Biotech Values

[DewDiligence]

MNTA 2013-2014 News Flow

[Miscellaneous revisions.]


Corporate and financial

• 1-Aug-2013: MNTA’s 2Q13 financial results and conference call.


Copaxone program

• 2H13: Ruling on Copaxone patent case by Appellate Court. (See #msg-85870008 for musings on why a reversal by the Appellate Court is more doable than some investors probably think.) All but one of the patents in the Copaxone litigation expire on 5/24/14, and the other one (a process patent) expires on 9/1/15; hence, if MNTA/NVS succeed in overturning the process patent, the potential launch date will be advanced by 15 months.

• Timing uncertain: FDA action on MNTA’s Copaxone ANDA. Although the FDA is now barred by court order from issuing a final approval of the ANDA before May 2014 (unless there’s a settlement or reversal of the District Court ruling), the FDA can issue a tentative approval, which will allow NVS/MNTA to launch their product upon the expiration of Teva’s patents. FDA tentative approval is highly consequential for MNTA investors because it will: i) re-validate MNTA’s technical prowess in replicating complex drugs; and ii) guarantee that generic Copaxone can be launched at the expiration of Teva’s patents (or sooner if there’s a settlement or reversal of the District Court on appeal).

• Timing uncertain: FDA action on Mylan’s Copaxone ANDA. The same restrictions on a final FDA approval described in the bullet item above apply to MYL’s Copaxone ANDA. (Note: MYL’s Copaxone ANDA was accepted for FDA review about 14 months after NVS/MNTA’s ANDA.)


FoB program

• Early 2014: Start of clinical trial for M923, the first compound in the BAX-MNTA FoB collaboration (which I think is Orencia). This will trigger two milestone payments from BAX (#msg-81498217). Note: MNTA has already established proof of concept on this compound.

• Early 2014: BAX decision whether to license M511, the third compound in the BAX-MNTA collaboration (which I think is Erbitux). If BAX licenses M511, MNTA will receive an up-front license fee and be eligible for additional milestone payments on this compound (#msg-81498217).

• Timing uncertain: Pre-IND progress on M834, the second compound in the BAX-MNTA collaboration (which I think is Humira). BAX has already licensed this product for further development.

• Timing uncertain: Selection of the fourth, fifth, and sixth FoB compounds to be developed in the BAX-MNTA collaboration (if any).


Other programs

• 1H14: M402 data (safety, tolerability, efficacy to determine dose(s) for further study) from first portion of phase-1/2 trial in pancreatic cancer. The revised trial design (adding Abraxane as a comparator) is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 . Data from the second (randomized) portion of the trial is expected in Jan 2015.

• Timing uncertain: Progress on IVIG program based on the sialic switch technology.