Tuesday, October 06, 2009

2010-11 flu season to see Afluria® vaccine marketed by extensive Merck field network in U.S.

CSL Biotherapies and its parent company, CSL Limited, one of the world's leading manufacturers of influenza vaccine, announced an agreement with Merck & Co., Inc. on rights to market and distribute Afluria® in the United States under an exclusive, six-year agreement.

Afluria, a CSL product, is a non-adjuvanted trivalent seasonal influenza vaccine sold in two different formulations: thimerosol-free, pre-filled syringes, and in multi-dose vials.

Merck will have the exclusive right to sell and distribute Afluria in the United States beginning with the 2010-11 seasonal influenza season. The manufacture, filling and packaging of Afluria will continue and will not change with this agreement; CSL Ltd. will retain the Afluria license.

"We are pleased to have reached this important agreement with Merck," said Paul R. Perreault, President of CSL Biotherapies U.S. "CSL is committed to providing influenza vaccine to the United States and we are now able to leverage Merck's extensive field network in meeting that commitment and in making Afluria available to many more people in the U.S. next flu season. This is yet another milestone in our companies' shared history of close collaboration and tru innovation in the area of vaccine development and distribution."

For the past several years, CSL and Merck have partnered together successfully in bringing Gardasil® to market in Australia and i other areas of the southern hemisphere. Merck markets Gardasil, a cervical cancer vaccine, and delivers royalties to CSL, which holds a key intellectual property patent on that product. The CSL Group, which includes CSL Biotherapies, has a combined heritage of outstanding contribution to medicine and human health with more than 90 years experience in the development and manufacture of vaccines and plasma protein biotherapies.

Afluria was approved by the U.S. FDA in September 2007 for active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria.

While Afluria represents CSL's first entry into the U.S. vaccine market, CSL-branded influenza vaccines are licensed in 27 countries worldwide. The company also provides bult antigen for influenza vaccine sold in 24 countries.

The CSL Group, which includes CSL Biotherapies, CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 10,000 employees and operates in 27 countries worldwide.

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