The company had been purchased through a management buyout (MBO) transaction led by investor H.I.G. in early 2007. Along with its generics, the company carries more than 3,000 brand products and 600 controlled substances. The group has five sales offices and three distribution centers nationwide. One of the company's biggest customers is the federal government, to which it provides more than 600 different items on the federal supply schedule. Harvard Drug distributes its products through four subsidiaries. The Major Pharmaceuticals division provides consumer products. Medical supplies Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 114 are offered its through Expert-med division. Its compounding agents are distributed though Letco Medical and veterinary products through its RS Veterinary Supply division. The company plans to grow its all of its business segments through acquisitions of specialty distributors and other suppliers 19. Fagen Pharmacy 915 S. Halleck DeMotte, IN 46310 United States 55.0 254 n/a 500 Phone: 219-987-6468 Fax: 219-987-7226 www.fagenpharmacy.com 20. H. D. Smith Wholesale Drug Company 3063 Fiat Ave. Springfield, IL 62703 United States It's all in the family at Fagen Pharmacy. The company operates more than 20 drugstores in small towns and midsize cities throughout northwest Indiana and the Chicago suburbs. Its store formats vary and include full-line drugstores, pharmacies within supermarkets, and one pharmacy that supplies assisted living facilities with pharmaceuticals. It also operates an online pharmacy. Like its national competitors, such as Walgreen and CVS, the chain offers health screenings, immunizations, and other in-store services. The family-run regional drugstore chain, founded by president and CEO Gerald Fagen as a single 4,000 sq. ft. location in 1972, has grown by acquiring independent drugstores With a name like Smith you might think it's all about generics, but H. D. Smith Wholesale Drug is more than that. The company supplies pharmaceuticals (brand name and generic), over-the-counter Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Melissa Fagen Director, Retail Operations 115 Phone: 217-753-1688 Fax: 217-467-8299 supplements, and other health care products to pharmacies, hospitals, and retailers. It also provides inventory management services for government agencies, including most branches of the military, veterans clinics, and federal prisons. In addition to supplying drugs, H. D. Smith offers a variety of marketing and merchandising services including pointof-purchase signage, store design, direct-to-consumer advertising programs, and loyalty program implementation. www.hdsmith.com H. D. Smith includes Texas Drug Company, Smith Medical Partners (its injectables and vaccine distributor), Barnes Wholesale Drug (California), and J.J. Balan (a generic drug telemarketer). It also has distribution warehouses in Illinois, Kentucky, New Jersey, Florida, and New Hampshire. The company announced a $46 million expansion project at its headquarters facilities in Illinois in 2007. Chairman Emeritus Henry Dale Smith founded the company in 1954. His descendents, Henry Dale Smith Jr. and J. Christopher Smith, hold the positions of CEO and president, respectively 21. Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015 United States Phone: 847-914-2500 63,335.0 238,000 Walgreen offers an old-fashioned tonic for fiscal fitness: quality over quantity and homespun growth rather than growth through acquisitions. It works. It operates nearly 7,500 drugstores in Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 116 Fax: 847-914-2804 www.wallgreens.com 50 states, the District of Columbia, Guam, and Puerto Rico, as well as two mail-order facilities. Prescription drugs account for about two-thirds of sales; the rest comes from general merchandise, over-the-counter medications, cosmetics, and groceries. Walgreen usually builds rather than buys stores, so it can pick prime locations. Most stores offer drivethrough pharmacies, and almost all offer one-hour photo processing. Walgreen is slowing future store openings to focus on strengthening existing stores. Walgreen's strategic shift coincides with a change in leadership, the deep recession and looming health care reform in the US, and follows a defeat by archrival CVS in a takeover battle for Longs Drug Stores in late 2008. Walgreen proved more successful in its acquisition of the specialty pharmacy business of McKesson Corporation, completed in December 2008. It made the purchase to further strengthen the #4 position of its Walgreens Specialty Pharmacy business. The sick US economy slowed sales and earnings growth, along with prescription drug sales, in fiscal 2009 and 2008 (relative to previous years) and caused Walgreen to curtail its break-neck pace of organic growth. In fall 2008 the firm announced that it will cut costs, unclutter its stores, and Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 117 change the way it fills prescriptions in response to increased competition and slowing drug sales. In 2009 the company trimmed its management ranks by about 1,000 positions (about 9% of its corporate management). To grow sales at existing stores, the company plans to begin selling beer and wine at about 3,100 of its stores as it procures liquor licenses. (Rivals CVS and Rite-Aid also stock alcohol in their stores.) Still, in fall 2009 the company opened its 7,000th drugstore and sees long-term potential for more than 13,000 US stores. With the opening of a store in Wasilla, Alaska, in mid-2009, Walgreen stamped its retail footprint on all 50 US states. Meanwhile, it picked up a regional rival that wasn't faring too well. Walgreen paid about $1 billion (including some $460 million in debt) for New Yorkbased drugstore chain Duane Reade. The purchase made Walgreen the market leader in New York City, adding Duane Reade's 250-plus stores in the metro area to Walgreen's 70 locations. The move is a strategic one for Walgreen, which is looking to expand in urban areas. Duane Reade was founded in lower Manhattan and was purchased from private equity firm Oak Hill Capital Partners. In recent years, the regional chain has worked to develop a new "urban box" store format to maximize sales per square foot in densely populated Manhattan. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 118 Walgreen plans to retain the Duane Reade name, as well as many Duane Reade employees. Walgreen boasts additional pending purchases, including about 20 Ike's and Super-D drugstores, based in Memphis, Tennessee, to be acquired from USA Drug. Walgreen also is buying several drugstores in Puerto Rico from El Amal. In early 2010 the uber retailer completed the acquisition of a dozen Eaton Apothecary pharmacies in Boston from Nyer Medical Group. The Eaton Apothecary deal was part of Nyer Medical Group's liquidation and is worth about $20 million. The pharmacy operator also bought 25 pharmacies from Snyder's Drug Stores, located in Minnesota, in 2010. (Ailing Snyder's was owned by Canada's Katz Group.) In 2009 the company acquired about a dozen Rite Aid locations and 30-plus stores from New Jersey-based Drug Fair. The scaled-back growth plan through 2011 is designed to reduce capital spending by about $1 billion and free up cash for investment in other activities. Walgreen also aims to play an increasingly important role in the solution to America's health care crisis through about 375 convenient care instore clinics operated by Take Care Health Systems. In a bid to diminish its reliance on retail stores for growth and expand its in-store network of health Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 119 clinics, Walgreen formed a new Health and Wellness division to operate clinics and pharmacies at large-company worksites. To that end, it has acquired two operators of worksite health centers, I-trax, Inc and Whole Health Management. Previously, Walgreen acquired in-store health clinic operator Take Care Health Systems, which managed about 145 clinics in about a dozen states, and made it part of the new Health and Wellness division. Walgreen also provides additional services to pharmacy patients and prescription drug and medical plans through Walgreens Health Services. The company's Walgreens Health Initiatives subsidiary offers specialty pharmacy, mail-order pharmacy, and pharmacy benefits management services. With more prescription drug business going to managed-care health plans, convenience has trumped price in the race to attract new customers. (Copays are the same at any chain, and sick folks are often short on patience.) Walgreen has led the movement in creating a "convenience drugstore" chain with freestanding stores. The strategy has several advantages. Walgreen's freestanding stores are more visible than those in strip malls and offer shoppers ample parking and easy in-and-out access. About a fifth of its stores are open 24 hours a day and the abundance of drive-through Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 120 pharmacies adds to the chain's convenience offerings. Because convenience also means being closer to customers, Walgreen builds new outlets at high-traffic locations (sometimes relocating new stores to better locations just blocks away) ΚΑΤΑΣΤΑΣΗ ΤΩΝ ΜΕΓΑΛΥΤΕΡΩΝ GENERIC ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΕΤΑΙΡΕΙΩΝ ΣΤΙΣ ΗΠΑ A/A COMPANY NAME, ADDRESS, PHONE, FAX 1. Baxter International Inc. 1 Baxter Pkwy. Deerfield, IL 60015-4625 United States Phone: 847-948-2000 Fax: 847-948-2016 www.baxter.com 2009 SALES (MIL. $) 12,562 EMPLOYEES OVERVIEW CONTACT 49,700 Why choose between making drugs and making medical equipment? Baxter International does it all. The company makes a wide variety of medical products across