VIVUS Confirms Receipt of Notice of Nomination From First Manhattan Co.
MOUNTAIN VIEW, Calif., March 8, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc.
(Nasdaq:VVUS), a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health, today confirmed that affiliates of First
Manhattan Co., which disclosed beneficial ownership of approximately 8.8% of
the outstanding shares of VIVUS, submitted to the Company a notice of
nomination of six director candidates to stand for election to the VIVUS Board
of Directors at the Company's 2013 Annual Meeting of Stockholders. VIVUS
stockholders are not required to take any action at this time.
The Company will review First Manhattan's notice to ensure it complies with
the Company's governing documents and applicable law. The Company's Board of
Directors and Nominating and Governance Committee will consider the
nominations in due course.
VIVUS issued the following statement:
The VIVUS Board of Directors and management team are committed to acting in
the best interests of the Company and all VIVUS stockholders and we have had
an open dialogue with First Manhattan since we first became aware of its
investment in our company.
The VIVUS Board and management team are committed to building value for all
stockholders. The Board is actively engaged in overseeing management's
execution of the Company's stated strategy of capitalizing on the large and
growing opportunities for its Qsymia^® and STENDRA^™ franchises. VIVUS is
executing the initial phases of its launch and commercialization strategy
and successfully expanding the clinical awareness and acceptance of Qsymia
as the Company pursues opportunities to expand patient access to this
best-in-class therapeutic. VIVUS also continues to make meaningful progress
in obtaining additional reimbursement coverage. VIVUS believes in the value
of its franchises, and the Company's 2013 goals are to continue expanding
access, through REMS modification, as well as reimbursement for Qsymia, and
securing partnerships for STENDRA. The Board is confident that the
achievement of these objectives will create value for all VIVUS
VIVUS noted that its Board of Directors comprises six highly qualified and
experienced directors, four of whom are independent, including the Chairman
of the Board, and all of whom are elected annually. VIVUS's directors are
proven business leaders with a broad range of management, financial,
clinical, and operational experience, as well as expertise in the
biopharmaceutical industry and other areas important to VIVUS.VIVUS has
added three new directors to the Board since 2008, including one within the
last twelve months.
The Company will present its recommendation with respect to the election of
directors in its proxy statement to be filed with the Securities and Exchange
Deutsche Bank Securities Inc. is serving as financial advisor, Hogan Lovells
US LLP is serving as legal advisor and Morrow & Co., LLC is serving as proxy
solicitor to the Company.
VIVUS is a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health for U.S., Europe and other world markets.
Qsymia is also in phase 2 clinical development for the treatment of type 2
diabetes and obstructive sleep apnea. For more information about the company,
please visit www.vivus.com.
Qsymia is approved in the U.S. and is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic weight
management in adults with an initial body mass index (BMI) of 30 kg/m^2 or
greater (obese) or 27 kg/m^2 or greater (overweight) in the presence of at
least one weight-related medical condition such as high blood pressure, type 2
diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been
established. The safety and effectiveness of Qsymia in combination with other
products intended for weight loss, including prescription and over-the-counter
drugs, and herbal preparations, have not been established.
For more information, visit: www.qsymia.com.
STENDRA (avanafil), was approved by FDA on April 27, 2012 for the treatment of
erectile dysfunction, or ED.STENDRA is a phosphodiesterase 5, or PDE5,
inhibitor indicated for the treatment of ED.
In March 2012, we submitted and the EMA accepted our MAA for avanafil.The
approved trade name for STENDRA in the EU is SPEDRA™.In July 2012, we
received the Day 120 List of Questions from the EMA.The Day 120 List of
Questions covers a broad range of topics including, without limitation,
questions relating to clinical relevance in certain populations as well as
questions regarding drug-drug interaction and pharmacokinetics.We are in the
process of preparing our response to the CHMP.
Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation, or MTPC. VIVUS
has development and commercial rights to avanafil for the treatment of sexual
dysfunction worldwide with the exception of certain Asian Pacific Rim
countries.Through collaboration arrangements with third parties, we intend to
commercialize STENDRA in the United States and, if approved, in the EU and
other territories outside the United States.
Administration of STENDRA with any form of organic nitrates, either regularly
and/or intermittently, is contraindicated. STENDRA is contraindicated in
patients with a known hypersensitivity to any component of the tablet.The
most common adverse reactions include headache, flushing, nasal congestion,
nasopharyngitis, and back pain.
