Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced
submission of a supplemental New Drug Application (sNDA) to the
United States (U.S.) Food and Drug Administration (FDA) and an
Extension Application to the European Union (E.U.) European
Medicines Agency (EMEA) for RELISTOR® (methylnaltrexone bromide)
subcutaneous injection for a new delivery system, pre-filled
syringes. RELISTOR was approved last year in single-use vials.
RELISTOR 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
been insufficient. If approved, pre-filled syringes of RELISTOR are
expected to be available in the U.S. and Europe as early as the
first half of 2010. Single-use vials of RELISTOR will continue to
be available.
“The development of RELISTOR in pre-filled syringes is an
important step in our plans to make this medication available in
more convenient forms,” says Paul J. Maddon, M.D., Ph.D., Founder,
Chief Executive Officer and Chief Science Officer, Progenics
Pharmaceuticals, Inc. “Pre-filled syringes, containing either 8 mg
or 12 mg doses of RELISTOR, will be ready-to-use, and will ease
preparation and administration for patients and caregivers.”
About Opioids, Constipation and RELISTOR (methylnaltrexone
bromide)
Opioid analgesics are frequently prescribed to manage pain in
palliative-care patients with advanced illness. Constipation
commonly occurs in these patients. RELISTOR is the first approved
medication that specifically targets the underlying cause of
OIC.
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
RELISTOR subcutaneous injection is approved in the United States
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. The drug is also approved for use in the European
Union, Canada, Australia, as well as several countries in Latin
America. Applications in additional countries are also 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 reported with RELISTOR compared with placebo in clinical
trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs.
5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea
(5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%).
RELISTOR full Prescribing Information for the U.S. is available
at www.relistor.com.
About the Collaboration Between Wyeth Pharmaceuticals
and Progenics
Progenics and Wyeth Pharmaceuticals in 2005 entered into an
exclusive, worldwide agreement for the joint development and
commercialization of methylnaltrexone for the treatment of
opioid-induced side effects The pending acquisition of Wyeth by
Pfizer Inc. does not trigger any change-of-control provisions in
the Progenics/Wyeth collaboration.
(PGNX-C)
About Progenics
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
supportive care, 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. Wyeth has worldwide rights to develop and commercialize
all forms of RELISTOR, except in Japan where Progenics has granted
Ono Pharmaceutical Co., Ltd. an exclusive license to the
subcutaneous form of RELISTOR for development and commercialization
in that country. RELISTOR is currently approved in over 30
countries, including the U.S. and E.U. member countries, Canada,
Australia, and several Latin American countries. In the U.S.,
RELISTOR 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. Marketing applications are pending
for RELISTOR in other countries. In the area of virology, Progenics
is developing the HIV-entry inhibitor PRO 140, a humanized
monoclonal antibody which binds to co-receptor CCR5 to inhibit HIV
entry. PRO 140 is currently in phase 2 clinical testing for the
treatment of HIV infection. The Company also has an HCV discovery
program to identify novel inhibitors of viral entry. In the area of
oncology, the Company is conducting a phase 1 clinical trial of a
human monoclonal antibody-drug conjugate (ADC) for the treatment of
prostate cancer—a selectively targeted chemotherapeutic 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
conducting phase 1 clinical trials with vaccines designed to treat
prostate cancer by stimulating an immune response to PSMA.
Editor’s Note: For more information about Progenics
Pharmaceuticals, Inc., please visit www.progenics.com.
PROGENICS DISCLOSURE NOTICE: This document contains
statements that do not relate strictly to historical fact, any of
which may be forward-looking statements within the meaning of the
U.S. Private Securities Litigation Reform Act of 1995. When we use
the words “anticipates,” “plans,” “expects” and similar
expressions, we are identifying forward-looking statements.
Forward-looking statements involve known and unknown risks and
uncertainties which may cause our actual results, performance or
achievements to be materially different from those expressed or
implied by forward-looking statements. While it is impossible to
identify or predict all such matters, these differences may result
from, among other things, the inherent uncertainty of the timing
and success of, and expense associated with, research, development,
regulatory approval and commercialization of our products and
product candidates, including the risks that clinical trials will
not commence or proceed as planned; products appearing promising in
early trials will not demonstrate efficacy or safety in
larger-scale trials; clinical trial data on our products and
product candidates will be unfavorable; our products will not
receive marketing approval from regulators or, if approved, do not
gain sufficient market acceptance to justify development and
commercialization costs; we, our collaborators or others might
identify side effects after the product is on the market; or
efficacy or safety concerns regarding marketed products, whether or
not originating from subsequent testing or other activities by us,
governmental regulators, other entities or organizations or
otherwise, and whether or not scientifically justified, may lead to
product recalls, withdrawals of marketing approval, reformulation
of the product, additional pre-clinical testing or clinical trials,
changes in labeling of the product, the need for additional
marketing applications, declining sales or other adverse
events.
We are also subject to risks and uncertainties associated with
the actions of our corporate, academic and other collaborators and
government regulatory agencies, including risks from market forces
and trends, such as those relating to the recently-announced
acquisition of our RELISTOR® collaborator, Wyeth Pharmaceuticals by
Pfizer Inc.; potential product liability; intellectual property,
litigation, environmental and other risks; the risk that licenses
to intellectual property may be terminated for our failure to
satisfy performance milestones; the risk of difficulties in, and
regulatory compliance relating to, manufacturing products; and the
uncertainty of our future profitability.
Risks and uncertainties also include general economic
conditions, including interest and currency exchange-rate
fluctuations and the availability of capital; changes in generally
accepted accounting principles; the impact of legislation and
regulatory compliance; the highly regulated nature of our business,
including government cost-containment initiatives and restrictions
on third-party payments for our products; trade buying patterns;
the competitive climate of our industry; and other factors set
forth in our Annual Report on Form 10-K and other reports filed
with the U.S. Securities and Exchange Commission. In particular, we
cannot assure you that RELISTOR will be commercially successful or
be approved in the future in other formulations, indications or
jurisdictions, or that any of our other programs will result in a
commercial product.
We do not have a policy of updating or revising forward-looking
statements and we assume no obligation to update any statements as
a result of new information or future events or developments. It
should not be assumed that our silence over time means that actual
events are bearing out as expressed or implied in forward-looking
statements.
About Wyeth
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 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 these applications will receive regulatory
approval or that RELISTOR will be commercially successful
or 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, among others, risks
related to our proposed merger with Pfizer, including satisfaction
of the conditions of the proposed merger on the proposed timeframe
or at all, contractual restrictions on the conduct of our business
included in the merger agreement, and the potential for loss of key
personnel, disruption in key business activities or any impact on
our relationships with third parties as a result of the
announcement of the proposed merger; 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;
the outcome of government investigations; 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; global economic conditions; interest and currency
exchange rate fluctuations and volatility in the credit and
financial markets; 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, 2008, which was filed with the
Securities and Exchange Commission on February 27, 2009. 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.
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