I. The Basic Switch Process

Transcription

Rx to OTC Switch Summit:
Assessing the Future of Switches in the US
and Beyond
Workshop:
Evaluating “Switchability” and Ensuring Successful
Regulatory and Commercial Outcomes
We work with consumer healthcare
companies to develop and implement
strategies for growth – on a portfolio or
brand basis
We help our clients implement tactics for
both organic and inorganic growth strategies
Acquisitions/Divestitures
Tech Search/In-Licensing
Rx to OTC Switch
Geographic Expansion
Partnerships
Marketing Initiatives
Experience and Assignments
• Our team members have contributed to dozens of Rx to
OTC switch programs at SmithKline Beecham, WarnerLambert, Pfizer, Pharmacia, Schering-Plough, Merck,
Chattem, etc.
• In the past four years, our firm has:
– Led the strategy, planning and program implementation of five
first-in-class Rx to OTC switch candidates, from both a
commercial and regulatory standpoint
– Assessed Rx to OTC switch potential for multiple Rx products
– Helped consumer healthcare companies develop evaluation
criteria
– Assisted Rx companies with Rx to OTC outlicensing strategies
– Accelerated timelines for existing Rx to OTC programs
– Participated in Rx to OTC switch Advisory Committee Meetings
Agenda
• Introductions
• The Basic Rx to OTC Switch Process
– Including NSURE Initiative
8:30am
8:45am
• Break
10:00am
• Key Switch Success Factors
• Evaluating Switch Opportunities
11:10am
10:20am
Level Setting
• How many of you are switch novices?
• How many are switch experts?
Doing a Switch is like Making an
Apple Pie
Apple Pie
Apple Pie
Switches are like Apple Pie
• There is no one, right recipe for switch
• There are some basic guidelines that should be followed
• There will be differences of opinion about how to achieve
the switch
• There can be similar ways to achieve the same outcome
• Be careful not to over-complicate your switch
• Some switches fail
• Each switch has historically had a different “spice” that
has made it unique
• … and it can get heated in the kitchen!
… BEFORE WE DISCUSS
SWITCHES …
Monograph vs. Switch
• OTC Monograph Process started in 1972
– FDA reviewed all currently (1972) marketed OTC products
– Determined which drugs, at what levels and in what
dosage forms, were safe and effective
– Set standard labeling
– Monographs enable all GMP manufacturers to launch
products according to guidelines without pre-clearance
– … although some monographs still not finalized
• Drugs not considered via the monograph process can only be
introduced to OTC market via NDA
– Most are “switched” from Rx marketing status
– A few (topical) drugs have been approved directly as
OTCs
Monograph vs. Switch
Monograph
Analgesics
Allergy
Heartburn
Switch
THE BASIC RX TO OTC
SWITCH PROCESS
OTC Principles
• According to FDA, OTC drugs generally have these
characteristics:
– Their benefits outweigh their risks
– The potential for misuse and abuse is low
– Consumers can use them for self-diagnosed
conditions
– They can be adequately labeled
– Health practitioners are not needed for the safe and
effective use of the product
OTC Principles
• CDER Director Janet Woodcock reaffirmed in 2001 that
“the default assumption of the Act is for drugs to be
marketed OTC without a prescription unless a decision is
made tha t consumers are not able to appropriately
diagnose their condition nor able to correctly choose the
remedy and use it safely based on OTC labeling”
• How FDA makes this decision continues to evolve,
however…
– FDA scheduled to present “updates on key Agency
initiatives such as FDA monograph modernization and
the Safe Use initiative” at CHPA RSQ on May 15th
Peck Principles (1990)
•
•
•
•
•
•
•
•
•
•
•
•
•
Does the switch candidate have special toxicity in its class?
Does the candidate have a large margin of safety?
Does the candidate’s frequency of dosing affect it’s safe use?
Has the candidate’s safety profile been defined at high dose?
Has the candidate been used for a sufficiently long time on the prescription
market to enable a full characterization of its safety profile?
What is the worldwide marketing experience of the switch candidate?
What foreign countries market the candidate OTC? What is its experience
in those countries?
What do the “use data” show?
Has a vigorous risk analysis been performed?
Has the efficacy literature been reviewed in a way to support the expected
usage and labeling of the switch candidate?
Is there a full understanding of the pharmacy-dynamics of the switch
candidate?
Is the minimally effective dose for the proposed OTC indication known?
Have possible drug-drug interactions for the switch candidate been
identified?
•
•
•
DeLap
Principles
(1998)
Fundamentals
– Can the condition be adequately self-diagnosed?
– Can the condition be adequately self-treated?
– Is the self-treatment product safe and effective for consumer use, under
conditions of actual use?
Points to Consider
– Is there a need for physician evaluation of the condition?
– What is the nature and severity of adverse effects of consumer misdiagnosis and
delay in correct diagnosis?
– Regarding effective product use, what is the nature of consumer understanding
of product use?
– What is the consumer understanding of expected benefit?
– Does the consumer have the ability to assess treatment effect?
Safe Product Use
– What is the consumer understanding of product directions for safe use?
– What is the consumer understanding of what to do if the product isn’t working?
– What is the consumer ability to identify adverse effects, and the consumer ability
to determine when adverse events may require professional care?
– What is the consumer expectation of safety?
OTC Principles
• It’s all about Risk vs. Benefit!
– Although “economic and comparative safety or
efficacy assessments are not party of the agency’s
switch decisions”
• Assuming that safety and efficacy have already been
demonstrated in an Rx setting, can a consumer safely
use the drug without the presence of a learned
intermediary?
– Focus is therefore more on consumer behavior than
safety and efficacy
• Can the consumer safely self-diagnose?
• Can the consumer safely self-treat?
– Adequate and appropriate labeling is key
Can the Consumer Self-Diagnose the
Condition?
• (For new OTC indications) will misdiagnosis result in
delayed treatment for a more serious condition?
– Are there more serious conditions with similar
symptoms?
• How common or rare are these conditions?
– What are the consequences of misdiagnosis?
– How are physicians diagnosing and prescribing?
• Using visual clues versus tests?
• Allowing consumers to self-diagnose or prescribing
over the phone?
Can the Consumer Safely Self-Treat
with the Drug?
• Will inappropriate patients know not to use the product?
– Diabetics, certain age groups, etc.
• Are there implications of inappropriate use?
– Addiction?
• Although nicotine is addicting …
– What if the consumer takes more than the
recommended dose?
• What side effects have been seen in use?
• What is the position of the professional/medical
community on broader access?
• Is any monitoring required to ensure safe/effective use?
Basic Switches Do not Exist
• In the past ten years …
– Only 14 new drugs brought to OTC market
– Only 6 First in Class switches
• In the past five years …
– Only 6 new drugs brought to OTC market
– Only 2 First in Class switches
• Almost no two switches have followed the same pathway
View switch list at:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm106378.htm
OTC Product
Approval
First in Class? Lesson(s) Learned
Lamisil Derm Gel (Novartis)
7/24/06
N
Plan B (Duramed)
8/24/06
Y
BTC for age verification
MiraLAX (Schering-Plough)
10/6/06
Y
Unmet consumer need
drove big $ sales
Zaditor (Novartis)
10/19/06
Y
No patent protection and
no spending = poor sales
Alaway (B&L)
12/1/06
N
Generic Zaditor
alli (GSK)
2/7/07
Y
“Read Me First” brochure
to enhance compliance
Zyrtec/Zyrtec-D (McNeil)
11/07
N
Prevacid 24 HR (Novartis)
5/18/09
N
Plan B One Step (Duramed)
7/10/09
N
OTC Product
Approval
First in Class? Lesson(s) Learned
Zegerid OTC (Schering-Plough)
12/1/09
N
Allegra/Allegra D (Chattem)
1/24/11
N
Oxytrol for Women (Merck)
1/25/13
Y
Left “men” Rx
Silhouette = Label
Neg Ad Comm vote
Nasacort Allergy 24 HR (Chattem)
10/11/13
Y
All ages switched
Human Factors Study
Blocked publication of
review/SBA
Nexium 24HR (Pfizer)
3/28/14
N
Efficacy required
Flonase Allergy Relief (GSK)
7/23/14
N
Booklet = Label
Additional claim
Rhinocort (McNeil)
3/23/15
N
Trade dress hidden
No Rx Product Equity
3rd PPI to market
Common Threads of Recent
Switches
• All demonstrated safety in an OTC setting via
adequate labeling
– Labels constructed using Drug Facts Label
format, despite limitations of this format
– Label readability tested via Label Comprehension
Studies
• Only “new information” required to be tested
– Consumer decision-making tested per Self
Selection Studies
– Actual Use Studies required to demonstrate safe
use (i.e., de-selection, compliance to label, etc.)
The Basic Rx to OTC Switch
Meet with FDA (Pre-IND Meeting)
Label Comprehension Study (LCS)
Self-Selection Study (SSS)
Actual Use Study (AUS)
File NDA
Advisory Committee Meeting
Meeting with FDA
• Rx to OTC switches involve both the Division of
Nonprescription Clinical Evaluation (DNCE) and the
therapeutic review Division
– Create a meeting request that will get the right people to
the meeting
• Start with the label = Pay close attention to indication
• Propose a development plan to FDA
– Make a compelling case (with data) for rationale for
switch and development plan
– If FDA requires a clinical study to approve the switch, it
will result in three years of Hatch-Waxman exclusivity
• Summarize all learnings at meeting end and confirm
understanding in formal minutes
– Although FDA can change their mind
Nasacort Pre-IND Meeting
• Nasacort Review and Summary Basis of Approval
(SBA)blocked from public review … but … check out Ad
Comm material!
