Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced today that
it has received a $50 million milestone payment from its worldwide
collaboration partner, Valeant Pharmaceuticals International, Inc.
(NYSE:VRX), resulting from the US Food and Drug Administration's
marketing approval last week of RELISTOR® Tablets for the treatment
of opioid-induced constipation in adults with chronic non-cancer
pain.
“We are pleased that our partner Valeant can now
offer RELISTOR in a more convenient tablet form to patients in
need,” said Mark Baker, Chief Executive Officer of Progenics. “This
and other sales milestone payments that we may receive from sales
of RELISTOR provide an important source of non-dilutive financing
for our Company as we approach topline, registrational data on
AZEDRA® and advance our diverse pipeline of prostate cancer imaging
agents and therapeutics.”
Under a 2011 collaboration with Salix
Pharmaceuticals, Inc. (acquired by Valeant in April 2015),
Progenics is also entitled to receive up to $200 million of sales
milestone payments based on specified U.S. sales targets. The sales
milestone payments range from $10 million when calendar-year U.S.
net sales first exceed $100 million, to $75 million when such sales
first exceed $1 billion. Each sales milestone payment is payable
one time only, and one or more, or all, sales milestones could
become payable within the same calendar year if the specified sales
levels are met. Progenics also earns tiered royalties on total
RELISTOR U.S. net sales, as follows: 15% on U.S. net sales up to
$100 million, 17% on the next $400 million in U.S. net sales, and
19% on U.S. net sales over $500 million. Outside of the U.S.
Progenics is entitled to receive 60% of any up-front milestone,
royalty and other revenue, net of certain costs, as specified in
our license agreement with Valeant.
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.
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 Progenics
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.
This press release may contain projections and
other "forward-looking statements" regarding future events.
Statements contained in this communication that refer to Progenics'
estimated or anticipated future results or other non-historical
facts are forward-looking statements that reflect Progenics'
current perspective of 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," "estimate," "expect," "forecast,"
"outlook," "guidance," "intend," "may," "might," "will,"
"possible," "potential," "predict," "project," or other similar
words, phrases or expressions. 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
unpredictability of results of clinical trials and other
development activities and collaborations, such as our
collaboration with Valeant on the RELISTOR oral formulation and the
Phase 3 clinical program for 1404; our ability to successfully
integrate EXINI Diagnostics AB and to develop and commercialize its
products; the unpredictability of the duration and results of
regulatory review of New Drug Applications and Investigational
NDAs; market acceptance for approved products; the effectiveness of
the efforts of our partners to market and sell products on which we
collaborate and the royalty revenue generated thereby; generic and
other competition; the possible impairment of, inability to obtain
and costs of obtaining intellectual property rights; possible
product 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, except as expressly required by law, Progenics
disclaims 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.
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.
(PGNX-F)
Contact:
Melissa Downs
Investor Relations
(914) 789-2801
mdowns@progenics.com
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