LAVAL, Quebec, Sept. 6, 2016 /PRNewswire/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX)
("Valeant") and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX)
("Progenics") today announced the U.S. commercial launch of
RELISTOR® (methylnaltrexone bromide) Tablets, which is
now available for prescribing. RELISTOR Tablets (450 mg once daily)
were approved by the U.S. Food and Drug Administration (FDA)
for the treatment of opioid-induced constipation (OIC) in adults
with chronic non-cancer pain on July 19,
2016.
"We are very pleased to launch RELISTOR Tablets in the U.S. and
provide an exceptional new treatment option for the millions of
patients who suffer from extreme discomfort due to OIC," said
Joseph C. Papa, Chief Executive
Officer of Valeant. "This new method of delivery for RELISTOR
offers healthcare professionals a novel alternative to address the
treatment of OIC – a growing need in pain management – and
demonstrates Valeant's continued commitment to delivering
innovative products that improve people's lives."
In addition, RELISTOR Tablets will be highlighted during poster
presentations at PAINWeek, the largest U.S. pain conference for
frontline clinicians, in Las Vegas,
Nevada, from September 6-10.
The posters will include the following:
- Webster LR, Harper JR, Israel RJ. "Oral methylnaltrexone is
efficacious and well tolerated for the treatment of opioid-induced
constipation in patients with chronic noncancer pain taking
concomitant methadone." PAINWeek Poster, public viewing
begins on Thursday, September 8 at
12:30 p.m. PT.
- Webster LR, Harper JR, Israel RJ. "Oral methylnaltrexone does
not negatively impact analgesia in patients with opioid-induced
constipation and chronic noncancer pain." PAINWeek Poster, public
viewing begins on Thursday, September
8 at 12:30 p.m. PT.
The RELISTOR Tablets data will also be presented by Steven Simon, M.D., Professor of Pathology,
University of Miami Health System,
during a product theatre, "Opioid-Induced Constipation When
Reliable and Rapid Relief Matters," on Friday, September 9 at 8
a.m. PT.
Important Safety Information about RELISTOR
RELISTOR® (methylnaltrexone bromide) Tablets are
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 OIC 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
healthcare provider.
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.
The most common adverse reactions (≥ 12%) in adult
patients with opioid-induced constipation and chronic non-cancer
pain receiving RELISTOR tablets were abdominal pain, diarrhea,
headaches, abdominal distention, hyperhidrosis, anxiety, muscle
spasms, rhinorrhea, and chills. Adverse reactions of abdominal
pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may
reflect symptoms of opioid withdrawal.
Please see complete Prescribing Information for RELISTOR at
www.valeant.com. For more information about RELISTOR, please visit
www.relistor.com.
About RELISTOR
Progenics has exclusively licensed
development and commercialization rights for its first commercial
product, RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily)
is approved in the United States
for the treatment of OIC in patients with chronic non-cancer
pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a
treatment for opioid-induced constipation approved in the United States and worldwide for patients
with advanced illness and chronic non-cancer pain.
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, gastrointestinal disorders, eye health, neurology and
branded generics. More information about Valeant can be found at
www.valeant.com.
Progenics Pharmaceuticals, Inc. is developing innovative
medicines and other products for targeting and treating cancer,
with a pipeline that includes several product candidates in
later-stage clinical development. These products in development
include therapeutic agents designed to precisely target cancer
(AZEDRA® and 1095), and PSMA-targeted
imaging agents for prostate cancer (1404 and
PyLTM) intended to enable clinicians and patients
to accurately visualize and manage their disease. Progenics
recently entered into an agreement with a subsidiary of Bayer AG
granting Bayer exclusive worldwide rights to develop and
commercialize products using our PSMA antibody technology in
combination with alpha-emitting radionuclides. In addition,
in late 2015 Progenics acquired EXINI Diagnostics AB, a leader in
the development of advanced artificial intelligence-based imaging
analysis tools and solutions for medical decision support. The
acquisition of EXINI complements Progenics' strategy to support its
imaging and therapeutic agents with sophisticated analytical tools
and other technologies to help physicians and patients visualize,
understand, target and treat cancer. Progenics' first
commercial product,
RELISTOR® (methylnaltrexone bromide) for
opioid-induced constipation, is partnered with and marketed by
Valeant Pharmaceuticals International, Inc. Additional
information on Progenics is available
at http://www.progenics.com.
Forward-looking Statements
This press release
contains forward-looking statements. 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 and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those
described in the forward-looking statements. 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. Neither Valeant nor Progenics undertakes any
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, unless required by
law. Additional information concerning Valeant and
Progenics and such risks and uncertainties is available on their
respective websites, and in the press releases and reports filed
with the U.S. Securities and Exchange Commission and, in the
case of Valeant, with the Canadian Securities
Administrators.
Valeant Contact Information:
Elif McDonald
elif.mcdonald@valeant.com
514-856-3855
877-281-6642 (toll free)
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
Progenics Contact Information:
Melissa Downs, Investor
Relations
(646) 975-2533
mdowns@progenics.com
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SOURCE Valeant Pharmaceuticals International, Inc.