VIVUS and Auxilium Announce FDA Acceptance of Supplemental Filing Seeking an Update of Prescribing Information for STENDRA

 VIVUS and Auxilium Announce FDA Acceptance of Supplemental Filing Seeking an
           Update of Prescribing Information for STENDRA (avanafil)

PR Newswire

MOUNTAIN VIEW, Calif. and CHESTERBROOK, Pa., Jan. 21, 2014

MOUNTAIN VIEW, Calif. and CHESTERBROOK, Pa., Jan. 21, 2014 /PRNewswire/ --
VIVUS, Inc. (Nasdaq: VVUS) and Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)
today announced that the U.S. Food and Drug Administration (FDA) has accepted
a supplemental application that proposes to revise the STENDRA^™ (avanafil)
prescribing information with efficacy and safety information from Study
TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of
Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." The PDUFA
date for the supplemental filing is September 20, 2014.

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO )

VIVUS had previously announced positive results from this multicenter,
placebo-controlled study designed to assess the efficacy of two dosage
strengths of STENDRA approximately 15 minutes after dosing.

In the 440-patient study conducted at 30 sites in the U.S., STENDRA patients
achieved statistically significant improvement versus placebo in the mean
proportion of attempts that resulted in erections sufficient for successful
intercourse as early as 10 minutes for the 200 mg dose and 12 minutes for the
100 mg dose following administration. The currently approved prescribing
information recommends administration approximately 30 minutes before sexual
activity.

About Avanafil

STENDRA (avanafil) is approved by the FDA in the U.S. for the treatment of
erectile dysfunction. STENDRA is rapidly absorbed and should be taken 30
minutes before sexual activity on an as-needed basis. STENDRA should not be
taken more than once per day and may be taken without regard to food and with
modest alcohol consumption. Auxilium Pharmaceuticals, Inc. has exclusive
marketing rights to STENDRA in the U.S. and Canada and is in the early stages
of commercializing STENDRA in the U.S.

STENDRA is currently available through retail and mail order pharmacies.
Auxilium offers programs that will help patients with out-of-pocket costs.

SPEDRA^™, the trade name for avanafil in the European Union (EU), is approved
by the European Medicines Agency (EMA) for the treatment of erectile
dysfunction in the EU. VIVUS has granted an exclusive license to the Menarini
Group through its subsidiary Berlin-Chemie AG to commercialize and promote
SPEDRA for the treatment of erectile dysfunction in over 40 European countries
plus Australia and New Zealand.

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 in discussions with other parties for the
commercialization rights to its remaining territories.

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
medical help.

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 atazanavir (Reyataz^®); some types of oral antifungal
medicines, such as ketoconazole (Nizoral^®), and itraconazole (Sporanox^®); or
some types of antibiotics, such as clarithromycin (Biaxin^®), telithromycin
(Ketek^®), or erythromycin.

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
right away.

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
congestion.

Please see full patient prescribing information for STENDRA (50 mg, 100 mg,
200 mg) tablets.

For more information, please visit www.Stendra.com.

About VIVUS

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 VIVUS, please
visit www.vivus.com.

About Auxilium

Auxilium is a fully integrated specialty biopharmaceutical company with a
focus on developing and commercializing innovative products for specialist
audiences. With a broad range of first- and second-line products across
multiple indications, Auxilium is an emerging leader in the men's healthcare
area and has strategically expanded its product portfolio and pipeline in
orthopedics, dermatology and other therapeutic areas. Auxilium now has a broad
portfolio of 12 approved products. In the U.S., Auxilium markets Edex^®
(alprostadil for injection), an injectable treatment for erectile dysfunction,
Osbon ErecAid^®, the leading device for aiding erectile dysfunction, STENDRA™
(avanafil), an oral erectile dysfunction therapy, Testim^® (testosterone gel)
for the topical treatment of hypogonadism, TESTOPEL^® (testosterone pellets) a
long-acting implantable testosterone replacement therapy, XIAFLEX^®
(collagenase clostridium histolyticum or CCH) for the treatment of Peyronie's
disease and XIAFLEX for the treatment of Dupuytren's contracture. Auxilium
also has programs in Phase 2 clinical development for the treatment of Frozen
Shoulder syndrome and cellulite. Auxilium's mission is to improve the lives of
patients throughout the world by successfully identifying, developing and
commercializing innovative specialty biopharmaceutical products. To learn
more, please visit www.Auxilium.com.

VIVUS SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995

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 regulatory review or approval of the supplemental
application that proposes to revise the avanafil prescribing information.
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, as amended by the Form 10-K/A filed on April 30, 2013, and
as amended by the Form 10-K/A filed on June 12, 2013, and periodic reports
filed with the Securities and Exchange Commission. VIVUS does not undertake an
obligation to update or revise any forward-looking statements.

AUXILIUM SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995

This news release contains forward-looking statements as defined by the
Private Securities Litigation Reform Act of 1995, which discuss matters that
are not facts, and may include words to indicate their uncertain nature such
as "believe," "expect," anticipate," "intend," "plan," "could," "estimate,"
"project," "will," and "target". Auxilium's forward-looking statements convey
its management's expectations, beliefs, plans and objectives regarding future
performance of Auxilium and are based upon preliminary information and
management assumptions. No specific assurances can be given regarding the
success of Auxilium's launch of STENDRA in the U.S. or Canada; or whether
STENDRA will receive a label expansion with efficacy and safety information
from Study TA-501. While Auxilium may elect to update the forward-looking
statements made in this news release in the future, Auxilium specifically
disclaims any obligation to do so. Such forward-looking statements are subject
to a wide range of risks and uncertainties that could cause results to differ
in material respects, including those relating to product development,
revenue, expense and earnings expectations, intellectual property rights,
results and timing of clinical trials, success of marketing efforts, the need
for additional research and testing, and the timing and content of decisions
made by regulatory authorities, including the U.S. Food and Drug
Administration, and those risks discussed in our reports on file with the
Securities and Exchange Commission (the "SEC"). Auxilium's SEC filings may be
accessed electronically by means of the SEC's home page on the Internet at
http://www.sec.gov or by means of the Auxilium's home page on the Internet at
http://www.auxilium.com under the heading "For Investors - SEC Filings." There
may be additional risks that Auxilium does not presently know or that Auxilium
currently believes are immaterial which could also cause actual results to
differ from those contained in the forward-looking statements.

CONTACT:

VIVUS, Inc.
Dana B. Shinbaum
Corporate Development & Investor Relations
shinbaum@vivus.com
(650) 934-5200

The Trout Group
Brian Korb
bkorb@troutgroup.com
646-378-2923

Auxilium Pharmaceuticals, Inc.
Keri P. Mattox / SVP,
IR & Corporate Communications
kmattox@auxilium.com
(484) 321-5900

Nichol L. Ochsner / Senior Director
IR & Corporate Communications
nochsner@auxilium.com
(484) 321-5900

SOURCE Auxilium Pharmaceuticals, Inc.

Website: http://www.auxilium.com/
 
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