WOODCLIFF LAKE, N.J., Sept. 14 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. , today announced that its development partner BioAlliance Pharma SA presented Phase III study results for miconazole Lauriad(R) mucoadhesive buccal tablets (MBT) that demonstrate noninferiority to clotrimazole troches for oropharyngeal candidiasis (OPC), an opportunistic infection of the mouth and throat. The data from this study, the largest study to date conducted in OPC, were presented in an oral presentation to attendees at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. More than 10,000 physicians, researchers and other healthcare professionals from around the globe gather each year at ICAAC to foster worldwide solutions to the problem of infectious diseases.
Miconazole MBT -- which delivers the antifungal miconazole via a mucoadhesive buccal tablet designed to enable once-daily dosing of the active ingredient at the site of infection -- is currently undergoing review by the U.S. Food and Drug Administration (FDA). If approved, Strativa, the exclusive U.S. distributor of miconazole MBT under a licensing agreement with BioAlliance Pharma SA, could make miconazole MBT available in the U.S. in the second half of 2010. While approved in 12 countries and marketed in several EU territories under the trade name Loramyc(R), miconazole MBT would be the first miconazole oral therapy available in the U.S.
OPC, also known as thrush, is an oral fungal infection most common in individuals with weakened immune systems -- particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.
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.
Safe Harbor Statement
Certain statements in this news 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 known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in Item 1A of the Company's subsequent Quarterly Reports on Form 10-Q, in other of the Company's filings with the SEC from time to time, including Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news 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.
Par Pharmaceutical Companies, Inc.