its three divisions, including drugs and vaccines, dialysis equipment, and IV supplies. Its BioScience segment makes protein and plasma therapies to treat hemophilia and immune disorders, as well as vaccines and biological sealants used to close surgical wounds. Baxter is a leading maker of intravenous (IV) supplies and systems via its Medication Delivery segment; the segment also makes infusion pumps and inhaled anesthetics. Baxter's Renal division makes dialyzers and other products for the treatment of end-stage renal disease (ESRD). Ludwig Hantson Corporate VP and President, International Baxter has sold off some underperforming units, including the majority of the services portion of its Renal division. It also spun off its Transfusion Therapies business, which Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 121 made blood-collection and storage products, into a new company called Fenwal in 2007. Fenwal, which still accounts for some of Baxter's annual income, is owned by investment firm Texas Pacific Group. The company's BioScience segment accounts for roughly 45% of sales, most of which comes from the sale of recombinant proteins and plasma products used to treat hemophilia and immune disorders. Recombinant proteins are useful because they are derived from DNA that is manufactured in the laboratory (meaning greater access to supply). Recombinant DNA does not exist naturally, but is created by combining DNA sequences that would not normally occur together. Among Baxter's BioScience products are hemophilia therapy Advate and Aralast NP, a plasma-derived drug for hereditary emphysema. The company increases sales of Advate and Aralast NP by pushing for greater adoption of the technology used to make them through aggressive marketing and educational campaigns. However, a glut of plasmaderived products from Baxter and its competitors combined with the high-price of obtaining such medications has caused a bit a of market-slowdown which Baxter intends to fight with a renewed marketing push aimed at physicians and hospitals in the US. The BioScience unit also makes vaccines for infectious diseases, such as tick-borne encephalitis and meningococcal meningitis. Baxter received authorization from the European Commission in 2009 to market its Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 122 pandemic influenza vaccine Celvapan H1N1 in Europe. The vaccine uses Baxter's Vero cell technology which allows rapid production and delivery of pandemic vaccines. Much of the company's R&D efforts are focused in the BioScience segment. It has an ongoing collaboration with Nektar Therapeutics, for example, to development blood-clotting proteins using Nektar's PEGylation technology. And it is working on other products in areas such as regenerative medicine and adult stem cell therapies. To jump into the bone grafting market, the company spent some $330 million to acquire UK-based ApaTech in 2010. ApaTech's bone grafting materials are already approved and sold in the US and Europe. The deal gave Baxter manufacturing and research facilities in Germany, the UK, and the US. Baxter's second largest division, Medication Delivery, makes intravenous drug delivery systems, infusion pumps, and anesthesia products. Products include inhaled and injectable anesthetics, as well as premixed drugs and parenteral nutrition products that are administered intravenously. The Medication Delivery segment has continued to see strong growth as demand for IV solutions and nutritional products has not seen any signs of slowing, especially in international markets. In 2009 Baxter expanded its infusion systems portfolio by entering into an agreement to distribute medical device maker SIGMA's SPECTRUM large volume infusion pumps domestically and internationally. The deal Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 123 also gave Baxter a 40% stake in the company (with the option to buy the rest of SIGMA over a three-year period) as well as access to future products under development. Along with dialyzers -- dialysis equipment used primarily in hospitals or clinics -Baxter's Renal division makes home-use dialyzers that use a technology called peritoneal dialysis. The company is betting on the growth of peritoneal dialysis and other home-use technologies, especially in developing markets that don't have the medical infrastructure needed for clinically administered dialysis. To that end, it entered an agreement with HHD and DEKA Research and Development to produce next generation home dialyzers. Baxter expanded further in renal therapies when it acquired the hemofiltration (renal replacement therapy) product line of Edwards Lifesciences in a $65 million deal in 2009. The Renal division is also a leading supplier of heparin, an anticoagulant used during dialysis and in critical care situations such as heart surgery. In 2008 Baxter halted production of heparin, however, after hundreds of bad reactions (including several deaths) occurred in patients using the drug. Subsequent investigations focused on raw heparin supplied to Baxter by a Chinese factory, which apparently added a cheaper ingredient into the drug which contaminated it. The heparin recall as well as the end of a marketing and distribution deal for generic propofol with Teva Pharmaceutical Industries caused the company to take a hit in sales in Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 124 2008. With manufacturing operations in more than two dozen countries and sales operations all over the world, Baxter International gets more than half of its revenue outside the US. Continued international expansion is key to the company's growth strategy. It is particularly keen on the possibilities of growing sales of its renal products in developing countries. It has also set up a joint venture in China to sell its parenteral nutrition 2. Novartis Corporation 608 5th Ave. New York, NY 10020 United States n/a 30,186 Phone: 212-307-1122 Fax: 212-246-0185 www.us.novartis.com 3. Mylan Inc. 1500 Corporate Dr. Canonsburg, PA 15317 United States Phone: 724-514-1800 5,092.8 15,500 Novartis Corporation has what the doctor ordered. As the North American headquarters of Switzerland-based Novartis AG, the unit handles administration, sales, and marketing for a vast product line of prescription drugs, consumer health products, vaccines, and veterinary products. But wait, there's more! Novartis Corporation also oversees the Novartis Institutes for Biomedical Research, which is headquartered in the US, and charged with the job of discovering new medicines to add to the company's everexpanding pipeline. Novartis Corporation also headlines dozens of other US business units including CIBA Vision, Novartis Pharmaceuticals, and the US operations of its Sandoz generics business Mylan knows you may not recognize the names of their drugs, but it hopes you'll appreciate their prices. Through Mylan Pharmaceuticals, Generics (UK), and other subsidiaries, the company is a global manufacturer of prescription generic drugs, Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Mary Lou Mumford General Manager Didier Barret President, Europe, Middle East, and Africa 125 Fax: 724-514-1870 www.milan.com holding a top 5 position in terms of sales, in more than a dozen of its worldwide markets. Mylan's pharmaceutical cabinet holds antibiotics, antidepressants, antiinflammatories, and laxatives. The company's customers include wholesalers, distributors, retail drugstore chains, and government agencies. Another Mylan division, Matrix, is a top producer of active pharmaceutical ingredients (APIs) for generic drugs. Mylan is led by CEO and chairman of the board Robert Coury. Mylan makes branded specialty pharmaceutical products through its Dey division. The biggest seller in the Dey segment is the company's EpiPen AutoInjector, used in the treatment of severe allergies. EpiPen is an epinephrine autoinjector and is the #1 prescribed treatment for severe allergic reactions, with a US market share of more than 95%. Mylan's generic pharmaceutical business is conducted primarily in North America, Europe, the Middle East, Africa, Australia, and the Asia-Pacific region. In the generics segment, 2008 sales to McKesson and Cardinal Health represented 12% and 10% of total sales. The company's Mylan Technologies subsidiary develops and manufactures generic transdermal patch products. Another unit, UDL Laboratories, puts generic drugs into unit-dose packaging for hospital and institutional use. The API business is conducted principally Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 126 through Matrix Laboratories in India. Docpharma, which is a subsidiary of Matrix Laboratories, is primarily a distributor of pharmaceutical products in the Benelux region of Europe. Mylan is involved in proprietary drug development through subsidiary Somerset Pharmaceuticals. Somerset Pharmaceuticals' primary products are Eldepryl, a drug for the treatment of Parkinson's disease; and Emsam, a transdermal patch for major depressive disorder that is marketed by Bristol-Myers Squibb. It was with an eye on global expansion that Mylan acquired control of Matrix Laboratories and created the new division to hold it. With 10 manufacturing facilities, it is one of the largest companies in India and is the world's largest supplier of generic antiretroviral pharmaceutical ingredients used to treat HIV/AIDS. Additionally, by having its own API producer in-house, Mylan hopes to gain an edge over competitors, who must obtain their ingredients from outside manufacturers. A key piece of Mylan's strategy is to be the first to file with the FDA to manufacture generic versions of popular drugs as they become fair game. Being first in line gives a manufacturer a three-month