Elite Pharmaceuticals, Inc. Announces First Shipment of Generic Phentermine
NORTHVALE, N.J., April 11, 2013 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals,
Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced the initial
shipment of phentermine HCl capsules 15 mg and 30 mg under the License,
Manufacturing and Supply Agreement with its sales and marketing partner,
triggering a milestone payment. Elite's sales and marketing partner will
distribute the product as part of a multi-product distribution agreement.
Phentermine is a member of the bariatric class of drugs intended to aid in
weight loss. For the twelve months ending December 31, 2012, Adipex-P® 15 mg
and 30 mg and its generic equivalents had total U.S. sales of approximately
$2.5 million and $5 million respectively according to IMS Health Data. U.S.
sales of this product are thought to be greater than the IMS data due to its
distribution through channels that are not included in IMS data.
"Elite has successfully launched another product line, this one encompassing
two dose strengths. Management remains dedicated to enhancing shareholder
value by expanding our generic portfolio of products, continuing the
development of our abuse-resistant opioid line of products, enhancing our
intellectual property, and strengthening the balance sheet," commented Jerry
Treppel, Elite's Chairman and CEO.
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 five commercial products currently being sold, an
additional product approved and soon to be launched, and one additional
product 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 Actavis and Ascend Laboratories
(previously a subsidiary of ThePharmaNetwork and now 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
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, 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 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
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