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Friday, 01/22/2010 1:15:02 PM

Friday, January 22, 2010 1:15:02 PM

Post# of 257253
NOVARTIS-SANOFI/LOVENOX (UPDATE 2)* Swiss group says has resolved issues faced in past

* Aims to launch generic as soon as gets FDA approval

* Sanofi shares down 1.5 percent

* Momenta shares rise 13.3 percent

(Adds Momenta shares, analyst comments)

LONDON, Jan 22 (Reuters) - Switzerland's Novartis AG said on Friday it was making progress with a generic copy of Sanofi-Aventis SA's blockbuster anti-clotting drug, Lovenox, after an analyst said Novartis was gearing up to launch its version.

The shares of Novartis partner Momenta Pharmaceuticals Inc soared more than 13 percent.

"We aspire to launch as soon as we get FDA (U.S. Food and Drug Administration) approval. We believe we have satisfactorily resolved each of the specific issues we've faced in the past," spokesman Eric Althoff said in response to a report that a launch could be imminent.

Sanofi shares fell 1.1 percent in Paris on concerns about future sales of its key drug, after broker Sanford Bernstein said U.S. approval for a generic version of the $4 billion-a-year product may be close. Novartis shares were up 0.1 percent.

Bernstein said it had learned that Novartis' generic Sandoz division was setting prices and soliciting pre-orders from U.S. purchasers for its generic form of Lovenox, or enoxaparin.

"This covert action suggests Novartis believes approval of its generic might finally be nearing," analyst Tim Anderson said in a note.

About 60 percent of Lovenox sales come from the United States, Anderson said.

"It has long been uncertain whether or when generics to Lovenox might get approved and, just because Novartis is doing this, does not mean they have certain approval," Anderson said. "It would, however, suggest that the odds of approvability are rising."

Anderson's note and Novartis' subsequent comments were driving Momenta stock higher on hopes the approval of generic Lovenox was imminent, said Canaccord Adams analyst Ritu Baral.

The drug would be Momenta's first marketed product, said Baral, who has expected a first-quarter approval.

Along with Novartis/Momenta, others seeking approval for a generic Lovenox include Teva Pharmaceutical Industries Ltd and a partnership of Watson Pharmaceuticals Inc and privately held Amphastar Pharmaceuticals.

Baral said a contamination controversy a couple of years ago over heparin, a material used in producing enoxaparin, led to considerable delays in the companies winning approval for generic Lovenox.

"That's why this has been a rather epic saga," Baral said.

Momenta shares were up $1.79, or 13.3 percent, at $15.21 trading on Nasdaq. (Reporting by Ben Hirschler and Sam Cage; additional reporting by Lewis Krauskopf in New York; editing by Andre Grenon

http://www.forexyard.com/en/news/Novartis-says-on-track-with-generic-Lovenox-2010-01-22T174800Z-UPDATE-2

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