Genzyme and Isis - Billion-dollar deals

Maureen Martino — Wed, 23 Jul 2008 08:33:10 -0400

Who: Genzyme
With: Isis Pharmaceuticals
What: $1.9 billion deal

Scoop: Genzyme agreed to fork over up to $1.9 billion for rights to Isis Pharmaceutical's flagship program mipomersen, a cholesterol drug candidate. The company reportedly survived a bidding war for the drug that involved 10 companies. Mipomersen blocks a gene that opens the gate to cholesterol in the blood. It's now about to enter Phase III trials after posting some impressive data for lowering bad cholesterol.

Cholesterol drug delay signals new FDA standards

Mon, 28 Apr 2008 06:59:58 -0400

In what may signal a major shift in FDA standards, Isis and Genzyme say that they expect to add another year to the development timeline for a closely watched cholesterol therapy in order to produce data demonstrating a reduced risk of heart attacks and related diseases rather than just an ability to lower levels of cholesterol. Researchers for the two companies say they now plan to file for approval in 2010. Shares of both companies were hurt by the announcement, with Isis shares dropping 29 percent Friday.

Genzyme agreed to buy $150 million of Isis shares and provide $175 million in a large upfront fee last January. The two companies planned to file for approval of mipomersen as a therapy targeted against a rare genetic disease. The decision, though, could have a wide ranging impact on drug developers if the FDA will no longer approve a drug based simply on its ability to lower cholesterol. And that could be a direct result of the brouhaha over data showing that Vytorin--while effective in lowering cholesterol--was no better than a generic in preventing thickening of the arteries.

- see this Genzyme/Isis release
- read the story in the Wall Street Journal