Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced
that its collaborator, Ono Pharmaceutical Co., Ltd., Osaka, Japan
(OSE-TYO: 4528) has begun clinical testing in Japan of RELISTOR�
(methylnaltrexone bromide) subcutaneous injection, the
first-in-class medicine approved in the U.S., Canada, the European
Union, Australia and Latin American countries for the treatment of
opioid-induced constipation. Ono has exclusive rights to
subcutaneous RELISTOR in Japan, where it is pursuing plans to
develop and commercialize the drug, designated ONO-3849, for the
treatment of opioid-induced constipation. RELISTOR is being
developed and commercialized in the rest of the world by Progenics
and Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE).
ONO-3849 is being developed in Japan according to the regulatory
agency guidelines of Japan�s Ministry of Health, Labor and Welfare,
and will be evaluated in Japanese patients with opioid-induced
constipation.
�Our collaboration with Ono exemplifies Progenics� corporate
strategy of maximizing market access to RELISTOR through key
geographic development and commercialization partnerships,� said
Paul J. Maddon, M.D., Ph.D., Progenics� Founder, Chief Executive
Officer and Chief Science Officer. �We believe the advancement of
RELISTOR into clinical studies in Japan demonstrates a shared
commitment of both organizations to providing patients in Japan who
suffer from opioid-induced constipation access to this
first-in-class product, if approved.�
In October of last year, Progenics announced an agreement by
which Ono has rights in Japan to the subcutaneous form of RELISTOR,
and is responsible for developing and commercializing subcutaneous
RELISTOR in Japan, including conducting the clinical development
necessary to support regulatory marketing approval. Under the
agreement, Progenics received an upfront fee, and is entitled to
commercial and development milestones, as well as royalties on
sales of RELISTOR in Japan.
About Subcutaneous RELISTOR
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.
In April of 2008, the U.S. Food and Drug Administration approved
RELISTOR 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. The use of RELISTOR beyond four months has not
been studied. RELISTOR is now approved in over 30 countries,
including the U.S., Canada, the European Union, Latin American
countries and Australia. 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 U.S. clinical trials were
abdominal pain, flatulence, and nausea.
- Full RELISTOR Prescribing
Information for the U.S. is available at www.relistor.com.
About the Progenics-Wyeth Worldwide Collaboration
Commercial sales of subcutaneous RELISTOR under the
Progenics-Wyeth collaboration began last year in the United States,
Canada and Europe following regulatory approvals in each of these
regions. RELISTOR is currently approved for use in over 30
countries.
(PGNX-G)
About the Company
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. RELISTOR is currently approved in over 30 countries, which
include approvals in the U.S., Canada and Australia, Latin American
countries, as well as all European Union member 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 a phase 1 clinical trial
with a vaccine designed to treat prostate cancer by stimulating an
immune response to PSMA.
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 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.
Editors Note:
For more information about Progenics Pharmaceuticals, Inc.,
please visit www.progenics.com.
For more information about RELISTOR, please visit
www.RELISTOR.com.
Additional information on Ono is available at
http://www.ono.co.jp/eng/default.htm.
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