Progenics Pharmaceuticals Provides Update on Timing of NDA Submission for AZEDRA®
August 31 2017 - 4:05PM
- All Sections of New Drug Application (NDA) Have
Been Submitted to the FDA, Except Notification of Pre-Approval
Inspection Readiness -
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company
developing innovative medicines and other products for targeting
and treating cancer, today announced that it has been notified by
its third-party vendor that the commercial drug product
manufacturing facility for AZEDRA
® requires more
time to prepare for pre-approval inspection by the U.S. Food and
Drug Administration (FDA). As a result, after consultation
with the FDA, Progenics has decided to postpone the finalization of
the New Drug Application (NDA) until the manufacturing site is
inspection-ready. The manufacturer has indicated it will need
up to a few months to complete this work. Under a rolling
submission, Progenics has submitted all portions of the NDA to the
FDA, except for the notification of pre-approval inspection
readiness.
“We are committed to filing a high-quality
application for AZEDRA and I believe that postponing the completion
of the submission to permit the manufacturer time to prepare for
their inspection is a worthwhile investment. Our interactions
with the FDA on the AZEDRA rolling submission continue to be
positive and productive. We understand that this delay could be up
to eight to twelve weeks, and we look forward to providing an
update as our manufacturer advances through their pre-approval
inspection work,” said Mark Baker, Chief Executive Officer of
Progenics. “This delay is unrelated to the manufacturing process
for AZEDRA, which is robust and has been validated. This
delay is also unrelated to the quality of the data we have
generated for AZEDRA, which we believe demonstrate the potential of
this much-needed therapy to deliver significant and meaningful
clinical benefit to patients with malignant, recurrent, and/or
unresectable pheochromocytoma and paraganglioma.”
Data from the pivotal Phase 2b study of AZEDRA,
including new data for key secondary endpoints, will be presented
at the 5th International Symposium on Pheochromocytoma and
Paraganglioma in Sydney, Australia on September 1, 2017 at 10:30
a.m. Eastern Australia Time. The data will be highlighted
during an oral presentation entitled “AZEDRA® (iobenguane I 131) in
Patients with Malignant and/or Recurrent and/or Unresectable
Pheochromocytoma or Paraganglioma: Final Results of a Multi-Center,
Open-Label, Pivotal Phase 2b Study”.
About AZEDRA®
AZEDRA® (iobenguane I-131), a radiotherapeutic
product candidate in development as a treatment for malignant
and/or recurrent pheochromocytoma and paraganglioma, rare tumors
found in the adrenal glands and outside of the adrenal glands,
respectively. AZEDRA® has been granted Breakthrough Therapy and
Orphan Drug designations, as well as Fast Track status in the U.S.
Under a SPA agreement with the U.S. Food and Drug Administration
(FDA), a Phase 2 pivotal study has been completed in patients with
malignant and/or recurrent and/or unresectable pheochromocytoma and
paraganglioma. There are currently no FDA-approved therapies
for the treatment of these ultra-orphan diseases.
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
OIC, 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, including our clinical
trials for AZEDRA and our other product candidates 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
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(PGNX-F)
Contact:
Melissa Downs
Investor Relations
(646) 975-2533
mdowns@progenics.com
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