Replies to post #152907 on Biotech Values

[DewDiligence]

Bullish things for MNTA that could happen at almost any time:

• FDA tentative approval of MNTA’s Copaxone ANDA, which would allow an at-risk launch of NVS/MNTA’s generic Copaxone at the expiration of Teva’s Orange Book patents in 2014 and a risk-free launch at the expiration of Teva’s last Copaxone patent in 2015.

• Monetization of MNTA’s Lovenox royalty stream (#msg-81550997).

• A partnership deal for M402.

• Unexpected progress on one or more of the compounds in the FoB program with BAX (#msg-81498217, #msg-70258421).

• A buyout offer from BAX, NVS, or someone else.

None of these individual items (except perhaps the first one) is especially likely to happen soon; however, the probability that at least one of the above events happens in a given time period is clearly much greater than the probability of any specific event.

[straight up]

Thanks for your reply. If there was no fight left in you, I would not even follow this stock any more. I made a hefty bet that MNTA could get the job done. The scientists did their part, but there have been failures. The company showed it has some substance and the Baxter deal is now the future. That future is at least 6 months before we start to get teased about products. I think, PPS will erode until then. Good Luck to All. Down to only 1500 shares, waiting for some good news to get back in.

[DewDiligence]

MNTA 2013-2014 News Flow

[Remove note re possible consolidation of MNTA-Amphastar
patent case with Classen case, which is no longer possible;
add item re 4Q12 financial results.]


Corporate and financial

• [15-Feb-2013]: MNTA reports 4Q12 financial results and updates financial outlook for 2013. (Note: 4Q12 Lovenox sales reported by NVS were higher than MNTA’s prior guidance.)


Lovenox

• Timing uncertain: Possible US Supreme Court review of the Lovenox patent suit against Amphastar. (The CAFC denied MNTA’s request for an ‘en banc’ rehearing on 11/20/12, and the USSC denied certiorari for the related Classen case on 1/14/13.)


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 NVS/MNTA’s ANDA before May 2014 (unless there’s a settlement or reversal of the District Court ruling on appeal), the FDA can issue a tentative approval, which will allow NVS/MNTA to launch their product upon the expiration of Teva’s patents. Inasmuch as NVS/MNTA had previously decided not to launch generic Copaxone “at risk,” an FDA tentative approval is as consequential for MNTA investors as a final approval; it will re-validate MNTA’s technical prowess in replicating complex drugs and guarantee that generic Copaxone can be launched at the expiration of Teva’s patents (or sooner in the event of 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 above bullet item apply to MYL’s Copaxone ANDA. (Note: MYL’s Copaxone ANDA was accepted for FDA review about 14 months after NVS/MNTA’s ANDA.)

• Late 2013/early 2014: Completion of the appeal of the District Court’s ruling in the Copaxone patent case. (If the Appellate Court were to reverse the District Court and find in favor of NVS/MNTA, a tentative FDA approval of NVS/MNTA’s Copaxone ANDA would be converted to a final approval.)


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 to formally 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: Progress on M834, the second compound in the BAX-MTA 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.


Other Programs

1H13: M402 data (safety, tolerability, efficacy to determine dose(s) for further study) from first portion of phase-1/2 trial in pancreatic cancer. (M402 is MNTA’s proprietary heparin-based cancer drug.)

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