AI
Monday, December 17, 2007 9:13:58 PM
>> a) MNTA continues to make steady, but not spectacular, progress on M118 and its other non-Lovenox programs.
Very likely.
>> b) The US passes legislation enabling follow-on biologics during 2008.
You're kidding - Congress passes important legislation. Small chance.
>>c) MNTA does not sell shares during 2008 before the status of the Lovenox ANDA is cemented.
Likely.
>> d) SNY is unable to reinstate its US Lovenox patent during the appeal be heard in early 2008.
As close to certainty as patent cases get - call it 95%. The Court of Appeals will look really silly if they overturn this case.
>> e) MNTA does not receive a buyout offer.
Sandoz should buy them before they partner M118 with any one else. When does the stand-still end?
>>I see four cases according to the status of the Lovenox ANDA:
>> Case 1 – MNTA/Sandoz obtains approval for generic Lovenox and neither Teva nor Amphastar obtain approval: $57 ($2.1B MC). I would have an even higher valuation for this case were it not for the possibility of SNY’s launching a Lovenox “authorized” generic.
20%
I do not think that it would be economically advantageous for SNY to launch an "authorized" generic provided they did not expect FDA to quickly approve other generic L's. Doing it would be an extreme scorched-earth approach which is not typical of pharma.
>> Case 2 – MNTA/Sandoz obtains approval for generic Lovenox and Teva or Amphastar do also: $24 ($900M MC).
20%
>> Case 3 – Nobody obtains approval for generic Lovenox but the application from MNTA/Sandoz remains under consideration by the FDA pending resolution of certain issues: $11 ($400M MC). This case is essentially the status quo with some “regression to the mean” vis-à-vis the unduly negative sentiment toward the stock that is currently suppressing the valuation, IMO.
50%
>> Case 4 – MNTA/Sandoz receives an FDA rejection of the Lovenox ANDA with no likelihood of a resubmission: $5.50 ($200M MC).
10%
$22.25
Thanks for the work, DD. Very interesting and thought provoking.
ij
Very likely.
>> b) The US passes legislation enabling follow-on biologics during 2008.
You're kidding - Congress passes important legislation. Small chance.
>>c) MNTA does not sell shares during 2008 before the status of the Lovenox ANDA is cemented.
Likely.
>> d) SNY is unable to reinstate its US Lovenox patent during the appeal be heard in early 2008.
As close to certainty as patent cases get - call it 95%. The Court of Appeals will look really silly if they overturn this case.
>> e) MNTA does not receive a buyout offer.
Sandoz should buy them before they partner M118 with any one else. When does the stand-still end?
>>I see four cases according to the status of the Lovenox ANDA:
>> Case 1 – MNTA/Sandoz obtains approval for generic Lovenox and neither Teva nor Amphastar obtain approval: $57 ($2.1B MC). I would have an even higher valuation for this case were it not for the possibility of SNY’s launching a Lovenox “authorized” generic.
20%
I do not think that it would be economically advantageous for SNY to launch an "authorized" generic provided they did not expect FDA to quickly approve other generic L's. Doing it would be an extreme scorched-earth approach which is not typical of pharma.
>> Case 2 – MNTA/Sandoz obtains approval for generic Lovenox and Teva or Amphastar do also: $24 ($900M MC).
20%
>> Case 3 – Nobody obtains approval for generic Lovenox but the application from MNTA/Sandoz remains under consideration by the FDA pending resolution of certain issues: $11 ($400M MC). This case is essentially the status quo with some “regression to the mean” vis-à-vis the unduly negative sentiment toward the stock that is currently suppressing the valuation, IMO.
50%
>> Case 4 – MNTA/Sandoz receives an FDA rejection of the Lovenox ANDA with no likelihood of a resubmission: $5.50 ($200M MC).
10%
$22.25
Thanks for the work, DD. Very interesting and thought provoking.
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)
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