Biotech Values

[DewDiligence]

Re: MNTA / FoB legislation

Craig Wheeler’s CC comments today on the recently enacted FoB legislation echo and expand upon the assertions in #msg-49822875, which was posted on this board yesterday.

From #msg-49822875:

The salient point…is that the recently enacted law (and the FDA regs it will spawn) is good news for such companies as MNTA and TEVA. These companies lobbied Congress to have the law written the way it ended up being written, giving the FDA discretion over whether to require clinical trials for a given biosimilar/biogeneric. Additionally, the companies were successful in getting the law to allow substitutable biogenerics at the FDA’s discretion.

The companies’ lobbying was not successful in reducing the 12-year period of data exclusivity for branded biologics, but the duration of data exclusivity is much less consequential than the provisions giving the FDA discretion over the requirement for clinical trials and allowing substitutable biogenerics.

Craig Wheeler on today’s CC (#msg-49869442):

…healthcare reform legislation has been passed that establishes a regulatory pathway for the FDA to approve Follow-on Biologics. The new legislation will allow the FDA to establish its own criteria for determining biosimilarity and interchangeability. In addition, it allows the FDA to use its discretion to determine the nature and extent of product characterization, as well as non-clinical and clinical testing on a product-by-product basis.

We are pleased with these provisions and expect that they will prove to be an advantage for Momenta. We are less pleased with the 12-year marketing facility and the lack of an honorable patent system. However, despite its limitations, the passage of the bill means we can now move forward with our FOB development program with greater clarity.

To achieve our goal to develop and commercialize a portfolio of competitive follow-on biologic products, our FoB program will require scale and significant capital. So we are continuing to engage in discussions with potential collaborative partners.

I should note that we are adapting our biologics tools to explore the development of novel biologics, to lay the foundation for future products there as well. We are excited by the progress we are making in engineering biologic products, and continue to believe this program represents a significant opportunity for the company, for both FoBs and novel products.