28-Feb-08 13:31 Momenta's generic Lovenox product likely to be stalled because of cautious environment at FDA, attorneys note
Story The FDA is taking a conservative approach in evalutating follow-on protein products before a biogeneric regulatory pathway is in place, which could spell bad news for Momenta's M-Enoxaparin candidate, sources say.
M-Enoxaparin is a generic version of Sanofi-Aventis' Lovenox, a blood thinner made of complex sugar chains. Privately-held generic drug maker Amphastar also has an application for generic Lovenox pending in front of the FDA.
The agency late last year issued a non-approvable letter to Momenta and partner Sandoz, requesting more immunogenicity data.
Lovenox was approved under the Food, Drug and Cosmetic Act (FDCA), which means that the FDA does have the authority to approve generic versions. Most biologics, in contrast, were approved under the Public Health Services Act, which is the focus of the current legislative push to create a generic approval process.
However, some attorneys are skeptical about whether the FDA is willing to approve a biogeneric even under the FDCA.
"We're in an election year - they're just shutting everything down," said Jill Deal, a partner at law firm Venable, who specializes in litigation and lobbying for the food and drug industry. "They're going to be very careful about what they do, and how they use 505(b)(2)."
Under the FDCA, a 505(b)(2) application relies on a reference product's previous safety and efficacy studies. Sandoz's Omnitrope, sometimes called the first biogeneric, was approved under this process.
Deal noted that the agency is also concerned about major drug companies threatening lawsuits over the scope of 505(b)(2) - something Pfizer did when Sandoz first submitted its application for Omnitrope. (Pfizer manufactures reference product Genotropin, a human growth hormone.)
"Periodically, there have been threats to take the agency to court over the scope of 505(b)(2)," she said, adding that the FDA would prefer not to get involved in a lawsuit.
Momenta's product, in contrast, was submitted under a standard ANDA, not a 505(b)(2). Even still, the FDA has been under heavy scrutiny over drug safety issues and likely wants some clarification on the science needed to approve follow-on proteins before issuing an opinion, according to David Rosen, a former FDA official and partner at law firm Foley & Lardner.
"Right now the issue is science … as opposed to not having a pathway," he said. "The FDA is still raising significant issues [on] how best to approach the concerns regarding immunogenecity."
Yet he acknowledged that many of those scientific concerns will be resolved once a pathway is in place under the PHSA.
Executives at Momenta and Sandoz did not respond to requests for comment. A former industry executive who said he recently spoke with Momenta noted that the company remains "optimistic" about its application. "But who knows," he said.
There are also questions about whether such a pathway will be in place this year, as people in the generics industry have previously told this news service.
"I don't think we're going to see a lot of stuff happening until there's an election," Rosen said.
"People have been trying to read the tea leafs - and it's just so hard in an election year," said Deborah Shelton, a partner at law firm Sheppard, Mullin, Richter & Hampton. "This is a really complex task."
Shelton wouldn't rule out the possibility that the FDA could approve other generic protein products under the FDCA, but that clinical trials for immunogenicity would be a key issue.
"The FDA has been under fire for pushing products through," she said. "I think the FDA has been pretty clear - and rightfully so - [that the Omnitrope approval] doesn't really tell us much."
Momenta has a market cap of USD 281.63m.
by Beth Herskovits
Source Pharmawire
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