Elite Pharmaceuticals Announces Manufacturing and License Agreement for Twelve
NORTHVALE, N.J., Oct. 8, 2013 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc.
("Elite" or the "Company") (OTCBB:ELTP) announced today the signing of a
Manufacturing and License Agreement ("Agreement") with Epic Pharma, LLC
("Epic"). Pursuant to the Agreement, Epic will have the right to manufacture,
market and sell in the United States and Puerto Rico twelve generic products
owned by Elite. Of the twelve products, Epic will have the exclusive right to
market six products and the non-exclusive right to market six additional
products. Epic is also responsible for all regulatory and pharmacovigilance
matters related to the products and for all costs related to the site transfer
for all products. Pursuant to the Agreement, Elite will receive a license fee
and milestone payments. The license fee will be computed as a percentage of
the gross profit, as defined in the Agreement, and earned by Epic as a result
of sales of the products. The license fee is payable monthly for the term of
the Agreement. The first milestone payment is due on or before November 15,
2013. Subsequent milestone payments are due upon the filing of each product's
supplement with the U.S. Food and Drug Administration ("FDA") and the FDA
approval of site transfer for each product as specifically itemized in the
agreement. The term of the License Agreement is 5 years and may be extended
for an additional 5 years upon mutual agreement.
"We are delighted that Elite elected to further develop our partnership by
awarding this licensing agreement to Epic for these recently acquired
products. This is a natural extension of our ongoing collaboration with Elite
and allows Elite to leverage Epic's ability to manufacture on a large scale,"
said Jeenarine Narine, President and COO of Epic.
Nasrat Hakim, President and CEO of Elite, stated, "Epic continues to be a
valuable partner to us. Epic is able to provide significant manufacturing
resources for making these large volume products and this will allow Elite to
maximize our profit potential for our generic business while we devote our
resources to the development of our abuse resistant products utilizing our
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release
products. Elite's strategy includes improving 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 approved products licensed to our partner Epic Pharma and 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 oral formulations of opioids for the treatment of
acute and chronic pain, which address the limitations of existing oral opioids
including 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 Mikah Pharma to develop a new product, 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: For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Elite Pharmaceuticals, Inc Logo
Press spacebar to pause and continue. Press esc to stop.