Elite Pharmaceuticals Announces Supplemental Application for Site Transfer of Isradipine
March 24 2014 - 8:00AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP)
today announced that on March 21, 2014, the Company filed a Changes
Being Effected in 30 Days (CBE-30) supplemental application with
the U.S. Food and Drug Administration (FDA) for the site transfer
of manufacturing for Isradipine 2.5 mg and 5 mg tablets to Elite's
Northvale facility.
Isradipine is one of the twelve products that Elite acquired
from Mikah and licensed to Epic Pharma ("Epic") last
year. Elite has agreed to manufacture the product for Epic as
covered under the Manufacturing and License Agreement between the
two companies. Epic will distribute the product as part of the
multi-product distribution agreement. The timing of site
approval is dependent on the FDA, and no assurances can be given
that the site approval will be received in 30 days.
Isradipine is a calcium channel blocker prescribed for
hypertension. Annual U.S. sales for immediate release
Isradipine tablets are approximately $6 million
annually. Currently there is only one other generic product
marketed in the U.S.
"Isradipine is the first of twelve approved ANDA's that Elite
intends to launch along with our partner, Epic Pharma," said Nasrat
Hakim, President and CEO of Elite. "While Elite's
primary strategic focus is the development and approval of our
abuse deterrent products, Elite expects to continue to grow its
generic product line revenue over time. We expect to announce
additional supplemental filings later this year."
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and
controlled release products. Elite's strategy includes assisting
partner companies in the life cycle management of products to
improve off-patent drug products and developing generic versions of
controlled release drug products with high barriers to entry. Elite
has seven commercial products currently being sold, twelve
additional approved products pending manufacturing site
transfer and two additional products under review pending approval
by the FDA. Elite's lead pipeline products include abuse
resistant opioids utilizing the Company's patented proprietary
technology, and a once-daily opioid. They are sustained
release oral formulations of opioids for the treatment of chronic
pain, which address two of the limitations of existing oral
opioids: the provision of consistent relief of baseline pain levels
and deterrence of potential abuse. Elite also provides
contract manufacturing for Ascend Laboratories (a subsidiary of
Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the
manufacturing and distribution of eleven approved products pending
manufacturing site, with Hi-Tech Pharmacal to develop an
intermediate for a generic product, and a Hong Kong based company
to develop a branded product for the United States market and its
territories. Elite operates a GMP and DEA registered facility
for research, development, and manufacturing located in Northvale,
NJ.
This news release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Including those related to the effects, if any, on future
results, performance or other expectations that may have some
correlation to the subject matter of this press release, readers
are cautioned that such forward-looking statements involve risks
and uncertainties including, without limitation, its ability to
obtain FDA approval of the transfers of the ANDAs or the timing of
such approval process, delays, uncertainties, inability to obtain
necessary ingredients and other factors not under the control of
Elite, which may cause actual results, performance or achievements
of Elite to be materially different from the results, performance
or other expectations that may be implied by these forward-looking
statements. These risks and other factors, including, without
limitation, the Company's ability to obtain sufficient funding
under the LPC Agreement or from other sources, the timing or
results of pending and future clinical trials, regulatory reviews
and approvals by the Food and Drug Administration and other
regulatory authorities, intellectual property protections and
defenses, and the Company's ability to operate as a going concern,
are discussed in Elite's filings with the Securities and Exchange
Commission, including its reports on forms 10-K, 10-Q and 8-K.
Elite undertakes no obligation to update any forward-looking
statements.
CONTACT: Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
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