“Genzyme is appealing because of its multiple sclerosis drug Campath, which could reach the market in 2012, plus a cholesterol lowering treatment, mipomersen, which is in late-stage clinical trials.”
“The drug from Isis, called mipomersen, is in late-stage clinical testing.”
“SUNDAY, March 14 (HealthDay News) -- A new drug called mipomersen reduced low-density lipoprotein (LDL) "bad" cholesterol by nearly 25 percent when added to current therapy in people with a rare genetic condition that causes extremely high cholesterol, a new study finds.”
“Carlsbad, Calif., drug-development company Isis Pharmaceuticals and large-cap biotechnology company Genzyme, based in Cambridge, Mass., said data from a late-stage study of mipomersen, which treats a rare genetic disorder that elevates patients 'cholesterol levels and puts them at higher risk for heart problems, met its primary endpoint.”
“These are Campath for treating multiple sclerosis; mipomersen, in development with Isis Pharmaceuticals Inc. for a rare cholesterol-related disorder; and eliglustat, an oral treatment for Gaucher's disease.”
“In this case, Mr. Crooke, disappointed with the market response after releasing the Phase III results of mipomersen back in May, upped the volume by saying mipomersen represents the third “remarkable” drug he has developed.”
“Carlsbad, Calif. -based Isis Pharmaceuticals and large-cap Genzyme said their mipomersen drug cut bad cholesterol levels by 25% in a late-stage study of patients who have a rare genetic disorder.”
“In January, Isis licensed mipomersen to Genzyme, which will develop and commercialize it.”
“The companies initially plan to file for approval of mipomersen as a treatment for a rare genetic disease involving high cholesterol, known as homozygous familial hypercholesterolemia, or hoFH.”
“The companies updated the timeline for regulatory submission of the drug, mipomersen, after receiving FDA guidance on what would be required before the agency could approve it.”
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