Biotech Values

[DewDiligence]

MNTA 2014-2015 News Flow

[Added 10/15/14 date for USSC hearing on Copaxone patent case.]


Copaxone program

• Timing uncertain: FDA action on NVS/MNTA’s Copaxone ANDA.

• Timing uncertain: FDA action on Mylan’s Copaxone ANDA. MYL’s Copaxone ANDA was accepted for FDA review 14 months after NVS/MNTA’s ANDA. Moreover, Court documents establish that NVS/MNTA submitted gene-expression data to the FDA in early May 2014, but they make no such assertion regarding a similar submission by MYL (#msg-101929561). (See #msg-95940872 for additional musings on MYL’s Copaxone ANDA.)

• 15-Oct-2014: US Supreme Court hearing action on Copaxone patent case. (Amicus brief from US DoJ supports MNTA’s position that Teva’s ‘808 patent is invalid: #msg-103869690.) A formal ruling by the USSC is likely in late 2014 or early 2015. (Note: With FDA approval, NVS/MNTA can launch generic Copaxone “at risk,” even if the Copaxone patent case has not been resolved.)


FoB program

• Late 2014: Filing of CTA (the EU equivalent of a U.S. IND) for lead FoB compound, M923. (M923 is likely Humira.) A phase-1 trial for M923 in the EU can begin shortly thereafter. The start of phase-1 will trigger a milestone payment from BAX of about $10M.

• Late 2014: Technical proof-of-concept milestone for M834, the second compound in the BAX-MNTA collaboration (which may be Orencia). Proof of concept for M834 will trigger a milestone payment from BAX of <$10M. A phase-1 trial of M834 is expected to begin in 2015.

• Timing uncertain: Selection of additional FoB compounds to be developed in the BAX-MNTA collaboration or by MNTA on its own.


Other programs

• 2H14: 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 .

• Timing uncertain: Progress on recombinant IVIG program.