COLLEGEVILLE, Pa., and TARRYTOWN, N.Y., May 22 /PRNewswire/ -- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics
Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced preliminary results
from two clinical trials conducted with investigational oral and
intravenous formulations of RELISTOR(TM) (methylnaltrexone bromide).
The first of these studies, a phase 2 trial, evaluated the effects of
an oral formulation of RELISTOR for the treatment of opioid-induced
constipation (OIC), in patients with chronic, non-malignant pain. This
study showed positive activity.
The second study, a phase 3 trial, examined the use of an intravenous
formulation of RELISTOR for post-operative ileus (POI). In this study, the
drug did not meet its primary or secondary end points.
RELISTOR Oral Formulation
The study of the RELISTOR oral formulation was a double-blind,
randomized, placebo-controlled phase 2 trial. In this four-week trial of
122 patients with chronic, non-malignant pain (such as back pain,
neuropathic pain or osteoarthritis) who were receiving opioids for pain
management, the once daily oral formulation of RELISTOR showed
statistically significant activity as assessed by the occurrence of
spontaneous bowel movements and other efficacy measures. This oral
formulation was also shown to be generally well tolerated.
"We are pleased by the preliminary findings of this oral formulation"
says Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and
Chief Science Officer of Progenics Pharmaceuticals, Inc. "We await results
within the coming months from a second, ongoing phase 2 study involving the
oral formulation of RELISTOR that was announced last July to have positive
activity in a phase 1 trial."
RELISTOR Intravenous Formulation
The Progenics-conducted phase 3 study of an intravenous formulation of
RELISTOR for patients with post-operative ileus (POI) did not meet the
primary or secondary end points, confirming the earlier findings of the
Wyeth phase 3 intravenous POI study announced on March 12, 2008. Progenics
and Wyeth will now study the results of both phase 3 intravenous POI
studies to determine whether and how to continue development of this
formulation of RELISTOR and this indication.
RELISTOR Franchise
"We are committed to continuing to develop the RELISTOR franchise to
help address the unmet medical needs of patients suffering from the
gastrointestinal side effects of opioids. Following the results from a
second phase 2 clinical trial of another oral formulation, Wyeth and
Progenics will further define the continued development plan for oral
RELISTOR," says Gary L. Stiles, M.D., Executive Vice President, Chief
Medical Officer, Wyeth Pharmaceuticals.
About RELISTOR and Opioids
RELISTOR is a peripherally acting mu-opioid receptor antagonist that
counteracts the constipating effects of opioid pain medications in the
gastrointestinal tract without affecting their ability to relieve pain.
Opioids provide pain relief by specifically interacting with mu-opioid
receptors within the central nervous system (CNS) -- the brain and spinal
cord. However, opioids also interact with mu-opioid receptors found outside
the CNS, such as those within the gastrointestinal tract, resulting in
constipation that can be debilitating. RELISTOR selectively displaces
opioids from the mu-opioid receptors outside the CNS, including those
located in the gastrointestinal tract, thereby decreasing their
constipating effects. Because of its chemical structure, RELISTOR does not
affect the opioid-mediated analgesic effects on the CNS.
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. Wyeth expects to make subcutaneous
RELISTOR available in the United States in early June. Subcutaneous
RELISTOR has also been approved in Canada and is awaiting Australian
approval and European approval, having received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP), the EMEA scientific
committee, in April.
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 with RELISTOR in clinical trials were
abdominal pain, flatulence, and nausea.
RELISTOR Prescribing Information is available at http://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 for the treatment of opioid-induced
side effects.
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 the subcutaneous form of
RELISTOR will be commercially successful in the United States and Canada or
that RELISTOR will be successfully developed and commercialized 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(TM) (methylnaltrexone bromide) for the treatment of
opioid-induced side effects, including constipation (subcutaneous and oral
formulations) and post-operative ileus (intravenous formulation). In the
U.S., RELISTOR (methylnaltrexone bromide) subcutaneous injection is
indicated for the treatment of opioid-induced constipation (OIC) in
patients with advanced illness who are receiving palliative care, when
response to laxative therapy has not been sufficient. In Canada, RELISTOR
(methylnaltrexone bromide injection) for subcutaneous use is indicated for
the treatment of OIC in patients with advanced illness receiving palliative
care. Applications are pending related to the potential marketing of
RELISTOR in Europe, where a Positive Opinion has been rendered by the
Committee for Medicinal Products for Human Use, the scientific committee of
the European Medicines Agency, as well as 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.
DISCLOSURE NOTICE: The information contained in this document is
current as of May 9, 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 the Company's licenses to intellectual property may
be terminated because of its 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 the Company may not be able to manufacture commercial quantities
of its 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.relistor.com http://www.progenics.com
CONTACT:
Media contact, Sal Foti of Wyeth
Pharmaceuticals, +1-484-865-3490, or Investor contact, Justin
Victoria of Wyeth, +1-973-660-5340; or Investor contacts, Richard
W. Krawiec, Ph.D., Corporate Affairs, +1-914-789-2814,
rkrawiec@progenics.com, or Dory A. Lombardo, Corporate Affairs,
+1-914-789-2818, dlombardo@progenics.com, both of Progenics
Pharmaceuticals, Inc.; or Media contact, Aline Schimmel of
WeissComm Partners, +1-312-284-4706, for Progenics
Pharmaceuticals, Inc.
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