VIVUS Announces Positive Recommendation From CHMP Supporting Avanafil Approval
MOUNTAIN VIEW, Calif., April 26, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc.
(Nasdaq:VVUS) today announced that the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion recommending the granting of a marketing authorization for avanafil
(SPEDRA™) for the treatment of erectile dysfunction (ED) in the European
Union. The CHMP recommendation will now be referred to the European Commission
(EC), which grants marketing authorization for medicines in the European
Union. A final decision from the EC regarding the SPEDRA Marketing
Authorization Application (MAA) is expected within approximately two months.
"We are pleased with the positive recommendation of the CHMP to support the
approval of SPEDRA," said Peter Tam, president of VIVUS, Inc. "This positive
opinion marks another important milestone in the drug development history of
VIVUS. We could not have accomplished this without the longstanding
collaboration and support of our partner Mitsubishi Tanabe Pharma Corporation
and our European team of advisors and consultants, all of whom have worked
diligently on the application. If approval of the MAA is granted by the EC, we
expect to complete our partnering discussions on a timely basis to allow for
the commercialization of SPEDRA in the EU."
"SPEDRA is the first next-generation PDE5 inhibitor and offers a unique
profile for the treatment of ED," said Prof. Francesco Montorsi, FRCS,
Professor and Chairman, Department of Urology and Director, Urological
Research Institute, Università Vita Salute San Raffaele, Milan, Italy. "Its
onset of action, PDE5 inhibition selectivity and absorption profile make it an
important new treatment option for the more than 20 million ED sufferers in
Europe. We look forward to the launch of SPEDRA and to providing patients with
this important new medication."
The MAA incorporated results from three placebo-controlled, randomized,
double-blind, multicenter studies: REVIVE, which included 646 men from the
general population with ED, REVIVE-Diabetes, which included 390 men with
diabetes, and REVIVE-RP, which included 298 men following radical
prostatectomy. Also contained within the MAA were the results from the
year-long safety study, TA-314, which included 712 continuation patients from
the REVIVE and REVIVE-Diabetes studies. Previously reported highlights from
the avanafil development program include:
*All doses tested, 50 mg, 100 mg and 200 mg, met each of the co-primary
*Erections sufficient for penetration (SEP2) were observed in 77% and 63%
of avanafil patients at the 200 mg dose, compared to 54% and 42% of
placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively;
*Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil
patients at the 200 mg dose, compared to 27% and 20% of placebo patients
in the REVIVE and REVIVE-Diabetes studies, respectively;
*Significant improvement in erectile function as measured by IIEF-EF domain
score was observed for all doses in avanafil-treated patients;
*Across all avanafil Phase 3 studies, successful intercourse (SEP3) was
observed in some avanafil-treated patients as early as 15 minutes after
*The most common side effects were headache, flushing, nasopharyngitis and
nasal congestion; and
*There were no drug-related serious adverse events reported in the studies.
ED affects an estimated 52 percent of men between the ages of 40 and 70.
Prevalence increases with age and can be caused by a variety of factors,
including medications (anti-hypertensives, histamine receptor antagonists);
lifestyle (tobacco, alcohol use); diseases (diabetes, cardiovascular
conditions, prostate cancer); and spinal cord injuries. Left untreated, ED can
negatively impact relationships and self-esteem, causing feelings of
embarrassment and guilt. However, about half of men being treated with
currently available PDE5 inhibitors are dissatisfied with treatment. The
market opportunity for ED medical treatments continues to grow, with worldwide
sales exceeding $5.5 billion in 2012.
STENDRA, or avanafil, was approved by the FDA for the treatment of erectile
dysfunction, or ED, in the U.S. VIVUS, through collaboration arrangements with
third parties, intends to market and sell STENDRA in the U.S., and if
approved, under the trade name SPEDRA in the EU and other territories outside
the U.S.Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation
(MTPC). VIVUS owns worldwide development and commercial rights to avanafil for
the treatment of sexual dysfunction, with the exception of certain Asian
Pacific Rim countries.
VIVUS is currently in discussions with potential partners to commercialize
STENDRA in the United States and other territories throughout the world.
It is recommended that STENDRA should be taken approximately 30 minutes before
sexual activity. STENDRA should not be taken more than once per day.For more
information about STENDRA, please visit www.Stendra.com.
Important Safety Information
STENDRA™ (avanafil) is prescribed to treat erectile dysfunction (ED).
Do not take STENDRA if you take nitrates, often prescribed for chest pain, as
this may cause a sudden, unsafe drop in blood pressure.
Discuss your general health status with your healthcare provider to ensure
that you are healthy enough to engage in sexual activity. If you experience
chest pain, nausea, or any other discomforts during sex, seek immediate
STENDRA may affect the way other medicines work. Tell your healthcare provider
if you take any of the following; medicines called HIV protease inhibitors,
such as ritonavir (Norvir), indinavir (Crixivan), saquinavir (Fortavase or
Invirase) or atazanir (Reyataz); some types of oral antifungal medicines, such
as ketoconazole (Nizoral), and itraconozale (Sporonox); or some types of
antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or
In the rare event of an erection lasting more than 4 hours, seek immediate
medical help to avoid long-term injury.
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction
medicines, including STENDRA) reported a sudden decrease or loss of vision. It
is not possible to determine whether these events are related directly to
these medicines or to other factors. If you experience sudden decrease or loss
of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor
Sudden decrease or loss of hearing has been rarely reported in people taking
PDE5 inhibitors, including STENDRA. It is not possible to determine whether
these events are related directly to the PDE5 inhibitors or to other factors.
If you experience sudden decrease or loss of hearing, stop taking STENDRA and
contact a doctor right away. If you have prostate problems or high blood
pressure for which you take medicines called alpha blockers or other
anti-hypertensives, your doctor may start you on a lower dose of STENDRA.
Drinking too much alcohol when taking STENDRA may lead to headache, dizziness,
and lower blood pressure.
STENDRA in combination with other treatments for ED is not recommended.
STENDRA does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA are headache, flushing, runny nose and
Please see full patient prescribing information for STENDRA (50 mg, 100 mg,
200 mg) tablets.
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 more information about the company,
please visit www.vivus.com.
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995 and are
subject to risks, uncertainties and other factors, including risks and
uncertainties related to whether the EC will approve the SPEDRA MAA on the
anticipated timing, or at all; the risks and uncertainties related to the
completion of our partnering discussions on acceptable terms and on a timely
basis; and the risks and uncertainties related to the launch and
commercialization of SPEDRA in the EU. These risks and uncertainties could
cause actual results to differ materially from those referred to in these
forward-looking statements. The reader is cautioned not to rely on these
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. VIVUS does not
undertake an obligation to update or revise any forward-looking statements.
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 THEY
BECOME 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
Financial Media Relations:
Joele Frank, Wilkinson Brimmer Katcher
Media Relations: GolinHarris
Investor Relations: The Trout Group
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