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[Biowatch]

MNTA conf call: MNTA & analysts sounded surprised by FDA letter

IMO, It is somewhat odd that the FDA Office of Generic Drugs seems to be adopting a new, very cautious approach to the approval of generic drugs. The agency is under pressure to make sure that no hazardous products (either drugs or food) reach the American public. There is also strong pressure to reduce the cost of health care, given that Medicare, Medicaid, and health insurance companies face skyrocketing expenses which will increase as the population ages. Approving generic drugs reduces health care costs.

As Dew mentioned, the FDA may be looking to Congress to pass legislation clarifying the approval process for generic biologic drugs.
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My notes on the conference call:
The immunogenicity issue came completely out of the blue. The FDA had NEVER raised the issue before in ANY of the communications between the FDA and MNTA. MNTA repeated several times that the immunogenicity issue had never been raised before.

The FDA told MNTA that they were now asking ALL companies submitting ANDAs to provide information addressing the issue of immunogenicity, although the FDA has not given them any hint whatsoever about what sort of data they want to see or what concerns they have. MNTA does not know what the agency (FDA) wants, so they can't make any statement regarding what studies they need to do. MNTA can't know how to address the FDA's concerns until they know what they are.

MNTA said that the letter from the FDA was very simple and clear, and that immunogenicity was the only issue the FDA raised.

Eric Schmidt asked if there was a change in the relationship between MNTA and the OGD (Office of Generic Drugs at FDA), as it seemed to be going quite smoothly a week ago. Eric asked if there was someone at the OGD that does not want this drug approved. MNTA said they were just as surprised as anyone about the letter, and they don't know what is going on with the agency, and they do not want to speculate.

When asked what motivation the FDA may have for this new approach, MNTA says they don't want to over-interpret what the FDA has stated. When asked who might be behind this letter, MNTA said they had no idea.

An analyst stated that TEVA has not received a letter from the FDA concerning generic Lovenox.

MNTA's view is that their product is identical to Lovenox.

MNTA will have $130 million at year end. An analyst asked for "some comfort" regarding MNTA's cash burn rate relative to their cash balance in light of current developments. MNTA said they will look at that closely, but they haven't given any guidance for 2008 yet.
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From the MNTA PR this morning:

The FDA's letter stated that the ANDA was not approvable because the application does not adequately address the potential for immunogenicity of the drug product and recommended that Sandoz and Momenta meet with the Office of Generic Drugs to determine what additional information should be provided to adequately address this concern. Sandoz and Momenta are working together to identify the additional information that is necessary to obtain approval of the ANDA.

``In a follow-up call, the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product. We believe that we can address what we anticipate to be the FDA's concerns, based on our detailed characterization of enoxaparin and on the current medical and scientific literature,' said Craig A. Wheeler, President and Chief Executive Officer. ``Our path forward will be determined in conjunction with Sandoz and the FDA.'