NuPathe Fact Sheet

NuPathe Fact Sheet
as of December 21, 2012
Ticker
NASDAQ: PATH
Executive Management
Armando Anido
Chief Executive Officer
Terri Sebree
President
Ezra Felker
VP Operations
Keith Goldan
VP and Chief Financial Officer
Michael Marino
VP and General Counsel
Jerry McLaughlin
VP and Chief Commercial
Officer
Mark Pierce, MD, PhD
VP and Chief Scientific Officer
Sanjay Sehgal, PhD
VP and Chief Regulatory Officer
Analyst Coverage
William Tanner, PhD
Lazard Capital Markets
Michael Schmidt, PhD
Leerink Swann
Elliot Wilbur, CFA
Needham & Company
Annabel Samimy
Stifel Nicolaus
Liana Moussatos, PhD
Wedbush Securities
Investor Relations Contact
John Woolford
Westwicke Partners
443-213-0506
[email protected]
NuPathe is a specialty pharmaceutical company focused on innovative neuroscience solutions. Our
most advanced product candidate, Zecuity™, is an active, single-use transdermal sumatriptan patch
that we are developing for the treatment of migraine. An NDA for this candidate was resubmitted to
the FDA on July 16, 2012; our PDUFA date is January 17, 2013. We have two other proprietary
product candidates that address large market opportunities: NP201 for the continuous symptomatic
treatment of Parkinson’s disease and NP202 for the long-term treatment of schizophrenia and
bipolar disorder. NuPathe is actively seeking partnerships to maximize the commercial potential for
our pipeline products in the U.S. and territories throughout the world.
Zecuity – The First and Only Migraine Patch
§ Zecuity is game-changing disruptive technology for migraine that
utilizes a proprietary active transdermal system to deliver
sumatriptan, the #1 prescribed migraine medication, in a rapid,
highly controlled and consistent manner.
§ Zecuity is uniquely positioned to address migraine-related nausea
(MRN), a significant unaddressed disease burden.
• Zecuity provides rapid relief of both headache pain and nausea
with an excellent tolerability profile while bypassing the GI
tract.
• The commercial attractiveness of Zecuity has been confirmed
through extensive market research with well over 700
physicians, 800 patients and payors accounting for>130 million
covered lives in the U.S.
§ NuPathe has issued patents for Zecuity to April 2027 with additional applications to 2029.
Migraine Market
§ Migraine is a serious and debilitating neurological disease afflicting a large underserved patient
population that is characterized by throbbing headache pain accompanied by associated
neurological and GI symptoms including nausea, vomiting, photophobia, and phonophobia.
§ In the U.S., 12% of adults (31 million) suffer from migraine with about three times as many women
as men. Approximately half are diagnosed and treated with medication.
§ Of the 16 million diagnosed and treated migraine patients, half (~8 million) experience MRN in
>50% of their migraine attacks.1,2
§ These frequent MRN patients report significantly more migraine disease burden, are less satisfied
with their current migraine medication and account for substantially higher headache-related
healthcare utilization compared with patients with who infrequently or never experience MRN:3
• 2.2 times the visits to a specialist
• 5.4 times as many emergency/urgent care visits
• 8.2 times higher overnight hospital stay costs
§ Limitations of current treatment options for patients with MRN:
• Tablets: >30% delay or avoid orally administered medications – too nauseated or fearful of
vomiting4,5,6
• Nasal sprays: taste issues, nausea, and vomiting are common adverse events7
• Injections: high incidence and intensity of “triptan-effects” related to Cmax8
§ The commercial opportunity is characterized as an attractive, specialist-driven opportunity in
which only ~10K neurologists and headache specialists account for a third of the market volume.9
An additional discrete primary care segment doubles the opportunity.
NuPathe Pipeline Status
Earlier-Stage Pipeline
NP201: Product candidate for the continuous symptomatic
treatment of Parkinson’s disease
§ NP201 consists of our LAD™ (long-acting delivery) technology,
combined with ropinirole, a leading FDA-approved dopamine
agonist to treat Parkinson’s disease. NP201 is designed to
provide up to two months of continuous delivery of ropinirole in
an easy-to-administer biodegradable implant.
§ Parkinson’s disease is a progressive, degenerative disease
characterized by movement symptoms such as tremor or
trembling in the hands, arms, and legs; rigidity of the limbs and
trunk; slowness of movement; and impaired balance and
coordination.
§ Parkinson’s disease affects about one million people in the U.S.
and more than four million people worldwide (Parkinson’s
Disease Foundation, 2010).
§ Based on a proof of concept study in a well-accepted animal
model for Parkinson’s disease, NuPathe believes NP201’s
continuous low-dose delivery has the potential to significantly
reduce “on-and-off” time and decrease the incidence of adverse
events associated with current oral medications.
§ NuPathe is seeking a partner for further development.
NP202: Product candidate for the long-term treatment of
schizophrenia and bipolar disorder
§ NP202 consists of our LAD (long-acting delivery) technology,
combined with risperidone, an FDA-approved atypical
antipsychotic used to treat schizophrenia and bipolar disorder.
§ Schizophrenia is a life-long serious psychiatric illness causing
people to lose touch with reality and often interferes with their
ability to think clearly, manage emotions, make decisions, and
relate to others that affects over two million adults in the U.S.
§ Bipolar disorder, or manic depression, is another lifelong
psychiatric illness that causes extreme shifts in mood, energy,
and functioning that affects more than 10 million adults in the
U.S.
§ To address patient noncompliance, a long-standing problem in
the treatment of schizophrenia and bipolar disorder, NP202 is
designed to provide three months of continuous delivery,
extending well beyond the currently available two- to four-week
treatments.
§ NuPathe is seeking a partner for further development.
References
1. Lipton, R. Data presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011.
2. Buse et al. Data presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011.
3. Lipton et al. Data presented at the Academy of Managed Care Pharmacy’s 2011 Educational Conference, October 2011.
4. National Headache Foundation Patient Survey, June 2008.
5. Silberstein, S. Migraine symptoms: results of a survey of self-reported migraineurs. Headache 1995;35:387-396.
6. NuPathe market research, 2008, 2011.
7. US Prescribing Information for Imitrex Nasal Spray.
8. US Prescribing Information for Imitrex Injection.
9. IMS and NuPathe internal analyses.
This Fact Sheet provides background information on NuPathe Inc. It should be read in conjunction with NuPathe’s press releases and filings with the
U.S. Securities and Exchange Commission, which are available in the “Investor Relations” section of the company’s website at www.nupathe.com.
© 2012 NuPathe Inc. All rights reserved. NuPathe, Zecuity, and LAD are trademarks of NuPathe Inc.
227 Washington Street | Conshohocken, PA 19428 | 484.567.0130 | www.nupathe.com