Oscient Pharmaceuticals Corporation's commercialization partner for Factive (gemifloxacin mesylate) tablets with European pharmaceutical company Menarini Group, has submitted a regulatory filing seeking approval of Factive in Europe.
Menarini, with broad sales and marketing coverage throughout Europe and expertise in research and clinical development, has the fourth largest pharmaceutical sales force in Europe and is second largest in terms of calls to primary care physicians.
"Menarini's pursuit of marketing approval for Factive in Europe is an important step in our commercialization plan for Factive in our licensed territories," stated Steven M Rauscher, president and chief executive officer of Oscient Pharmaceuticals. "Menarini is a strong, experienced partner, and we look forward to working together to build the Factive brand in Europe".
Menarini is seeking approval of Factive for the treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis. The regulatory review time in Europe is approximately 12 months.
Oscient granted commercialization rights to Menarini for Factive in Europe last year. The oral antibiotic market in Europe is estimated at $5 billion, with France, Germany, Italy and Spain representing the largest markets. Oscient licenses the rights to commercialize Factive in North America and Europe from LG Life Sciences. In 2006, Oscient forged partnerships for the commercialization of the drug in Mexico and Canada.
The Menarini Group is a privately owned pharmaceutical company headquartered in Florence, Italy. Menarini employs approximately 13,000 people, with a strong presence in Western and Eastern Europe, Asia and Central America. In addition to advancing products through internal research and development, Menarini has strong experience in seeking regulatory approval and marketing in-licensed products from a large number of pharmaceutical companies.