Tuesday, Strativa Pharmaceuticals, the propreitary products division of Par Pharmaceutical Companies Inc. (PRX), announced that the U.S Food and Drug Administration or FDA has accepted the new drug application, or NDA, for miconazole Lauriad mucoadhesive buccal tablets for treatment of oropharyngeal candidiasis, or OPC, commonly known as oral thrush.
The NDA for the drug was earlier rejected by FDA, and Bio Alliance Pharma SA, the license holder of miconazole Lauriad under the trade name Loramyc in Europe, resubmitted the NDA in June.
BioAlliance Pharma SA has an agreement with Strativa for exclusive U.S. distribution of its miconazole MBT. Strativa would pay BioAlliance $20 million as well as a royalty on future net sales after approval by the FDA. BioAlliance may also be entitled to receive milestone payments if net sales achieve specified targets.
Miconazole MBT delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection, the company said.
John MacPhee, president of Strativa Pharmaceuticals said "The NDA acceptance of miconazole MBT represents a significant milestone for Strativa Pharmaceuticals as this would be the first oral miconazole therapy available in the U.S. and would provide healthcare providers with a new option for treating OPC."
Oropharyngeal candidiasis is an oral infection, common with HIV/AIDS and those undergoing cancer treatments. OPC causes lesions and inflammation in the mouth.
Miconazole MBT is approved in 11 countries, and if approved in the US, Strativa could launch miconazole MBT in the second half of 2010.
While releasing its full-year results, BioAlliance's President and CEO Dominique Costantini had said, "At the end of the full first year of Loramyc sales in France, we can see that our first marketed product is integrating well into prescribing habits and expert recommendations. Loramyc has been administered to nearly 20,000 patients and consolidated sales have reached the symbolic €1 million threshold."
PRX is currently trading at $20.59, up 3.74% on NYSE.
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