Biotech Values

[DewDiligence]

ODAC Endorses Fragmin

[As previously noted (#msg-12471287), thrombosis is the second leading cause of death in cancer patients after cancer itself. Fragmin is a low molecular weight heparin similar to SNY’s Lovenox. The FDA originally wanted to reject Fragmin for cancer but later acquiesced to convening ODAC; thus, the probably is very high that Fragmin will now obtain an FDA cancer indication. (Fragmin is already approved as a cancer treatment in Canada.)]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060906:MTFH63483_2...

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Wed Sep 6, 2006 7:37 PM ET
By Susan Heavey

SILVER SPRING, Md., Sept 6 (Reuters) - Pfizer Inc's <PFE> anti-blood-clotting drug Fragmin effectively prevents blood clots in cancer patients and warrants wider approval, a U.S. advisory panel overwhelmingly said on Wednesday.

Concerns about patient deaths in the study were not enough to call for additional data before approval, the Food and Drug Administration panel of outside experts also said.

Fragmin already is sold for treating clots in various surgical patients, among other uses. The FDA usually follows the advice of its advisory panels.

Chemotherapy patients can be prone to blood clots, caused by intravenous lines or the drugs themselves.

While fewer patients taking Fragmin experienced a recurrent blood clot during the company's single study, FDA staff reviewers expressed concern about the number of patients who were left out of the study because they died.

Seventeen percent of Fragmin patients were discontinued from the study because of death compared with 7 percent of another group taking the generic anti-clotting drug warfarin.

However, overall 39 percent of those taking Fragmin died compared with 41 percent taking warfarin.

FDA officials said it was not clear whether the difference was due to Fragmin or another reason such as how patients were classified under the study.

Panelist Dr. Gary Lyman, an oncology professor at the University of Rochester, said such issues with classifying the deaths seemed likely. "I think the explanation offered is plausible," he said.

The panel, in a 12-0 vote, said Fragmin was shown effective. Still, some said they had other concerns including price as well as whether the injectable drug should be limited to certain cancer patients.

"The concern I have is the cost," said panel chairwoman Dr. Maha Hussain, a medical professor at the University of Michigan, noting that warfarin is inexpensive and widely available.

Drug prices can vary by retailer, although the FDA does not factor cost into its approval decisions.

Pfizer officials said costs of monitoring patients and other issues also must be taken into account, adding that Fragmin is more manageable than other alternatives. They said their drug helped reduce recurring clots by 52 percent.

FDA staff said Fragmin could also cause major bleeding, increased liver enzymes and fewer blood platelets.

Japan's Eisai Co Ltd. <4523.T> owns the rights to promote Fragmin in the United States.

Shares of Pfizer, the world's largest drugmaker, closed down 12 cents at $27.72 on the New York Stock Exchange on Wednesday, ahead of the panel's vote.
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