[Updates from 3Q13 CC; the most notable change is delay of a phase-1 trial for M923 from 1H14 to 2H14.]
Copaxone program
• Timing uncertain; likely before 5/24/14: FDA action on MNTA’s Copaxone ANDA. On the 3Q13 CC, Craig wheeler noted that the FDA’s new GDUFA guidelines take into account the patent-expiration date of the branded drug.
• 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. The patent expiration date is the same as for MNTA’s ANDA.
FoB program
• 2H14: 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: BAX has already licensed this product and MNTA has already established proof of concept.
• Timing uncertain: Start of clinical trials for M834, the second compound in the BAX-MNTA collaboration (which I think is Humira). Note: BAX has already licensed this product for further development.
• Timing uncertain: BAX decision whether to 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: Selection of the fourth, fifth, and sixth FoB compounds to be developed in the BAX-MNTA collaboration (if any).
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 revised trial design (adding Abraxane as a comparator) is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 . Data from the second (randomized) portion of the trial is expected in Jan 2015.
• Timing uncertain: Progress on IVIG program based on the sialic switch technology.
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