Isis, Genzyme submit European MAA for mipomersen to treat familial hypercholesterolemia

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that Genzyme has submitted a marketing authorization application (MAA) to the European Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for the treatment of homozygous and severe heterozygous familial hypercholesterolemia.

"This MAA submission is another significant step in the development of mipomersen," said Vice President and General Manager of Genzyme's Cardiovascular Business, Paula Soteropoulos. "We also look forward to our upcoming U.S. regulatory submission later this year, as these submissions move us closer to our goal of making mipomersen available to patients who are in the greatest need of new treatments."

Genzyme and Isis also announced today that, if the necessary approvals are granted, mipomersen would be marketed under the brand name Kynamro^®, the registered name that has been submitted to health authorities for the investigational agent.

"Mipomersen has the potential to change the management of patients with homozygous and severe heterozygous familial hypercholesterolemia," said Chairman and CEO of Isis Pharmaceuticals, Stanley T. Crooke. "We are excited by the progress we are making with Genzyme on this important development program, which demonstrates the promise of antisense technology to meet unmet medical needs."

Source: Genzyme