Further info re: Canaccord/Genuity
MNTA : NASDAQ : US$14.66 | US$650.9M | Buy , Target US$27.00
• Focus on m-enox safety at NATF summit: experts cautious but no safety issues/cases so far. Reiterate BUY, $27 target
Reiterate BUY, $27 target on increased confidence of good market uptake, longer exclusivity of m-enox. We attended the North American Thrombosis Foundation Summit (Boston) Saturday. Topics included the safety profile of MNTA and partner Sandoz’s m-enoxaparin (m-enox), now the only approved generic of Sanofi’s low-molecular-weight heparin Lovenox (enoxaparin). M-enox was
approved July 23, 2010.
No documented safety cases, including HIT cases, with m-enox. One major safety concern Sanofi and experts expressed around m-enox was incidence of HIT(heparin-induced thrombocytopenia), a serious immune reaction. NATF experts noted thus far, there are no m-enox safety issues (e.g. HIT) despite continued, careful monitoring, but suggested that more rigorous safety registry be set up for
complex and biological generics.
Chain mapping patent vs. possible Teva generic enox approval H1/11. MNTA was issued a new method patent on heparin characterization, including low molecular weight chains, with analytical methods like various HPLC. There is speculation that MNTA’s growing heparin characterization patent estate may enjoin Teva from commercializing a generic enox despite FDA approval. Teva previouslyindicated its generic enox would be approved imminently, but now guides to approval around the end of the year, similar to our estimate.
H2/10 M-enox sales, H1/11 M356 ruling may be key catalysts. We think m-enox’s launch is going well and MNTA/Sandoz will get positive clarity (e.g. Markman ruling) in the M356 generic Copaxone patent suit in H1/11. Our $27 target is based on a sum-of-the-parts analysis.
Risks. Litigation risk: SNY’s suit against FDA on generic enox, Teva’s patent suit on M356. Competitive risk: SNY AG and TEVA generic enox. Regulatory/clinical risk: development/FDA review of M356 and pipeline.