VIVUS, Inc.
VVUS (the "Company") today mailed a letter to stockholders providing
an update on the Company's recent progress. The full text of the letter
follows.
Dear Fellow Stockholder:
I am writing to update you regarding our recent accomplishments. Since
Qsymia^® (phentermine and topiramate extended-release) capsules CIV was
approved last year, our strategic objectives have been to raise awareness of
its benefits among healthcare providers specializing in metabolic disease and
to remove barriers to patient access while maintaining full control of this
highly valuable asset. We believe that our recent progress has greatly
improved our options for maximizing stockholder value and we remain open to
considering a broad range of opportunities to achieve this important goal. To
this end, we have begun discussions with large pharmaceutical companies to
explore how we can work together to increase reach to prescribing physicians
and the public. We believe this is critical to maximizing the value of Qsymia.
Over the past seven months since the launch of Qsymia, VIVUS has successfully
built the commercial foundation for the medical obesity treatment category and
the Qsymia brand. Prior to the Qsymia launch, obesity was not recognized by
providers as a medical condition that warranted treatment. Just this month,
the American Association of Clinical Endocrinologists (AACE) published
treatment algorithms which include the use of pharmacotherapy as a first-line
management for overweight and obese patients with prediabetes, diabetes, and
other obesity-related co-morbidities. Before we entered the market,
reimbursement for branded medication in this category was nonexistent. Because
of our extensive effort with payors, we have attained access to Qsymia for 34%
of commercial lives in the U.S., and the Veterans Administration (VA) has
recently added Qsymia to its national formulary. This is the fundamental work
that needed to be accomplished in order to build a new medical treatment
category, and we have made great progress through these efforts.
In mid-April, VIVUS successfully achieved another major milestone in our
ongoing commercialization efforts with FDA approval of our Risk Evaluation and
Mitigation Strategy (REMS) modification for Qsymia. This approval will allow
patients to access Qsymia at certified retail pharmacies nationwide. Since the
approval, we have been busy executing the implementation plan to ensure
certified retail pharmacy availability of Qsymia by mid-July 2013.
VIVUS has built sustainable momentum with cardiometabolic specialists and
accomplished several key milestones that set the foundation for the medical
obesity treatment category. One of our most important goals for 2013 is the
expansion of both access and reimbursement for Qsymia, the only FDA-approved
oral medication shown to achieve more than 10% average weight loss in obese
patients.
VIVUS HAS ACHIEVED IMPORTANT MILESTONES FOR QSYMIA AND STENDRA
In 2012, despite a difficult FDA environment, we successfully developed and
achieved FDA approvals for Qsymia and STENDRA™ (avanafil).
In the case of Qsymia, the approval came with a REMS and Elements To Assure
Safe Use including allowing distribution only by certified mail order
pharmacies. The recent FDA approval of our amendment and modification to the
REMS for Qsymia is an important accomplishment in our ongoing
commercialization strategy. This critical milestone indicates broader and
improved patient access to Qsymia through thousands of certified retail
pharmacies, and significantly simplifies the prescribing and dispensing
process for healthcare providers.
Both Qsymia and STENDRA were internally developed and VIVUS has maintained
full ownership of these assets, providing us with the flexibility to pursue a
full range of options to maximize stockholder value.
VIVUS HAS SUCCESSFULLY EXECUTED
THE INITIAL PHASE OF ITS COMMERCIAL STRATEGY
Since the approval of Qsymia, our team has hit the ground running. Under the
oversight of our Board, VIVUS management has implemented a clear, consistent
and ongoing strategy to build a successful Qsymia franchise. We have
proactively educated healthcare providers (specifically, cardiometabolic
specialists and other key opinion leaders) about obesity as a chronic medical
condition requiring treatment and educated these thought leaders about
Qsymia's favorable efficacy and safety profile. As of March 31, 2013, we have
made nearly 90,000 calls on 25,000 targeted healthcare providers, and since
launch we have trained more than 300 physician speakers who have conducted
approximately 800 peer-to-peer programs for more than 9,300 participating
attendee physicians. We also have conducted continuing medical education
programs for over 13,000 healthcare providers. Additionally, as of March 31,
2013, more than 39,500 unique patients have been dispensed a prescription for
Qsymia since launch.
