Biotech Values

[floblu14]

F.D.A. Approves First Generic Blood-Thinner - NY Times

The Food and Drug Administration Friday approved the first generic version of Sanofi-Aventis’s big-selling blood thinner Lovenox, in an action that could offer hints of how the agency will handle generic biotechnology drugs.

Lovenox is made from heparin, a complex mixture of sugar chains derived from the intestines of pigs. The question that has confronted the F.D.A. is whether such a complex drug could be copied exactly enough to make a generic form that could be seamlessly substituted for the brand-name product.

The agency Friday, said it could, approving a form of the drug developed by Sandoz, the generic division of Novartis, using technology from Momenta Pharmaceuticals of Cambridge, Mass.

Momenta, which applied for approval of its drug five years ago, claims its technology can accurately characterize such complex mixtures. Its technology was used to help characterize the contamination of heparin products from China that killed dozens of people in 2007 and 2008.

Shares of Momenta were up 54 percent to $18.40 around 2:30 p.m., while shares of Sanofi fell about 5 percent to $29.17. Lovenox, known generically as enoxaparin, is the French company’s second biggest drug, with sales last year of 3.0 billion Euros, or about $3.9 billion.

The drug is widely used by hospitals to prevent deep vein thrombosis, a potentially deadly blood clotting condition, so there could be big savings to the health system if the generic version is much cheaper. Sandoz has not yet said what it will charge, and with its product being the only generic on the market, its price might not be that much below that of Lovenox.

Another company, Amphastar Pharmaceuticals, has been trying to win approval for its own generic Lovenox but has not yet succeeded.

Sanofi-Aventis and its representatives had tried to block approval using the argument that Lovenox was too complex to be copied.

But Keith Webber, an F.D.A. official, said in a statement that Momenta and Sandoz had done a study of their drug in healthy volunteers and run a series of sophisticated analytical tests to “assure that the drug would be as safe and effective as the band name product.’’

The F.D.A. released a 45-page explanation of why it rejected Sanofi’s petition. Analysts and pharmaceutical executives immediately began scrutinizing it for clues as to how the agency would handle copycat versions of other complex molecules.

“It does indicate that the F.D.A. is going to set quite a high bar for equivalence of these complex molecules,’’ Craig Wheeler, the chief executive of Momenta, told securities analysts on a conference call Friday.

One big issue is so-called generic versions of biologic drugs, which are proteins made in living cells. They include such drugs as Amgen’s red blood cell booster Epogen, Biogen’s Avonex for multiple sclerosis, and Genentech’s cancer drugs Avastin and Herceptin. (Lovenox, while a natural product, is not considered a biologic.)

The health care bill passed earlier this year gave the F.D.A. authority to approve so-called generic biologic drugs but the agency still must work out standards.

Biotechnology companies have used the same arguments as Sanofi, arguing that biologic drugs are too complex to be accurately copied. They argue that clinical trials are needed to prove the copycats are safe and effective, which would raise the cost of these drugs.

Momenta and Sandoz are hoping to next win approval for a generic version of Copaxone, a multiple sclerosis drug that is also a complex mixture but not a biologic.

The manufacturer of Copaxone, Teva, is the world’s biggest generic drug manufacturer. It has argued that it can accurately copy biologic drugs. But when it comes to its own drug, Copaxone, it switches sides. It has argued that Copaxone is too complex to be copied by other companies.

http://prescriptions.blogs.nytimes.com/2010/07/23/f-d-a-approves-first-generic-blood-thinner/