LAVAL, Quebec and TARRYTOWN, N.Y., April
24, 2015 /CNW/ -- Valeant Pharmaceuticals International,
Inc. (NYSE: VRX) (TSX: VRX) and Progenics
Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that
the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) has adopted a
positive opinion recommending a new indication for
RELISTOR® (methylnaltrexone bromide) Subcutaneous
Injection for the treatment of opioid-induced constipation (OIC)
when response to laxative therapy has not been sufficient in adult
patients, aged 18 years and older. Additionally, the Committee has
recommended a one-year extension of data/marketing protection for
RELISTOR, to 11 years from the date of approval, citing the fact
that RELISTOR offers a major contribution to patient care in
comparison to existing therapies.
The CHMP is responsible for reviewing medicinal product
applications for safety, quality and efficacy. The CHMP's positive
opinion on RELISTOR will be reviewed by the European Commission,
which has the authority to approve medicines for the European
Union. The final decision will be applicable to all 28 European
Union member countries plus Iceland and Norway. If approved, it is anticipated that
RELISTOR will be immediately available to this newly expanded
population of patients in the EU using opioids to control chronic
non-cancer pain.
"The positive CHMP opinion brings RELISTOR one step closer to
providing a treatment for the millions of patients in Europe who suffer from debilitating
constipation while taking opioids for chronic non-cancer pain,"
said Mark Baker, Chief Executive
Officer of Progenics. "RELISTOR offers a meaningful benefit to
patients who are unable to manage their constipation with less
effective laxative therapies."
Tage Ramakrishna, M.D., Chief
Medical Officer of Valeant, added, "Today's positive opinion
recognizes the clinical benefit of RELISTOR, which treats the
underlying cause of OIC without interfering with the centrally
acting analgesic properties of the opioid. We are committed to
realizing the full potential of this important franchise, and if
approved, we will work quickly to bring this needed medicine to
European patients."
About RELISTOR
Progenics has exclusively licensed development and
commercialization rights for its first commercial product,
RELISTOR, to Salix Pharmaceuticals, Ltd., a Valeant Pharmaceuticals
International, Inc. company. RELISTOR (methylnaltrexone bromide)
Subcutaneous Injection is a first-in-class treatment for
opioid-induced constipation approved in the United
States for patients with chronic non-cancer pain, and in the
U.S. and more than 50 other countries for patients with advanced
illness.
Important Safety Information about RELISTOR
RELISTOR® (methylnaltrexone bromide)
Subcutaneous Injection is contraindicated in patients with known or
suspected gastrointestinal obstruction and patients at increased
risk of recurrent obstruction, due to the potential for
gastrointestinal perforation.
Cases of gastrointestinal perforation have been reported in
adult patients with opioid-induced constipation and advanced
illness with conditions that may be associated with localized or
diffuse reduction of structural integrity in the wall of the
gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's
syndrome, diverticular disease, infiltrative gastrointestinal tract
malignancies or peritoneal metastases). Take into account the
overall risk-benefit profile when using RELISTOR in patients with
these conditions or other conditions which might result in impaired
integrity of the gastrointestinal tract wall (e.g., Crohn's
disease). Monitor for the development of severe, persistent, or
worsening abdominal pain; discontinue RELISTOR in patients who
develop this symptom.
If severe or persistent diarrhea occurs during treatment, advise
patients to discontinue therapy with RELISTOR and consult their
physician.
Symptoms consistent with opioid withdrawal, including
hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and
yawning have occurred in patients treated with RELISTOR.
Patients having disruptions to the blood-brain barrier may be at
increased risk for opioid withdrawal and/or reduced analgesia. Take
into account the overall risk-benefit profile when using RELISTOR
in such patients. Monitor for adequacy of analgesia and symptoms of
opioid withdrawal in such patients.
Avoid concomitant use of RELISTOR with other opioid antagonists
because of the potential for additive effects of opioid receptor
antagonism and increased risk of opioid withdrawal.
RELISTOR may precipitate opioid withdrawal in a fetus and should
be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus. In nursing mothers, a decision
should be made to discontinue nursing or discontinue the drug,
taking into account the importance of the drug to the mother.
In the clinical study in adult patients with opioid-induced
constipation and chronic non-cancer pain, the most common adverse
reactions (> 1%) were abdominal pain, nausea, diarrhea, and
hyperhidrosis, hot flush, tremor, and chills.