window of exclusivity, while its competitors have to wait before they can produce an equivalent product. In its biggest deal yet, Mylan spent nearly $7 billion to acquire Generics (UK) Ltd. from Merck. Mylan won out in a bidding war that Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 127 included its major rivals Actavis Group and Teva, with the prize being a business almost twice Mylan's size. Following the acquisition, the company changed its name from Mylan Laboratories to just plain Mylan. Akin to a frog swallowing a salmon, Mylan estimated it will take two to three years to fully realize the benefit of the deal that closed in late 2007. In 2009 Mylan formed a partnership with Indian biotech firm Biocon to expand into the growing field of generic biotech drugs. The two companies will co-develop and market biologic therapies in numerous countries 4. Hospira, Inc. 275 N. Field Dr. Lake Forest, IL 60045 United States Phone: 224-212-2000 Fax: 224-212-3350 www.hospira.com 3,879.3 13,500 Hospira helps hospitals help the hurting. The company, a spinoff of drug manufacturer Abbott Laboratories, makes specialty injectable pharmaceuticals (primarily generics) and drug delivery equipment. Its medication delivery systems include drug pumps, infusion therapy devices, and related medication management software. Its injectable drugs include cardiovascular, anesthesia, and anti-infective therapies. In addition, Hesperia provides contract manufacturing services for injectable pharmaceuticals. A good portion of Hospira's sales are to group purchasing organizations (GPOs), including Broadlane, Novation, and Premier. Global acquisitions remain a key part of the company's strategy for future growth, and in early 2010 it acquired the generic injectable drug business of India-based Orchid Chemicals for $400 million. The purchase included a manufacturing and research Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Ron Squarer Chief Commercial Officer 128 facility in India and a long-term exclusive agreement with Orchid to supply Hospira with active pharmaceutical ingredients (APIs). The company has also announced plans to acquire drug developer Javelin Pharmaceuticals. The purchase (worth about $145 million) will give Hospira access to a new pain medication Dyloject, which has been submitted to the FDA for approval. The deal hit a stumbling block in mid-2010 when Javelin filed suit against Hospira and the unit formed to acquire Javelin, Discus Acquisition Corp., alleging that the two failed to accept and pay for Javelin shares that had already been tendered and also breached terms of the two companies' original loan agreement (under which Hospira was to lend Javelin $2 million). The suit seeks to compel Hospira and Discus to complete the acquisition. In 2008 Hospira acquired Sculptor Developmental Technologies, the bar-code medication management software business of St. Clair Health. Hospira continues to use the St. Clair Hospital in Pittsburgh as a testing and development site for its medication administration products. The purchase contributed to Hospira's efforts to beef up product offerings in the areas of patient safety (avoiding medication errors) and clinician efficiency in health care facilities. In addition, the company acquired Australian pharmaceutical maker Mayne Pharma for about $2 billion a few years ago. The purchase positioned Hospira as the world's largest generic injectable drug manufacturer Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 129 and significantly expanded its roster of oncology treatments. Hospira had acquired another Australian firm, BresaGen, the previous year; BresaGen conducted biotechnology therapeutic research. Hospira's research and development efforts are focused on creating new generic pharmaceuticals, as well as new and improved medication management including IV infusion pumps and software to control their function. Hospira has about 15 manufacturing facilities globally after closing a few to concentrate manufacturing in other locations, and outsourcing some production to third-party suppliers. Its North Carolina, Texas, Kansas, Costa Rica, and Australia (Victoria) locations account the majority of output. In 2009 the company announced corporate streamlining measures, including a 10% workforce reduction by the end of the year. Hospira also laid out plans to trim its product line and review options for noncore operations. Later that year it sold its critical care product line, with full marketing rights, to ICU Medical for $35 million. The critical care business already operated under a manufacturing partnership between ICU Medical and Hospira. In early 2010 the company sold its brain function monitoring business to SEDLine, a private research firm backed by Masimo Corporation 5. Perrigo Company 515 Eastern Ave. 2,006.9 7,250 Perrigo makes its name by making sure you never see it. One of the US's largest Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 John Hendrickson 130 Allegan, MI 49010 United States Phone: 269-673-8451 Fax: 269-673-9128 www.perrigo.com manufacturers of generic and private-label over-the-counter pharmaceuticals and supplements, Perrigo makes products that use similar packaging and discount pricing to compete with leading national brands. The company makes more than 1,300 products, including pain relievers, cough and cold remedies, dietary supplements, and smoking cessation products -- some of which are sold under its own Good Sense brand. It also makes more than 250 generic prescription products for other companies. Its Active Pharmaceutical Ingredients (API) division manufactures the raw materials used by generic and branded pharmaceutical companies worldwide. Perrigo's international consumer health care product subsidiaries Quimica y Farmacia (Mexico) and Wrafton (UK) offer over-thecounter and store-brand pharmaceutical products. Perrigo manufactures generic prescription drugs at facilities in the US and Israel, and subsidiary Chemagis makes APIs in Israel, Germany, and China. In 2010 the company divested its consumer products operations (but not its manufacturing operations) in Israel. The business primarily sold consumer products to the Israeli market, including cosmetics, toiletries, and detergents. Perrigo has grown its pharmaceuticals business through acquisitions of product lines it either doesn't have or that would complement its existing businesses. For example, in 2008 it expanded its manufacturing operations by acquiring US Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 EVP Global Operations and Supply Chain 131 contract OTC drugmaker J.B. Laboratories for $44 million and Unico Holdings, a US maker of nutrition and hygiene products, for $49 million. Both companies have been integrated into the Perrigo organization. In a departure from all things pharmaceutical, in 2010 Perrigo purchased PBM Holdings, a US-based private manufacturer and marketer of store-brand infant formulas and baby foods. The $808 million acquisition took advantage of Perrigo's existing private-label relationships with retailers, and gave it a deeper presence in the OTC consumer products market. To expand internationally, the firm has made purchases abroad including the acquisition of UK company Galpharm Healthcare, a manufacturer of store brand products, in 2008. It then bought Mexican drugmaker Laboratorios Diba for $25 million to expand its manufacturing capacity. In 2010 the company agreed to acquire Australian OTC products maker Orion Laboratories for $48 million. Perrigo's ongoing efforts to introduce a generic version of Mucinex (guaifenesin) have been stymied by Mucinex maker Adams Respiratory, which has filed a blizzard of patent infringement lawsuits seeking to protect its lucrative market niche. The company won the rights to begin selling a version of Johnson & Johnson's Monistat vaginal infection product after a similar series of lawsuits. It plans to begin marketing the products in 2010. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 132 Along with snapping up other company's products, Perrigo has its own in-house research and development team that whips up generic formulations of name brand products, as well as responds to changes in existing national brand products by reformulating existing company products. Perrigo's clients include such retailers as WalMart, CVS, and Walgreen and such wholesalers as SUPERVALU and McKesson. Wal-Mart is its largest customer, however, and accounts for more than 20% of sales. The company's consumer healthcare segment has its own sales force to work with its largest customers. Vice Chairman Moshe Arkin owns about 10% of Perrigo, and director Michael Jandernoa holds just over a 3% stake 6. Boehringer Ingelheim Corporation 900 Ridgebury Rd. Ridgefield, CT 06877 United States n/a 6,000 Phone: 203-798-9988 Fax: 203-791-6234 www.us.boehringeringelheim.com 7. Watson Pharmaceuticals, Inc 2,793 5,830 As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside subsidiaries that produce and sell drugs (both prescription and over-thecounter), animal health products, and chemicals for the US market. It sells its prescription and OTC products through its largest unit Boehringer Ingelheim Pharmaceuticals. Additionally, the firm's Roxane Laboratories makes generic drugs and its Ben Venue Laboratories is a contract pharmaceutical manufacturer and provides drug development services to other pharmaceutical companies Watson Pharmaceuticals tries to have the best of both worlds, with operations in the US Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Peter Hansbury General Manager, Contract Manufacturing Division Thomas Russillo EVP Global 133 311 Bonnie Cir. Corona, CA 92880-2882 United States Phone: 951-493-5300 Fax: 973-355-8301 