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Strativa Pharmaceuticals, the Proprietary Products Division of Par Pharmaceutical, Provides an Update on Development Status of Pafuramidine and Other in-Licensed Products
Date:12/28/2007

status. At that time, Immtech and the independent experts in liver toxicity will prepare a summary of the available safety data and recommendations for presentation to the FDA. The clinical hold may be released after FDA has received satisfactory data regarding the safety of pafuramidine.

In return for the commercialization rights to pafuramidine, Par paid Immtech an initial payment of $3 million, which Par incurred as Research & Development (R&D) expense in 2007. Should pafuramidine advance through its ongoing Phase III clinical trials and U.S. regulatory review and approval, Par will pay Immtech up to $29 million in development milestones.

Loramyc(R) (miconazole Lauriad(R)) for the treatment of oropharyngeal candidiasis:

In July 2007, Par Pharmaceutical, Inc. entered into an exclusive licensing agreement under which Par received commercialization rights in the U.S. to BioAlliance Pharma's Loramyc(R) (miconazole Lauriad(R)). Loramyc(R) is an innovative antifungal therapy in Phase III development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer.

Loramyc(R), which received marketing authorization in France in October 2006, is an antifungal delivered in a mucoadhesive buccal tablet, enabling an early and extended release of the active ingredient at the site of infection, with once-daily dosing.

Patient enrollment has been completed in the pivotal Phase III clinical trial intended to support U.S. registration. Trial results are expected in the first half of 2008 and a new drug application is expected to be submitted to FDA in the second half of 2008.

In return for the commercialization rights to Loramyc(R), Par paid BioAlliance an initial payment of $15 million, which Par incurred as R&D expense in 2007. Upon FDA approval of the product, Par will also pay BioAlliance $20 million. In addition to royalties on sales, BioAll
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SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2007 PR Newswire.
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