UPDATE 2-Teva's Lovenox copy nears approval; Momenta shrs fall

Tue Jan 25, 2011 11:54am EST

* Teva says FDA completes review of marketing application

* Momenta shares down 19 pct

* Teva up 3 pct (Adds analyst comments, details; updates share movement)

By Shravya Jain

BANGALORE, Jan 25 (Reuters) - Teva Pharmaceutical Industries' TEVA.O (TEVA.TA) copy of blood thinner Lovenox moved a step closer to approval, sending shares of the current generic maker of the drug, Momenta Pharmaceuticals (MNTA.O), tumbling 19 percent.

Momenta had in July got U.S. approval to sell its copy of Sanofi-Aventis' (SASY.PA) drug in partnership with Sandoz, the generic division of Swiss drugmaker Novartis AG (NOVN.VX).

"The near term impact would be severe as Momenta's commercial revenues are only coming from Lovenox and were Teva to launch its drug, the terms of the agreement with Sandoz dictate that Momenta would instead be paid a royalty than a profit share," Wedbush Securities analyst Duane Nash said.

He sees Momenta earning about $20 million a month in revenue from its Lovenox copy if Teva's version does not get approved and only about $5-$7 million a month if Teva's version get approval.

In the third quarter, Momenta collected $44.2 million from Lovenox sales.

On Tuesday, Teva said it got an action letter that indicates that the Food and Drug Administration has completed its review of the marketing application for the drug and sought response to a list of questions.

Teva said it plans to respond to the questions "in the near future."

Wedbush's Nash says Momenta will fare better in the longer term, with expectations of higher revenue from its generic version of Teva's blockbuster multiple sclerosis drug Copaxone.

"The trick for Momenta would be to hopefully have a delay (in Teva's Lovenox copy getting approved) until they can make more progress with the other assets," he said.

Momenta sued Teva alleging patent infringement in December. [ID:nN02130439]

Momenta shares were down 16 percent at $13.21 on Nasdaq, after touching a low of $12.81. Teva shares were up 3.34 percent at $54.42 on Nasdaq. (Reporting by Shravya Jain in Bangalore; Editing by Unnikrishnan Nair, Prem Udayabhanu)

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