Micromet (MITI) Rated buy
Micromet's platform technology has recently been validated with blinatumomab in two hematologic oncology treatment settings, including advanced non-Hodgkin's lymphoma and as means of clearing minimal residual disease in adult acute lymphoblastic leukemia patients following front-line therapy. Data from a Phase 2 trial investigating blinatumomab in the latter setting is most encouraging, in our view, with important response duration data from this trial expected at ASH in early December. After recently regaining 100% of worldwide rights to blinatumomab from Medimmune, MITI intends to moves this agent into Phase 3 registration trials next year. - George Farmer
Momenta Pharmaceuticals (MNTA) Rated buy
We expect that M-Enoxaparin, Momenta and partner Sandoz's generic version of Lovenox, will be approved and launched around the beginning of 2010. We think that all regulatory safety and supply quality control concerns have been addressed, and that the drug will see rapid adoption by hospital and cardiac care centers. We think MNTA will receive meaningful royalties from M-Enoxaparin sales over 2010 into 2011 as sales and supply ramps.
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 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 reversability 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. - Ritu Baral