In clinical studies in adult patients with opioid-induced
constipation and advanced illness, the most common adverse
reactions (> 5%) were abdominal pain, flatulence, nausea,
dizziness, and diarrhea.
Please see complete Prescribing Information for
RELISTOR.
For more information about RELISTOR, please visit
www.relistor.com.
About the Companies
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX)
is a multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, eye health, neurology and
branded generics. More information about Valeant Pharmaceuticals
International, inc. can be found
at www.valeant.com.
Progenics Pharmaceuticals, Inc. is developing innovative
medicines for oncology, with a pipeline that includes several
product candidates in later-stage clinical development. Progenics'
first-in-class PSMA-targeted technology platform for prostate
cancer includes an antibody drug conjugate therapeutic which
completed a two-cohort phase 2 clinical trial and a small molecule
imaging agent that has also completed a phase 2 trial. Among other
assets in its pipeline of targeted radiotherapy and molecular
imaging compounds is Azedra™, an ultra-orphan
radiotherapy candidate currently in a phase 2 study under an SPA.
Progenics' first commercial product,
RELISTOR® (methylnaltrexone bromide) for
opioid-induced constipation, is partnered with and marketed by
Salix Pharmaceuticals, Ltd., a Valeant Pharmaceuticals
International, Inc. company. For additional information, please
visit www.progenics.com.
PROGENICS DISCLOSURE NOTICE: This press release may contain
projections and other forward-looking statements regarding future
events. Such statements are predictions only, and are subject to
risks and uncertainties that could cause actual events or results
to differ materially. These risks and uncertainties include, among
others, the cost, timing and results of clinical trials and other
development activities; the unpredictability of the duration and
results of regulatory review of New Drug Applications and
Investigational NDAs; market acceptance for approved products; the
sales of products by our partners and the royalty revenue generated
thereby; generic and other competition; the possible impairment of,
inability to obtain and costs of obtaining intellectual property
rights; and possible safety or efficacy concerns, general business,
financial and accounting matters, litigation and other risks. More
information concerning Progenics and such risks and uncertainties
is available on its website, and in its press releases and reports
it files with the U.S. Securities and Exchange Commission.
Progenics is providing the information in this press release as of
its date and does not undertake any obligation to update or revise
it, whether as a result of new information, future events or
circumstances or otherwise.
Additional information concerning Progenics and its business
may be available in press releases or other public announcements
and public filings made after this release. For more information,
please visit www.progenics.com. Please follow us
on LinkedIn®.
Information on or accessed through our website or social
media sites is not included in the company's SEC filings.
Forward-looking Statements
This press release may contain forward-looking statements,
including, but not limited to, statements regarding the positive
opinion from CHMP, the recognition of the clinical benefit of
RELISTOR, the approval of RELISTOR, and the potential to bring this
product to European patients. Forward-looking statements may
generally be identified by the use of the words "anticipates,"
"expects," "intends," "plans," "should," "could," "would," "may,"
"will," "believes," "estimates," "potential," "target," or
"continue" and variations or similar expressions. These statements
are based upon the current expectations and beliefs of management
of Valeant and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those
described in the forward-looking statements. These risks and
uncertainties include the risks and uncertainties discussed in
Valeant's most recent annual or quarterly report and detailed from
time to time in Valeant's other filings with the Securities and
Exchange Commission (the "SEC") and the Canadian Securities
Administrators, which factors are incorporated herein by reference.
Readers are cautioned not to place undue reliance on any of these
forward-looking statements. These forward-looking statements speak
only as of the date hereof. Valeant undertakes no obligation
to update any of these forward-looking statements to reflect events
or circumstances after the date of this press release or to reflect
actual outcomes.
Editor's Note:
Additional information on Valeant is available at
http://www.valeant.com.
Additional information on Progenics is available at
http://www.progenics.com.
Valeant
Contact:
|
Laurie W.
Little
Investor Relations
(949)
461-6002
laurie.little@valeant.com
|
|
|
|
|
Progenics
Contact:
|
Melissa
Downs
Investor
Relations
(914)
789-2801
mdowns@progenics.com
|
|
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SOURCE Valeant Pharmaceuticals International, Inc.