Genzyme has entered into a $325 million licensing deal with Isis Pharmaceuticals to commercialize mipomersen, Isis' lipid-lowering treatment for high-risk cardiovascular patients.
Mipomersen is in Phase III clinical trials for the treatment of familial hypercholesterolemia, a genetic disease that inhibits the body's ability to metabolize low-density lipoprotein cholesterol.
About 10,000 people worldwide have the condition, which can cause heart attacks in patients as young as nine-years-old. Isis expects to file for approval of the drug in 2009, the companies said in a statement.
“We had interest from many large companies and small companies,” Isis CEO Stanley Crooke said in a Bloomberg News report. “We're going to target this product to a select group of physicians and patients, and Genzyme is perfect for that. It's what they do for a living.”
Genzyme will pay Isis $150 million to purchase five million shares of Isis common stock for $30 per share. Upon completion of final contracts, Genzyme will pay Isis a $175 million up-front mipomersen license fee. In addition to this initial $325 million, Isis has the potential to receive significant milestone payments for mipomersen. Once the product is launched, the two companies will share profits.
After the drug is approved for familial hypercholesterolemia, the companies hope to gain expanded approval for about 10 million patients who have one malfunctioning copy of the gene, Crooke added.
Mipomersen pricing will be based on “appropriate value for patients with an unmet medical need,” Crooke added.
Genzyme is known for selling some of the world's most expensive medicines for rare genetic disorders.