• “FDA advised that label comprehension studies
should focus on the priming of the Nasacort AQ
pump, which was a more unique aspect of consumer
directions. FDA also requested a human factors study
to assess consumers’ performance in these tasks. Selfselection and actual consumer use studies were not
deemed necessary given the experience with other OTC
products and labels, including those for OTC AR
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UC
products.”
M362907.pdf
Nasacort Pre-IND Meeting (II)
• “A key consideration in the switch approval of Nasacort AQ is
the age recommendation for OTC use. Sanofi initially
proposed to the FDA that the OTC indication be
restricted to 18 years of age and older. FDA did not
agree, indicating that they were unaware of any data that
would preclude OTC approval for the full age range of 2
years and older, and requested a justification for an age
restriction. Sanofi conducted a comprehensive review of
Nasacort AQ safety information including for the pediatric
population. ... In light of the benefits of OTC access, the
safety evaluation and consistent with the FDA’s
recommendation, Sanofi filed for a full switch (2 years of age
and older) where the indication, population and duration of
use reflect the current approved prescription labeling.”
M362907.pdf
Label Comprehension Study
• A Label Comprehension Study (LCS) is a consumer
behavior study that assesses the extent to which
consumers understand the information on
nonprescription drug product labeling and then apply this
information when making drug product use decisions in a
hypothetical situation.
– Performed as an “open-book” test
– Supplemented with low medical literacy participants
– Focuses on what’s different versus existing OTC
labels
• Data derived from a label comprehension study can
identify areas on the label that would benefit from clearer
or simpler presentation of important consumer
information.
Nasacort - Can Consumers use the
Bottle without Being Taught?
(From the Nasacort Ad Comm Briefing Document):
• “The primary objectives in testing the DFL and CIL
focused on consumer understanding of the following
label directions:
– DFL: Get a new bottle ready (primed) before first use.
– CIL: A new bottle of Nasacort must be primed before
first use.”
M362907.pdf
Claritin – Focus on CIU
(From the Claritin NDAC briefing documents):
• “This label comprehension study was designed to evaluate Claritin
® 24 for over-the- counter (OTC) treatment of chronic idiopathic
urticaria (CIU). Claritin ® 24 (loratadine) is currently a prescription
medication prescribed for the treatment of seasonal allergic rhinitis
and chronic idiopathic urticaria. Currently CIU is not an OTC
indication for any product marketed in the U.S. The label study was
designed to evaluate whether consumers can understand label
directions, and in particular the new indication and direction for
previously diagnosed, recurring or chronic hives. This review did not
examine the entire Label Comprehension Study, but focused on
issues that will likely be discussed at the Advisory Committee
meeting.
• The objectives of this study were to evaluate if consumers:
– understand the uses, directions and warnings as based on
reading the product label
– can accurately self-recognize CIU upon recurrence and
appropriately self-select Claritin for use”
Source: http://www.fda.gov/ohrms/dockets/ac/02/briefing/3850b1_07_LabelComp-Review.pdf
Oxytrol Required Multiple Label
Comprehension Studies
• From the Summary Basis of Approval:
– Pilot LCS
– LCS of enhanced pregnancy warning
– LCS of diabetes warning
– LCS among 65 and older women
– LCS among women with diabetes risk
– Pivotal LCS among female OAB sufferers
Source: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211Orig1s000SumR.pdf
Self Selection Study
• A Self-Selection Study (SSS) is a consumer behavior
study that assesses the ability of consumers to apply
drug labeling information to their personal health
situation to make correct decisions about whether or not
it is appropriate for them to use a drug product.
– Particular focus on populations that should NOT use
the product
• FDA guidance published April 2013
• As with Label Comprehension Studies, there is specific
expertise required to conduct these studies
– Two key research organizations (Pegus and
Concentrics)
A Notable Self Selection Failure
• Singulair (May 2014 Advisory Committee Meeting)
– Concerns about increased risk of neuropsychiatric
events in teens
• Only 57.7% of adolescents correctly identified that
the product was not for them in a targeted selfselection study when initially asked
– Concerns about inappropriate use for asthma
• The outer carton included a banner on the front
AND back of the carton:
THIS PRODUCT IS ONLY FOR ALLERGIES.
DO NOT USE TO TREAT ASTHMA.
• Nearly 16% of asthma sufferers without allergy
symptoms felt that the product would be
appropriate for them to use
Proposed Mevacor Daily™ Label 2007
Notable Self Selection Failures
• Mevacor
– Merck tried to switch Mevacor in 2000, 2005 and
2007
– Concern about fetal toxicity associated with the drug
– Merck failed to demonstrate that women under the
age of 55, or women who could get pregnant, would
not self-select OTC Mevacor
A Self Selection Success
• Gyne-Lotrimin (1990)
– Initial concerns about self-diagnosis
– Schering-Plough labeled the product both to describe
the symptoms, and to state that the product should
only be used by women who had previously
experienced a yeast infection
– Schering-Plough also demonstrated that women were
as accurate as their doctors in recognizing recurrence
– Key learning: the “standard of care” is not always
standard
How Many Oxytrol Studies?
• Oxytrol required three self-selection studies with an evolving
label
– First Self Selection Study:
• Decisions compared to a physician’s diagnosis
• 89.4% of normal literates and 91.2% of low literates made a
correct self-selection decision
– Self Selection Study with only men:
• >90% self-selected correctly not to use the product
• PDP tested was pink and contained an image of a woman
– Self Selection Study among pregnant women with OAB
symptoms:
• Study participants had to recognize that urinary frequency could
be an early sign of pregnancy and that they should ask a health
care provider before using Oxytrol if they were pregnant or
nursing
The Definition of Labeling is
Expanding …
• Includes images on Primary Display Panel
– Earlier in the Oxytrol development program, the icon
on the package featured a woman wearing a “stylized
tent-like dress”
– While men were able to understand that the product
in the pink package was not for them …
– This package tested poorly with pregnant women
– In the final label review, FDA noted that the label is
approved with “the silhouette of a woman … with a
thin waist and slightly leaning back”
OPDP and Labeling
• OPDP (formerly DDMAC) will also consider OTC brand
name
– Particularly if an indication or dosage remains Rx
– What does the suffix convey?
Prevacid 24 HR
• Clear lack of consistency!
Plan B One Step
Zegerid OTC
Allegra/Allegra D
Oxytrol for Women
Nasacort Allergy 24 HR
Nexium 24HR
Flonase Allergy Relief
Actual Use Study
• An Actual Use Study (AUS) is a clinical study used to
simulate the OTC use of a product to predict if a drug
will be used properly, safely, and effectively in the OTC
setting.
• Examples of things an Actual Use Study can assess are:
– Adherence (taking the drug and performing any
monitoring for efficacy and safety in accordance with
the drug label)
– Safety (adverse events that occur during the study)
– Efficacy (whether the clinical benefit in the
prescription setting is reproduced in the OTC setting
or with a different OTC indication)
Recent Actual Use Studies
• Oxytrol
– Primary endpoint in CONTROL Actual Use Study:
• Proportion of verified users who did not stop use when they
developed new or worsening symptoms over all verified users
• Lipitor
– As reported on clinicaltrials.gov. Last updated March
2015 with completion December 2014.
– Primary endpoints:
• Percentage of subjects who comply with the direction to check
their low-density lipoprotein cholesterol (LDL C) level after 26
weeks
• Percentage of subjects who, after checking their LDL C level,
take the appropriate action based on their test results
Other Studies May Be Conducted or
Required
• Nasacort required to do Human Factors Study to
demonstrate that consumers could prime and use the
pump
– Human Factors Studies are designed to show how
consumer interact with the product
– Also required to demonstrate that consumers did not
perforate their septum
• Nexium required to demonstrate efficacy for frequent
heartburn, a different indication than the Rx indications
• Flonase conducted a Phase IV study to demonstrate
efficacy against the allergy symptom: “itchy, watery eyes”
Advisory Committee Meetings
• After filing a switch NDA, FDA may convene a
Nonprescription Drugs Advisory Committee (NDAC) to
obtain broader input on whether the sponsor has
demonstrated that the drug product can be used safely
and efficaciously by consumers without a learned
intermediary
– Particularly for first-in-class drugs
• Recent NDAC meetings: Singulair (2014), Nasacort (2013),
Oxytrol (2012)
• There were no switches reviewed in 2011 or 2010
• Required for Nasacort (2013), but not Flonase (2014) or
Rhinocort (2015)
• Required for Prilosec (2000) but not Nexium (2014)
Advisory Committee Meetings
• NDAC meetings to discuss switches are public events,
often attended by competitors, and include:
– Presentations from sponsor and FDA
– Comments from interest groups
– Discussion, and voting
• Although FDA asks the Advisory Committee to vote, FDA
does not always follow their recommendations
– NDAC voted 10 to 6 for Nasacort, but 5 to 6 against
Oxytrol
• Months of preparation are required by the sponsor in
advance of an Advisory Committee meeting
What Nasacort Did Well
• Prepared for opposing views of public advocacy and
health professional groups
– Engaged them
– Listened to their concerns
– Transparent with intentions and respectful of their
POV
• Interfaced well with FDA to prepare for Ad Comm
– Anticipated concerns of Advisory Committee and
shared expectations with FDA
– Practiced, revised and practiced core presentation
repeatedly and shared it with FDA
– Respectful and genuinely open, appreciative and
cooperative with FDA
Slide courtesy Bernie Simone, VP Rx to OTC Switches, Chattem
What Nasacort Did Well
• Conducted well-designed comprehension and
human factors studies and presented them in a
clear, complete and concise manner
• Prepared for thousands of possible questions that
helped hone the Core Presentation
• Incorporated excellent consultants and integrated
them effectively
– Team of Rivals
Slide courtesy Bernie Simone, VP Rx to OTC Switches, Chattem
Switch Program Costs and Timing
• Assuming a First in Class switch:
Label Comprehension
Self-Selection
Actual Use
Prepare/Approve NDA
TOTAL
Duration
6 months
Cost
$250K
5 months
1.5 years
> 1 year
5 years
$500K
$2.5MM
$2.2MM+
>$6MM
Does not include: repeating studies, Ad Comm preparation,
personnel costs, outside consultants, at-risk launch
preparation
Some Topical Products have been approved
for OTC sale in the US without prior Rx
history
• Abreva, a product for cold sores, and Mexoryl, a
sunscreen, were approved by FDA for OTC use without
prior Rx use in the US (2000 and 2006 respectively)
• Both products had extensive clinical programs.