WITH EXPANDED ACCESS AND REIMBURSEMENT,
WE BELIEVE THAT QSYMIA CAN BECOME A TOP-SELLING DRUG
Providing retail access to Qsymia through certified pharmacies, the next step
in our commercialization strategy, is well underway and is expected to be
introduced by mid-July 2013. This phase of our strategy includes the
certification of thousands of retail pharmacies, stocking of Qsymia in the
distribution system and the continued notification of the product's
availability to prescribers and patients. Once completed, healthcare providers
will be able to send patients directly to certified pharmacies to fill their
Qsymia prescriptions, which will significantly reduce time between
provider-patient discussions and initiation of therapy. We believe that the
proven clinical efficacy and broader access for patients through certified
retail pharmacies will result in significant prescription growth, and will
help Qsymia realize its potential to become a top-selling drug.
We have made significant progress in our reimbursement efforts. Qsymia is
currently available on the Express Scripts national formulary, and in April
2013, we successfully entered into an agreement with Medco Health Solutions
(Medco) whereby Qsymia has been added to the Medco national formulary. Under
the agreement, patients covered by Medco will have a co-payment of
approximately $50.00 to $60.00 for a monthly prescription of Qsymia. These
formulary agreements with the largest Pharmacy Benefit Managers (PBM) in the
U.S. should significantly reduce out-of-pocket costs for many patients who are
prescribed Qsymia and should support continued patient and clinician adoption.
The Veterans Administration National PBM recently published a Criteria for Use
for Qsymia. Now veterans whose body mass index (BMI) and other health criteria
fall within the Qsymia label can access Qsymia for a co-pay of $9.00. Clearly,
decision makers at Medco, Express Scripts and the VA have taken significant
steps to address medical obesity within their membership.
We also were pleased to see published in Health Economics Review (Feb-2013) a
study demonstrating that effective medical treatment providing 10% to 15%
weight loss can lead to significant reductions in Medicare spending by
reversing or mitigating health consequences such as type 2 diabetes,
hypertension and dyslipidemia in obese or overweight patients. These types of
data are critical to potential payors and public policy makers as they
demonstrate the positive impact that an effective weight loss therapeutic drug
can have on healthcare costs. We believe that the medical obesity category is
emerging and the drug treatment rate for this indication will increase. For
example, the American Association of Clinical Endocrinologists has
incorporated obesity management and FDA-approved anti-obesity medications -
along with lifestyle modifications - into a new comprehensive treatment
algorithm for individuals with prediabetes, diabetes, dyslipidemia and
hypertension.
WE REMAIN COMMITTED TO QSIVA™ APPROVAL IN EUROPE
AND INTEND TO FILE IN OTHER TERRITORIES AROUND THE WORLD
As evidenced by the recent withdrawal of a competitive product's marketing
authorization application (MAA) from the centralized procedure in Europe, the
regulatory environment in Europe remains challenging for new obesity
therapies. For us, Europe remains an important opportunity. We are currently
working with our European team of clinical, legal, and regulatory advisors to
evaluate and confirm our regulatory strategy in Europe, which may include a
near-term filing of an MAA under the decentralized procedure in selected
countries. Longer-term, we may utilize interim data from our Cardiovascular
Outcomes Trial (CVOT) to file in the remainder of the countries.
VIVUS RECENTLY RECEIVED A POSITIVE RECOMMENDATION SUPPORTING
APPROVAL OF THE EUROPEAN VERSION OF STENDRA
VIVUS recently announced that the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
recommending the granting of a marketing authorization in the European Union
for SPEDRA™ (avanafil), for the treatment of erectile dysfunction. This
positive opinion is another important milestone in the VIVUS regulatory track
record and positions us to participate in a large opportunity in the European
market. We remain focused on monetizing the value of the STENDRA asset for
stockholders, and we are engaged in partnership talks with several companies
for commercialization in the U.S. and international markets.
