Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigation
August 10 2007 - 9:30AM
PR Newswire (US)
COLLEGEVILLE, Pa., Aug. 10 /PRNewswire/ -- Wyeth Pharmaceuticals, a
division of Wyeth (NYSE:WYE), and Solvay Pharmaceuticals, Inc.
announced today the receipt of an action letter from the U.S. Food
and Drug Administration (FDA) in response to the New Drug
Application (NDA) for bifeprunox, an atypical antipsychotic that
was reviewed for the acute treatment of schizophrenia, as well as
the maintenance of stable adult patients. The Agency stated that
the drug was not approvable at this time. The FDA stated in the
letter that bifeprunox demonstrated effectiveness in the long-term
maintenance study and indicated that a second positive maintenance
study could be sufficient to support a maintenance claim for
bifeprunox. The Companies believe that bifeprunox offers distinct
benefits for the long-term maintenance of patients with
schizophrenia. The Companies will meet with the FDA to discuss
study design and to assess how this additional study combined with
ongoing and planned studies might support a maintenance indication.
Although the FDA acknowledged that bifeprunox separated from
placebo in two short-term studies in the acute setting, the Agency
concluded that the efficacy data, when compared to reference drugs,
were not sufficient for approval. The Agency also requested further
information regarding human metabolism of bifeprunox, and
additional information regarding a complex case of a patient who
died while participating in one of the trials. "We believe that
bifeprunox is a promising drug for the treatment of schizophrenia
and that there is a need for new treatment options to help people
with schizophrenia manage their disease," says Laurence Downey,
M.D., President and CEO of Solvay Pharmaceuticals, Inc. "We will
work with the FDA to address its comments and pursue the approval
of bifeprunox as soon as possible." "The development of bifeprunox
offers the possibility of a new treatment approach for patients
where maintaining stability is challenged by the metabolic
consequences frequently encountered with long-term therapy. We
continue to support the development of the compound and the
approach," adds Gary L. Stiles, M.D., Executive Vice President and
Chief Medical Officer, Wyeth Pharmaceuticals. Bifeprunox, a partial
dopamine agonist designed to normalize levels of chemical activity
in the brain, has been studied in approximately 2,650 patients with
schizophrenia at more than 200 Phase 2 and 3 clinical trial sites
in the United States and throughout the world. About Solvay
Pharmaceuticals, Inc. Solvay Pharmaceuticals, Inc., of Marietta,
Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more
information, visit http://www.solvaypharmaceuticals-us.com/. Solvay
Pharmaceuticals is a research driven group of companies that
constitute the global pharmaceutical business of the Solvay Group.
The company seeks to fulfill carefully selected, unmet medical
needs in the therapeutic areas of neuroscience, cardiometabolic,
influenza vaccines, gastroenterology, and men's and women's health.
Its 2006 sales were EUR 2.6 billion and it employs approximately
10,000 people worldwide. For more information, visit
http://www.solvaypharmaceuticals.com/. SOLVAY is an international
chemical and pharmaceutical Group with headquarters in Brussels. It
employs some 30,000 people in 50 countries. In 2006 its
consolidated sales amounted to EUR 9.4 billion generated by its
three activity sectors: Chemicals, Plastics and Pharmaceuticals.
SOLVAY (Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR)
is listed on the Euronext stock exchange in Brussels. Details are
available at http://www.solvay.com/. About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in
the areas of women's health care, infectious disease,
gastrointestinal health, central nervous system, inflammation,
transplantation, hemophilia, oncology, vaccines and nutritional
products. 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
non-prescription 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. The statements in this press release that are not
historical facts are forward-looking statements based on current
expectations of future events and are subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. In particular,
the statements in this press release regarding our expectations for
bifeprunox are based on a preliminary analysis of the FDA action
letter received on August 9, 2007 and our expectations as to future
development and regulatory review of the product, all of which are
subject to risks and uncertainties. Risks and uncertainties include
the inherent uncertainty of the timing and success of, and expense
associated with, research, development, regulatory approval and
commercialization of our products, including with respect to our
pipeline products (including bifeprunox); government cost-
containment initiatives; restrictions on third-party payments for
our products; substantial competition in our industry, including
from branded and generic products; data generated on our products;
the importance of strong performance from our principal products
and our anticipated new product introductions; the highly regulated
nature of our business; product liability, intellectual property
and other litigation risks and environmental liabilities;
uncertainty regarding our intellectual property rights and those of
others; difficulties associated with, and regulatory compliance
with respect to, manufacturing of our products; risks associated
with our strategic relationships; economic conditions including
interest and currency exchange rate fluctuations; changes in
generally accepted accounting principles; trade buying patterns;
the impact of legislation and regulatory compliance; risks and
uncertainties associated with global operations and sales; and
other risks and uncertainties, including those detailed from time
to time in our periodic reports filed with the Securities and
Exchange Commission, including our current reports on Form 8-K,
quarterly reports on Form 10-Q and annual report on Form 10-K,
particularly the discussion under the caption "Item 1A, Risk
Factors." The forward-looking statements in this press release are
qualified by these risk factors. We assume no obligation to
publicly update any forward-looking statements, whether as a result
of new information, future developments or otherwise. DATASOURCE:
Wyeth Pharmaceuticals CONTACT: Gwen Fisher, +1-484-865-5160, or
Natalie de Vane, +1-484-865-5139, both of Wyeth Pharmaceuticals; or
Investors, Justin Victoria of Wyeth, +1-973-660-5340 Web site:
http://www.wyeth.com/ http://www.solvay.com/
http://www.solvaypharmaceuticals.com/
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