Progenics Pharmaceuticals Completes Submission of NDA for AZEDRA® (iobenguane I 131) in Pheochromocytoma and Paraganglioma
November 02 2017 - 7:45AM
Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company
developing innovative medicines and imaging analytical tools for
targeting and treating cancer, announced today that it has
completed the rolling submission of its New Drug Application (NDA)
for AZEDRA® in patients with malignant, recurrent and/or
unresectable pheochromocytoma and paraganglioma, which are rare
neuroendocrine tumors.
AZEDRA has received Breakthrough Therapy, Orphan
Drug and Fast Track designations from the FDA. There are currently
no approved therapeutics in the U.S. for the treatment of
malignant, recurrent, and/or unresectable pheochromocytoma or
paraganglioma. The NDA remains subject to FDA regulatory
review and approval.
“The completion of our NDA submission marks a
significant milestone for Progenics and our AZEDRA development
program,” said Mark Baker, Chief Executive Officer of Progenics.
"If approved, AZEDRA has the potential to address a significant
unmet need in pheochromocytoma and paraganglioma, an ultra-orphan
indication.”
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) criteria.
AZEDRA was also shown to be safe and generally well tolerated.
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, recurrent, and/or unresectable pheochromocytoma and
paraganglioma. There are currently no FDA-approved therapies
for the treatment of these ultra-orphan diseases.
About Pheochromocytoma and
Paraganglioma
Pheochromocytoma and paraganglioma are rare
neuroendocrine tumors that arise from cells of the autonomic
nervous system. When pheochromocytomas are located outside the
adrenal glands, they are called paragangliomas. 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
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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
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and other risks. More information concerning Progenics and such
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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
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(PGNX-F)
Contact:
Melissa Downs Investor Relations (646) 975-2533
mdowns@progenics.com
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