NORTHVALE, N.J., May 24, 2010 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. announced today the acquisition of a currently approved Abbreviated New Drug Application (ANDA) for hydromorphone hydrochloride 8 mg tablets from Mikah Pharma LLC. The hydromorphone hydrochloride tablets are the generic equivalent of Dilaudid(R) 8 mg. The brand product and its generic equivalents had annual sales of approximately $28 million in 2009 and there are currently four other approved generic manufacturers plus the innovator. The transfer of the ANDA will begin immediately and Elite expects to begin manufacture of the product later in the year.
“This acquisition continues our strategy of leveraging the manufacturing expertise of the company into products that can generate positive cash flow to support our research activities. We hope to be able to announce other such product acquisitions in the future,” stated Elite Chairman and CEO Jerry Treppel.
About Elite Pharmaceuticals
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.
CONTACT: Elite Pharmaceuticals, Inc. Investor Relations Dianne Will 518-398-6222 Dianne@elitepharma.com