Mexoryl also had an extensive history of use in
Europe.
– There were 33 in vivo and 5 in vitro studies
conducted on Abreva in addition to 3 clinical efficacy
studies
– In addition to its non-US marketing history, 18
studies were conducted on Mexoryl
Abreva Pre-Approval Studies
Pre-Clinical/Non-Clinical
38 Total Studies (33 in vivo + 5 in vitro)
•
1 in vitro Pharmacokinetic study
•
4 in vitro Genotoxicity studies
•
5 Safety Pharmacology Studies
•
2 Hours Body temperature in Mice(n = 24)
•
2 Hours Sleeping Time in Mice (n = 24)
•
4 Hours Cardiovascular and Respiratory in Mice (n = 24)
•
4 Hours Gastrointestinal Tract in Mice (n = 24)
•
3 Hours Urinary Output in Mice (n = 24)
•
4 Repeat 168-Hour ADME studies in Mice (n = 76)
•
24-hour Absorption and Pharmacokinetics study in Rabbits (n =
12)
•
6 Reproductive and Development
•
4 Day Oral Dose Range in Rats (n = 36)
•
20 Day Oral Dose Range in Rats (n = 24)
•
12 Day Oral Dose Range in Rabbits (n = 4)
•
29 Day Dose Range in Rabbits (n = 16)
•
71 – 90 Day General Reproduction in Rats (n = 176)
•
1 Hour General Reproduction in Rabbits (n = 16)
•
17 Toxicology studies
•
15 day Oral Toxicity in Rats (n = 10)
•
26-week Oral Toxicity in Rats (n = 160)
•
26-week Oral Toxicity in Dogs (n = 32)
•
15 day Dermal Toxicity in Rats(n= 10)
•
13 Week Dermal Toxicity in Mice (n = 60)
•
28 Day Repeated-Dose Dermal Toxicity in Rabbits (n = 60)
•
28 Day Dermal Tolerance in Rabbits (n = 8)
•
4 Hour Skin Irritation/Corrosion in Rabbits (n = 3; 10%
formula)
•
4 Hour Skin Irritation/Corrosion in Rabbits (n = 3; 20%
formula)
•
1 Hour Eye Irritation in Rabbits (n = 3; 10% formula)
•
1 Hour Eye Irritation in Rabbits (n = 3; 20% formula)
•
8 Day Hypersensitivity in Guinea Pigs (n = 30; 20%
formula)
•
8 Day Hypersensitivity in Guinea Pigs (n = 30; 25%
formula)
•
7 Day Phototoxicity in Guinea Pigs (n = 6)
•
10 Day Penile Irritation in Rabbits (n = 40)
•
10 Day Vaginal Irritation in Rabbits (n = 50)
•
28 Day Vaginal Toxicity in Rabbits (n = 5)
Clinical
3 Clinical Efficacy Studies
•
2 Week Randomized, double blind study in Patients with Recurrent Herpes Labialis (n = 63)
•
18 Hour Disease duration study (n = 312)
•
16 Hour Disease duration study (n = 312)
Mexoryl Pre-Approval Studies
Pre-clinical/ Non-Clinical
8 Total Studies (2 in vitro + 6 in vivo)
2 in vitro
• Critical Wavelength Study of Test Formulations
• E. Coli genotoxicity in presence of UVA and UVB light
6 in vivo
• Clastogenicity in Rodents (n = UNK)
• 104 Week Dermal Carcinogenicity in Mice (n = UNK)
• 2 Week Topical Toxicology on Rodents (n = UNK)
• 2 Week Oral Toxicology in Rodents (n = UNK)
• 26 Week Oral Toxicology in Rats (n = UNK)
• 6 to 21 Day Reproductive Toxicology in Rats (n = UNK)
Clinical
10 Clinical Studies
• 1 week Phase 1 Dermal Safety Study (n = 223)
• 20 Day Phase 2 Efficacy study on 7 Test Formulations (n = 100)
• 22 Day Phase 2 Efficacy Study on 6 Test Formulations (n = 49)
• 10 Day Phase 3 Efficacy Study on 1 Test Formulation (n = 14)
• 12 Month Phase 3 Safety Study (n = 1,048)
• 6 Hour Photosensitization (n = 137)
• 48 Hour Phototoxicity (n = 26)
• 6 Week Acnegenicity/ Comedogenicity (n = 44)
• 8 Day Pharmacokinetic Study in Healthy Males (n = 6)
NSURE INITIATIVE
FDA’s NSURE Initiative
• In March, 2012, FDA held a public hearing to consider
expanding “the conditions of safe use” under which more
OTC drugs could be made available to address undertreatment of common diseases that could benefit public
health.
• FDA cited the following public health concerns:
– Significant undertreatment of common diseases and
conditions
– Lack of regular access to medical and pharmacologic
care
– Decreased access to health services
See http://www.gpo.gov/fdsys/pkg/FR-2012-02-28/pdf/2012-4597.pdf
• In the meeting notice, FDA specifically cited
hyperlipidemia, hypertension, migraine headaches,
diabetes, asthma and chronic obstructive pulmonary
disease (COPD) as underserved conditions
• FDA convened the meeting to question whether
innovative technologies could be used to expand which
drugs products could be safely used OTC
– Approximately 30 speakers provided broad
representation of different views (consumer,
professional organizations, academia)
– FDA received over 180 comments from a variety of
stakeholders
• Comments addressed a variety of areas:
– Access and data concerns
– Effect of paradigm on health care
– Effect of paradigm on health care costs
– Specific drugs, diagnostics and technologies
– Conditions of safe use
– Barrier to successful implementation
• Subsequent to the March 2012 Public Hearing:
– FDA named the initiative NSURE (Nonprescription
Safe Use Regulatory Expansion)
– Held three expert workshops to further explore the
issues
The NSURE Workshops
• 11/8/12: “Nonprescription Medications with Conditions of
Safe Use as a Novel Solution for Undertreated Diseases
or Conditions”
• 5/9/13: “Innovative Technologies and Nonprescription
Medications: Addressing Undertreated Diseases and
Conditions through Technology Enabled Self-Care”
• 11/4/13: “Exploring Implications of the Nonprescription
Drug Safe Use Regulatory Expansion (NSURE) Initiative
on Reimbursement and Access”
• It has been over a year, and next steps are unclear …
looking forward to update on May 15th!
NSURE’s Potential
• Evolving 21st Century communication tools to assist with
proper decision-making and safe use could include:
– Pharmacist integration into product monitoring and simple
diagnostic testing (i.e. blood pressure testing and monitoring?)
– Computerized kiosks with self-selection algorithms that could
intervene with the ability to purchase the drug if self-selection is
inappropriate (i.e., cholesterol risk factors?)
– Algorithms that limit the quantity of medication available to help
ensure proper adherence with usage instructions
– Smart phone capabilities integrated with drug use monitoring or to
help thwart potential for drug-drug interactions
• There’s an app for that!
– Interactive computer programs used by consumers and monitored
by sponsor companies
Some Issues For Consideration
• Will new regulations be required to approve a new,
expanded definition of labeling?
• If “tools” designed to aid self-selection are added to OTC
drugs, will these be considered drug-device
combinations?
• What would be required when these new technologies
are updated with enhancements, something that can be
expected to happen frequently?
Do We Need NSURE?
• Long ago, FDA demonstrated their willingness to
consider “collateral measures” in Rx to OTC switch
approvals
– 1996: Nicorette switch included “User’s Guide
and Audiotape”
– 2007: Alli switch included “Read me First” insert
• 2014: The approved Flonase label includes a 36page booklet!
H *!4I #:*(>#:*(*4-3. %#?' -*%-#FG' 1 2(*
Merck Self Selection Patent
Enhancing Self-Treatment
US Patent Application 20080153122
Method and System for Enhancing Self-Treatment of Onychomycosis
Can Technology Aid Consumer SelfSelection?
