Replies to post #197132 on Biotech Values

[DewDiligence]

MNTA’s Necuparanib phase-2 trial on temporary enrollment hold (but stock +2%, presumably on analyst upgrade):

http://finance.yahoo.com/news/momenta-announces-temporary-pause-patient-130000114.html

The DSMB met to discuss a limited number of specific toxicities, including thrombocytopenia, risk of bleeding, and thromboembolic events. After thorough review, the DSMB found no safety signals to suggest the need to unblind results, close the study, or discontinue dosing in patients already enrolled in the trial.

The DSMB did recommend that the company amend its protocol to standardize the approach to diagnosing and managing thrombocytopenia and consider holding new patient accrual until the amendment is instituted. The DSMB also noted that the causes of thrombocytopenia and subsequent bleeding in these patients can be multifactorial.

The Company is assessing whether its protocol amendment and enrollment pause will delay release of top-line data beyond the first half of 2017 [it likely will, IMO].

[DewDiligence]

MNTA 2015-2017 News Flow

[Necuparanib update.]


Glatopa program

• 2-May-2016: USPTO inter partes review of Teva’s three Orange Book patents for the 40mg formulation of Copaxone. (Approximately 80% of patents where the USPTO grants an IPR are ultimately invalidated; if Teva’s 40mg Copaxone patents are invalidated, MNTA could launch a generic version of 40mg Copaxone, with FDA approval, as soon as Jan 2017, when Teva’s Hatch-Waxman exclusivity on the 40mg formulation expires.)

• 26-Sep-2016: US patent trial on Teva’s 40mg Copaxone patents. (This trial may be mooted if the May 2016 IPR [above] invalidates Teva’s patents.)


Lovenox program

• 2016: US District Court trial of NVS/MNTA vs AMPH/AGN on infringement of MNTA’s Lovenox patents, which could result in substantial damages payable to NVS/MNTA. (The Appellate Court remanded the case to the District Court on 11/10/15, finding that AMPH/AGN are not protected by the Hatch-Waxman Safe Harbor: #msg-118404904, #msg-115468100.)


FoB program

• Before end 2015: Partnership deal for MNTA’s FoB compounds other than Humira. (MNTA’s Humira FoB is already partnered with BXLT.)

• Jan 2016: USPTO inter partes review against BMY on US Orencia patent.

• Early 2016: PK/PD data for Humira FoB. (The phase-3 trial in psoriasis started on 10/5/15; regulatory submissions expected in 2017 if no hitch.)

• 2H16: Orencia FoB starts phase-1.

• Timing unknown: New pipeline disclosures re M597, M615, M282, M706, M730, or M740. (See slide #53 at link in #msg-107107809.)


Sialylated IVIG program

• Late 2016: Start phase-1 trials for first two of three sialylated-IVIG candidates (of which two are recombinant and one is plasma-derived). The third candidate will start phase-1 in 2017.


Necuparanib program

• Guess—2H17: Top-line phase-2 data trial in pancreatic cancer. I bumped the timing from 1H17 to 2H17 based on the temporary enrollment halt announced on 11/13/15 (#msg-118473682). Trial listing at: http://www.clinicaltrials.gov/ct2/show/NCT01621243 .