For more information about STENDRA, visit www.STENDRA.com, or for full
prescribing information see
Forward Looking Statements
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely,"
"may," "plan," "potential," "predict," "opportunity" and "should," among
others. There are a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements. These
factors include, but are not limited to, our limited commercial experience
with Qsymia in the U.S.; the timing of initiation and completion of the
clinical studies required as part of the approval of Qsymia by the United
States Food and Drug Administration, or FDA; the response from the FDA to the
data that VIVUS will submit relating to post-approval clinical studies; the
impact of the indicated uses and contraindications contained in the Qsymia
label and the Risk Evaluation and Mitigation Strategy, or REMS, requirements;
the impact of distribution of Qsymia through a certified home delivery
pharmacy network; whether or not the FDA approves our amendment to the REMS
for Qsymia, which, if approved, would allow dispensing through select
certified retail pharmacies to increase access while meeting all requirements
of the REMS; that we may be required to provide further analysis of previously
submitted clinical trial data; the negative opinion of the European Medicines
Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, for
the Marketing Authorization Application, or MAA, for Qsymia; our ability to
successfully commercialize or establish a marketing partnership for avanafil,
which will be marketed in the U.S. under the name STENDRA™; the ability of our
partners to obtain and maintain regulatory approvals to manufacture and
adequately supply our products to meet demand; our history of losses and
variable quarterly results; substantial competition; risks related to the
failure to protect our intellectual property and litigation in which we may
become involved; uncertainties of government or third party payer
reimbursement; our reliance on sole source suppliers; our limited sales and
marketing and manufacturing experience; our reliance on third parties and our
collaborative partners; our failure to continue to develop innovative
investigational drug candidates and drugs; risks related to the failure to
obtain FDA or foreign authority clearances or approvals and noncompliance with
FDA or foreign authority regulations; our ability to demonstrate through
clinical testing the safety and effectiveness of our investigational drug
candidates; the timing of initiation and completion of clinical trials and
submissions to foreign authorities; the results of post-marketing studies are
not favorable; compliance with post-marketing regulatory standards is not
maintained; the volatility and liquidity of the financial markets; our
liquidity and capital resources; and our expected future revenues, operations
and expenditures. As with any pharmaceutical in development, there are
significant risks in the development, the regulatory approval, and the
commercialization of new products. There are no guarantees that the product
will receive regulatory approval outside the United States for any indication
or prove to be commercially successful. VIVUS does not undertake an obligation
to update or revise any forward-looking statements. Investors should read the
risk factors set forth in VIVUS's Form 10-K for the year ending December 31,
2012, and periodic reports filed with the Securities and Exchange Commission.
Important Additional Information
VIVUS,its directors and certain of its executive officers may be deemed to be
participants in the solicitation of proxies from VIVUS stockholders in
connection with the matters to be considered at VIVUS's 2013 Annual Meeting of
Stockholders. VIVUS intends to file a proxy statement with the U.S. Securities
and Exchange Commission (the "SEC") in connection with any such solicitation
of proxies from VIVUS stockholders.INVESTORS AND STOCKHOLDERS ARE STRONGLY
ENCOURAGED TO READ ANY SUCH PROXY STATEMENT AND ACCOMPANYING PROXY CARD AND
OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN
THEYBECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION.Information
regarding the identity of potential participants, and their direct or indirect
interests, by security holdings or otherwise, will be set forth in the proxy
statement and other materials to be filed with the SEC in connection with
VIVUS's 2013 Annual Meeting of Stockholders. Information regarding the direct
and indirect beneficial ownership of VIVUS's directors and executive officers
in VIVUS securities is included in their SEC filings on Forms 3, 4 and 5, and
additional information can also be found in VIVUS's Annual Report on Form 10-K
for the year ended December 31, 2012, filed with the SEC on February 26, 2013,
and in VIVUS's definitive proxy statement on Schedule 14A in connection with
VIVUS's 2012 Annual Meeting of Stockholders, filed with the SEC on April 25,
2012. Stockholders will be able to obtain any proxy statement, any amendments
or supplements to the proxy statement and other documents filed by VIVUS with
the SEC for no charge at the SEC's website at www.sec.gov. Copies will also be
available at no charge at the Investor Relations section of VIVUS's corporate
website at www.vivus.com.
CONTACT: VIVUS, Inc.
Timothy E. Morris
Chief Financial Officer
Joele Frank, Wilkinson Brimmer Katcher
Matthew Sherman / Jennifer Beugelmans
Morrow & Co., LLC
Joseph Mills / John Ferguson
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