VIVUS Announces Termination of Agreement for the Development of Testosterone MDTS
MOUNTAIN VIEW, Calif., March 31 /PRNewswire-FirstCall/ -- VIVUS, Inc. (NASDAQ:VVUS) today announced that it has terminated the Development and Commercialization Agreement with FemPharm Pty Ltd. (a wholly owned subsidiary of Acrux Limited) for Luramist(TM), a metered dose transdermal application of testosterone for women. The Agreement with FemPharm was originally signed in 2004 along with the agreement to develop Evamist, a metered dose transdermal estradiol spray for menopause. The company will return rights to Luramist to FemPharm and focus its efforts on its late stage investigational product candidates: Qnexa for obesity and avanafil for erectile dysfunction.
"The decision to terminate the agreement was made in view of the significant long-term safety requirements for the approval of testosterone products in women," stated Peter Tam, president of VIVUS. "We believe it is in our shareholders' best interests to pursue other therapeutic candidates."
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. The company's lead product in clinical development, Qnexa®, has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of October 28, 2010. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor for the treatment of erectile dysfunction. MUSE® (alprostadil), a first generation therapy for the treatment of erectile dysfunction, is already on the market and generating revenue for VIVUS. 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. These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimated" and "intend," among others. These forward-looking
statements are based on VIVUS' current expectations and actual
results could differ materially. 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, substantial competition; uncertainties of patent
protection and litigation; uncertainties of government or third
party payer reimbursement; reliance on sole source suppliers;
limited sales and marketing efforts and dependence upon third
parties; risks related to the development of innovative products;
and risks related to failure to obtain FDA clearances or approvals
and noncompliance with FDA regulations. As with any pharmaceutical
under development, there are significant risks in the development,
regulatory approval and commercialization of new products. There
are no guarantees that future clinical studies discussed in this
press release will be completed or successful or that any product
will receive regulatory approval for any indication or prove to be
commercially successful. VIVUS does not undertake an obligation to
update or revise any forward-looking statement. Investors should
read the risk factors set forth in VIVUS' Form 10-K for the year
ended December 31, 2009 and periodic reports filed with the
Securities and Exchange Commission.
CONTACT: -------- VIVUS, Inc. Investor Relations: The Trout Group Timothy E. Morris Brian Korb Chief Financial Officer 646-378-2923 650-934-5200
Source: VIVUS, Inc.
CONTACT: VIVUS, Inc., Timothy E. Morris, Chief Financial
+1-650-934-5200; or Investor Relations: The Trout Group, Brian Korb,
Web Site: http://www.vivus.com/
Posted: March 2010