GSK developed a prototype
electronic aid to selfselection using:
• a simulated electronic
kiosk
• a model drug named
“Cardiocor” – an OTC
statin for cholesterol
reduction
• 9 step self selection
algorithm based on the
Mevacor- Daily™ Drug
Facts label
Slide courtesy Erin Oliver, Head, US Regulatory Affairs, GlaxoSmithKline Consumer
Exploratory Study of an Electronic
Self-Selection Aid
• Exploratory study evaluated the use of technology to
supplement the product label
– Ease of use (electronic self-selection aid)
– Impact on correct decision making
• Compared 2 groups
– Label only (n = 155)
– Label + electronic self-selection aid (n = 155)
• Use of the electronic aid significantly improved overall
correct selection (46.5% vs. 73.5%; p <0.001)
• Subjects found the device easy to use and helpful in
making a selection decision
Slide courtesy Erin Oliver, Head, US Regulatory Affairs, GlaxoSmithKline Consumer
In The News
“CVS Health has confirmed a report that it is planning to open a
CVS Health Digital Innovation Lab this winter in Boston that will
focus on “building customer-centric experiences in health care.”
As initially reported on BetaBoston.com, the new 15,000-sq.-ft.
office space will be centrally located to the medical community in
Longwood and the tech community in Cambridge, and will
enable CVS Health to further explore the “digital enablement of
health care.”
In the article, Tilzer also pointed to another project in
development — “lab stores” in Boston, New York and Menlo
Park, Calif. Tilzer said the stores will provide a “live environment”
and will open next year. "The lab stores will provide a 'live
environment' to 'explore whether they can be meaningful,'" Tilzer
told
BetaBoston.com.”
As reported
in Drug Store News, November 18, 2014
Incorporating Monitoring Devices?
• Garmin Vivofit Wireless Activity
Tracker & Heart Rate Monitor
Bundle learns your current activity
level, creates a personalized daily
goal, tracks progress, tracks heart
rate and reminds you to move.
$119.99
• Can the next generation of Rx to OTC switches include
“monitors” to enhance compliance? Track results?
• Would monitors be considered a drug-device
combination?
NSURE Final Thoughts
• The successful switch of new and more challenging
categories may require:
– The ability to use and validate non-traditional
communication methods to aid consumers in making
more complex choices
– Facilitating self-selection and use decisions can be
accomplished with the PDP, DFL and …
• Help lines, CDs,
• User guides, support materials
• Websites, on-line, personalized programs
NSURE Final Thoughts (II)
• The successful switch of new and more challenging
categories may require:
– More cooperative dialogue between the Agency and
Sponsors on these novel ideas to assure “safe use”
using new tools
– A shared perspective of the:
• Safety consequences of use and misuse
• The possibilities and the limitations of new
technologies and the retail environment
• A fair and balanced assessment of the incremental
OTC risk vs. the current Rx Standard of Care to
achieve increased access to the under-served
patients without compromising safety
BREAK
KEY SWITCH SUCCESS
FACTORS
Not All Switches Are Successful
OTC Product
Approval
Sales >$100MM?
alli (GSK)
2007
Initially
Zyrtec/Zyrtec-D (McNeil)
2007
Yes
Prevacid 24 HR (Novartis)
2009
Initially
Plan B One Step (Duramed)
2009
No
Zegerid OTC (Schering-Plough)
2009
No
Allegra/Allegra D (Chattem)
2011
Yes
Oxytrol for Women (Merck)
2013
No
Nasacort Allergy 24 HR (Chattem)
2013
Yes
Nexium 24HR (Pfizer)
2014
Yes
Flonase Allergy Relief (GSK)
2014
Yes
Rhinocort (McNeil)
2015
???
The Size of the Prize
US OTC Sales*
Mucinex
$781MM
Advil
$705MM
Vicks
$576MM
Tylenol
$506MM
Claritin
$497MM
Aleve
$414MM
Zyrtec
$407MM
Allegra
$332MM
Bayer
$331MM
Prilosec OTC
$304MM
• Vicks and Bayer are the
only top 10 US OTC
brands that were not Rx to
OTC switches
• Rx to OTC switches drove
27% of OTC growth in last
5 years**
* Nielsen latest 52 weeks xAOC w/e 2/21/15
** IRI Presentation at CHPA Annual Meeting, March 2015
Lessons Learned
Drivers of Rx to OTC Switches
1. Rx Factors: Brand Equity (including DTC)
2. Order of Entry (vs other Switches and Private Label)
3. Satisfaction with Current Category Choices Prior to
Switch
a. Implications for pricing
4. Professional Marketing (including Managed Care)
5. Excellence in Execution
a.
b.
c.
Consumer Advertising and Promotion
Retail Planning
Lifecycle Management
6. A High Performing Team
Lessons Learned
Switch
a.
b.
c.
Retail Planning
At Least Initially, Rx Brand Equity
Matters
• Rx brands bring existing users
• Moreover, well known brands have established inherent
trust
– “millions of prescriptions …”
• For this reason, key to switch at/by patent expiry
– Brand names erode over time (i.e., Lipitor)
• Astra Zeneca spent over $1B marketing “the purple pill”
– Rumored that Pfizer paid for Rx marketing prior to switch
• Sanofi spent $600M on DTC advertising prior to Allegra
switch
• Could be impediment to switching birth control pill?
Who Will Win the PPI War?
H2
OTC
Approval
OTC Sales
($MM)*
Rx Sales prior
to Patent Exp
Observations
Prilosec
6/20/03
$304.3
$3.7B (2001)
Now with wildberry coating
Prevacid 5/18/09
$84.0
$3.4B (2007)
Cut back on Year 2 spending
Zegerid
12/1/09
$31.4
$0.1B (2009)
No brand equity
Superiority that can’t be
communicated
Nexium
3/28/14
$199.0
$6.1B (2013)
“The Purple Pill” was #1 Rx
brand
Price parity with Prilosec
< 11
months
of sales
• Who Will Win the INS War?
• Flonase vs Nasacort vs Rhinocort?
Low Rx Equity Products with OTC
Success
• Some brands have experienced higher sales OTC than
Rx
– Immodium ($103.2MM)
• Problem resolved for most patients before they
received prescription from doctor
– Pepcid ($88.6MM)
• Relatively late entry to Rx category, but first OTC
H2 antagonist
– MiraLax ($191.4MM)
• Provided meaningful benefits versus existing OTC
laxatives
Implications for Switch
• Rx drugs with strong brand equities, and therefore high
TRx, bring consumers with them when they switch
– A notable exception is Rx drugs that address a key
unmet consumer need in the OTC marketplace will
source new volume
• For a drug that will switch at or after patent expiration, it
may be worthwhile to continue to spend Rx marketing
dollars until the switch occurs
• Competitive intelligence is key: If larger, more well
known competitors are due to switch in the same
timeframe, the value of your switch may be limited
– Nasacort vs Flonase vs Rhinocort?
Lessons Learned
Switch
a.
b.
c.
Retail Planning
Order of Entry Important, But not
Insurmountable
+5 K&0"#, "=%] . "%N&"%+, /. 05 &. , "#>L$%
( 0- $0%&'%A, "01%
, 7KS7!, D!SF - 7L!#N[S#!
#* . . S##!SRNH O[S#!
%
&3!%3!%!U!' (!
, 41&4!' (! #%@
S0$4%0$!q"!
S0$45!
G%
GFFT %
E%
QF%e%QOT %
H%
OO%e%POT %
M%
OF%e%OOT %
O%
MO%e%OOT %
P%
MF%e%OFT %
• j #, "#6%n%H%!: ;"6<%%
an%G%;, %VEl/%,&: b%
%
%
• CLL$D0#%n%H%!: ;"6<%
an%H%;, %CLL$0D1%,&: b%
%
%
%n%E%!: ;"6<%
• j 10"$6%
ao%*L#0;";, %;, %I$#0%Gb%%
\!H , F - B!#N[S#!
a` %2 ;LL;&, /b%
$110
$62
O&4=&0$!' (!!
&3!
' 3&=!#%@
O49@
VXU!
Prilosec 9/03
Prevacid 11/09
N$: %40&- . 6"%)0$, - /%EFF
+, '&! 6#, %!#L$/%R#"#=%
E%&'%Ei%%+7+%
4#0"%
N. 5 >$0%H=%
%2 #03$";, D%!6;$, 6$=%B&L. 5 $%GM=%
! &. 06$U%%
Slide courtesy Bob Sanders, EVP, Healthcare Practice Leader, IRI
Long-Term Impact of Order
(Nearly 20 Years Later)
H2
OTC Approval
Sales
($MM)
Observations
Pepcid
4/28/95
$88.6
Pepcid Complete approved 2000
Tagamet 6/19/95
$9.7
Was #1 Rx, but two pill OTC dose
Tagamet 200 approved 1999
$118.0
Zantac 150 approved 2004
Clear Positioning “No pill relieves
heartburn faster”
Zantac
12/19/95
Axid
5/9/96
$0
Not enough room for #4
• Consider also PPI Order of Entry
Private Label Timing Material to LongTerm
Potential,
not
Initial
Success
40;J
#"$%X#>$L%
) ;5 ;, D%2 But
#"$0;#L%
"&%X&,
D9)$05
%4&"$, ";#L=%%
] . "%N&"%+, ;";#L%!. 66$//%%
N[[S? 7N!f !N@
@
&4C5+!DKN!NPP4' 8&1!s%02%45!6W""p!O4' 12=$!#) 9PP&1!
! "#$%&' #$( ) $%"#$*"#+,$
O498%$&![%A&@
![%20=) &1!90!NP49@
_!, 0&!H ' 0$) ![%$&4!
• C'"$0%
&, $%1$#0=%40;J #"$%X#>$L%: #/%EOT %"<$%/;d$%&'%
CLL$D0#%
/#L$/i%CLL$D0#%L&/"%% - .&( .$%( $/.&01%#$213#+$
+14) 5"&) 6$&*$' 1%#.&1+$
G@
QT %
&'%
/: ;"6<;, D%J&L. 5 $%"&%40;J #"$%X#>$L@
%
cL7- S. !f !N@
@
&4C5+!DKN!NPP4' 8&1!6WWXp!#) 9PP&1!s%02%45!6WWZ!
