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Biotech / Medical : Momenta Pharmaceuticals Inc.
MNTA 52.480.0%Oct 2 5:00 PM EST
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From: mopgcw1/30/2011 11:41:03 AM
   of 3027
 
cs:teva

FDA letter increases our confidence in generic Lovenox timing, and does not change our estimates. We had assumed a
2Q:2011 launch of Lovenox in our model and Teva's action letter from FDA, announced today, is consistent with this
expectation.

! Minor Deficiency Letter is encouraging. FDA sent Teva a Minor Deficiency letter, which indicates that FDA has completed
its review of Teva's Lovenox ANDA, including Teva's responses to prior questions, and stipulates a short list of questions
that Teva stated it plans to answer in the near future. Although Teva did not disclose the details of the letter it received,
responses to minor deficiency letters are typically reviewed by FDA within 60 days, so a response by Teva within 2-3
months could enable a 2Q11 approval.

! Our 2011 EPS from Lovenox is $0.05 - $0.10. Our model includes this contribution based on a 2Q11 launch of Lovenox and
today's news affirms our estimate.
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