Study Demonstrated Efficacy of RELISTOR for Use in Advanced-Illness
Patients with Opioid-Induced Constipation
COLLEGEVILLE, Pa. and TARRYTOWN, N.Y., May 28 /PRNewswire-FirstCall/ --
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics
Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the publication of
results from a pivotal phase 3 trial of RELISTOR(TM) (methylnaltrexone
bromide) subcutaneous injection in the May 29, 2008 issue of the New
England Journal of Medicine. RELISTOR is a newly approved therapy 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.
The clinical study showed that significantly more OIC patients with
advanced illness experienced bowel movements (laxation) within four hours
of receiving their first dose of subcutaneous RELISTOR than patients
receiving placebo, without the use of a rescue laxative (48 percent vs. 15
percent; P<0.001). The study also demonstrated that RELISTOR did not impair
the ability of opioids to provide pain relief, and the drug was generally
well tolerated.
"Effectively managing pain is critical for patients with advanced
illness," says Jay Thomas, M.D., Ph.D., a lead author of the study and
Clinical Medical Director of The San Diego Hospice and the Institute for
Palliative Medicine. "However, the side effects associated with many pain
medications can represent a significant barrier to providing good pain
management for those patients. The data published in NEJM are particularly
exciting because not only do they demonstrate that RELISTOR has the
potential to relieve OIC effectively, but that it does so without
interfering with much-needed pain relief."
Each year, more than 1.5 million Americans receive palliative care due
to an advanced illness, such as incurable cancer, end-stage heart and lung
disease, or AIDS. A considerable number of these patients are prescribed
opioids to manage their pain, and experts say that constipation occurs in
practically all of them. However, for many, laxatives do not provide
sufficient relief. RELISTOR, administered via subcutaneous injection, is a
peripherally acting mu-opioid receptor antagonist that counteracts the
constipating effects of opioid pain medications in the gastrointestinal
tract without impacting opioid-mediated analgesic effects on the central
nervous system.
Study Design and Results
The double-blind, randomized, placebo-controlled phase 3 trial examined
the efficacy and safety of subcutaneous RELISTOR in relieving OIC in
patients with an advanced illness. Co-primary end points were the
proportion of patients with a rescue-free bowel movement within four hours
of the first dose, and the proportion of patients with rescue-free bowel
movements occurring within four hours of at least two of the first four
doses, both compared to placebo. Patients who completed the two-week,
placebo-controlled trial were eligible to enter a subsequent three-month,
open-label extension study. Patients in the extension study received
RELISTOR as needed, not more frequently than once daily, for up to three
months.
In the double-blind phase of the study, 48 percent of patients
experienced a bowel movement within four hours of receiving the first dose
of RELISTOR (0.15 mg/kg), more than three times the rate seen in patients
treated with placebo (15 percent; P<0.001). Half of the RELISTOR patients
who responded within 4 hours did so within 30 minutes. Additionally, more
patients receiving RELISTOR (52 percent) experienced a bowel movement
within four hours of receiving at least two of the first four doses than
those receiving placebo (8 percent) (P<0.001). The response rates remained
consistent throughout the extension study. Overall safety data from the
studies showed that RELISTOR was generally well tolerated. The most
frequently reported adverse events were abdominal pain and flatulence.
Full study results from this first published analysis of a phase 3
subcutaneous RELISTOR trial can be found in the current issue of the New
England Journal of Medicine (http://content.nejm.org).
About RELISTOR
RELISTOR was recently approved in the United States for the treatment
of opioid-induced constipation in patients with advanced illness who are
receiving palliative care, when response to laxative therapy has not been
sufficient. Use of RELISTOR beyond four months has not been studied.
RELISTOR has also been approved in Canada and received a positive opinion
from the Committee for Medicinal Products for Human Use (CHMP), the
scientific committee of the European Medicines Agency (EMEA). EMEA
regulatory action is pending.
Important Safety Information for 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 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 as well as the
treatment of HIV infection and cancer. The Company, in collaboration with
Wyeth, is developing RELISTOR 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 May 28, 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 Progenics is available at http://www.progenics.com.
Additional information on Wyeth is available at http://www.wyeth.com.
Additional information regarding RELISTOR is available at
http://www.relistor.com.
SOURCE Wyeth Pharmaceuticals
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Related links:
http://www.wyeth.com
http://content.nejm.org http://www.progenics.com
http://www.relistor.com
CONTACT:
Media Contact: Sal Foti, Wyeth
Pharmaceuticals +1-484-865-3490; Investor Contact: Justin
Victoria, Wyeth, +1-973-660-5340; or Progenics Pharmaceuticals,
Inc., Investor Contacts: 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
Contact: Aline Schimmel, WeissComm Partners +1-312-284-4706, for
Progenics Pharmaceuticals, Inc.
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