Strativa Pharmaceuticals, a Division of Par Pharmaceutical, Announces the Discontinuation of the Development Program for Pafuramidine
WOODCLIFF LAKE, N.J., February 25, 2008 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. today announced that its development partner, Immtech Pharmaceuticals, Inc. has chosen to discontinue the development program for pafuramidine maleate, an investigative therapy.
On February 22, 2008, Immtech announced that it had received additional reports of adverse events related to abnormal kidney function that resulted in hospitalization of several volunteers from the ongoing safety study. These events occurred more than 60 days after subjects received pafuramidine. Kidney biopsy results have been interpreted as being consistent with drug- induced hypersensitivity and inflammation. The affected safety study volunteers are receiving full follow-up monitoring and medical care.
After receiving recommendations from the Data Safety Monitoring Board, the Steering Committee for the pneumocystis pneumonia (PCP) study and others, and in consultation with the US Food and Drug Administration (FDA) and Immtech's licensing partners, including Strativa, Immtech has chosen to discontinue the development program for pafuramidine.
Previously, Strativa had acquired commercialization rights in the U.S. to the Phase III oral drug candidate for the treatment of PCP in AIDS patients for $3 million, which was incurred as Research & Development (R&D) expense in 2007. In light of Immtech's discontinuation of the pafuramidine development program, no further payments are due to Immtech from Strativa under the commercialization agreement.
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Supported by Par's financial and organizational capabilities including substantial cash resources, Strativa Pharmaceuticals is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for introduction and to help ensure their success after launch. For additional information, please visit www.strativapharma.com
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com
Immtech Pharmaceuticals, Inc. is focused on developing and commercializing drugs to treat infectious diseases. Immtech has a well defined, expanding library of compounds targeting drug-resistant Gram-positive bacteria, fungal infections, Hepatitis C and other serious diseases. Immtech holds exclusive worldwide licenses to certain patents, patent applications and technology for products derived from a proprietary pharmaceutical platform. For additional information, visit http://www.immtechpharma.com
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Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and, as such, are subject to risks and uncertainties, including the extent and impact of litigation arising out of the accounting issues described in the Company's filings with the Securities and Exchange Commission (SEC), the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against the Company, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the company's filings with the SEC, such as the Company's reports on Form 10-K, Form 10-Q and Form 8-K, and amendments thereto. Any forward-looking statements included in this press release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
CONTACT: Allison Wey, Senior Director, Investor Relations and CorporateAffairs of Par Pharmaceutical Companies, Inc., +1-201-802-4000
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Posted: February 2008