Replies to post #17755 on Momenta Pharmaceuticals, Inc. (MNTA)

[tony111]

Think about it. Copaxone is super complex and Mylan is able to crack it and gain FDA approval. You can argue it took them extra 2 years to do so, but I do no think MNTA's analytical technique is special anymore. They can certainly make high quality biosimilars, but who knows what FDA would do about interchangeability. I still see their FcRn IVIG innovative medicine pretty attractive, but we won't have any data on it for a couple years. Its dead money. Have to admit MNTA is clouded with bad luck (lost the enox case, delayed 20mg copaxone approval, missed the chance of early 40mg copaxone approval from a warning letter), but its really not a good investment retrospectively.

[Regulardoc]

I may have assumed wrongly twelve years ago that MNTA had a unique characterization platform and knowledge that allowed them to be able to produce near exact replicas of complicated molecules or mixtures. Even if they had that technology, and even if is best in class, clearly others over time have developed their own set of tools to characterize complex compounds to the degree that the FDA feels is reasonably close.

One of MNTA's limitations/challenges is that by the time one of its products attains FDA approval, other companies may have caught up and other pharma has developed alternative therapeutic options such as the oral anticoagulants or oral MS drugs that the public is more likely to accept and wish to take.

They also have several partnerships that lead to conflicting stances. As jbog mentioned. Novartis has Gilenya, so they may drag their feet in supporting Glatopa. Pfizer, the erstwhile Fill and Finish, actually has a dog in the copaxone race and MYL clearly is a partner, yet a competitor.

MNTA has to date chosen certain "drugs" for evaluation with limited market share such as intracoronary LMWH which failed in studies. Also spends way too much time, energy and especially money in pursuing legal battles that perhaps should not have been engaged in the first place. Only one that bore fruit was the SNY patent issues with Lovenox.

Have to wonder how old CW feels about deciding to do a 50% share with their immune globulin partnership given that the present revenue stream is sorely lacking for the company as a whole.

Overall, cannot provide advice on holding your investment, but MNTA either needs to try to sell itself or develop a product that has a long term life expectancy. There is absolutely no credible scientific reason for the FDA not to have approved 40 mg given the two years lead time of a product that had already received approval for the 20 mg formulation. MNTA and NVS should have been prepared for all possible snafus for a process that should have been a cakewalk.