Biotech Values

[DewDiligence]

MNTA 2014-2015 News Flow

[Miscellaneous updates.]


Copaxone program

• Timing uncertain; likely before 5/24/14: FDA action on MNTA’s Copaxone ANDA. The FDA’s new GDUFA guidelines take into account the patent-expiration date of the branded drug (#msg-95940872).

• Timing uncertain: FDA action on Mylan’s Copaxone ANDA. Note: MYL’s Copaxone ANDA was accepted for FDA review 14 months after MNTA’s ANDA. (See #msg-95940872 for musings on MYL’s Copaxone ANDA.)


FoB program

• 2H14: Start of phase-1 trial for M923 in the EU. M923, the lead compound in the BAX-MNTA FoB collaboration, is very likely Humira (#msg-97137725); the start of phase-1 will trigger a milestone payment from BAX of $10M or slightly more.

• 2H14: Technical proof-of-concept milestone for M834, the second compound in the BAX-MNTA collaboration, which I think is Orencia; the PoC milestone for M834 will trigger a milestone payment from BAX of <$10M. (A phase-1 trial of M834 is expected to begin in early 2015.)

• Timing uncertain: Selection of additional compounds to be developed in the BAX-MNTA collaboration (possibly including a replacement for M511).


Other programs

• 2014: M402 data (safety, tolerability, efficacy to determine dose(s) for further study) from first portion of phase-1/2 trial in pancreatic cancer. The trial is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 . The second (randomized) portion of the trial is expected in late 2014 or early 2015.

• Timing uncertain: Progress on recombinant IVIG program.