MNTA - Two Articles I Consider Extremely Bullish for Imminent Approval of mL.
DAVOS-Sanofi CEO says braced for generic Lovenox
Wed, Jan 27 2010
* Lovenox not part of the future at French drugmaker
* Sanofi will be "extremely vigilant" on generic safety
* CEO says not interested in Germany's Ratiopharm
By Ben Hirschler
DAVOS, Switzerland, Jan 27 (Reuters) - Sanofi-Aventis <SASY.PA> is already anticipating the arrival of generic forms of its blockbuster anticoagulant Lovenox and doesn't view the drug as part of the company's future, its CEO said on Wednesday.
The French group's rival Novartis <NOVN.VX> hopes to win U.S. approval soon for its copy of Lovenox and worries about an imminent launch have knocked Sanofi shares in recent days.
"It will have a hit on sales but for us it (Lovenox) is not a growth platform for the future," Chris Viehbacher told Reuters on the sidelines of the World Economic Forum.
"Lovenox isn't part of the future of the company ... and we essentially built into our 2013 guidance the appearance of a non-substitutable generic. If there weren't a generic for Lovenox it would be an upside for the business."
There has been mounting speculation in the past week that Novartis's generics unit Sandoz and its partner Momenta Pharmaceuticals <MNTA.O> are gearing up to launch a generic form of the drug, which sells some $4 billion a year worldwide.
Along with Novartis/Momenta, others seeking approval for a generic Lovenox include Teva Pharmaceutical Industries <TEVA.TA> and a partnership of Watson Pharmaceuticals <WPI.N> and privately held Amphastar Pharmaceuticals.
Lovenox is a complex biological drug and Viehbacher said authorities would have to look long and hard to ensure any copy delivered the same safety and efficacy as the original.
"We are certainly going to be extremely vigilant on all the safety issues," he said.
UPDATE 2-Novartis says on track with generic Lovenox
Fri, Jan 22 2010
* 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 <NOVN.VX> said on Friday it was making progress with a generic copy of Sanofi-Aventis SA's <SASY.PA> 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 <MNTA.O> 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 <TEVA.TA> and a partnership of Watson Pharmaceuticals Inc <WPI.N> 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.
AI
