English Version
Pharmaceutical Writers/Business Editors/Biotech Writers
COLLEGEVILLE, Pa., & TARRYTOWN, N.Y.--(BUSINESS WIRE)--July 3,
2008--Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that
the companies have received marketing approval for RELISTOR(TM)
(methylnaltrexone bromide) subcutaneous injection from the European
Commission. RELISTOR is now approved in the 27 member states of the
European Union as well as Iceland, Norway, and Liechtenstein for the
treatment of opioid-induced constipation (OIC) in advanced illness
patients who are receiving palliative care when response to usual
laxative therapy has not been sufficient. RELISTOR is the first
approved treatment for OIC in the European Union.
"The approval of RELISTOR by the European Commission is another
major milestone for this innovative therapy, the first medicine
approved for the treatment of opioid-induced constipation in advanced
illness patients," says Paul J. Maddon, M.D., Ph.D., Founder, Chief
Executive Officer and Chief Science Officer of Progenics. "Approval in
Europe significantly extends the availability of RELISTOR for advanced
illness patients receiving palliative care who experience
opioid-induced constipation, a potentially debilitating side effect of
opioid therapy."
Joseph M. Mahady, President, Wyeth Pharmaceuticals, says: "We are
proud to be able to offer this new innovation to physicians and health
care providers caring for palliative care patients with advanced
illness. We are pleased to have received regulatory approvals for
RELISTOR from Canada, the United States, and Europe in quick
succession, as they represent significantly developed markets for
opioid use in palliative care patients."
Commercial launch of RELISTOR in Europe will be rolled out on a
country-by-country basis, with the first launch anticipated to occur
later this month.
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. Each year, more than 1.5 million Americans receive palliative
care due to an advanced illness, such as incurable cancer and other
end-stage diseases. Similar figures are not available for Europe as a
whole.
About Subcutaneous RELISTOR
On April 24, 2008, the United States Food and Drug Administration
approved RELISTOR subcutaneous injection for the treatment of OIC in
patients with advanced illness who are receiving palliative care, when
response to laxative therapy has not been sufficient. The use of
RELISTOR beyond four months has not been studied. RELISTOR was made
available in the United States on June 2. On March 28, 2008, this form
of RELISTOR was approved by Health Canada and was launched on May 27,
2008. A marketing application for subcutaneous RELISTOR was submitted
to the Australian Therapeutic Goods Administration in August 2007 and
is under review. Other applications in additional countries are also
pending.
Important Safety Information for Subcutaneous RELISTOR
-- RELISTOR is contraindicated in patients with known or
suspected mechanical gastrointestinal obstruction.
-- If severe or persistent diarrhea occurs during treatment,
advise patients to discontinue therapy with RELISTOR and
consult their physician.
-- Use of RELISTOR has not been studied in patients with
peritoneal catheters.
-- The most common adverse reactions reported with RELISTOR in
clinical trials were abdominal pain, flatulence, and nausea.
-- Full RELISTOR Prescribing Information for the U.S. is
available at www.relistor.com.
About the Collaboration
In December 2005, Wyeth and Progenics Pharmaceuticals entered into
an exclusive, worldwide agreement for the joint development and
commercialization of methylnaltrexone.
(PGNX-G)
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, virology - including human immunodeficiency virus
(HIV) and hepatitis C virus (HCV) infections - and oncology.
Progenics, in collaboration with Wyeth, is developing RELISTOR
(methylnaltrexone bromide) for the treatment of opioid-induced side
effects. The subcutaneous form of RELISTOR is approved for use in the
U.S., Canada and European Union member states as well as in Iceland,
Norway and Liechtenstein. Applications are pending related to the
potential marketing of RELISTOR in Australia and other countries. In
the area of virology, Progenics is developing the HIV entry inhibitor
PRO 140, a humanized monoclonal antibody targeting the entry
co-receptor CCR5, which has completed phase 1b clinical studies with
positive results. PRO 140 is currently in phase 2 clinical testing.
Pre-clinical programs for the development of novel HCV entry
inhibitors are also underway. In the area of oncology, the Company is
developing a human monoclonal antibody-drug conjugate (ADC) for the
treatment of prostate cancer - a selectively targeted cytotoxic
antibody directed against prostate-specific membrane antigen (PSMA).
PSMA is a protein found on the surface of prostate cancer cells as
well as in blood vessels supplying other solid tumors. Progenics is
also developing vaccines designed to treat prostate cancer by
stimulating an immune response to PSMA.
PROGENICS DISCLOSURE NOTICE: The information contained in this
document is current as of July 3, 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
Additional information on Progenics is available at
--30--TM/ny*
CONTACT: Wyeth:
Media:
Sal Foti, 484-865-3490
or
Douglas Petkus, 484-865-5140
or
Investor:
Justin Victoria, 973-660-5340
or
Progenics Pharmaceuticals, Inc.:
Investor:
Corporate Affairs
Richard W. Krawiec, Ph.D., 914-789-2814
or
Dory A. Lombardo, 914-789-2818
or
Media:
WeissComm Partners
Aline Schimmel, 312-284-4706
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