[Updates: New section on competition in MS (includes updates on Cladribine and Campath); notes on MNTA’s early-stage cancer program (from JPM webcast); Teva’s comments on the FDA’s handling of the Lovenox ANDA’s; revised table of biotech buyouts.]
What is MNTA’s business all about? #msg-31026200Transcript from 2Q08 CC #msg-28748329MNTA helps FDA with contaminated heparin #msg-33978205 Post-mortem on above story #msg-345123202009-2010 news flow #msg-25473104 Capsule explanation of proprietary technology #msg-338670742003 article from Signals (still a good read) #msg-19626947 Sugars, peptides and glycoproteins, in that order #msg-24624700 Apropos to above (2005 PR) #msg-28865474 Characterizing a compound by “ruling out” structures #msg-34857329Early-stage cancer program (from 1/09 JPM webcast) #msg-33498974Tidbits from Nov 2008 DB webcast #msg-29053373 Tidbits from May 2008 DB webcast
Generic Lovenox program #msg-32449872Sandoz submits response to FDA #msg-33862924Sandoz pays the freight #msg-33839164Profit split depends on # of generics #msg-33892399 Musings on MNTA’s slice of Lovenox pie #msg-34007446Sanofi likely to launch an ‘authorized’ generic #msg-33858393What about ANDA’s from Teva and Amphastar? #msg-33960572 HSP filed ANDA for vial only #msg-35090820 Why the Lovenox ANDA’s have taken so long to process #msg-33311968 Amphastar’s 180-day clock has started #msg-33839413 Estimated royalty if multiple generics #msg-12685766 Royalty payable to MIT #msg-33246663Lovenox sells $3.2B/yr, 59% in US #msg-28934793 Could be largest-selling generic of all time #msg-26739674 Lovenox US market share #msg-28936334 What indications do Lovenox sales come from? #msg-12222305 2006 agreement extends partnership to EU #msg-29728035 How generic Rx’s are written in EU
M118 (proprietary anticoagulant) program #msg-26897124 “Checklist” rationale for M118 program #msg-26900300M118 has blockbuster potential #msg-32382532 Program update from UBS webcast (9/23/08) #msg-29698599M118 vs new oral anticoagulants #msg-27272430 Meeting an unmet need #msg-26898084 How M118 binds both FIIa and FXa (graphic) #msg-32382585M118 clinical trials #msg-31029674 Musings on lack of drug interactions
Follow-on Biologics (FoB) programs #msg-27114485US FoB’s are a question of when not if #msg-33759265 Rep. Dingell’s ouster good for FoB prospects #msg-26837144Salient FoB quote from MNTA’s CEO #msg-12222305 PR announcing 2006 FoB deal with Sandoz #msg-34383144 M249 (Aranesp?) discontinued; $178M in milestones remain #msg-34383579What is M178? (table of biologic patent expirations) #msg-20699044 Largest-selling biologics by class #msg-34365756 Musings on MRK’s pseudo-FoB program (1) #msg-34108345 Musings on MRK’s pseudo-FoB program (2) #msg-33866262 Reference website for FoB’s
Competition: multiple sclerosis #msg-35065247Comparative efficacy of approved MS drugs #msg-31249570Tysabri forecasts unrealistic, analysts say #msg-31553565 Musings on MS drugs in development (genisi) #msg-35023606 Merck Serono’s phase-3 Cladribine data #msg-31515145 FTY720 runs into a safety setback… #msg-34138665 …but shows good results, all told, in first phase-3 trial #msg-31519342 MS drugs in phase-2 or phase-3 #msg-34832939 Musings on Campath (with another table of MS drugs) #msg-29902618 Mylan enters the Copaxone fray—sort of.
Competition: miscellaneous #msg-33839321 Procognia is not a serious competitor #msg-33597614 Also-ran companies in the FoB arena