Biotech Values

[DewDiligence]

MNTA update on generic Lovenox: no clinical trials
have been requested by FDA. However, MNTA’s
response to the FDA’s new letter is deferred until
3Q08 due to the extent of the in vitro and animal
tests requested. The confirmation that no clinical
trials will be needed is of course bullish; however,
this was largely expected given the recent guidance
from MNTA and NVS. On the other hand, the
Lovenox timeline has been stretched out by a quarter
or two, which is obviously a negative. Since the good
news—no clinical trials—was largely expected while
the bad news—reply to FDA deferred until 3Q08—
was not, I think this PR is somewhat bearish for the
near-term share price.

http://biz.yahoo.com/pz/080429/141283.html

>>
Momenta Pharmaceuticals Receives Regulatory Guidance on M-Enoxaparin ANDA

Tuesday April 29, 5:50 pm ET

Company Expects to Submit Amendment to ANDA in Third Quarter, 2008

CAMBRIDGE, Mass., April 29, 2008 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NasdaqGM: MNTA ), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the Food and Drug Administration (FDA) has provided guidance regarding the Abbreviated New Drug Application (ANDA) for M-Enoxaparin. Momenta is developing M-Enoxaparin, a technology-enabled generic version of Lovenox(r), in collaboration with Sandoz, the generics division of Novartis AG.

Earlier this year, Momenta and Sandoz submitted a proposal to FDA for addressing the potential immunogenicity of M-Enoxaparin, in response to FDA's letter of November, 2007. On April 28, 2008, FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the Company's approach and proposal. FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed. The agency has not requested human clinical trials at this time.

``We are pleased that the FDA has clarified our path forward for M-Enoxaparin by providing written direction regarding their expectations for our application,' commented Craig A. Wheeler, Chief Executive Officer of Momenta. ``We are still evaluating the FDA's guidance, but, based on our preliminary assessment, we hope to submit the amendment containing the requested additional data in the third quarter.'
<<