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Wyeth Pharmaceuticals

Wyeth and Progenics Receive Positive Opinion From European Committee for RELISTOR for the Treatment of Opioid-Induced Constipation in Advanced-Illness Patients

COLLEGEVILLE, Pennsylvania and TARRYTOWN, New York, April 24
(ots/PRNewswire)

-

- Final Decision from European Commission Expected by Mid-2008
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
Web site: 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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