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Wyeth and Progenics Pharmaceuticals Announce Submission of Marketing Application in Europe for the Subcutaneous Formulation of Methylnaltrexone

Geschrieben am 14-05-2007

Collegeville, Pennsylvania and Tarrytown, New York
(ots/PRNewswire) -

- Application for the Treatment of Opioid-Induced Constipation in
Patients with Advanced Illness -

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) announced today that
Wyeth has submitted a marketing application to the European Medicines
Agency (EMEA) for a subcutaneous formulation of methylnaltrexone for
the treatment of opioid-induced constipation (OIC) in patients with
advanced illness. Methylnaltrexone is a peripherally acting
opioid-receptor antagonist that is designed to treat OIC without
interfering with pain relief. A New Drug Application for the same
formulation of methylnaltrexone was submitted by Progenics to the
U.S. Food and Drug Administration on March 30, 2007.

"Methylnaltrexone has the potential to address a major
gastrointestinal side effect of opioid therapy. Therefore, this EMEA
application is an important development and a major milestone," says
Gary L. Stiles, M.D., Executive Vice President, Chief Medical
Officer, Wyeth Pharmaceuticals.

The marketing application is based on data from two Phase 3
studies that evaluated the safety and efficacy of the subcutaneous
formulation of methylnaltrexone in the treatment of OIC in patients
with advanced illness. All of the primary efficacy endpoints of the
studies were positive and statistically significant, and the therapy
generally was well-tolerated.

Opioid analgesics commonly are prescribed to manage pain in
patients with advanced illness. Some experts have stated that
constipation occurs in nearly all patients on opioid therapy. There
currently is no approved medication that specifically targets the
underlying cause of OIC to relieve constipation in this patient
population.

Opioids provide pain relief by interacting with specific opioid
receptors located in the central nervous system (CNS) - the brain and
the vertebral column. However, opioids also interact with the
receptors outside the CNS, such as those affecting the
gastrointestinal (GI) tract, altering intestinal motility and
resulting in constipation that can be debilitating. Patients
suffering from OIC may experience dry, hard stools; straining during
evacuation; and incomplete and infrequent evacuation. Other symptoms
of OIC can include nausea, vomiting and abdominal discomfort or pain.
If left untreated or unresolved, OIC can lead to fecal impaction that
may require manual removal.

"This milestone represents our commitment to patients who suffer
from the debilitating effects of OIC and offers them hope," says Paul
J. Maddon, M.D., Ph.D., Progenics' Founder, Chief Executive Officer
and Chief Science Officer. "Progenics filed a New Drug Application
for this formulation of methylnaltrexone with the U.S. Food and Drug
Administration in March of this year. The progress we have made with
submissions to U.S. and European Union regulatory agencies
underscores the strength of the collaboration between Progenics and
Wyeth, and of our joint dedication to serving the needs of these
seriously ill patients."

Submission of this EMEA application will result in a US$4 million
milestone payment being made to Progenics Pharmaceuticals. In
December of 2005, Wyeth and Progenics entered into an exclusive,
worldwide agreement for the joint development and commercialization
of methylnaltrexone for the treatment of opioid-induced side effects,
including constipation and post-operative ileus (POI), a prolonged
dysfunction of the GI tract following surgery. Under the terms of the
collaboration, Wyeth received worldwide rights to methylnaltrexone,
and Progenics retained an option to co-promote the product in the
United States. The companies are collaborating on worldwide
development. The transaction included an upfront payment of US$60
million to Progenics with as much as an additional US$356.5 million
payable upon achievement of certain milestones. Wyeth has agreed to
pay Progenics royalties on worldwide sales and co-promotion fees
within the United States. Additionally, Wyeth is responsible for all
ongoing and future development and commercialization costs.

About Methylnaltrexone

Methylnaltrexone is an investigational drug that is being studied
as a treatment for the peripheral side effects of opioid analgesics.
It is designed to mitigate the effect of opioids on peripheral
receptors without interfering with central nervous system pain
relief. Methylnaltrexone is being developed in subcutaneous and oral
forms to treat opioid-induced constipation and an intravenous form
for POI.

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 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 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. These 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; 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.

Progenics Pharmaceuticals, Inc., of Tarrytown, N.Y., 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 has four product candidates in clinical
development and several others in preclinical development. The
Company, in collaboration with Wyeth, is developing methylnaltrexone
for the treatment of opioid-induced side effects, including
constipation and post-operative ileus.

PROGENICS DISCLOSURE NOTICE: The information contained in this
document is current as of May 14, 2007. 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,
2006, 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


ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media: Sal Foti, Wyeth Pharmaceuticals, +1-484-865-3490, or Gwen
Fisher, Wyeth Pharmaceuticals, +1-484-865-5160, or Investor: Justin
Victoria, Wyeth, +1-973-660-5340; Investor: Richard W. Krawiec,
Ph.D., Vice President, Corporate Affairs, Progenics Pharmaceuticals,
Inc., +1-914-789-2800, rkrawiec@progenics.com; Media: Barri
Winiarski, WeissComm Partners, +1-914-584-7468


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