Elite Pharmaceuticals Announces First Shipment of Generic Phendimetrazine
NORTHVALE, N.J., Nov. 15, 2012 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc.
("Elite") (OTCBB:ELTP) announced today the initial shipment of Phendimetrazine
tartrate 35 mg tablets, the generic equivalent of Bontril PDM® 35 mg tablets
under the previously announced manufacturing and supply agreement with Mikah
Pharma ("Mikah"). Actavis, Inc. ("Actavis"), recently acquired by Watson
Pharmaceuticals Inc. ("Watson"), will distribute the product as part of a
distribution agreement between Mikah and Actavis.
Bontril PDM and its generic equivalents had total U.S. sales of approximately
$3.5 million for the twelve months ending September 2012 based on IMS Health
Data. Elite will be compensated at an agreed upon price for the manufacturing
and packaging of the product.
"The manufacture of PDM by Elite for Mikah and its subsequent distribution by
Actavis/Watson represents another example of the Company's strategy for
enhancing our generic pipeline and cash flow," commented Jerry Treppel,
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 three commercial products being sold through a
partner, two products produced for partners under contract manufacturing
agreements, two additional products approved and pending launch, and two
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
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.
The Elite Pharmaceuticals, Inc. logo is available at
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
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
CONTACT: For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Elite Pharmaceuticals, Inc Logo
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