TORONTO (BW HealthWire) – Biovail Corporation International (NYSE:BVF)(TSE:BVF) today announced that it has acquired under license the exclusive rights to market Ampligen(R) in Canada from Hemispherx Biopharma, Inc. (AMEX:HEB) in return for an initial undertaking by Biovail to purchase approximately $2 million in Hemispherx common shares from treasury. Crystaal plans to submit to the TPP in the near future a new drug submission seeking marketing approval for Ampligen in the treatment of Chronic Fatigue Immune Deficiency Syndrome (CFIDS), also known as Myalgic Encephalomyelitis (ME).
Approximately 50,000 Canadians suffer from CFIDS, which is a severely debilitating and complex disorder for which no specific and effective treatment is available in Canada. Ampligen is currently available in Canada under the Emergency Drug Release Program. Ampligen is being clinically evaluated in a confirmatory large phase III trial for CFIDS and the new drug submission will be submitted to the TPP upon completion of certain tests. Other potential uses for Ampligen include the treatment of AIDS, Hepatitis B and Renal Cell Carcinoma. Ampligen will be marketed by Crystaal, Biovail’s Canadian marketing division.
Crystaal, a division of Biovail, is engaged in the registration, marketing and distribution of branded pharmaceutical products developed by Biovail or acquired from third parties worldwide. Crystaal also promotes Brexidol(R), Tiazac(R), Retavase(R), Cardiac STATus(TM), and co-promotes Celexa(R) in Canada.
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies.
“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995.
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPP 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, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company’s filings with the U.S. Securities and Exchange Commission.
Contact: Biovail Corporation Eugene Melnyk or Kenneth G. Howling, 416/285-6000