www.watsonpharm.com generics market and the higher-profit-margin branded drug business. The company's broad generics portfolio of about 140 products includes treatments for hypertension and pain, as well as smoking cessation products, antidepressants, and oral contraceptives. Its line of about 30 branded drugs focuses on urology and nephrology; it markets its branded products, including treatments for iron deficiency anemia and overactive bladder, to specialist physicians in the US. Additionally, Watson distributes its own and third-party products to independent pharmacies and health care providers through its Anda and Valmed subsidiaries. Watson Pharmaceuticals' bread and butter is its generics line, accounting for about 60% of sales. An important part of the company's generics business is its generic oral contraceptive line. Watson has a leading position in the US in generic oral contraceptives with roughly two dozen different oral contraceptive products and about a 35% market share. Its top five oral contraceptives TriNessa, Low-Ogestrel, Necon, Lutera, and Microgestin, account for almost 50% of the total Watson oral contraceptives portfolio. The generics business overall has struggled with the loss of a key product and the general decline of generics revenue over time. The big loss came a few years ago when a distribution agreement with Purdue Pharma for oxycodone HCl (generic OxyContin) ended. Name-brand drug companies sometimes authorize an "official" generic Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Generics and Global Operations 134 form when a drug goes off-patent, in order to recoup some losses that inevitably result from generic competition. Watson had distributed the authorized generic of OxyContin since the drug lost patent protection in 2005, and the drug was a big contributor to the company's revenue. Watson's strategy for combating declining sales (as well as the loss of the OxyContin deal) is to develop and acquire new products to beef up its pipeline. In 2009 alone the company launched about a dozen new products including Metoprolol ER to treat angina, emergency contraceptive NextChoice, and Galantamine for the treatment of Alzheimer's disease. The previous year Watson introduced a generic version of Biovail's antidepressant Wellbutrin XL, Johnson & Johnson's Duragesic pain patch and its Alzheimer drug Razadyne, Duramed's Mircette oral contraceptive, and GSK's Nicorette smoking cessation gum. Additionally, the company co-promotes AndroGel, a male hormone replacement therapy, with Unimed and distributes an authorized generic of Merck's Fosamax. To pick up a few more products, expand its development pipeline, and broaden its geographic presence, Watson spent about $1.75 billion to acquire privately held Arrow Group in 2009. Arrow develops and manufactures generic pharmaceuticals in Canada, Malta, and Brazil and distributes its products in more than 20 countries. Major products in the company's branded Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 135 drug segment include prostate therapies Trelstar and Rapaflo. Watson is building its branded product line through several partnerships and joint ventures, as well as through acquisitions of later-stage drug candidates. Because it relies on partnerships to augment its product line, the company's bottom line is also vulnerable to the expiration of those deals. For example, Watson lost a key product in 2009 when its license agreement with Sanofi-Aventis for anemia drug Ferrlecit ended. To stave off losses related to losing licenses, Watson has been trimming costs by consolidating some operations and moving some manufacturing operations overseas. It established a plant in Goa, India, for example, and has announced the closures of some US facilities, including the planned closure of a facility in Carmel, New York (it will transfer these operations to Goa). It owns or has invested in plants in China and other parts of India and plans to continue its overseas growth; however, Watson divested its interest in an API (active pharmaceutical ingredient) plant in Taiwan in 2010 after deciding that the operation was not key to the company's long-term growth strategy 8. Forest Laboratories, Inc 909 3rd Ave. New York, NY 10022-4731 United States Phone: 212-421-7850 Fax: 212-750-9152 4,192.9 5,200 Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures name-brand as well as generic prescription and over-the-counter pharmaceutical products. The company's central nervous system (CNS) pharmaceutical line includes antidepressants Celexa and Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 David F. Solomon VP Business Development and Strategic Planning 136 www.frx.com Lexapro, as well as Namenda, which treats Alzheimer's disease. Other products include treatments for thyroid disease, hypertension, respiratory ailments, and pain. Forest Laboratories markets directly to doctors, hospitals, drugstore chains, managed care organizations, and distributors through its own sales force in the US; it also has affiliated and independent sales representatives in the UK and Ireland. Subsidiary Inwood Laboratories promotes the company's generic products. Nearly 90% of the company's sales revenues come from large pharmaceutical distributors McKesson, Cardinal Health, and AmerisourceBergen, which deliver Forest's products to customers on a wholesale basis. Despite fierce competition from other established brands, Forest Laboratories has found a niche in the antidepressant market. With Celexa's recent conversion to generic status, however, the company has become more dependent on sales of Lexapro, which accounts for around two-thirds of the company's revenues. In 2009 Lexapro received FDA approval for use to treat depression in adolescents, neatly extending the brand's potential profitability. Namenda is another top seller in the CNS field, accounting for about a quarter of Forest's sales. The firm is working to develop and release new drug candidates that it hopes will make up for any decline in sales seen from generic competition. Recent releases include Bystolic for hypertension treatment in 2007 and Savella for fibromyalgia in 2009. Its pipeline Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 137 includes potential drugs to treat neuropathic pain, gastrointestinal disorders, asthma, and schizophrenia; many of the company's development programs are collaborative efforts with other pharmaceutical companies. To bolster its biopharmaceutical research capabilities, Forest Laboratories purchased private biotech firm Cerexa for about $494 million in early 2007. Cerexa brought with it a series of injectable antibiotics under development to combat bacterial infections including MRSA (methicillin-resistant Staphylococcus aureus). The company ended a co-promotion agreement with Daiichi Sankyo in 2008 for the hypertension drug Axor to focus on sales efforts for its other commercial products. The two companies have historically marketed antihypertensive drug Benicar together; Forest continues to receive royalties from the agreement but has stopped actively marketing the drug. 9. Falcon Pharmaceuticals, Ltd 6201 South Fwy. Fort Worth, TX 76134-2099 United States Phone: 817-293-0450 Fax: 800-777-2799 www.falconfharma.com n/a 3,000 Falcon Pharmaceuticals has a keen eye for alternatives. The company specializes in making generic equivalents of ophthalmic drugs that treat a range of eye conditions, as well as otic (ear) and nasal ailments. Its lead product, Timolol GFS, is a generic equivalent of Merck's glaucoma treatment Timoptic-XE gel. The company also offers anti-infective, steroid, anti-viral, anti-allergy, and anesthetic pharmaceutical products without the markup typically associated with brand names. Falcon Pharmaceuticals is a subsidiary of eye care Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Mike Hemrick VP 138 products company Alcon. The company manufactures about 30 generic formulations of name-brand drugs, including glaucoma treatment brimonidine, eye inflammation treatment prednisolone, and otic and ophthalmic suspensions of hydrocortisone. Falcon Pharmaceuticals regularly looks for opportunities to develop additional products as patented drugs reach their expiration dates. Alcon formed the subsidiary in 1994 to develop and market generic versions of Alcon's and other drugmakers' products 10. Mylan Pharmaceuticals, Inc 781 Chestnut Ridge Rd. Morgantown, WV 26505 United States Phone: 304-599-2595 Toll Free: 800-826-9526 Fax: 304-598-3232 www.mylanpharms.com n/a 2,000 Mylan Pharmaceuticals isn't a snob when it comes to labels -- the company is the generic research and development, manufacturing, marketing, and distribution division of Mylan. Mylan Pharmaceuticals offers more than 200 generic prescription products developed inhouse and through distribution agreements with other pharmaceutical companies. Mylan devotes most of its research and development efforts to the creation of extended oral dosages. Its sister company Mylan Technologies develops transdermal and polymer film patches. Its products are sold to pharmaceutical wholesalers, distributors, mail order pharmacies, and drugstore chains. Mylan Pharmaceuticals is hoping to take full advantage of its manufacturing capacity of some 35 million doses as an aging population combined with efforts to reduce health care costs, and the resultant reliance on lessexpensive generics continue to fuel demand Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Larry Salmon Manager 139 in that industry. The company is also focused on filling a niche by bringing generics to the US market that are difficult to formulate or manufacture, or for which the ingredients are difficult to obtain. Past examples of such drugs are