Biovail Corporation confirmed that GlaxoSmithKline (GSK) has exercised its option pursuant to the agreement between Biovail and GSK with respect to Wellbutrin XL (a once daily version of bupropion HCl). Biovail licensed worldwide (excluding Canada) sales and distribution rights to the product to GSK in October 2001. GSK intends to develop and register the product in the European Union (EU) and in certain other key Western, Central and East European markets, as well as in Asia, Latin America, the Middle East, Africa and certain other emerging world markets. Pursuant to the terms of the agreement, Biovail will manufacture the product to meet GSK's global supply requirements.
"This is a clear indication of GSK's confidence in the product's global potential," commented Eugene Melnyk, Biovail's chairman and CEO. "This commitment to world-wide commercialization of Wellbutrin XL includes on-going clinical research programs."
Upon successful completion of clinical studies, GSK intends to submit Marketing Authorization Applications for the product from 2006 onwards to secure as wide an approval as possible in EU and in certain other key Western, Central and East European markets.
GSK is currently reviewing its strategies with respect to registration and commercialization of the product in Latin America, Africa, Asia and other emerging markets. As the regulatory regimes in each of the geographic areas differ markedly, GSK is reviewing each jurisdiction in order to determine the optimum filing strategy in order to maximize the commercial value of the product.
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.