Replies to post #83480 on Biotech Values

[ThomasS]

MNTA: If I may:

"M-Enoxaparin, its my understanding that MNTA produces an exact replica of the molecule so it doesn't make sense to conduct clinical trials for the immunogenicity issue."
-True, unless the FDA is concerned about immunogenicity in general with Lovenox, and chose this opportunity to pursue such thought with a new application from the generic applicant. It would be more difficult to go after the marketed product with such concerns.
Besides, should the FDA believe that the MNTA version is "an exact replica"? They may now, but they may not have thought this back in 2007 or so when some FDA staffer came up with the brilliant idea.


"Their technology puts them ahead of TEVA & other generic manufactures who have also filed ANDA's for M-Enoxaparin."
-That is the assumption that MNTA and MNTA investors are making. However, there isn't yet empirical proof of such. There is anecdotal proof: Why hasn't TEVA's application been approved? (I believe it is 6 years old) Why didn't the FDA work with TEVA to resolve the Heparin contamination issue?
This is core to Dew's (and my) assumption that MNTA will get the only approval, if there is one. MNTA's technology may have raised the bar too high for anyone else. Otherwise, the FDA would be approving generics from companies with inferior analytic capabilities. I suspect they would not do so with more complex entities to come.
TEVA is a powerhouse and may have the goods. We'll see!

[ThomasS]

MNTA: One last thought on MNTA's odds. TEVA is a large company with some 200 applications (and probably 10 lawyers for each.) They also own proprietary compounds such as Copaxone.
On the other hand, Momenta is small, nimble and has been almost singularly focused on Generic Lovenox for years. They were also spawned out of the MIT research juggernaut.
Having the backing of Novartis is rather telling, imo.
I like their odds.

[DewDiligence]

MNTA – This is how I handicap the Lovenox ANDA’s from
MNTA/NVS, Teva, and Amphastar. The table below lists
the various outcomes in descending order of desirability
for MNTA shareholders (JMHO, FWIW).

 
                                      PROBABILITY THAT  
                                 INDICATED RESULT PERTAINS 
                                    AS OF INDICATED DATE  
                                    12/31/09    12/31/10 
 MNTA/NVS ANDA approved; other 
 ANDA’s rejected or no action         24%         68% 
  
 No FDA action on MNTA/NVS 
 ANDA; other ANDA’s rejected           4%           * 
  
 Written FDA request to MNTA/NVS 
 for new analysis; other ANDA’s 
 rejected                              6%          4% 
  
 MNTA/NVS ANDA approved; other 
 ANDA or ANDA’s also approved          4%         14% 
  
 No FDA action on any ANDA’s          46%           * 
  
 Written FDA request to all  
 applicants for new analysis          12%          6% 
  
 MNTA/NVS ANDA rejected                4%          8% 
  
 All cases not included above           *           * 
                                     ====        ==== 
                                     100%        100% 
  
 *Less than 0.5%