Replies to post #189988 on Biotech Values

[jq1234]

MNTA: FDA denied TEVA citizen petition and approved generic Copaxone based on 4 criteria

Based on our current understanding of the product, its indication and its mechanisms of action, this can be accomplished by showing equivalence between the ANDA product and RLD as to the following criteria:

1. Fundamental reaction scheme;
2. Physicochemical properties including composition;
3. Structural signatures for polymerization and depolymerization; and
4. Results in a biological assay.

These four criteria take into account the inherent molecular diversity associated with glatiramer acetate and, taken together, are designed to provide overlapping and confirmatory evidence of active ingredient sameness through which FDA can conclude that generic glatiramer acetate injection has the same active ingredient as Copaxone.

http://www.regulations.gov/contentStreamer?documentId=FDA-2015-P-1050-0012&attachmentNumber=1&disposition=attachment&contentType=pdf

[GrthzGd]

MNTA conference call in 30 minutes:

Management will host a conference call today at 1:30 pm ET. To access the call, please dial [phone] (domestic) or [phone] (international) prior to the scheduled conference call time and provide the access code 30313041. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through July 16, 2014. To access the replay, please dial [phone] (domestic) or [phone] (international) and provide the access code 30313041.

The audio webcast of the presentation will be available live on the "Investors" section of the company's website located at www.momentapharma.com. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.