THE VIVUS BOARD OF DIRECTORS IS ACTIVELY ENGAGED IN OUR COMPANY'S FUTURE. THE
VIVUS BOARD CONSISTS OF NINE HIGHLY-QUALIFIED DIRECTORS, SEVEN OF WHOM ARE
INDEPENDENT AND FOUR OF WHOM WERE APPOINTED WITHIN THE LAST THIRTEEN MONTHS
The VIVUS Board of Directors has played a critical role in our recent progress
and in positioning VIVUS with the flexibility to maintain a full range of
options to opportunistically maximize value for all of our stockholders. The
Board is comprised of proven business leaders who possess a broad range of
management, financial, clinical and operational experience, as well as
expertise in the biopharmaceutical industry and other areas important to
VIVUS. To further accelerate execution of the VIVUS strategy, the Board
recently appointed three new highly-qualified independent directors: Robert N.
Wilson, chairman of Mevion Medical Systems and former vice chairman of the
Board of Directors of Johnson & Johnson; J. Martin Carroll, former senior
executive at Boehringer Ingelheim; and Jorge Plutzky, M.D., a leading
clinician, researcher and scientist. The VIVUS Board consists of nine
highly-qualified directors, seven of whom are independent and four of whom
were appointed within the last thirteen months.
Mr. Wilson served in several key roles at Johnson & Johnson, including the
Executive Committee from 1983 through 2003 and Vice Chairman of the Board of
Directors from 1988 through 2003. Mr. Wilson played a key role in the rapid
growth of the pharmaceutical, device and diagnostic businesses within Johnson
& Johnson. He is a highly qualified and experienced professional with proven
leadership in the healthcare industry and invaluable expertise in
pharmaceutical development, brand building and operations.
Mr. Carroll served in a number of top roles at Boehringer Ingelheim including
Head, Global Strategy and Development and Managing Director, President and
Chief Executive Officer, U.S. from 2003 through 2011. During his tenure, Mr.
Carroll was instrumental in guiding the launch of Spiriva^® and Pradaxa^® in
the U.S. In addition, he was involved in the diabetes market through BI's
partnership with Eli Lilly and the launch of Tradjenta^®, a novel option for
treating type 2 diabetes. Mr. Carroll played a major role in working with the
BI board of managing directors to develop strategic approaches for a number of
BI businesses, focusing mainly on pharmaceuticals.
Dr. Plutzky is Director of the Vascular Disease Prevention Program, which
includes the Lipid/Prevention Clinic, in the Cardiovascular Medicine Division
at Brigham and Women's Hospital, a role he has held since 1996. He is
internationally recognized as an expert in both the basic science and clinical
issues related to lipid disorders and cardiometabolic disease. Dr. Plutzky is
known particularly for his broad interdisciplinary background that spans
endocrinology and cardiology, and for his extensive experience with
biotechnology and pharmaceutical concerns, as well as regulatory affairs. He
is a member of the scientific advisory boards of the Sarnoff Cardiovascular
Research Foundation and Ember Therapeutics, and he has also been elected to
the American Society for Clinical Investigation.
We look forward to their contributions as we continue to execute critical
steps in our commercialization strategy.
We also recently announced that Richard Fante, former president U.S., CEO
North America and regional vice president Americas at AstraZeneca, has agreed
to provide advisory services to the Company. Mr. Fante's vast experience and
unique perspectives building several primary care products into market-leading
brands will be extremely valuable as we seek to expand Qsymia's primary care
presence.
You should also be aware that a dissident stockholder, First Manhattan Co.,
has nominated six of its own hand-picked representatives to replace existing
members of your Company's Board of Directors and effectively seize control of
your Company. We strongly believe that a near-complete turnover of the Board
at this time would significantly jeopardize the progress we are making toward
our strategic objectives and is not in the best interest of stockholders. We
intend to vigorously oppose First Manhattan's hostile solicitation and urge
you to DISREGARD ALL WHITE PROXY CARDS SENT TO YOU BY FIRST MANHATTAN. We
expect to communicate more fully about this in the near future.
VIVUS HAS SIGNIFICANT OPPORTUNITIES AHEAD
VIVUS is at a critical juncture in its development. We believe in the value of
our franchises and our ability to successfully commercialize Qsymia.
In connection with the upcoming VIVUS 2013 Annual Meeting of Stockholders, you
can expect to hear more from the VIVUS team about the progress we are making
in commercializing and developing innovative, next-generation therapies to
address unmet needs around the world and how we are driving value for all of
our stockholders.
On behalf of the VIVUS Board of Directors and management team, I appreciate
the continued interest and support of all of our stockholders.
/s/
Leland F. Wilson
Chief Executive Officer
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Posted In: News
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in