Replies to post #13893 on Momenta Pharmaceuticals, Inc. (MNTA)

[MTB]

jbog,

Thanks for your gracious reply. I couldn't help myself -- though I've found myself agreeing with you more and more over the years:). I couldn't agree more on the poor timing of the ATM.

That noted, I've seen no reason to alter my prior option on the non-viability of the Mylan generic. I've pasted a reply I gave in April (message#13342) on the details of why I don't think it will every be FDA approved.

After a long drought, it is good to have some water.

MTB

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The fine print from the FDA CP reply this morning gives evidence that Mylan's entry will not be approved (ever) and that MNTA will remain the first and only generic copaxone for the foreseeable future(see below).

In addition, MNTA's generic achieved full substitutability -- a remarkable achievement that lots of firms are gunning for and will hugely value. This gives tremendous and overdue validation to MNTA's analytic methods. The prospects of a buyout just markedly increased -- more for what they've demonstrated they can do, than for the $$$ to be made from Copaxone.


Whatever the court does, September is coming regardless and the cash will be flowing into MNTA. For the time in a very long time, to not take advantage of the current gross misreading of MNTA's prospects (and investors understandable disgust with past performance), is a mistake.

I'll be adding to my position.

MTB

From the FDA reply this AM, page 29:

"In addition to the characterizations and assays performed by generic sponsors, FDA’s internal laboratory developed and performed its own testing of multiple batches of Copaxone, the proposed generic glatiramer acetate injection, glatiramer acetate-like products marketed outside of the United States (Specifically, these include samples of the Natco product marketed in India and Ukraine), and negative controls, in each case using high-resolution analytical techniques . . .
This method is sufficiently sensitive such that the batch-to-batch variations of Copaxone can be detected. Based on appropriate statistical analysis of the results, the glatiramer acetate-like products marketed outside of the United States and negative controls can be clearly distinguished from Copaxone batches. However, when applying the same testing, no significant differences were observed between the proposed generic glatiramer acetate injection under consideration by FDA and Copaxone."

The short answer: Mylan has submitted Natco's generic copaxone for FDA approval. The FDA has tested Natco/ Mylan's product and says, it is not the same as the reference Teva product. MNTA's is. MNTA will remain the sole generic.