ViroPharma
and Wyeth Announce Achievement of Proof of Concept Milestone for HCV-796 - Companies
Preparing to Initiate Phase 2 Clinical Evaluation August
14, 2006 ViroPharma
Incorporated (Nasdaq: VPHM) and Wyeth (NYSE: WYE) today announced that while the
analysis of data from their Phase 1b study of HCV-796, an investigational oral
non-nucleoside hepatitis C virus (HCV) polymerase inhibitor, in combination with
pegylated interferon, is still ongoing, data analyzed to date indicate that HCV-796
has achieved a "proof of concept" milestone under the companies' agreements.
The companies expect that preliminary data from the Phase 1b study will be available
for release by the end of August 2006. Based upon the preliminary data reviewed
to date, ViroPharma and Wyeth are preparing to initiate Phase 2 combination studies
of HCV-796. The companies expect to begin dosing patients in the Phase 2 study
in the fourth quarter of 2006. In
connection with meeting the proof of concept milestone, ViroPharma will issue
to Wyeth 981,836 shares of ViroPharma's common stock for a purchase price of Ten
Million Dollars ($10,000,000), which represents the last of three stock purchases
outlined in the companies' agreements. The price per share for the stock was based
on a premium to a trailing average price. "ViroPharma
and Wyeth have been partners in hepatitis C antiviral development since 1999;
through the years, our goal has been to identify, develop and eventually market
drugs to treat hepatitis C patients," said Michel de Rosen, ViroPharma's
president and chief executive officer. "HCV-796 is the most promising compound
we have developed together to date, and we look forward to announcing the Phase
1b data later this month. The achievement of this milestone and progression toward
Phase 2 clinical trials marks an exciting time for us, and a promising opportunity
for patients with HCV." "With
HCV-796, we now have for the first time in our collaboration a unique compound
with a novel mechanism of action that has achieved proof of concept in combination
with pegylated interferon," commented Robert Ruffolo, Ph.D., Wyeth Pharmaceutical's
president of research. "We are excited to reach this milestone and to be
collaborating with ViroPharma to move this promising compound toward Phase 2 trials." In
December 1999, ViroPharma and Wyeth entered into an alliance to develop and commercialize
ViroPharma's lead small molecule antiviral drug candidates for hepatitis C virus
(HCV) and to discover, develop and commercialize additional novel inhibitors of
HCV. In this agreement, Wyeth agreed to purchase shares of ViroPharma's common
stock at the time of completion of certain product development milestones. Under
rules promulgated by the Securities and Exchange Commission, ViroPharma is required
to publicly file, via Form 8-K, the fact that common stock is being issued in
connection with the achievement of the proof of concept milestone. About
HCV-796 HCV-796
is an investigational non-nucleoside polymerase inhibitor compound for the treatment
of hepatitis C that is being evaluated in ongoing clinical trials in combination
with PEG-Interferon by ViroPharma and Wyeth. About
ViroPharma Incorporated ViroPharma
Incorporated is a biopharmaceutical company dedicated to the development and commercialization
of products that address serious diseases treated by physician specialists and
in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral
administration for treatment of antibiotic-associated pseudomembranous colitis
caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus,
including methicillin-resistant strains (for prescribing information, please download
the package insert. ViroPharma currently focuses its drug development activities
in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more
information on ViroPharma, visit the company's website at http://www.viropharma.com. About
Wyeth Wyeth
is one of the world's largest research-driven pharmaceutical and health care products
companies. It is a leader in the discovery, development, manufacturing, and marketing
of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines
that improve the quality of life for people worldwide. The Company's major divisions
include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health. |