Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for AZEDRA® (iobenguane I 131) in Pheochromocytom...
30 December 2017 - 12:30AM
Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company
developing innovative medicines and imaging analytical tools for
targeting and treating cancer, announced today that the U.S.
Food and Drug Administration (FDA) has accepted for review the
New Drug Application (NDA) for AZEDRA® in patients with
malignant, recurrent and/or unresectable pheochromocytoma and
paraganglioma, which are rare neuroendocrine tumors.
The FDA granted Progenics’ request for Priority
Review and has set an action date of April 30, 2018 under
the Prescription Drug User Fee Act (PDUFA).
“With no FDA-approved therapies for these rare
tumors, AZEDRA has the potential to address the high unmet need of
patients with malignant pheochromocytoma and paraganglioma,” said
Mark Baker, Chief Executive Officer of Progenics. “We are pleased
that the FDA has accepted our NDA with Priority Review, and look
forward to working with the Agency during the review process.
At the same time, we will continue to lay the groundwork for our
commercial plan and prepare to launch quickly following a potential
approval.”
The NDA is supported by data from a pivotal
phase 2b open-label, multi-center trial that was conducted under a
Special Protocol Assessment (SPA) with the FDA. The trial met the
primary endpoint evaluating the proportion of pheochromocytoma and
paraganglioma patients who achieved a 50% or greater reduction of
all antihypertensive medication for at least six months, and showed
favorable results from a key secondary endpoint evaluating the
proportion of patients with overall tumor response as measured by
Response Evaluation Criteria In Solid Tumors (RECIST). AZEDRA was
also shown to be safe and generally well tolerated.
About AZEDRA®
AZEDRA (iobenguane I 131) is a
high-specific-activity radiotherapeutic product candidate in
development as a treatment for malignant, recurrent, or
unresectable pheochromocytoma and paraganglioma, which are rare
neuroendocrine tumors of neural crest origin. AZEDRA is a
substrate for norepinephrine reuptake transporter which is highly
expressed on the cell surface of neuroendocrine tumors.
AZEDRA has been granted Orphan Drug designation, Fast Track status,
and Breakthrough Therapy designation in the U.S. Under a SPA
agreement with the FDA, a phase 2b pivotal study has been completed
in patients with malignant, recurrent, or unresectable
pheochromocytoma and paraganglioma. There are currently no
FDA-approved therapies for the treatment of this ultra-rare
disease.
About Pheochromocytoma and
Paraganglioma
Pheochromocytoma and paraganglioma are rare
neuroendocrine tumors that arise from cells of the autonomic
nervous system. Pheochromocytoma forms in the adrenal medulla,
whereas paragangliomas form outside the adrenal gland. Standard
treatment options for these tumors include surgery, palliative
therapy and symptom management. Pheochromocytoma and paraganglioma
tumors frequently secrete high levels of hormones that can lead to
life-threatening hypertension, heart failure, and stroke in these
patients. Malignant and recurrent pheochromocytoma and
paraganglioma may result in unresectable disease with a poor
prognosis, representing a significant management challenge with
very limited treatment options and no approved anti-tumor
therapies.
About Progenics
Progenics develops innovative medicines and
other technologies to target and treat cancer. Progenics' pipeline
includes: 1) therapeutic agents designed to precisely target cancer
(AZEDRA® and 1095), 2) PSMA-targeted imaging agents for prostate
cancer (1404 and PyL™), and 3) imaging analysis tools. Progenics'
first commercial product, RELISTOR® (methylnaltrexone bromide)
for opioid-induced constipation, is partnered with 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 the Phase 3
clinical program for 1404; our ability to successfully develop and
commercialize the products of EXINI Diagnostics AB; the
unpredictability of the duration and results of regulatory review
of New Drug Applications (NDA) and Investigational NDAs, including
our NDA for AZEDRA and related inspections of Progenics’ and its
contract manufacturing organizations’ facilities and other sites
and other requirements that will need to be met before any approval
is obtained; 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, regulatory 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, including those risk factors included in
its Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2017, as updated in its Quarterly Report on
Form 10-Q for the quarterly period ended June 30, 2017.
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. Information on or accessed
through our website or social media sites is not included in the
company's SEC filings. AZEDRA is a registered trademark
of Progenics Pharmaceuticals, Inc. Other trademarks are the
property of their respective owners.
(PGNX-F)
Contact:
Melissa Downs Investor Relations (646) 975-2533
mdowns@progenics.com
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