Momenta and Sandoz are also developing M356, a generic version of the multiple sclerosis drug Copaxone, and have filed the first complete Paragraph IV ANDA thereby securing 180-day generic exclusivity and engendering a patent infringement lawsuit from TEVA. We think that the upcoming Markman claims-construction hearing (likely in December) that is part of this suit will underscore Sandoz's/MNTA strong arguments regarding the lack of validity of the TEVA Copaxone patent estate. We believe there is good chance that this hearing may provide positive clarity on M356's legal position.
We also believe that MNTA's novel Phase 2 anticoagulant M118 could be a promising anticoagulant with broad use across almost the entire ACS treatment algorithm. M118 has been engineered to have to strong Xa/IIa mediated anticoagulation, monitorability and reversibility as heparin, with the high bioavailability and improved safety of Lovenox. New Phase 2 data from the EMINENCE trial showed statistical non-inferiority to heparin and very good safety. As a result, the company may strike a rich M118 partnership in 2010 that could be a key catalyst for the shares.
FWIW
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