MNTA hits 12-month high on strong volume, but no news. FWIW, July marks the 5-year anniversary of the FDA’s acceptance of MNTA’s Copaxone ANDA for review (#msg-30621490), which might be a duration the FDA does not wish to exceed.
Also, I updated the MNTA ReadMeFirst yesterday, LOL.
[Appellate Court invalidates Teva’s 2015 Copaxone patent—entry on this item has been deleted. MNTA/NVS will now surely launch generic Copaxone in May 2014 if they have FDA approval.]
Corporate and financial
• 1-Aug-2013: MNTA’s 2Q13 financial results and conference call.
Copaxone program
• 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 May 2014 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.
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