O498%$&![%A&@
![%20=) &1!%$!$) &!#%J &!- 9J &!
• C'"$0%
&, $%1$#0=%40;J #"$%X#>$L%: #/%HFT %"<$%/;d$%&'%
j 10"$6%
/#L$/@
%
O7SI N. /K!f !B&%4$A240+!DKN!NPP4' 8&1!H %5!6WW] p!#) 9PP&1!F ' 8&J A&4!6WW] !
O498%$&![%A&@
!#$%4$&1!#&@
@
90C!90!H %5!6W"6!
• C'"$0%
&, $%1$#0=%40;J #"$%X#>$L%: #/%MGT %"<$%/;d$%&'%
40$J #6;- %/#L$/i%40$J #6;- %
L&/"%M\ T %&'%
/: ;"6<;, D%J&L. 5 $%"&%40;J #"$%X#>$L%@
%
%( $%"#$+( ) 67%#.' $*&8#$
( ,$%"#$*9 &%5"#: $3.1) : ;!
"#$%!& ' ( ) %!*) +$, - %!, .!
) /012%$3$45!' 6%, 124) 15!
0+$4$0' 17!8 #) +) !
*, %%$61) 9!%: $40#!
0' ; - $- ' 4) %!%#, 21- !1, , ( !
., +!) /012%$3$45!3) +%2%!
<+$3' 4) !=' 6) 1!4#+, 2>#!
*' 4) ; 4%9!- , %) !., +& %!, +!
, 4#) +!2; $?2) !
0#' +' 04) +$%4$0%7!!!
! &. 06$U%%
+7+%N#";&, #L%*&, /. 5 $0%4#, $Li%CLL$D0#%";5 $%
K$0;&- U%%
OE%
Z $$3/%$, - ;, D%E[EP[GEi%
j 10"$6%";5 $%
K$0;&- U%%
OE%
Z $$3/%
$, - ;, D%GG[E[FYi%
40$J #6;- %OE%
: $$3/%$, - ;, D%2 #1%EFGHi%
4( ! %
T %/#L$/%&, $%1$#0%K&/"%
Private Label OTCs
Acne Treatments
Adult Incontinence
Antacid Liquids/Powders
Antacid Tablets
Antismoking Gum
Cold/Allergy/Sinus Liquid/Powder
Cold/Allergy/Sinus Tablet/Pckets
Cough/Sore Throat Drops
Cough Syrup
External Analgesics Rubs
Eye/Lens Solutions
0%
10%
20%
30%
40%
50%
Percent category dollar sales in Drug COT
In well-developed OTC categories, Private Label penetration often
exceeds 40% dollar share in the Drug Class of Trade
Source: Drug Store Management 2014-2015 State of Industry Report
60%
What happens to Rx Generics upon
switch?
• Zaditor switch approved 2006 with no exclusivity
– Three generics already approved Rx (Apotex, Akorn,
Alcon)
– Office of Generic Drugs issued notice that labeling
needs to be updated for OTC sale
– In theory, manufacturers must update their labels and
stop selling Rx within 6 month window
• Apotex began manufacturing product under Claritin
Eye and Zyrtec Eye
• No major compliance issues
switch?
• MiraLax approved OTC in 2006 with a number of Rx
generic competitors already in the market
– In theory, MiraLax had 3 years of Hatch-Waxman
exclusivity
• Rx sales should have stopped within 6 months
• There should have been no OTC sales
– In reality, doctors kept writing (colonoscopy prep)
prescriptions and pharmacists kept filling (ORx)
– Schering tried to get FDA to enforce that the Rx drugs
were “misbranded”
• This is not an important enforcement issue for FDA
switch?
• Nasacort approved 2013 with one generic competitor
(Teva) and no exclusivity
– Nasacort filed a legal challenge to block the
publication of their SBA so that (private label)
competitors would not know specifics of their
approved label until Nasacort launched
– There are still no OTC private label versions of
Nasacort in the market; Teva appears to still be
distributing Rx
Private Label Strategies
• Nasacort filed a legal challenge to block the publication of
their SBA so that private label competitors would not know
specifics of their approved label until Nasacort launched
• Flonase gained three years of Hatch-Waxman exclusivity for
two ocular symptoms: itchy eyes and watery eyes
– Will Private Label still be able to claim “compare to the
active ingredient in Flonase”?
– The 36-page booklet, considered part of the approved
label, may also be a barrier to private label to competition
• Many OTC brands use development of new dosage forms as
a means to stay one step ahead of private label
• Nexium tried to create an “ownable” package
• Rhinocort trade dress blocked. FDA website says
“Information Being Posted Pending FDA’s Review of
Confidentiality Claims”*
* http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020746Orig1s032lbl.pdf
• Consider switching prior to patent expiration
• Create exclusivity
– Develop a reason why a clinical study is required by
FDA and help FDA to request it
• Fight ORx products as being mislabeled
• Plan for continuous marketing investment once the
product is launched OTC
• Actively plan lifecycle management after OTC launch
Lessons Learned
Switch
4. Professional Marketing (including Managed
Care)
a. Consumer Advertising and Promotion
b. Retail Planning
c. Lifecycle Management
Satisfaction with Current Choices Is
00$, "%*<&;6$/%%
*. Success
%: ;"<%
! #";/'#6";&,
Important
for
;/%+5 K&0"#, "%'&0%!. 66$//%
N[[S7? L!#* DDS7S7#!
#N- /#DN. - /, F !
BSN7- M* 7F !#* DDS7S7#!
B/? B!
B/? B!
6TU!
: ;"<%( ) *%
N&"%!#";/';$- %
CJ #;L#>L$%
*<&;6$/%*. 00$, "L1%
!!
TU!
Z &03%&0%
! #1%;"%kR&$/, l"%
7$L;$J $%!1/"$5 /m%9%40;L&/$6%
( ) *%*<&;6$/%
X;3$%2 &0$%
Z &. L- %
) 0$#"5 $, "/%
'&0%CLL$0D1%
VU!
Z &03%&0%
! #1%;"%kR&$/, l"%
7$L;$J $%!1/"$5 /m%9%40$J #6;- %
[, g !
[, g !
>VU!
! : ;"6<%C5 &, D%C, ";<;/"#5 ;, $%
C6";J $%+, D0$- ;$, "%
!!
!H SK/* H !
!H SK/* H !
XTU!
#N- /#DN. - /, F !
XWU!
"&%
;/%kN&"<;, D%
! #1%"<$0$%
R;/L;3$%[%;"%Z &03/m%e%4X%( 5 $K%
H SNF /F ? D* [!MSF SD/- #!. 7/- /. N[!D, 7!B/? B!#N- /#DN. - /, F !. N- S? , 7/S#!
! &. 06$U%+7+%*. /"&5 %!"
Delivering Satisfaction
• Providing a meaningful, differentiated proposition
– Conducting market research is key
• The messages that worked for the Rx product may
not work in the OTC environment
• Are there specific messages that will work for the
partners of the sufferers?
– How is the product differentiated versus current OTC
offerings? How is it competitively superior?
• And how can this difference be communicated in a
simple way?
– Prilosec: “1 Pill. 0 Heartburn. 24 Hours.”
– Orudus: No clear benefit versus ibuprofen
Delivering Satisfaction
• … at reasonable pricing
– Can’t charge more without added benefit!
• Nexium “forced” to price parity versus Prilosec
• Flonase is priced slightly higher than Nasacort –
presumably for ocular symptom relief claims
– Is there a sweet spot between store brand entries and
what consumers co-pay for Rx?
The ACA has brought new patients into
the market with very high
deductibles/co-pays
Statistics on exchange enrollments, by plan tier1
Plan type
% of
enrollees
Premium1
Deductible2
Preferred/non-preferred
brand drug
Bronze
19%
$3,552
$5,081
35%/36% coinsurance
Silver
62%
$3,828
$2,907
$47/$89 copay
Gold
12%
$4,536
$1,277
$39/$85 copay
Platinum
7%
$4,656
$347
$31/$61 copay
1. Average annual premium for 40-year-old across 34 different states
2. Deductible for an individual enrollee
Source: HealthPocket.com accessed May 27, 2014
Source: Heather Sumner to Susan Levy, 12/23/14
• Need product differentiation that translates to meaningful
consumer benefits
• Clear positioning via identification of key targets and
breakthrough and engaging advertising
• Consumers won’t pay more money for a brand that
offers no advantages versus lower priced OTC brands …
or versus generic Rx’s
• Premium pricing versus private label needs to be
justified
Lessons Learned
Switch
a.
b.
c.
Retail Planning
Professional Marketing
• Successful Rx to OTC switches have leveraged
professional marketing and relationships with medical
professionals
– Key to develop these relationships prior to Advisory
Committee for first-in-class switches
• Professional marketing includes, but is not limited to:
– Medical professionals (detailing)
– Managed care
Allegra Success: Growth in HCP
CLL$D0#%!. 66$//U
%S 0&: "<%;, %V*4%7$6&5 5 $, - #";&,
Recommendation
N[[S? 7N!#B, g SK!O, #/- /I S!? 7, g - B!- 7SF K#!!
/F !#O/- S!, D!MS/F ? !>41!SF - 7NF - !/F !, - . !N[[S7? L !
N8&4%C&!g &&a@
5!7&=' J J &01%$9' 03!
