Progenics Pharmaceuticals Announces Phase 2 Clinical Trial of Subcutaneous Methylnaltrexone in Japan by Ono Pharmaceutical
TARRYTOWN, N.Y.--(BUSINESS WIRE)--
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the
initiation of a phase 2 clinical trial of subcutaneous methylnaltrexone
in Japan by its collaborator, Ono Pharmaceutical Co., Ltd. (OSE-TYO:
4528). The drug, designated ONO-3849 in Japan, is being evaluated for
the treatment of opioid-induced constipation (OIC) in patients with
advanced illness such as cancer. Subcutaneous methylnaltrexone is
already marketed in the U.S. and in certain ex-U.S. markets under the
brand name RELISTOR®.
"Ono's commencement of this trial is an important step for the expansion
of the methylnaltrexone franchise into Japan," said Paul J. Maddon,
M.D., Ph.D., Progenics' Founder, Chief Executive and Chief Science
Officer. "Their work complements ours in the U.S., where we are planning
to submit a supplemental New Drug Application for subcutaneous RELISTOR
in chronic, non-cancer pain patients, and recently have initiated a
phase 3 study of oral RELISTOR."
Ono's phase 2, multi-center, randomized, double-blind,
placebo-controlled, parallel-group comparison study is designed to
demonstrate efficacy and safety of subcutaneous methylnaltrexone in
Japanese subjects.
About 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 over 50 countries worldwide,
including in the European Union, Canada, Australia and Brazil.
Applications in additional countries are pending. In the 27 member
states of the E.U., as well as Iceland, Norway and Liechtenstein,
RELISTOR is approved for the treatment of opioid-induced constipation in
advanced illness patients who are receiving palliative care when
response to usual laxative therapy has not been sufficient. In Canada,
the drug is approved for the treatment of opioid-induced constipation in
patients with advanced illness, receiving palliative care. When response
to laxatives has been insufficient, RELISTOR should be used as an
adjunct therapy to induce a prompt bowel movement. RELISTOR is the brand
name under which methylnaltrexone is marketed outside Japan by Wyeth, a
wholly-owned subsidiary of Pfizer.
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
-
Rare cases of gastrointestinal (GI) perforation have been reported in
advanced illness patients. Use RELISTOR with caution in patients with
known or suspected lesions of the GI tract
-
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%)
-
Safety and efficacy of RELISTOR have not been established in pediatric
patients
RELISTOR full Prescribing Information for the U.S. is available at www.relistor.com.
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 not been
sufficient. Use of RELISTOR beyond 4 months has not been studied.
About the Progenics-Ono Collaboration
Ono Pharmaceutical has an exclusive license from Progenics to the
subcutaneous form of methylnaltrexone (RELISTOR), designated ONO-3849 in
Japan, where it is developing and plans to commercialize the drug for
the treatment of opioid-induced constipation. Under their agreement, Ono
is responsible for conducting the clinical development necessary to
support regulatory marketing approval. Progenics received an upfront fee
for the license and is entitled to commercial and development
milestones, as well as royalties on sales of methylnaltrexone in Japan.
(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
gastroenterology, oncology and infectious diseases. Progenics is
developing RELISTOR® (methylnaltrexone bromide) for the
treatment of opioid-induced constipation. RELISTOR is now approved in
over 50 countries, including the U.S., E.U., Canada, Australia and
Brazil. Progenics is pursuing strategic options for RELISTOR, including
licensing, collaboration, strategic alliances and U.S. commercialization
or co-promotion, following termination of its 2005 collaboration with
Wyeth Pharmaceuticals, now a Pfizer Inc. subsidiary, which is continuing
manufacturing, sales, marketing, clinical, and certain development and
regulatory activities for RELISTOR during the transition. Ono
Pharmaceutical Co., Ltd. has an exclusive license from Progenics for
development and commercialization of subcutaneous RELISTOR in Japan. In
oncology, the Company is conducting a phase 1 clinical trial of PSMA
ADC, a human monoclonal antibody-drug conjugate for the treatment of
prostate cancer. PSMA is a protein found on the surface of prostate
cancer cells as well as in blood vessels supplying other solid tumors.
Progenics also is developing the viral-entry inhibitor PRO 140, a
humanized monoclonal antibody to inhibit human immunodeficiency virus
(HIV) infection, which is currently in phase 2 clinical testing. In
early development, Progenics is evaluating novel antibodies to toxins
produced by the bacterium C. difficile, as well as single-agent
multiplex PI3-Kinase inhibitors as a potential strategy to combat some
of the most aggressive forms of cancer, and is also seeking to identify
novel entry-inhibitors of HCV infection.
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; competing products
currently on the market or in development might reduce the commercial
potential of our products; 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; potential product liability; intellectual property, litigation,
environmental and other risks; the risk that we may not be able to enter
into favorable collaboration or other relationships or that existing or
future relationships may not proceed as planned; the risk that current
and pending patent protection for our products may be invalid,
unenforceable or challenged, or fail to provide adequate market
exclusivity, or that our rights to in-licensed 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.
Editors Note:
For more information, please visit www.progenics.com.
For
more information about RELISTOR, please visit www.RELISTOR.com.
Investors:
Progenics Pharmaceuticals, Inc.
Amy Martini,
914-789-2816
Corporate Affairs
amartini@progenics.com
or
Media:
Scienta
Communications
Aline Schimmel, 312-238-8957
aschimmel@scientapr.com
Source: Progenics Pharmaceuticals, Inc.
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