Biotech Values

[DewDiligence]

MNTA 2013-2014 News Flow

[Miscellaneous updates, including M402 trial.]


Lovenox

• Mid 2013: US Supreme Court decision whether to accept MNTA’s Lovenox case for review of the Appellate Court’s decision based on the Hatch-Waxman Safe Harbor. Amphastar, the defendant in this action, has until 5/24/13 to submit a brief to the USSC. (Once the USSC rules on certiorari, it may take 6-9 months before the case is heard, and then it may take several months for a ruling to be issued. Hence, the soonest a USSC reversal could realistically happen is the middle of 2014. Still, I would expect MNTA’s share price to react moderately well if the USSC merely grants certiorari.)


Copaxone

• Timing uncertain: FDA action on NVS/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).

• Circa 4Q13: Ruling on Copaxone patent case by Appellate Court. (Oral arguments began on 5/7/13.) See #msg-85870008 for musings on why a reversal by the Appellate Court is more likely than some investors probably think.

• 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 or thereabouts: 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.