LAVAL, Quebec and
TARRYTOWN, N.Y., July 19, 2016 /CNW/ -- Valeant Pharmaceuticals
International, Inc. (NYSE & TSX: VRX) and Progenics
Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S.
Food and Drug Administration has approved RELISTOR®
(methylnaltrexone bromide) Tablets for the treatment of
opioid-induced constipation (OIC) in adults with chronic non-cancer
pain. Valeant expects to commence sales of RELISTOR Tablets in the
U.S. in the third quarter of 2016.
"Opioid-induced constipation represents a long-lasting and
potentially debilitating side effect of opioid therapy for millions
of patients suffering from chronic pain," commented Joseph C. Papa, Chief Executive Officer of
Valeant. "We believe Oral RELISTOR represents a new alternative
treatment for OIC, and we look forward to introducing the more
convenient oral formulation as soon as practicable."
"We are delighted that this milestone for RELISTOR has been
achieved, and that patients suffering from OIC will have this new
treatment option," said Mark Baker,
Chief Executive Officer of Progenics. "We expect the market to be
receptive to a more convenient oral tablet formulation of
RELISTOR's well-established subcutaneous preparation. We would like
to thank, in particular, Dr. Tage
Ramakrishna and Dr. Robert
Israel of Valeant for their work over many years in the
clinical development of RELISTOR."
"RELISTOR has a unique mechanism of action that binds to
mu-opioid receptors without impacting the opioid-mediated analgesic
effects on the central nervous system," said Richard L. Rauck, MD, Medical Director, Center
for Clinical Research, President, Carolinas Pain Institute,
President of the Sceptor Pain Foundation of which he is a founding
member, and Immediate Past President of the World Institute of
Pain. "This represents a true breakthrough in the treatment of OIC,
and addresses a large and growing need in the field of pain
management."
Today, the FDA approved RELISTOR Tablets (450 mg once daily) for
the treatment of OIC in adults with chronic non-cancer pain.
Previously, RELISTOR Subcutaneous Injection (12 mg and 8 mg) was
approved in 2008 for the treatment of OIC in adults with advanced
illness who are receiving palliative care and in 2014 for the
treatment of OIC in adults with chronic non-cancer pain.
About the Phase 3 Clinical Trial of Oral RELISTOR for OIC in
Chronic Non-Cancer Pain (NCP)
A randomized, double-blind, Phase 3 trial was conducted to
evaluate once-daily dosing of 450 mg (n=200) methylnaltrexone
(MNTX) tablets compared to placebo (n=201) in adults with chronic
NCP. In the 450 mg treatment arm, MNTX tablets demonstrated
statistically significant improvements in rescue-free bowel
movement (RFBM) within 4 hours of administration over 28 days of
dosing when compared to placebo treatment, achieving the primary
endpoint. The 450 mg treatment group also achieved statistical
significance for the first key secondary efficacy endpoint where a
higher percentage of responders (i.e., had ≥3 RFBMs/week, with an
increase of ≥1 RFBM/week from baseline for at least 3 of the 4
weeks) was observed with MNTX treatment as compared to placebo.
Overall, efficacy of oral methylnaltrexone in this study was
comparable to that reported in clinical studies of subcutaneous
methylnaltrexone in subjects with chronic, non-cancer pain. The
overall observed safety profile seen in patients treated with oral
methylnaltrexone was comparable to placebo in this study.
Important Safety Information about RELISTOR
RELISTOR® (methylnaltrexone bromide) Tablets 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 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
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 may contain projections and other
"forward-looking statements" regarding future events, including,
but not limited to statements respecting the anticipated timing of
the commenced of sales of Oral RELISTOR, the expected market
reaction to Oral RELISTOR and statements referring to Progenics' or
Valeant's estimated or anticipated future results or other
non-historical facts. Forward-looking statements reflect and our
based on Progenics' and Valeant's respective current beliefs,
expectations and perspectives on existing trends and information as
of the date of this communication. Forward looking statements
generally will be accompanied by words such as "anticipate,"
"believe," "plan," "could," "should," "would," "estimate,"
"expect," "forecast," "outlook," "guidance," "intend," "may,"
"might," "will," "possible," "potential," "predict," "project,"
"target," "continue" or other similar words, phrases or
expressions. Such statements are predictions only, and are subject
to certain risks and uncertainties that could cause actual events
or results to differ materially from those described
in the forward-looking statements. These risks and
uncertainties include the risk and uncertainties described on
Progenics' and Valeant's respective websites, and in their
respective press releases and reports filed with the U.S.
Securities and Exchange Commission and, in the case of
Valeant, the Canadian Securities Administrators, which risks
and uncertainties are incorporated herein by reference.
Readers are cautioned not to place undue reliance on any of
these forward-looking statements. Progenics and
Valeant are providing the information in this press release as of
its date and, except as expressly required by law, Progenics and
Valeant each disclaim any intent or obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or circumstances or otherwise.
Valeant Contacts:
Laurie W.
Little
laurie.little@valeant.com
or
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:
Melissa
Downs, Investor Relations
(914) 789-2801
mdowns@progenics.com
Logo -
http://photos.prnewswire.com/prnh/20101025/LA87217LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/valeant-and-progenics-announce-fda-approves-relistor-tablets-for-the-treatment-of-opioid-induced-constipation-in-adults-with-chronic-non-cancer-pain-300301032.html
SOURCE Valeant Pharmaceuticals International, Inc.