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Re: ThomasS post# 91780

Friday, 03/05/2010 8:57:10 PM

Friday, March 05, 2010 8:57:10 PM

Post# of 252819
MNTA re M118: It’s hard to negotiate a partnership for a drug with big potential when the financial resources of your company could radically change tomorrow, but this is exactly the situation MNTA finds itself in while waiting for the FDA to rule on generic Lovenox.

Craig Wheeler addressed this point on the most recent CC (#msg-46564147).

In order to secure premium pricing it will be critical for M118 to demonstrate superiority over competitive agents in a pivotal trial of ACS patients. This means that the continued clinical development of the product will require a large Phase III trial of approximately 15,000 patients and a significant financial investment. Consequently, we are actively seeking a collaboration partner to finance and support the further clinical development of M118. We have targeted global pharmaceutical companies that are committed and have expertise in the global development and commercialization of novel cardiovascular products.

With the recent mergers in the pharma industry and the fact that some companies are exiting the cardiovascular business [e.g. PFE—see #msg-32523077], there are a limited number of companies that meet our criteria. We are currently in discussion with several companies.

The terms we can negotiate with a partner will depend on several factors, including the amount of financial contribution that we at Momenta can provide. Until we receive a decision on M-Enoxaparin or enter into an M118 collaboration, we are not planning to dedicate additional resources to further the development of M118. We will not start the next trial until we have a partner or funding available, but we do remain committed to the product and its continued development.



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