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Strativa Pharmaceuticals Announces Phase III Results for Loramyc(R) to Treat Oropharyngeal Candidiasis
Date:4/21/2008

WOODCLIFF LAKE, N.J., April 21 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its development partner, BioAlliance Pharma reported preliminary, top-line results for a Phase III study of Loramyc(R) (miconazole Lauriad(R)) mucoadhesive buccal tablets, in the treatment of oropharyngeal candidiasis (OPC).

Top line data show that Loramyc(R) achieved its primary endpoint of noninferiority to Mycelex(R) Troche (clotrimazole)* in the complete resolution of signs and symptoms of OPC (complete clinical cure). The randomized, double-blind, double-dummy study was conducted in 577 HIV-positive patients in 40 sites in the United States, Canada, and South Africa. All secondary endpoints were also met.

Loramyc(R), which is approved in Europe and currently being marketed in France, is an antifungal delivered in a mucoadhesive buccal tablet designed to enable local once-daily dosing of the active ingredient at the site of infection.

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)). In return for the commercialization rights to Loramyc(R), Par paid BioAlliance an initial payment of $15 million, which Par incurred as a research and development (R&D) expense in 2007. Upon FDA approval of the product, Par will also pay BioAlliance $20 million. In addition to royalties on sales, BioAlliance may receive milestone payments on future sales.

John MacPhee, president of Strativa Pharmaceuticals, said, "We are pleased with the results of this trial. There is a significant need fo
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SOURCE Par Pharmaceutical Companies, Inc.
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