Healthcare Industry News: Lauriad
News Release - July 3, 2007
Par Pharmaceutical Licenses U.S. Commercialization Rights to Loramyc(TM) From BioAlliance PharmaInnovative Antifungal in Phase III Development to Treat Oropharyngeal Candidiasis, an Opportunistic Infection in Immunocompromised Patients
Aimed at Expanding Par's Portfolio of Supportive Care Products
WOODCLIFF LAKE, N.J., July 3 (HSMN NewsFeed) -- Par Pharmaceutical Companies, Inc. (NYSE: PRX ) today announced it has entered into an exclusive licensing agreement under which Par will receive commercialization rights in the U.S. to BioAlliance Pharma's Loramyc (miconazole Lauriad®), an innovative antifungal therapy currently in Phase III development for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer.
Under the agreement, BioAlliance will receive an initial payment of $15 million. Par will also pay BioAlliance $20 million upon FDA approval. In addition to royalties on sales, BioAlliance may receive milestone payments on future sales.
Loramyc, 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 the infection, with once-daily dosing.
The ongoing pivotal Phase III trial for Loramyc involves 540 patients at 40 sites in the U.S., Canada and South Africa.
John A. MacPhee, president of Par's Branded Products Division, said: "We believe our collaboration with BioAlliance will lead to an important treatment option. It also advances Par's strategy to build a portfolio specifically addressing supportive care, and we will continue to look for additional products that leverage our existing commercial presence in specialty markets."
Dominique Costantini, CEO of BioAlliance said: "Par is the ideal partner for Loramyc commercialization in the U.S., with a sales force dedicated to supportive care and a product portfolio in which Loramyc will represent an important addition. This major milestone for patients and the medical community is also an important step for our company and its shareholders, delivered in due time."
Par Pharmaceutical Companies, 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.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the development of innovative therapeutics targeting drug resistance in cancer, HIV and opportunistic infections. For press release and other company information, visit www.bioalliancepharma.com.
Safe Harbor Statement
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 issue described in this and prior public announcements, including the lawsuit brought against the company by the trustee for the company's Senior Subordinated Convertible Notes seeking an accelerated payment of the $200 million of principal of and accrued interest on the notes or, in the alternative, damages, 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 Securities and Exchange Commission (SEC), such as the company's reports on Form 10-K, Form 10-Q, and Form 8-K, and amendments thereto. The company can make no assurance as to the potential effects of the restatement, including the effects of any investigations, informal or otherwise, conducted by the SEC, or other entities, or lawsuits filed against the company in connection therewith. Any forward-looking statements included in this press release are made as of the date here of 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.
Source: Par Pharmaceutical
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