pain medication fentanyl, epilepsy treatment levetiracetam, psychiatric drug divalproex, and over-active bladder medication oxybutynin. Those drugs (and others like them) continue to contribute to the company's bottom-line, even several years after their initial launch, because competition remains limited due to their high barriers to entry 11. Endo Pharmaceuticals Holdings Inc 100 Endo Blvd. Chadds Ford, PA 19317 United States Phone: 610-558-9800 Fax: 610-558-8979 www.endo.com 1,460.8 1,487 Endo Pharmaceuticals wants the pain to end, preferably through the drugs it acquires and markets. The pharmaceutical company has a portfolio of both branded and generic prescription products for pain management. Its best-selling drug is Lidoderm, a lidocaine patch that treats nerve pain caused by shingles; it accounts for about two-thirds of the company's revenue. Endo also sells wellknown pain meds Percodan and Percocet, as well as migraine therapy Frova. Its generics include morphine and oxycodone tablets. The company markets its drugs in the US through its own domestic sales force; however, it outsources almost everything else, from manufacturing to distribution to clinical development acitivities. Eschewing the integrated business model favored by most pharmaceutical companies, Endo has built its business on alliances with Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Sandeep Gupta VP 140 other firms. It in-licenses or acquires drug candidates and uses contract research organizations to implement the clinical development programs it designs. It also outsources manufacturing (largely to Novartis Consumer Health and Teikoku Seiyaku) and warehouse and distribution activities(to UPS Supply Chain Solutions). Although the pain management market is at its core, Endo Pharmaceuticals made a move to expand into other therapeutic areas, specifically endocrinology, oncology, and urology, through its acquisition of Indevus Pharmaceuticals, a maker of therapies for ailments including overactive bladder, hormone disorders, and prostate cancer. The 2009 deal cost the company $370 million, plus potential additional milestone payments of $267 million. Endo also gained drug delivery technologies through the acquisition. One of the drugs that came with Indevus was VALSTAR, an approved treatment for an aggressive form of bladder cancer that had been shelved years earlier due to formulation problems. Endo immediately set to relaunching the product for a quick return on its investment. In 2010 the company moved to expand further in the field of urology when it agreed to purchase HealthTronics through a $258 million tender offer and debt transaction. The acquisition will strengthen Endo's offering of urological therapies and expand its operations into the new area of non-pharmaceutical treatments. HealthTronics, which will become a wholly owned subsidiary of Endo, offers Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 141 medical equipment including kidney stone lithotripters, cryosurgery (freezing of tissue), and diagnostics for prostate enlargement and cancer, as well as other urological conditions. The purchase will also widen Endo's customer base of urological professionals. The company's branded prescription pharmaceuticals, which heavily outweigh its generics in sales, are marketed to physicians in anesthesiology, neurology, oncology, urology, pain management, primary care, and surgery. It also targets retail pharmacies throughout the US. Endo Pharmaceuticals was created in 1997 through the management buyout of a pharmaceutical joint venture between DuPont and Merck 12. APP Pharmaceuticals, LLC 1501 E. Woodfield Rd. Ste. 300 E. Schaumburg, IL 601735837 United States Phone: 847-413-2075 Toll Free: 888-386-1300 Fax: 800-743-7082 www.appdrugs.com n/a 1,375 Your eyes are getting heavy. You're getting sleepy. No hypnotist here, just APP Pharmaceuticals, a company that develops, makes, and markets anesthetics and other injectable drugs. Specializing in generics, APP's critical care products segment includes market-leading general anesthetic Diprivan and blood thinner Heparin. Other product segments focus on injectable oncology treatments and drugs that fight ear, heart, respiratory tract, skin, and sinus infections. APP markets through a direct sales force and often sells through group purchasing organizations to customers that include hospitals, long-term care facilities, and clinics in North America. The company is a subsidiary of German medical firm Fresenius. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Steve Weltler Manager 142 The German health care group purchased APP Pharmaceuticals in 2008 to expand its global generic injectables business and to gain entry into the US drug market. Following the acquisition, APP became part of the company's Fresenius Kabi division, which makes infusion therapy and clinical nutrition products. At the close of 2009 APP Pharmaceuticals CEO Thomas Silberg retired, and Fresenius Kabi executive John Ducker was appointed to the post. In addition to its marketed generics, APP Pharmaceuticals has a steady stream of new drug applications awaiting regulatory approval and more than 70 product candidates in development across its core oncology, anti-infective, and critical care categories. Its US research and development facility focuses on pharmaceutical formulation, analystical chemistry, and drug delivery. American Pharmaceutical Partners Inc. merged with American BioScience in 2006 to form Abraxis BioScience. In 2007 Abraxis spun off the generic injectables business as APP Pharmaceuticals, leaving Abraxis to focus on developing a patented oncological drug 13. Ben Venue Laboratories, Inc 300 Northfield Rd. Bedford, OH 44146-4650 United States Phone: 440-232-3320 Fax: 440-439-6398 n/a 1,103 Ben Venue Laboratories prides itself on having products that are clean, clear, and cold. A subsidiary of German drug firm Boehringer Ingelheim, the company provides contract manufacturing services, including product and process development and regulatory compliance services. The company specializes in manufacturing liquid and Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Peter Hansbury General Manager, Contract Manufacturing Division 143 lyophilized (freeze-dried) pharmaceuticals. Ben Venue's Bedford Laboratories division provides contract manufacturing of generic injectable pharmaceuticals. Customers include multinational drugmakers, small biotech development firms, and government agencies. www.benvenue.com The company's Bedford Laboratories division has expanded its operations as a contract developer and manufacturer of generic sterile pharmaceuticals through internal research and development efforts. Its products include generic versions of injectable oncology pharmaceuticals sold under the Bedford brand 14. Amphastar Pharmaceuticals, Inc 11570 6th St. Rancho Cucamonga, CA 91730 United States Phone: 909-980-9484 Toll Free: 800-423-4136 Fax: 909-980-8296 www.amphastar.com 300 1,040 Amphastar Pharmaceuticals wants to help drugs help themselves. A maker of injectable and inhalant drugs and drug delivery systems, the company focuses on drugs that are difficult to manufacture or can be improved with new delivery systems. Amphastar's products include Amphadase (increases absorption and dispersion of injected drugs), Duocaine (anesthetic for eye surgery), Cortrosyn (tests for adrenal gland disorders), and prefilled disposable pipettes (single-dose dispenser for liquids, creams, and other forms). The company also offers contract manufacturing services, including labeling and packaging, cold storage, and aseptic filling. The company's Massachusetts-based Armstrong Pharmaceuticals subsidiary manufactures metered dose inhalers used to administer respiratory drugs for asthma and Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Peter Langosh VP Operations 144 obstructive pulmonary disease. Along with generic prescription inhalers and nasal sprays the company also manufactures the branded asthma drug Primatene Mist, which is sold over the counter. Amphastar's California-based International Medication systems subsidiary manufactures pre-filled syringes and vials with injectable and topical drugs. Its products range from lidocaine and morphine used in emergency medicine to Vitamin K administered to newborn babies 15. Teva Pharmaceuticals USA 1090 Horsham Rd. North Wales, PA 194541090 United States Phone: 215-591-3000 Fax: 215-591-8600 www.tevausa.com n/a 1,025 When the pharmacist asks you if a generic equivalent is acceptable, Teva hopes you'll say "yes." Teva Pharmaceuticals USA, the US subsidiary of massive Israeli generic drug maker Teva Pharmaceutical Industries, develops, manufactures, and markets both generic and branded pharmaceuticals. The company is the largest manufacturer of generic drugs in the US; its product roster boasts more than 400 generic equivalents of prescription drugs in a wide variety of therapeutic categories, including cardiovascular, anti-inflammatory, antiinfective, oncology, central nervous system, and dermatological. Teva Pharmaceuticals USA (along with its cousin to the North, Teva Canada Ltd.) accounts for about 60% of its parent company's sales. Teva Pharmaceuticals USA itself gets about half of its revenues from direct sales to drugstores and a third from drug wholesalers; other customers include mail-order pharmacies, distributors, and Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Robert Jernick Manager 145 hospitals. Its production capabilities include a variety of dosage forms, such as tablets, capsules, ointments, creams, liquids, injectables, and inhalants. The company expects US demand for generics to continue to grow as the population ages and as the nation continues to