MEDIA RELEASE PR35496
VIVUS Prevailed In Acrux Arbitration
MOUNTAIN VIEW, Calif., July 24 /PRNewswire-AsiaNet/ --
VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative,
next-generation therapies to address unmet needs in obesity, diabetes and sexual
health, announced that it had prevailed in a binding arbitration hearing brought by
Fempharm Pty Ltd (a wholly owned subsidiary of Acrux Limited) concerning a dispute
related to the development of Luramist, a metered dose transdermal application of
testosterone for women. VIVUS had received an interim ruling from the independent
arbitration panel convened by the Judicial Arbitration and Mediation Service (JAMS) in
California. The panel ruled in favor of VIVUS and found that VIVUS was in compliance
with the Luramist license agreement and that VIVUS has used diligent, commercially
reasonable efforts to develop Luramist. The panel had further ruled in favor
of VIVUS on its counter claim that Acrux had breached the Luramist license agreement
by failing to provide certain know-how and certain improvements in the formulation and
delivery device for Luramist. The panel denied the Acrux claim for additional milestone
payments. The panel ordered Acrux to turn over certain information to VIVUS that was
previously withheld by Acrux in violation of the agreement. In an additional interim ruling,
the panel has further ruled that a new date by which the first phase 3 trial for Luramist is
to be initiated is reset from the original date of April 30, 2006 to April 1, 2010 to reflect
the U.S. regulatory environment during the development period. Acrux will be eligible to
receive the previously agreed upon milestone payment of $1 million on the sooner of the
initiation of the phase 3 trials or April 1, 2010. The results of the arbitration were
previously included on a Form 8-K filed with the United States Securities and Exchange
Commission.
About VIVUS
VIVUS is a biopharmaceutical company developing innovative, next-generation
therapies to address unmet needs in obesity, diabetes and sexual health. The
Company's lead investigational product in clinical development, Qnexa(TM), is expected
to complete phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in
phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual
health, VIVUS is in phase 3 development with avanafil, its PDE5 inhibitor drug
candidate, and in phase 2 development of Luramist(TM), its drug candidate for the
treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R)
(alprostadil), a first generation therapy for the treatment of ED, is already on the market
and generating revenue for VIVUS. For more information about the company, please
CONTACT:
VIVUS, Inc. Investor Relations: The Trout Group
Timothy E. Morris Brian Korb
Chief Financial Officer 646-378-2923
650-934-5200
Public Relations: Pure Communications, Inc.
Sheryl Seapy
949-608-0841
SOURCE: VIVUS, Inc.
CONTACT: Timothy E. Morris,
Chief Financial Officer,
VIVUS, Inc.,
+1-650-934-5200,
Investor Relations: Brian Korb,
The Trout Group,
+1-646-378-2923,
Public Relations: Sheryl Seapy,
Pure Communications, Inc.,
+1-949-608-0841
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