First Drug for Opioid-Induced Constipation to Launch
in United States
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that
the U.S. Food and Drug Administration (FDA) has approved RELISTORâ„¢ (methylnaltrexone bromide) subcutaneous injection 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 clinical studies, RELISTOR significantly decreased
the constipating effects of opioids without interfering with pain
relief. Wyeth expects to make RELISTOR available in the United States in
early June.
"The approval of RELISTOR is a transformative
event for Progenics Pharmaceuticals," says
Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief
Science Officer, Progenics Pharmaceuticals, Inc. "This
is our first U.S. product approval. I am proud of what our Company has
achieved and especially want to thank our patients and investigators who
participated in the RELISTOR development program. This program has
greatly benefited from our collaboration with Wyeth to develop and
commercialize the RELISTOR platform of products."
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. Many of these patients
are prescribed opioids to manage their pain, and
experts have stated that constipation that can be debilitating occurs in
practically all of them.
"We are pleased to make RELISTOR available to
patients to address this serious unmet medical need," says Bernard Poussot, President and Chief Executive Officer, Wyeth. "As
Wyeth´s third new medicine to receive FDA
approval in 2008, RELISTOR is an excellent example of Wyeth´s
continuing commitment to develop and deliver medicines that work in
novel ways and provide important new treatment options for patients."
Jay Thomas, M.D., Ph.D., an investigator in the subcutaneous RELISTOR
clinical trial program and Clinical Medical Director of San Diego
Hospice and the Institute of Palliative Medicine, says: "Opioid
analgesics are the mainstay therapy for pain management in
advanced-illness patients receiving palliative care. Side effects
associated with opioids, such as constipation, can be severe enough to
limit pain management. I am pleased that we now have a new treatment
option to provide relief to advanced-illness patients with OIC."
About RELISTOR and Opioids
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
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. The efficacy and safety
profile of RELISTOR was established in two phase 3 clinical trials. Use
of RELISTOR beyond four months has not been studied.
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 will be 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 for the treatment of
opioid-induced side effects. In accordance with the terms of the
collaboration, this U.S. marketing approval triggers a $15 million
milestone payment to Progenics from Wyeth.
(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 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 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 Progenics available at http://www.progenics.com
Additional information on Wyeth available at http://www.wyeth.com
