Final Decision from European Commission Expected by Mid-2008
COLLEGEVILLE, Pa. and TARRYTOWN, N.Y., April 24 /PRNewswire-FirstCall/
-- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics
Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies
have received a positive opinion for RELISTOR(TM) (methylnaltrexone
bromide) subcutaneous injection from the Committee for Medicinal Products
for Human Use (CHMP), the scientific committee of the European Medicines
Agency (EMEA). The companies are seeking the approval of RELISTOR in Europe
for the treatment of opioid-induced constipation in advanced-illness
patients who are receiving palliative care when response to usual laxative
therapy has not been sufficient.
The CHMP is responsible for reviewing medicinal product applications
for safety, quality and efficacy. The CHMP's positive opinion for RELISTOR
will now be forwarded to the European Commission for a final decision,
which is anticipated by mid-year.
RELISTOR, administered via subcutaneous injection, is a peripherally
acting mu-opioid receptor antagonist that decreases the constipating
effects of opioid pain medications in the gastrointestinal tract without
affecting their ability to relieve pain.
About the Subcutaneous RELISTOR Clinical Investigational Program
In March 2007, Progenics submitted a New Drug Application for
subcutaneous RELISTOR for the treatment of opioid-induced constipation
(OIC) in patients receiving palliative care to the U.S. Food and Drug
Administration. This application has a Prescription Drug User Fee Act
(PDUFA) date of April 30, 2008. In May 2007, Wyeth submitted a Marketing
Authorization Application (MAA) in Europe to the European Medicines Agency
(EMEA) for subcutaneous RELISTOR. The EMEA review is ongoing. In August
2007, Wyeth submitted a marketing application to the Therapeutic Goods
Administration division of the Australian government for subcutaneous
RELISTOR. On March 28, 2008, RELISTOR received approval from Canada for the
treatment of opioid-induced constipation (OIC) in patients with advanced
illness receiving palliative care.
About the Companies
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, nutritionals 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.
WYETH DISCLOSURE NOTICE: The statements in this press release that are
not historical facts are forward-looking statements that are subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. In
particular, there can be no assurance that RELISTOR will be commercially
successful or that RELISTOR will be approved in the future in other
formulations or indications and/or in other countries. Other risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied by forward-looking statements include, without
limitation, the inherent uncertainty of the timing and success of, and
expense associated with, research, development, regulatory approval and
commercialization of our products and pipeline products; government
cost-containment initiatives; restrictions on third-party payments for our
products; substantial competition in our industry, including from branded
and generic products; emerging data on our products and pipeline 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" in
our Annual Report on Form 10-K for the year ended December 31, 2007, which
was filed with the Securities and Exchange Commission on February 29, 2008.
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.
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a
biopharmaceutical company focusing on the development and commercialization
of innovative therapeutic products to treat the unmet medical needs of
patients with debilitating conditions and life-threatening diseases.
Principal programs are directed toward gastroenterology as well as the
treatment of HIV infection and cancer. The Company, in collaboration with
Wyeth, is developing methylnaltrexone for the treatment of opioid-induced
side effects, including constipation (oral and subcutaneous formulations)
and postoperative ileus (intravenous formulation). In the area of HIV
infection, the Company is developing the viral-entry inhibitor PRO 140, a
humanized monoclonal antibody targeting the HIV entry co-receptor CCR5,
which has completed phase 1b clinical studies with positive results. In the
area of prostate cancer, the Company is developing a human monoclonal
antibody drug conjugate - a selectively targeted cytotoxic antibody
directed against prostate-specific membrane antigen (PSMA), a protein found
on the surface of prostate cancer cells. Progenics is also developing
vaccines designed to stimulate an immune response to PSMA.
PROGENICS DISCLOSURE NOTICE: The information contained in this document
is current as of April 24, 2008. This press release contains
forward-looking statements. Any statements contained herein that are not
statements of historical fact may be forward-looking statements. When the
Company uses the words "anticipates," "plans," "expects" and similar
expressions, it is identifying forward-looking statements. Such
forward-looking statements involve risks and uncertainties which may cause
the Company's actual results, performance or achievements to be materially
different from those expressed or implied by forward-looking statements.
Such factors include, among others, the uncertainties associated with
product development, the risk that clinical trials will not commence or
proceed as planned, the risks and uncertainties associated with dependence
upon the actions of our corporate, academic and other collaborators and of
government regulatory agencies, the risk that our licenses to intellectual
property may be terminated because of our failure to have satisfied
performance milestones, the risk that products that appear promising in
early clinical trials do not demonstrate efficacy in larger-scale clinical
trials, the risk that we may not be able to manufacture commercial
quantities of our products, the uncertainty of future profitability and
other factors set forth more fully in the Company's Annual Report on Form
10-K for the fiscal year ended December 31, 2007, and other reports filed
with the Securities and Exchange Commission, to which investors are
referred for further information. In particular, the Company cannot assure
you that any of its programs will result in a commercial product. Progenics
does not have a policy of updating or revising forward-looking statements
and assumes no obligation to update any forward-looking statements
contained in this document as a result of new information or future events
or developments. Thus, it should not be assumed that the Company's silence
over time means that actual events are bearing out as expressed or implied
in such forward-looking statements.
Editor's Note:
Additional information on Wyeth is available at http://www.wyeth.com
Additional information on Progenics is available at
http://www.progenics.com
SOURCE Wyeth Pharmaceuticals
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Related links:
http://www.wyeth.com
http://www.progenics.com
CONTACT:
Wyeth: Media, Sal Foti, Wyeth
Pharmaceuticals, +1-484-865-3490, Douglas Petkus, Wyeth,
+1-484-865-5140, Gwen Fisher, Wyeth Pharmaceuticals,
+1-484-865-5160, or Investors, Justin Victoria, Wyeth,
+1-973-660-5340; or Progenics Pharmaceuticals, Inc.: Investors,
Richard W. Krawiec, Ph.D., Vice President, Corporate Affairs,
+1-914-789-2814, rkrawiec@progenics.com, Dory A. Lombardo, Senior
Manager, Corporate Affairs, +1-914-789-2818,
dlombardo@progenics.com, Media, Aline Schimmel, WeissComm
Partners, +1-312-284-4706, Julie Normart, WeissComm Partners,
+1-415-946-1087
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