GP
GM
GE
GF
Y
P
M
%%%%CLL$D0#%( ) *%7$6&5 5 $, - #";&, /
E
F
! &. 0
Allegra Professional Launch
Source: Allegra Marketing Director, 12/31/14
Allegra Professional Reminders
Managed Care Plays an Important
*#0$%4L#1/%#, %+5 K&0"#, "%7&L$%
78%^#6"&0/U%2 #, #D$- %Role
%
&C4%!#: 9$=) !90!- : ' !g %53!89%!$) &94!N1o219=%$9' 0!F &$: ' 4a3^!
@
%03!N=$&1!' 0!$) &!N@
H %0%C&1!. %4&!O@
EFGG%"&%EFGH%
>1%OFT %'0&5 %
^$8&'$, #- ;, $%78%
&'%
• ! "$#- ;L1%0#;/$- %6&9K#1/%
( ) *%CLL$D0#%e%%
/60;K"/%a>L. $%>#0/%>$L&: b%"&%6&;, 6;- $%: ;"<%"<$%L#. , 6<%&'%
• 7$_$6"$- %^$8&'$, #- ;, $%78%
"<#"%: $0$%
78%
&'%
&+!7$_$6";&, %0#"$%;, - ;6#"$/%"<$%T %
!19((&4&0=&!(4' J !$) &!O4&8%=91!&; %J P@
%!(201%J &0$%@
"&%L#. , 6<%&'%
D$, $0;6/%aOT %K0;&0%
, . 5 >$0%'&0%
#%J$01%L&: %
%N&05 #LL1%
: 0;""$, %>1%- &6"&0/=%>. "%0$_$6"$- %>1%2 *( /@
%
"<$%( ) *%CLL$D0#%L#. , 6<@
( ) *%CLL$D0#bi%"<;/%0#"$%;, 60$#/$- %- 0#5 #";6#LL1%;, %"<$%$#0L1%- #1/%&'%
3!%01!/0=4&%3&!90!. ' P%53!
%45!. ' 0$4' @
%$&1^!. ) %0C&!90!D' 4J 2@
&C4%!#: 9$=) p!M' $) !H . , <7&@
@
P&1!N@
: ' !b&5!D%=$' 43!B&@
- !!!!!!
EF
GO
Y"W+6Z!%8C+!=' P%5!%$!, - . !
%20=) !
&C4%!@
@
N@
OFT
!6W">!
Y"V+] >!%8C+!=' P%5!A5!NP49@
MFT
HFT
GF
EFT
GFT
F
FT
EFGFFG
EFGFFE
EFGFFH
EFGFFM
EFGFFO
EFGFFP
EFGFFQ
EFGFFY
EFGFF\
EFGFGF
EFGFGG
EFGFGE
EFGGFG
EFGGFE
EFGGFH
EFGGFM
EFGGFO
EFGGFP
EFGGFQ
EFGGFY
EFGGF\
EFGGGF
EFGGGG
EFGGGE
EFGEFG
EFGEFE
EFGEFH
EFGEFM
EFGEFO
EFGEFP
EFGEFQ
EFGEFY
EFGEF\
EFGEGF
EFGEGG
EFGEGE
EFGHFG
EFGHFE
EFGHFH
EFGHFM
EFGHFO
EFGHFP
EFGHFQ
EFGHFY
EFGHF\
O
^$8&'$, #- ;, $%78%2 *( %7$_$6";&, %7#"$
%%%%CLL$D0#%( ) *%7$6&5 5 $, - #";&, /
^$8&'$, #- ;, $%4#";$, "%4#1
! &. 06$U%%!15 K<&, 1%V$#L"<%!&L. ";&, /
HE%
Allegra Managed Care Activity
• Allegra executed a comprehensive managed care plan:
– Live meeting with “Champions” and kick off TC with account
teams and senior leadership
– Account manager backgrounder and leave-behind
– Training deck
– Letter templates
– Coupons
– Brochure
– Newsletter copy
– FAQ
– Web banner
– Email templates
– Email and direct mail for Medco Health Store
– SmartCare plan engagement
– Xerox employer group (free sample/coupon program)
Allegra Managed Care Activity
Zyrtec Managed Care
• Zyrtec approached Managed Care providers and
employer health plans prior to switch and found them to
be quite cooperative and helpful
– Worked with plans to engage members and change
formulary status
• Total Managed Care launch investment of $15.8MM
• The result was that 27% of Zyrtec OTC volume was
sourced from Zyrtec Rx volume and 27% from other Rx
allergy volume
• With Year 1 sales of $610MM, this strategy provided a
21x return on investment
Source: Conversation with former Zyrtec Managed Care Director, 1/5/15
• Trial rates are 4x higher with Professional
recommendations
– May need to change size of professional sampling
vehicle
• For a drug that will switch at or after patent expiration, it
may be worthwhile to continue to spend Rx marketing
dollars until the switch occurs
• The Professional Plan should consider:
– Developing a publication plan to create credibility with
the medical community
– Engagement of Key Opinion Leaders about switch
– Advocacy Groups
– Managed Care
Lessons Learned
Switch
a.
b.
c.
Retail Planning
Heavy Media Spend Beyond Year 1
is a Must for Success
Allegra’s Pre-Launch Efforts Were
CLL$D0#l/%40$9X#.Phenomenal
, 6<%A''&0"/%Z $0$%4<$, &5 $, #L%%
-I !
• CLL$D0#%/"#0"$- %#%/"0&, D%
K. /<%>$'&0$%"<$%K0&- . 6"%
<;"%"<$%/<$LJ $/%
• A#0L1%#- U%: <;"$%6&#"%
<$#L"<6#0$%K0&'$//;&, #L%%%
/<&: ;, D%: <$0$%CLL$D0#%
: &. L- %>$%;, %"<$%#;/L$%
/F <#- , 7S!
• CLL$D0#%<#- %/;D, ;';6#, "%
K0&5 &";&, #L%/K$, - ;, D%
;, 9/"&0$%>$'&0$%L#. , 6<=%
- 0;J ;, D%$86;"$5 $, "%#, - %
#""$, ";&, %"&%"<$%- #"$%
#J #;L#>L$%
• k*&5 ;, D%!&&, m%#- /%;, %
0$"#;L$0%%
6;06. L#0/%
#, . /N[!H SK/N!
• ! &6;#L%5 $- ;#%: #/%#%
'&6. /%'&0%"<$%L#. , 6<%
>$6#. /$%;"%K0&J ;- $- %
$8K&/. 0$%#, - %
&KK&0". , ;"1%'&0%>0#, - %
#- J &6#"$/%
• R;/6&. , "%&''$0/%'&0%"0;#L%
• ^#6$>&&3%
• ) : ;""$0%
[ N* F . B!g SM#/- S!
• ! "0&, D%>0#, - ;, D%'0&5 %%
78%<$0;"#D$%
• A- . 6#";&, %;, '&05 #";&, %
'&0%6&, /. 5 $0/%#, - %
V*4/=%6&5 KL$5 $, "$- %
: ;"<%#%̀P%6&. K&, %&''$0%
• 40&- . 6"%L&6#"&0%9%: <#"%
/"&0$/%<#- %K0&- . 6"%#/%
/&&, %#/%#J #;L#>L$%
• ( , L;, $%>#, , $0%#- /%: ;"<%
"<$%&K";&, %"&%K0$9&0- $0%%
! &. 06$U%( , L;, $%7$/$#06<%#, - %+, - . /"01%*&, J $0/
Allegra’s OTC Launch was 360° and
Integrated
% Rx scripts pre launch)
er Switch Strategy
ate Label launch by suing FDA to prevent
of Nasacort labeling prior to launch
e, integrated consumer marketing campaign
wareness including starting TV advertising
Chattem is Repeating their Launch
Integrated, Well-Funded
Formula with Nasacort
Go-to-Market Plans
Award Winning
Winning Shelf
Award
Shelf Tray
Tray
ailer
et of
driving
ce
cate
trial
onal
cent trial
Meaningful, Differentiated
Proposition
Innovative interactive shelf
tray helps overcome high
barrier to usage by educating
at shelf
Source: IRI, 49wks Ending 1/11/15
Portfolio Efficiencies
Efficiencies
Portfolio
360° Heavy
Heavy Media
Media
360°
• Rx to OTC switches require an integrated
consumer/professional/retailer plan
– Synergistic across all mediums
– Need to get the vehicles right
• Rx to OTC switches require HEAVY, continued spending
– Typically $50MM to $100MM+ Year 1 and 50-100% of
Year 1 Sales
– Typically 35% to 50% Year 2 Sales
– Examples:
• Monistat outspent Gyne-Lotrimin by 33%
• For blockbuster Rx to OTC switches, the media
spending starts (continues) when the product is still Rx
– Pfizer rumored to have spent $300MM last year on
pre- and post-launch spend for Nexium
• OTC spending should begin pre-launch to build
excitement
• Investment needs to continue beyond years 1 and 2
• Credibility is key: consider using a spokesperson
Strong Retail Partnerships Critical to
! "0&, D%7$"#;L%4#0",
$0/<;K/%
*0;";6#L%"&%+, ;";#L%!. 66$//%
Initial
Success
7S- N/[!SF ? N? SH SF - !
%
! "0&, D%0$"#;L$0%
$, D#D$5 $, "%: ;"<%/$L$6"%
0$"#;L$0/%. /;, D%J#0;$- %
'&05 #"/%
O7SI N. /K!6TB7!