look for ways to reduce escalating health care costs. To meet that expected demand and to solidify its position in the US market, Teva acquired US generics maker Barr Pharmaceuticals for $7.5 billion in 2008. Barr's operations were later integrated into the Teva organization, upping Teva Pharmaceuticals USA's annual prescriptions to about 600 million or more than 20% of all US generic prescriptions written. Teva Pharmaceuticals USA also seeks to keep its pipeline pumping out generics and to that end, the company has more than 200 new generic drugs awaiting FDA approval. Along with performing its own research and development, the company forms alliances with other pharmaceutical firms to license and market generic versions of their branded drugs. Teva Pharmaceuticals USA has one such agreement with Biovail, which expires in 2011, to market three of its hypertension treatments (Adalat CC, Cardizem CD, and Procardia XL). The company's roots go back to Lemmon Pharmaceutical Company, founded in 1945. Lemmon Pharmaceutical was acquired by Teva Pharmaceutical Industries in 1981 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 146 16. Dey, L.P. 2751 Napa Valley Corporate Dr. Napa, CA 94558 United States Phone: 707-224-3200 Fax: 707-224-9264 www.dey.com n/a 1,000 Dey helps people breathe easier. The company, a subsidiary of generic drugmaker Mylan, makes prescription drugs for the treatment of allergies and respiratory diseases. Dey markets EpiPen autoinjectors, used by patients to self-administer epinephrine for severe allergic reactions. Its premeasured unit-dose inhalation products include treatments for asthma and chronic obstructive pulmonary disease (COPD). These treatments, called bronchodialators, are used in air-driven breathing devices called nebulizers and include branded DuoNeb and Perforomist products. It also offers several non-branded generic nebulizer treatments. A direct sales force markets Dey's products to doctors, pharmacies, and wholesalers. EpiPen, the company's top product accounting for more than half of sales, is the most-prescribed treatment for severe allergic reactions in the US. Dey launched its Perforomist inhalation solution for the treatment of COPD, chronic bronchitis, and emphysema in 2007. The company plans to pursue the development and commercialization of additional product lines. In late 2007 former parent Merck KGaA sold certain generic and specialty businesses, including Dey, to Mylan for a whopping $6.7 billion. Merck was looking to reduce debt from previous acquisitions, while Mylan boosted its already-stable position in the global generics market through the acquisitions. Mylan explored strategic options for Dey in 2008, but decided to keep the business later that year. Mylan plans to Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Garry L. Michaud SVP Operations 147 restructure Dey's operations. Dey started out in 1978 as a purely generic drug maker, but has expanded over the years to include branded products. Dey uses existing respiratory treatments to develop its patented products using its drug delivery technologies. It has also directed R&D efforts towards new dosage and drug delivery innovations. Dey is facing some federal and state lawsuits over alleged false drug-price reporting 17. Roxane Laboratories, Inc 1809 Wilson Rd. Columbus, OH 43216-6532 United States Phone: 614-276-4000 Fax: 614-279-5517 www.roxane.com n/a 1,000 This Roxane isn't being wooed by Cyrano. Roxane Laboratories, a US-based subsidiary of Germany's Boehringer Ingelheim, oversees the development, manufacturing, and marketing of its parent company's generic drug business in the US. It markets more than 75 medications in some 250 package sizes, focusing on oral liquids, sustainedrelease and controlled-release tablets, cancer drugs, and nasal sprays. It also distributes narcotics, such as meperidine (generic Demerol) and methadone. Products developed and marketed by Roxane are manufactured by its sister company, Boehringer Inghelheim Roxane, also located in Columbus, Ohio. Roxane depends on a continual flow of new drug approvals to refresh its product lineup. Its research and development operations aim to file a steady stream of abbreviated new drug applications with the FDA. Such applications simply demonstrate the company's ability to make functionally Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Mark Edmonds VP Operations 148 equivalent versions of existing drugs, and requesting permission to do so. Recent approvals included a version of GlaxoSmithKline's Valtrex (herpes simplex, 2010 18. Sandoz Inc. 506 Carnegie Center Ste. 400 Princeton, NJ 08540-6243 United States Phone: 609-627-8500 Fax: 609-627-8659 www.us.sandoz.com 135.2 850 Sandoz, Inc. makes it easier to swallow the cost of prescription medicines. As the US arm of Swiss giant Novartis' generic Sandoz International division, the firm is one of the largest generic drug makers in the US, manufacturing more than 200 generic oraldosage drugs. The company's product portfolio includes drugs to fight infections, arthritis pain, cardiovascular and gastrointestinal disorders, and central nervous system disorders. Sandoz markets its products to wholesalers, drug stores, government agencies, HMOs, and hospitals. The company operates two manufacturing facilities in the US. Sandoz does more than just manufacturing of its parent's drugs. It is active in the research and development of new generics, shepherding them through testing and FDA approval, and finally handling the manufacturing, packaging, and distribution of the drugs. Don DeGolyer was appointed CEO of Sandoz, Inc. in 2010. He replaced Christine Mundkur who held the position for barely a year, but steered the company through the turbulence of the economic recession. Formerly named Geneva Pharmaceuticals, the company was brought under the Sandoz Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Sharon Jones Director 149 name in 2003 as Novartis sought to consolidate its generics businesses. Novartis acquired Eon Labs in 2005 and integrated it into Sandoz, Inc. to further strengthen its position in the US generic pharmaceutical market. 19. Impax Laboratories, Inc. 30831 Huntwood Ave. Hayward, CA 94544 United States 358.4 801 Phone: 510-476-2000 Fax: 510-471-3200 www.impaxlabs.com IMPAX Laboratories hopes that its combination of generic and branded pharmaceuticals will make an impact on its financial health. The company makes specialty generic pharmaceuticals, which it markets through its Global Pharmaceuticals division and through marketing alliances with other firms, including Teva. It concentrates on controlled-release versions of branded pharmaceuticals and niche pharmaceuticals that require difficult-to-obtain raw materials or specialized expertise. The company's branded pharmaceuticals business (called IMPAX Pharmaceuticals) is developing drugs that target Parkinson's disease, epilepsy, and other central nervous system disorders. Peter R. Terreri Director The company's Global Pharmaceuticals division sells its generic products to wholesalers, chain drug stores, and mail order pharmacies. IMPAX also works through strategic alliances; its deal with Teva, for instance, gives the generics giant US rights to some versions of its generic Claritin, Wellbutrin SR, and Prilosec products 20. Actavis U.S. 60 Columbia Rd. Bldg. B Morristown, NJ 07960 n/a 740 Keeping its parent active in the US is Actavis US. As its name implies, the company is the US manufacturing and marketing unit of global generics firm Actavis. As such it makes Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Ken Hunt Manager 150 United States Phone: 973-993-4500 Fax: 973-993-4303 www.actavis.us a variety of generic equivalents of both prescription and OTC drugs, in a number of forms, including liquids, tablets, creams, and suppositories. Among other consumer and specialty drugs, it makes anxiety, depression, and pain medications. Actavis US has manufacturing facilities in Maryland, New Jersey, and North Carolina, from which it ships its own products and provides contract manufacturing services to third parties. Overseeing the US market for its parent is no small feat, since it comprises about one third of Actavis' sales. Some of Actavis US' notable drug releases have included Kadian, an extended release pain medication, the generic form of the antidepressant Wellbutrin XL, and Levetiracetam, a generic form of Keppra, an epilepsy drug. Actavis US ran into some trouble at its facility in Towata, New Jersey, in 2008 after the FDA found some manufacturing violations. The plant issued a voluntary recall of about 60 medications and worked with the FDA to meet all of its requirements before restarting production in 2009. The company marked the opening by reintroducing one of its biggest sellers, pain medication oxycodone, in the US. In 2010 Actavis consolidated its New Jersey manufacturing operations into its Elizabeth plant, which resulted in the closure of the Towata plant. The move came as part of the company's efforts to cut expenses and improve operational efficiencies. Actavis entered North America and created its US subsidiary in 2005 with three acquisitions: Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 151 Amide Pharmaceuticals, Abrika Pharmaceuticals, and the Human Generics division of Alpharma 21. Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Dr. Detroit, MI 48202 United States Phone: 313-871-8400 Fax: 313-871-8314 www.caraco.com 337.2 667 Caraco Pharmaceutical Laboratories is cooking up cheaper versions of prescription drugs in the Motor City. The Detroit-based drug company makes generic knock-offs of a wide variety of pharmaceuticals, producing about 60 prescription products in various strengths and dosages. Its product lineup includes treatments for high blood pressure, cancer, nervous system conditions, diabetes, allergies, and pain. Indian drugmaker Sun Pharmaceutical Industries owns about 75% of the firm and licenses US marketing rights to Caraco for more than two dozen drugs. Caraco markets its products throughout the US and Puerto Rico, selling primarily to pharmaceutical wholesalers. The fast-growing company has added to its product list by focusing on hard-to-make drugs, as well as therapies that cater to niche markets such as epilepsy. However, it is increasingly challenging the validity of brandname drug patents, hoping to be the first to file generic applications with the FDA, a status that gives drugmakers a period of market exclusivity. A majority of the development work for the company's products is performed at laboratories in Mumbai and Vadodara, India operated by Sun Pharmaceuticals. Sun Pharmaceuticals also supplies Caraco with a substantial portion of its raw materials for Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 152 drug-making. Along with pharmaceutical wholesalers, Caraco's products are marketed toward a wide range of other customers including buying groups, retail pharmacies, distributors, and hospitals. The company's three largest customers -- AmerisourceBergen, McKesson, and Cardinal Health -combined account for nearly half of its total sales. Though the company has experienced pretty steady growth within its product lines, it hasn't been without problems. In 2009, the FDA seized more than three dozen different types of generic drugs from three manufacturing plants in Michigan due to what it said were violations of manufacturing standards having to do with the size of the tablets being made. The affected drugs included generic versions of certain antidiabetic agents, high blood pressure medicines, and anti-anxiety medications. Following the move by the FDA, Caraco signed a consent decree by which the company cannot resume manufacturing its products until it gets written notification independent experts and the agency. The stoppage led the company to layoff more than 400 employees in two phases late in the year. Jitendra Doshi became interim CEO of the company in 2009 following the resignation of Daniel Movins. Doshi previously served as Caraco's interim CEO for nearly two years between 2003 and 2005, prior to the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 153 appointment of Movins 22. Par Pharmaceutical Companies, Inc. 300 Tice Blvd. Woodcliff Lake, NJ 07677 United States Phone: 201-802-4000 Fax: 201-802-4600 1,193.2 616 Par Pharmaceutical Companies is your insurance company's resource for cheaper drugs. The company markets about 70 generic drugs in more than 240 dosages; its generic product line focuses on central nervous system, cardiovascular, and antiinflammatory medications, as well as infectious disease. Par manufactures some of its own products, but in many cases it distributes drugs manufactured by strategic partners. The company is moving into the branded pharmaceutical market as well by developing updated versions of off-patent drugs. Its first marketed brand-name product, Megace ES, treats anorexia and severe weight loss associated with AIDS; the drug is a version of a compound owned by Bristol-Myers Squibb. In addition to its own portfolio of off-patent generics, Par Pharmaceutical sells some authorized generics, which are off-brand versions of drugs that are sanctioned by the patent holders. Par has sold an authorized generic version of diabetes drug Glucophage, under contract with Bristol Myers Squibb; it has had other authorized generic contracts with GlaxoSmithKline for Flonase and Zantac and with AstraZeneca for Toprol XL. In conjunction with a reduction of its generics business, the company is seeking to expand its branded products division, Strativa Pharmaceuticals. To that end it acquired the rights to develop Nascobal, a vitamin B-12 nasal spray, in 2009. It anticipates future Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 154 company growth will come from this sort of in-licensing deal. In 2008 Strativa partnered with Alfacell, acquiring the US commercialization rights to that company's investigational cancer drug, Onconase. The following year it signed a similar deal with MonoSol for its chemotherapy-induced nausea treatment. Strativa also has an ongoing marketing relationship with Solvay's for its testosterone replacement product Androgel. Par sells mainly to wholesalers and retail pharmacy chains; its largest customers, which account for just over half of revenues, include drug distributors McKesson, Cardinal Health, and AmerisourceBergen 23. Nycomed US Inc. 60 Baylis Rd. Melville, NY 11747 United States Phone: 631-454-7677 Fax: 631-454-6389 www.altanainc.com 257 575 Nycomed US is the US specialty pharmaceutical business of Switzerland's Nycomed International. It operates through three divisions and is focused on making and selling drugs for dermatological and ophthalmic conditions. Its largest division E. Fougera & Co. primarily makes generic topical steroids, antibiotics, and antifungals. It makes both prescription and over the counter products for use in hospitals and sale through retailers. Fougera's sister division PharmaDerm develops, manufactures, and markets branded prescription dermatology products. Nycomed US' Savage Laboratories makes prescription emergency medicines including antivenin for snake bites and an antidote for digitalis poisoning. Nycomed US operates a manufacturing Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Ann Bryant VP Business Development 155 facility in New York and two distribution centers in Arizona and Pennsylvania. In 2008 parent Nycomed acquired Bradley Pharmaceuticals, another US-based niche player with a focus on dermatology. Nycomed integrated Bradley's operations -- which include sales of branded and generic drugs -into Nycomed US's Fougera and PharmaDerm units. Formerly owned by ALTANA AG, the company was bought by Nycomed in 2006, along with ALTANA AG's other pharmaceutical operations. The company had previously grown with the acquisition of the US dermatology business of GlaxoSmithKline Consumer Healthcare. Through the deal, PharmaDerm added corticosteroid Aclovate, anti-inflammatory Cutivate, and antibiotic Emgel, among other products 24. Upsher-Smith Laboratories, Inc 6701 Evenstad Dr. Maple Grove, MN 55369 United States Phone: 763-315-2000 Fax: 763-315-2001 www.upsher-smith.com n/a 550 Upsher-Smith Laboratories (U-S) makes drugs for us all. Its products include generic prescription and over-the-counter medications, focused primarily on the therapeutic areas of cardiology, dermatology, and women's health. Among its cardiology products are folic acid supplement Folgard, anticoagulant Jantoven, and heart arrhythmia treatment Pacerone. It also sells several moisturizers and cleansers under the AmLactin and Clenia brand names. The company is also moving into treatments for diseases of the central nervous system. Founded in 1919, U-S maintains Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Tom Burke EVP Commercial Operations 156 manufacturing facilities in Minneapolis and Denver. Looking to expand beyond its traditional generic market, the company has taken a small stake in Proximagen Neuroscience, a British firm that is developing a treatment for Parkinson's disease. U-S spent about $6 million for a 7% stake in the company in hopes of bringing its drug, PRXI, to market. Its a first step in fulfilling U-S' plans to introduce four new proprietary drugs by 2017. The family-owned firm may see its future plans in jeopardy, however. One more victim of scam-investor Bernie Madoff, both the controlling Evenstad family (father and son Ken and Mark, chairman and CEO, respectively run the firm) and the company's profit-sharing fund were heavily invested in Madoff's Ponzi scheme that collapsed in late 2008. The FBI froze all investments when Madoff was arrested. 25. Paddock Laboratories, Inc 3940 Quebec Ave. North Minneapolis, MN 55427 United States Phone: 763-546-4676 Fax: 763-546-4842 www.paddocklabs.com 120 375 Paddock Laboratories can help you corral all sorts of pharmaceutical goodies. The company develops and manufactures bioequivalent generic pharmaceuticals and OTC specialty products. Paddock's product line includes suppositories, diabetes treatments, topical powders, enemas, injectables, and dermatological offerings, as well as compounding bases and charcoal products. Its manufacturing facilities are located in Minneapolis, Minnesota. In addition to the US market, some of Paddock's products are sold in Europe and the Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Ed Maloney VP Business Development 157 26. Hi-Tech Pharmacal Co., Inc 369 Bayview Ave. Amityville, NY 11701 United States Phone: 631-789-8228 Fax: 631-789-8429 www.hiteckpharm.com 108.7 375 Asia/Pacific region through distributors. The company was founded in 1977 by Chairman Bruce Paddock Hi-Tech Pharmacal combines imitation with innovation, making and distributing dozens of liquid and semi-solid prescription, over-thecounter (OTC), and nutritional products. The company primarily produces generic forms of prescription drugs, including off-brand versions of antibiotic Bactrim (made by Roche) and allergy medicine Flonase (from GlaxoSmithKline), as well as prescription skin creams, mouthwashes, and pediatric multivitamins. Hi-Tech also makes branded over-the-counter products, including a line of products for diabetes patients and the Zostrix line of pain and arthritis medications. In addition, the company has a handful of branded prescription products. Hi-Tech's expertise is with difficult-tomanufacture liquid and semi-solid dosage products, including ophthalmic and inhaled pharmaceuticals. It provides contract manufacturing services to other drug firms needing this specialty. The company's products are marketed across the US through large retailers and wholesale distributors. Sales of generic drugs bring in about threefourths of Hi-Tech's revenue, and the company wants to speed up R&D and regulatory submissions in order to expand its core prescription drug line. Its generic product line focuses on oral solutions and suspensions, creams and ointments, and nasal sprays, including cough and cold products and prescription vitamins. Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Eyal Mares VP Operations 158 The company also expands its generic business through acquisitions. The company widened its product line when it purchased privately held ECR Pharmaceuticals for $5.1 million in 2009. ECR manufactures branded specialty prescription drugs (allergy, headache, and dermatitis) and promotes them through an in-house force of sales representatives active in the mid-Atlantic and southern US. The firm's Health Care Products division, which handles its branded OTC business, targets diabetes sufferers with such products as DiabetiSweet (sugar substitute) and DiabetiDerm (moisturizing lotion). It intends to continue developing new products for its niche diabetes market, possibly expanding into complementary areas such as podiatry. The family of the company's founder Bernard Seltzer (who died in 2007), including CEO David Seltzer, own about a quarter of the firm 27. Akorn, Inc. 1925 West Field Court Suite 300 Lake Forest, IL 60045 United States Phone: 847-279-6100 Fax: 800-943-3694 www.akorn.com 75.9 329 Akorn works hard to grow roots in several segments of the pharmaceutical industry. The company makes and sells specialty therapeutic and diagnostic pharmaceuticals in categories including ophthalmology, rheumatology, and anesthesia. Akorn's ophthalmic segment includes antibiotics, glaucoma treatments, lubricating ointments, diagnostic stains and dyes, and contact lens accessories. The firm's injectable segment includes drugs for rheumatoid arthritis and pain management. Akorn's products are sold nationally to hospitals, physicians, Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Steven J. Meyer Director 159 pharmacies, and wholesalers. Akorn also provides contract manufacturing services for other drugmakers. Chairman John Kapoor controls about a third of the company. The company has internal development operations, but many of its products are generic drugs licensed from external sources. Akorn has teamed with three Indian pharmaceutical firms -- Strides Arcolab, Cipla, and Serum Institute of India -- to make available to Akorn certain products (including an oral anti-infective and some oncology drugs) it can sell to hospitals and retailers in the US and Canada. With the launch of its Tetanus-Diptheria (Td) vaccine, the company formed a new operating segment dubbed biologics and vaccines. The Td vaccine is licensed from Massachusetts Biologic Laboratories. Following the successful launch of the Td vaccine, the company began to market and distribute an influenza virus vaccine Afluria (which it licensed from CSL Biotherapies). Both vaccines are marketed directly to hospitals and doctors, as well through wholesalers and distributors. The company's three biggest customers account for about half of its sales revenue. Top customers are Cardinal Health (which is also one of Akorn's biggest suppliers), McKesson, and AmerisourceBergen. Chairman Kapoor is the company's largest shareholder with a 32% stake, while Pequot Capital Management owns a 29% interest in Akorn. When Arthur Przybyl resigned as CEO Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 160 in 2009, CFO Jeffrey Whitnell briefly served as interim CEO before choosing to leave the company. The board then appointed newcomers Raj Rai as interim CEO (and later gave him the position on a permanent basis) and Timothy Dick as CFO in mid-2009 28. Lannett Company, Inc. 9000 State Rd. Philadelphia, PA 191361615 United States Phone: 215-333-9000 Fax: 215-333-9004 www.lanett.com 119 277 Lannett banks on the designation of "bioequivalent" for its products. The firm manufactures and markets generic prescription drugs such as painkillers (including two versions of Novartis' migraine treatment Fiorinal), anticonvulsants for epileptics, and Digoxin for congestive heart failure (a version of Lanoxin). The company has also developed a generic version of Abbott Laboratories' Synthroid. While it manufactures some of its products, Jerome Stevens Pharmaceuticals manufactures a significant portion of Lannett's inventories. Lannett prefers to focus on products with few generic competitors. Chairman William Farber and his family own more than half of the company. Formed in 1942, Lannett is one of the oldest generics manufacturers in the US. While the company manufacturers and/or distributes over 20 different generic drugs, four formulas account for more than 75% of its sales. Most of its products are sold as generics, but some receive private labeling with a customer's name. Its customers include the big wholesale US pharmaceutical distributors as well as group purchasing organizations, chain drug stores, and other pharmaceutical companies. Its Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Stephen J. Kovary VP Operations 161 largest single customer, Walgreens, accounted for more than 35% of sales in 2007. Lannett holds supply and development agreements with a handful of domestic and foreign companies, including Banner Pharmacaps. It also has agreements for new product formulation and development with other companies, but it intends to conduct its own manufacturing of any such products. The company's 2007 acquisition of Cody Laboratories expanded its manufacturing capacity and it has been steadily beefing up its product development staff to bring more products through the FDA approval process 29. Momenta Pharmaceuticals, Inc. 675 W. Kendall St. Cambridge, MA 02142 United States Phone: 617-491-9700 Fax: 617-621-0431 www.momentapharma.com 20.2 176 Momenta Pharmaceuticals looks to increase momentum for its drug candidates. The biotech company specializes in engineering complex sugars to improve versions of existing drugs, as well as to discover moreeffective new drugs. By analyzing complex sugars, the company provides a more comprehensive picture of the roles sugars play in cell function, disease, and drug action. Momenta has several products in the pipeline, including M-Enoxaparin, a generic version of heparin drug Lovenox from Sanofi-Aventis to treat patients with deep-vein thrombosis and acute coronary syndromes. The company is also developing a generic version of multiple sclerosis treatment Copaxone (marketed by Sanofi-Aventis and Teva). Novartis and its generics arm Sandoz have teamed with Momenta to develop and market Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Barbara Rosengren VP 162 M-Enoxaparin. This partnership has been the source of all of the company's revenues. The two companies are working to get the drug approved by the FDA. The company is also developing a proprietary anticoagulant candidate to treat cardiovascular ailments including acute coronary syndromes. Another discovery stage program is exploring the role of complex sugars in cancer treatment. Momenta Pharmaceuticals was founded in 2001. Novartis owns a 13% stake in the company 30. Spectrum Pharmaceuticals, Inc 157 Technology Dr. Irvine, CA 92618 United States Phone: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com 38 158 Spectrum Pharmaceuticals sees a rainbow of opportunities in its drug development pipeline. The drug firm, which focuses on anti-cancer therapies, won FDA approval in 2008 for its injectable LEVOleucovorin for use with some osteosarcoma patients; the drug reduces the toxic effects of a certain type of chemotherapy. Another investigational candidate, EOquin, is being studied as a bladder cancer treatment. Spectrum has licensed global rights to a third anti-cancer compound, satraplatin, to GPC Biotech. Additionally, in 2008 the company sold to Par Pharmaceutical its share of profits for the authorized generic of GlaxoSmithKline's migraine drug Imitrex; Par had been Spectrum's marketing partner for the drug. Spectrum has a number of other investigational drugs in its pipeline, most of which are focused in the areas of cancer and urology. And it continues to add candidates to Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Michael Adam SVP Pharmaceutical operations 163 the mix, usually through in-licensing compounds in later stages of development. In 2007, for instance, it licensed ortataxel, a potential cancer treatment, from Italian drug developer Indena. The company has been building its sales and marketing organization to launch LEVOleucovorin in the US in 2008. The drug, which the company is also developing for additional indications such as colorectal cancer, is already sold outside the US by Pfizer (through its acquisition of Wyeth) and Sanofi-Aventis. Spectrum works and plays well with others. It formed a collaboration agreement with Allergan for the development of EOquin for bladder treatment in 2008. The two companies will work together to develop and commercialize the drug; the deal will earn Spectrum $42 million plus a potential additional $304 million in milestone payments. That same year Spectrum formed RIT Oncology, a joint venture with Cell Therapeutics to market that company's drug Zevalin, a treatment for non-Hodgkin's lymphoma. In 2009 Cell Therapeutics exercised its option to sell the remaining interest in RIT Oncology to Spectrum Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010
