Biotech Values

[DewDiligence]

More on Amphastar’s Lovenox whining (from the WSJ).
It sounds like Amphastar is pretty sure its own Lovenox
ANDA is not getting approved.

http://online.wsj.com/article/SB10001424052748703894304575047350165401086.html

›FDA Clears Drug Chief of Conflict

FEBRUARY 5, 2010, 3:24 P.M. ET
By ALICIA MUNDY

WASHINGTON—The inspector general of the Department of Health and Human Services has cleared the chief of the drug division at the Food and Drug Administration of allegations of conflict of interest stemming from her interactions with scientists at a biotechnology company that has a long-pending application at the agency.

FDA officials, who disclosed the HHS decision on Thursday, also said that Janet Woodcock, the director of the Center for Drug Evaluation and Research, had voluntarily withdrawn in August from a drug approval process involving Momenta Pharmaceuticals Inc., of Cambridge, Mass., and Amphastar Pharmaceuticals Inc. of Rancho Cucamonga, Calif.

Momenta and Amphastar have applied for FDA approval to sell generic versions of Lovenox, a blood thinner that is estimated to have brought more than $4 billion in global sales to maker Sanofi-Aventis SA last year, according to market researcher IMS Health. Lovenox is a low-molecular-weight form of heparin, a widely used drug.

Amphastar has alleged in letters to the FDA that Dr. Woodcock is biased in favor of Momenta.

FDA Chief Counsel Ralph Tyler said the Health and Human Services inspector general recently concluded that Dr. Woodcock hadn't done anything to meet the definition of a conflict of interest. He also said the FDA had earlier cleared Dr. Woodcock of a conflict of interest.

In a letter to Amphastar in September denying the company's allegations, the FDA wrote, "Dr. Woodcock does not have a financial interest in any of the entities" affected by the pending drug application.

Amphastar's general counsel, Jason Shandell, said on Friday the FDA narrowly tailored its review to legal issues. "We never asserted she got any money—that would be illegal. Our focus was on the appearance of impropriety and its impact on the approval system," he said.

The agency hasn't made Dr. Woodcock available for interviews, but FDA officials repeatedly have denied any bias in the pending decision.

Last year, Amphastar began raising issues that it said worked in its competitor's favor. For example, it cited Dr. Woodcock's attendance at a 2007 conference in Thailand with one of Momenta's principals shortly after Amphastar's application for generic Lovenox was held up by the FDA.

Amphastar also said Dr. Woodcock gave Momenta and its scientists' high-profile roles in 2008 in the FDA's investigation of contaminated heparin originating in China. The tainted drug was linked to more than 80 deaths in the U.S. Dr. Woodcock and Momenta scientists were co-authors on two scientific papers that discussed how the agency's task force solved the crisis.

Several analysts on Wall Street saw Momenta's role in the heparin probe as a sign it had the inside track at the FDA in the race to sell generic Lovenox, and Momenta's stock rose around the time the papers were published.

FDA Deputy Commissioner Joshua Sharfstein said late Thursday that Momenta's scientists were brought into the Chinese heparin crisis because of their expertise. He said helping the agency address a public-health crisis shouldn't preclude a company from applying for a drug approval. Mr. Tyler said such issues "can't handcuff the agency for all time" in reviewing a company's drug application.

A Momenta spokeswoman declined to comment on the probes into Dr. Woodcock. [“No comment” is absolutely the right comment here.] Momenta's partner in its application is Sandoz, a unit of Swiss drug maker Novartis AG. Momenta is scheduled to discuss its business at an investors' presentation in New York on Monday.‹