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, the first compound in the BAX-MNTA FoB collaboration; this will trigger a milestone payment from BAX of approximately $10M.

• 2H14: Start of phase-1 trial for M834, the second compound in the BAX-MNTA collaboration; this will trigger a milestone payment from BAX of approximately $9M.

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


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 trial is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 . Data from the second (randomized) portion of the trial is expected in early 2015.

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