%
40$J #6;- %EMV7%<#- %/"0&, D%
K<#05 #6;/"%;, '&05 #";&, #L%
K0$K#0#";&, %aK#63$"/=%
: $>/;"$=%^Cp /=%
6L;, ;6#L%
- $"#;L/b%
N[[S? 7N!
%
CLL$D0#%0$#6<$- %YFT %
- ;/"0;>. ";&, %: ;"<;, %%
E%: $$3/%&'%L#. , 6<%
. I #!g SM#/- S!
%
*B! %k! #J ;, D/%*$, "0#Lm%
: $>/;"$%'$#". 0$- %CLL$D0#9
>0#, - $- %6&, "$, "=%
;, 6L. - ;, D%#%K&LL$, %6&. , "%
'&0$6#/"$0%
! &. 06$U%( , L;, $%7$/$#06<%#, - %+, - . /"01%*&, J $0/#"
H
Integrate with Retail Customers at All
Levels
Retailer Expectations
Brand
Positioning
Contact Strategy
At all Levels
Incremental Category Growth
Shopper
Insights
Merchants
Profitability versus pharmacy
Strategic Alignment – Health
Global
Market Best
Practices
Internal
Team
Marketing
Retailer
Leadership
Team
Customized Plans
Speed to Market
Professional
Engagement
Supply
Chain
Health
Care
Clinics
Operations
Marketing Support
Multi
Channel
Knowledge
Engagement of Pharmacist
Slide courtesy Market Performance Group (MPG)
Pharmacy
Operations
Manufacturer and Retailer Partnership
Planning Requires 18-24 Months LeadTime
PRE LAUNCH
6-12 months
Brand positioning
Marketing mix
Connection plan
Pricing strategy
Shopper Platform
• Budgets / Spend
• Co-Marketing
concepts
• Merchandising
Objectives
• Logistics planning
•
•
•
•
• Review plans with
Executive MGT and
operations
• Promotional
planning
• Engage supply chain
management
• Put in place patient
retention plans
• Finalize planograms
• Off Shelf
merchandising
• Speed to market
plan
• Loyalty programs
• Marketing support
• Private Brand
Planning
• Pricing strategy
MANUFACTURER
12-18 months
• Share concept
• Strategic Targets
• Volumetric
projections
• Source of volume
estimates
• Define success
criteria
• Review with Retail
leadership team
•
•
•
•
•
RETAILER
18+ months
POST LAUNCH
• Review concept
• Review current
profitability
(pharmacy)
• Establish switch
team
• Review with
Leadership team
• Begin
merchandising
strategy
• War room on
competition
• Engage Marketing
• Management to
allocate resources
• Finalize budget and
JBP
0-6 months
Problem solving
Refinement
Finalization
Begin path forward
planning
(Commercial and
Product Innovation)
Slide courtesy Market Performance Group (MPG)
0-6months
6+ months
• Launch learning
• Success criteria
analysis
• Plan correction /
optimization
• Path forward
learning – inputs for
planning
• Assess & refine
strategies
• Optimize tactics
• Share innovation
concepts
• Define future
success criteria
• Monitor share
• Review sales and
profits to plan
• Visit competition –
document learning
from competition
• Review planogram
for productivity
• Private brand
strategy
• Share review
• Measure
performance to
plan with supplier
• Review inventory
levels
• Look to build
market basket
Allegra Pharmacy Kit
Enrollment
Manufacturer Switch Strategy
• Heavy reliance on retail activity
• Incent and drive awareness in pre-launch
• Flood marketplace early and consistently
• Target existing OTC users
Go-to-Market Plans
Nexium 24 HR Had Aggressive In-Store
Retail
Execution
Aggressive In-Store Retail Execution
Aggressive Pre-Launch Shelf Savers
Pre-Launch Announcements and
Offers (in-store & on-line)
Shelf Merchandising Trays
Multiple Display Configurations
Customized In-Store Materials
Heavy Flonase Pre-Launch Activity
• Will Rhinocort be
able to generate
this level of
excitement in the
fall?
e an
-
Oxytrol Failed With Its Shelf
Shelf
Placement
Placement
L
not
• Adjacent to categories no longer relevant to
• Array
of different
products
target
shopper
(e.g. pregnancy
kits)
• Adjacent to categories no
"There
your o
messa
• Begin planning with retailers two years in advance
– Starting with top to top meetings
– Retailers are seeking customization
• For a new OTC category, conduct market research to
identify optimal store placement
– Communicate store placement in media
• Identify the ideal, protectable package
– Engage packaging design firm
– Get feedback from retailers
– Hide packaging from private label
• Consider likelihood of theft for high priced items
– Engage with experts to leverage cutting age
technology
– Include loss prevention in retailer meetings
– Consider anti-theft displays
• Launch can be optimized with rapid distribution of
product
– Need to make immediate shelf placement as easy as
possible for retailers
Proposition
ild with immediate and aggressive
eting and retail execution
onse to 2nd Gen Switch (Regulatory)
proval to change label to more closely
yrtec in the range of allergies it treats
ion
Go-to-Market Plans
Lifecycle Management: Claritin
Billboard
Audience/Type
Audience/Type
Continuous Pipeline
Forms
Forms
Sizes
Sizes
on
xt
-D with Pseudoephedrine
Oral Dissolving Tablets
on
ew
Children's
Liqui-Gels
X-Large Size - 70CT
• Claritin has also
grown via
compelling claims
(i.e., Claritin
Clear) and
innovative
outlicensing
efforts
From the Claritin Graveyard
• Claritin Hives
– Although Claritin was approved for OTC use of
allergies in November, 2002, it took Schering-Plough
another year before it could obtain approval of a
“Hives” indication
– Product discontinued due to low sales
From the Claritin Graveyard
• Claritin Eye
– When Zaditor (ketotifen) switched in 2006, it did not
obtain exclusivity; private label versions were
immediately available. Both Claritin and Zyrtec
launched allergy eye products given the ability of the
product to deliver non-drowsy, 12 hour ocular allergy
relief.
– Required Label Comprehension Study to
demonstrate that consumers understood
that product contained a different active
– Discontinued due to manufacturing site issues
• Developing a pipeline of products to create a billboard at
shelf should also be part of the long-term plan
–
–
–
–
–
–
Advil 1984
Advil Cold & Sinus 1989
Advil Migraine Liquigels 2000
Children’s Advil Cold 2002
Advil PM 2005
Advil Congestion Relief 2010
• Because new dosage forms will not be “monograph”,
they will require (expensive and time-consuming) NDAs
as well
Lessons Learned
Switch
a.
b.
c.
Retail Planning
Successful Switches Require a High
Performing Team
• With multiple facets required for a successful Rx to OTC
switch, the project team needs to be higher performing
than that of a “typical” OTC new product launch
– Senior Management support, particularly to secure
resources (people and dollars) and remove
roadblocks
– Typically more multi-disciplinary than most project
teams
– Requires all team members to possess:
• Out-of-the-box thinking
• Problem solving skills
• Collaborative mindset
Almost Always “Us” vs. “Them”
• Nearly all switches:
– Involve “transfer of power” from Rx to OTC division,
either internally, or …
– Are Joint Venture between an Rx company and a
different OTC company, and …
– May have both global and local teams
• As a consequence, decision-making processes are key
– Need to determine who has responsibility for which
decisions (RACI chart suggested)
• i.e., OTC claim studies may impact current Rx
product
– Need escalation process
Critical to Outline Commitments Up-Front
• Particularly when there are multiple parties involved, it is
key to use a structured approach to outline:
– Roles and Responsibilities
• Project Sponsor
• Project Leader
• Alliance Management?
– Project Scope
• With implications for required resources
– Project Timing
• Requires complex project management (and
frequent updates to plan) … across a multi-year
project
Finding the Right Expertise
• Of the 14 molecules switched in last ten years in the US,
only 6 were first-in-class, so limited industry switch
expertise
• Only a couple of firms with expertise in consumer
behavior switch studies
– Pegus, Concentrics
• Unlike launching an OTC line extension, switches also
require:
– Stakeholder Management/working with Advocacy
Groups
– Working with Managed Care, and Professional Plan
– Issues Management (potentially), more PR, etc.
Project Horseshoe
129
– … basically, a much larger, high powered team
Implications for Traditional OTC
Functions
• Regulatory Affairs
– Need to create a label that enables consumers to
safely and effectively self-diagnose and self-treat
– Need to help FDA see benefit versus risk
– Need to figure out how to delay PL entries (Nasacort)
– Need to do homework to figure out how to claim
Rx/ORx product is “mislabeled” (MiraLax)
– Need to use “voice of the consumer” to guide
regulatory strategy
• Regulatory can’t follow the rules … it needs to establish
new ones!
Functions
• Medical/Clinical Affairs
– Need to analyze Rx and global data to understand
real world experience and risks … to create a label
that minimizes risk for general population
– Need to use “voice of the consumer” to guide clinical
strategy … and drive differentiation versus existing
OTCs
– Need to contribute to Professional Plan and Managed
Care strategy
– May need to publish studies to establish drug
credibility
– May need to contribute to thinking about how to
enhance compliance
Functions
• Marketing/Market Research
– Need to ensure label communicates clearly …
starting with the indication
– Need to coordinate a more synergistic integrated
consumer/retailer/professional … working with lots of
agencies across many platforms
– Need to delve deeply into consumer behavior
– May need to conduct competitive intelligence and/or
lead war gaming exercises
– May need to determine shelf placement if creating a
new OTC category (i.e., Viagra)
Functions
• Operations/Logistics
– Need to get demand forecast right internally and
externally, working with Marketing and Sales
• Especially special packs and displays
• Need to get sizing right, including trial vehicles
• Need to determine if current Rx facility can handle
OTC volume
– If OTC package different from Rx, need to determine
implications
– May need to get product manufactured before label
approved to facilitate quick launch
Functions
• Packaging
– Need to create something protectable/ownable …
especially versus private label
– May need to consider how to incorporate new
technologies, from behavioral support mechanisms to
theft prevention
•
Sales
– Need to engage retailers strategically, not just
tactically, at all levels
– etc.
