Momenta receives FDA approval to market generic version of blood thinner Lovenox

Momenta receives OK for generic version of Lovenox

TRENTON, N.J. — Biotechnology company Momenta Pharmaceuticals Inc. said Friday the U.S. Food and Drug Administration approved its generic version of Sanofi-Aventis SA’s Lovenox, an injected drug for preventing life-threatening blood clots.

The approval of the drug, known by the chemical name enoxaparin, sent shares of Momenta soaring more than 80 percent. France’s Sanofi, which made $3.9 billion from Lovenox last year, saw its shares fall 4 percent.

The FDA’s decision could have much broader implications for the biotechnology and generic industries, BernsteinResearch analyst Dr. Tim Anderson wrote to investors.

Lovenox is technically not a biologic drug — a complex medicine made inside special, live cells rather than by combining chemicals. However, “functionally and effectively it is,” Anderson wrote, because it is derived from animal materials and is heavily processed and purified.

The FDA’s decision to make Momenta’s drug fully “substitutable” for Lovenox, according to Anderson, “might signal what FDA may also ultimately do when it comes to ‘true’ biologics that generic companies are also pursuing.”

Generic companies for years have wanted to expand from making copycat versions of pills to making complex drugs equivalent to biologic drugs, which command high prices. The healthcare overhaul gave the FDA the authority and a process to approve such so-called bioequivalent drugs.

Before the generic Lovenox was approved, the FDA required “among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” Keith Webber, deputy director of the FDA’s Office of Pharmaceutical Science, said in a statement.

Shares of Momenta, based in Cambridge, Mass., jumped $9.77, or 82 percent, to $21.70 in regular trading and another 45 cents after hours.

“This is the first product based on Momenta’s technology platform to be approved, and demonstrates our ability to … develop a complex mixture drug like Lovenox,” said the company’s president, Craig Wheeler.

Lovenox is the second-best selling drug for Sanofi-Aventis, saw shares fall $1.29 to $29.35 in U.S. trading. The company said it is “concerned by potential implications for patient safety.”

“The product approved today has not been subjected to extensive clinical trials to demonstrate its efficacy and safety as Sanofi-Aventis has done” with Lovenox, Sanofi said in a statement.

Enoxaparin can prevent blood clots in deep veins, as in the thigh or lower leg, which can break free and cause a fatal blockage in a lung artery, according to the FDA. At least 100,000 such clots occur in the U.S. each year; they are the third-most common cause of death in hospitalized patients.

The drug can also be used to prevent blood clots in patients suffering a heart attack or chest pain, or those confined to bed.

Momenta developed the drug under a collaboration agreement with Sandoz, the generics business of Swiss drugmaker Novartis AG.

Meanwhile, Israel’s Teva Pharmaceutical Industries Ltd. on Friday said it believes it also has demonstrated to the FDA that its proposed version of generic Lovenox meets the agency’s criteria for approval.

AP Business Writer Tom Murphy in Indianapolis contributed to this story.