Elite Pharmaceuticals, Inc. Announces Second Closing of Strategic Alliance
Agreement With Epic Pharma
NORTHVALE, N.J., Nov. 5, 2009 (GLOBE NEWSWIRE) -- On October 30, 2009, Elite
Pharmaceuticals, Inc. ("Elite") (OTCBB:ELTP) completed the second closing of the
Strategic Alliance Agreement (the "Alliance") with Epic Pharma, LLC and Epic
Investments, LLC, a wholly-owned subsidiary of Epic Pharma, LLC (collectively
"Epic") pursuant to the terms in the Alliance entered into on March 18, 2009 and
previously disclosed.
Under this Alliance, Epic and its employees and consultants are using and will
continue to use a portion of the Registrant's facility located at 165 Ludlow
Avenue, Northvale, New Jersey (the "Facility"), for the purpose of developing
new generic drug products at Epic's cost and expense, other than Facility
related expenses. Under the Alliance (i) at least eight additional generic drug
products will be developed by Epic at Elite's facility with the intent of filing
abbreviated new drug applications for obtaining United States Food and Drug
Administration ("FDA") approval of such generic drugs, (ii) Elite will be
entitled to 15% of the profits generated from the sales of such additional
generic drug products upon approval by the FDA, and (iii) Epic and Elite will
share with each other certain resources, technology and know-how in the
development of drug products, which Elite believes will benefit the continued
development of its current drug products. Epic will also be entitled to receive
additional shares of Elite's Common Stock and warrants to purchase shares of
Elite's Common Stock upon achievement of certain milestones relating to the
eight additional generic drug products being developed together.
In order to provide Elite with the additional capital necessary for the product
development and synergies presented by the strategic relationship with Epic,
Epic agreed to invest $3.75 million in Elite through the purchase of Elite's
Series E Preferred Stock and common stock warrants. In the October 30 closing,
Epic invested the first $1.0 million of this total amount, and acquired 1,000
shares of Series E Preferred Stock, which is presently convertible into 20
million shares of common stock.
Epic representatives also hold three seats on the board of directors of Elite.
Those Directors were approved by a majority vote of the outstanding shares of
Elite stock at the annual meeting of stockholders held on October 23, 2009.
Elite's board of directors consists of a total of seven directors
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. Two of Elite's products, Lodrane 24(r) and Lodrane 24D(r), are marketed
by a partner, ECR Pharmaceuticals, for allergy treatment. Elite's lead pipeline
products are novel sustained release oral formulations of oxycodone 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. Both products, ELI-216, a once-daily abuse
resistant oxycodone, and ELI-154, a once-daily oxycodone, are in late-stage
development. Elite, with partners, also has an ANDA filed with the FDA for a
generic equivalent of a pain product and has a generic gastrointestinal drug
product in clinical development. Elite operates a GMP and DEA registered
facility for research, development, and manufacturing located in Northvale, NJ.
This news release contains forward-looking statements, including those related
to the preliminary nature of the clinical program results and the potential for
further product development, that involve known and unknown risks, delays,
uncertainties and other factors not under the control of Elite, which may cause
actual results, performance or achievements of the companies to be materially
different from the results, performance or other expectations implied by these
forward-looking statements. In particular, because substantial future testing
will be required prior to approval, the results described above may not be
supported by additional data or by the results of subsequent trials. These risks
and other factors, including the timing or results of pending and future
clinical trials, regulatory reviews and approvals by the Food and Drug
Administration and other regulatory authorities, and intellectual property
protections and defenses, are discussed in Elite's filings with the Securities
and Exchange Commission such as the 10-K, 10-Q and 8-K reports. Elite undertakes
no obligation to update any forward-looking statements.
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CONTACT: Elite Pharmaceuticals, Inc.
Investor Relations
Dianne Will
518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