Final Thoughts on Team
• The Rx to OTC switch
– Requires all team members to possess:
• Out-of-the-box thinking
• Problem solving skills
• Collaborative mindset
– And a strong project leader … who identifies
obstacles and removes roadblocks
• For a $100MM opportunity … every week missed in the
marketplace represents $2MM in lost revenue
EVALUATING SWITCH
OPPORTUNITIES
Evaluating Switch Opportunities
• A preliminary evaluation of Rx to OTC switch
opportunities considers both the technical and
commercial aspects
– Technical
• Can the consumer properly self-diagnose the
condition
– i.e., Could the consumer self-diagnose rosacea
when they really have lupus?
• Can the drug be used safely without a learned
intermediary?
– Commercial
• Will the cost to switch the drug and launch the
product provide a return on investment?
The Technical Evaluation
• Applying a structured Risk-Benefit framework
• Sources of information include:
– What actually happens in diagnosis and treatment of the
condition?
– Global Rx history and adverse event experience
• Are there “black box” warnings? Are they valid?
• Is the drug scheduled as an addictive substance? Is
the scheduling appropriate?
– ex-US OTC history and experience
• see: http://www.aesgp.eu/facts-figures/otc-ingredients/
• Assume that certain diseases (cancer) and treatments
(injectables) are non-starters
The Technical Evaluation
• Start by creating a draft Drug Facts Label!!
– What is the Indication?
– When should the consumer stop use and see a
doctor
– Are there special populations that should not take the
drug?
– (And how is it better than current OTC options?)
• Proving that consumers will safely understand and follow
the DFL will dictate the proposed Rx to OTC switch
program
Structured Risk-Benefit Framework
• An assessment of absolute benefit & risk is conducted
as part of the Rx approval process
• For Rx to OTC switch – it’s important to assess the
incremental risks and benefits associated with the
drug’s use in a nonprescription setting
• A structured framework can facilitate this process:
– By considering risk-benefit domains common to OTC
drugs and
– Evaluating product specific considerations
• Not meant to be an exhaustive list, simply a framework
General OTC Risk/Benefit
Domains
Convenience/improved access
Improved clinical outcomes
BENEFIT
CONSIDERATIONS
Public health benefits
Enhanced consumer involvement
BENEFIT / RISK
CONSIDERATIONS
Economic benefits
Unintended misuse/abuse
Intentional misuse with therapeutic
intent
RISK
CONSIDERATIONS
Accidental ingestionIntentional overdose
Brass et al. Clinical Pharmacology &
Therapeutics, Volume 90, Number 6,
December 2011
Worsened outcome due to selfmanagement
Product Specific
Considerations
The Scar Treatment
• A client approached us about evaluating the OTC
potential of a scar treatment that they were developing
– The drug was designed to work on keloid scars and
was in early phase Rx development
– The inventors envisioned that a direct to OTC switch
could be a faster, more profitable pathway
– The drug works to “paralyze” the types of cells in scar
tissue … which is, apparently, similar to heart muscle
– The inventors noted that the drug should be safe if
used on “healed” scars and if it did not get into the
blood stream …
The Commercial Evaluation
• Rx to OTC switch should be considered early within any
Rx asset’s lifecycle management strategy
– For many drugs, the ideal switch timing is the day of
patent expiration
– Simultaneous OTC may be possible via existing or
alternate indications
– Simultaneous OTC may be possible with lower dose
– Simultaneous OTC may be possible for specific
population
– Direct to OTC may be possible, particularly with
topical products
The Size of the Prize
• If the dynamics are right, there are cases where drugs
have provided higher topline revenue as OTCs than as
Rx drugs
– Order of entry: Pepcid
– Self-treatment convenience: Immodium
– Awareness and better consumer experience: MiraLax
• While “big” OTC brands are not blockbusters compared
to Rx drugs, OTCs can live into perpetuity with strong
messaging and innovation
– Listerine is over 100 years old
– Benadryl (switched in 1985) sales are $239MM*
• The US OTC market is estimated between $20B to $30B
– Switches drove 27% of OTC growth in last 5 years**
The largest
OTC
brands
were formerly available Rx
*– Nielsen
latest 52US
weeks
xAOC
w/e 2/21/15
** IRI Presentation at CHPA Annual Meeting, March 2015
• There is no “plug and play” model for the commercial
evaluation of Rx to OTC switches
– Is the switch competing in an existing OTC category
or creating a new one?
• If an existing OTC category …
– What is the order of entry?
» How do you protect from Private Label?
– Will you steal share or grow the category?
» What will the impact be on the remaining Rx
business for this brand and other Rx’s?
» What will Managed Care do?
» How will you drive doctor
recommendations?
• If an existing OTC category (continued) …
– Is there a meaningful advantage that can be
communicated to consumers versus current
OTC treatment options?
» Zegerid is the only immediate release PPI,
but can’t communicate speed of relief
– What will you need to spend to gain share of
voice?
– How will the product be priced versus existing
OTC options?
• Additional considerations for a new OTC category …
– Is the drug used for prevention or treatment?
– How annoying is the condition/how motivated are
users?
– How large is the sufferer population?
– Is the drug for acute or chronic use?
• Sales for OTC emergency contraception, while
stronger than Rx, don’t lend themselves to high
repeat rates
– How to optimize the price versus Rx co-pays?
– How strong is the brand’s Rx equity and current
sales?
The Lice Treatment
• A client approached us about evaluating the OTC potential
of their Rx lice treatment
– The liquid product is applied to the scalp on Day 0 and
Day 7
– The amount of liquid varied based on the length of hair.
For a girl with long hair, a physician would prescribe six
8oz bottles (using 24 ounces for each treatment)
– The cost of goods dictated that the retail price would be
in the $40 to $50 range
– It is unlikely that a new OTC entrant could grow the
category: sufferers treat!
– It would be challenging for the Rx product to steal share:
it offered no competitive claims vs existing OTC
products, had little brand equity and poor sales
Financial: The Size of the Prize
• In some cases, there may be greater
value in “milking” an Rx whose patent
has expired (versus receiving OTC
licensing fees)
– Particularly if the Rx is not
differentiated from existing OTCs
– Rx drugs have much higher margins
(but are lower volume) than OTCs
– Launch costs for switches often
exceed first year revenue
– And private label will readily take
40% of branded sales
The Onychomycosis Drug
• A consumer healthcare company approached an Rx
company with a topical drug to treat onychomycosis (nail
fungus) about OTC switch rights
– The Pharma company did not have an OTC
division/capabilities
– The Pharma company’s analysis showed that 90% of
Rx sales would be lost within 6 weeks of patent
expiration
– The product had a 90% profit margin
– Even though the OTC product was expected to have
higher sales, the OTC licensing revenue would not be
higher than the profit derived from “milking” the Rx
Commercialization Options Recent
Partnership Deals
• Outlicense rights:
– In May 2014, Lilly announced that it had given Sanofi the
Rx to OTC switch rights for Cialis
– 8/12/12 Pfizer pays $250MM upfront (plus milestone and
royalty payments) for OTC rights on Nexium ($6B Rx)
and right of first refusal on Rhinocort
• Meanwhile, Pfizer declined and McNeil licensed Rhinocort
– Merck’s recent OTC launch of Oxytrol licensed from
Watson
• Bayer now allowing rights to revert back to Actavis
– In October 2006, Schering-Plough paid Santarus $15
million upfront for the Rx to OTC switch rights for
Zegerid
• The deal included an additional $65 million in regulatory and
Commercialization Options Recent
Partnership Deals
• Acquire OTC capabilities:
– 12/21/09 Sanofi pays $1.9B to acquire Chattem,
providing switch capabilities for Allegra (and Nasacort)
• Form JV:
– 11/3/11 P&G/Teva form PGT Healthcare “a new model in
the industry” to focus on best-in-class development and
state-of-the-art commercialization of branded OTC
medicines
Finding Switch Gold
• Is there switch gold in your Rx pipeline?
– Convincing the Pharma colleagues to begin switch
planning is an uphill battle
– Pfizer has been working on the Lipitor switch since
2000
• Is there switch gold in the pipelines of other Rx
companies?
– Pharma companies often do not start thinking about
OTC as an option until the patent is nearly expired
– The financial argument needs to be compelling for the
Pharma company
– And sometimes, the Pharma company in-licensed the
compound … and the license is “silent” on OTC rights
• The time is now to evaluate potential switches in 2020
and beyond!
QUESTIONS?
Contact:
Susan B. Levy
Principal and Founder
908-654-1054 (Office)
973-713-3637 (Mobile)
[email protected]
www.susanblevyconsulting.com
THANK YOU!

I. The Basic Switch Process

Transcription

Similar documents

The Pharmacy Field Trip:

Salon Product

Clinuvel _ Epitan

(Rx) and Over-the-Counter (OTC) Drug Misuse Among Youth

Misuse And Abuse Of Over the Counter Drugs

Customer Service Measurements - PetMeds ® Investor Relations

show daily newspaper

December 2013