PHARMA: Isis CEO says Genzyme, Sanofi deal good for Isis drug
Crooke is confident mipomersen partnership will continue
PHARMA: Isis CEO says Genzyme, Sanofi deal good for Isis drug
By BRADLEY J. FIKES - bfikes@nctimes.com North County Times - The Californian | Posted: Wednesday, February 16, 2011 4:23 pm
CARLSBAD ---- Genzyme Corp. and Sanofi-Aventis made it official Wednesday: After months of rumors and negotiations, Genzyme has agreed to be purchased by the French drug giant in an all-cash deal for $20.1 billion.
Watching from the sidelines and apparently pleased were executives of Isis Pharmaceuticals Inc., which is in a partnership with Cambridge, Mass.-based Genzyme to develop mipomersen, Isis' flagship cholesterol and lipid-lowering drug.
Isis CEO Stanley T. Crooke said he's convinced Sanofi will continue that partnership, and enhance it with Sanofi's marketing muscle.
"We believe, from everything we've been told, that Sanofi is quite committed to mipomersen," Crooke said. "In the end, that added scale and extra funding will be very good in our view for the launch and continued development of mipomersen."
Crooke declined to specify whether Isis had directly heard from Sanofi officials.
Developing mipomersen is extremely important to Isis, which has only one drug approved by regulators. That drug, Vitravene, treats an AIDS-related viral infection that causes blindness. It never became a big seller.
Mipomersen could yield $1.9 billion for Isis under terms of its partnership with Genzyme, which paid $175 million up-front plus $150 million for 5 million shares of stock. If successful, the drug would also be confirmation that Isis' gene-blocking technology, called antisense, can produce useful, profitable drugs.
Damian Conover, an analyst who covers Sanofi, was also optimistic about mipomersen's future.
"I think it's an important drug," Conover said.
However, Sanofi is most concerned now with completing plans to manufacture Genzyme's drugs for rare diseases, said Conover, with the Chicago-based research company Morningstar.
Once the manufacturing is taken care of, Sanofi will turn its attention to Genzyme's pipeline of drugs in testing, Conover said.
Mipomersen is far along in the pipeline. Genzyme plans to file for European approval to treat familial hypercholesterolemia in the first half of this year, the company said Wednesday in its fourth-quarter earnings statement. The disease causes very high levels of LDL, or "bad" cholesterol, associated with high risk of heart attacks and other cardiovascular damage.
Mipomersen has been found in several clinical trials to dramatically decrease levels of LDL cholesterol and disease-causing lipids. However, the trial results have raised safety concerns about possible liver damage.
To alleviate risk concerns, Isis and Genzyme have planned to first apply to treat those with familial hypercholesterolemia, which greatly increases the risk of fatal heart attacks.
After mipomersen is approved for severe and mild forms of the disease, the companies plan to ask for approval for those who don't have the disease, but are also at high risk, Crooke said. About 1 million people in the United States fit into that category, he said. |
