 |
UPDATE: Novartis' Generic Lovenox Launch In 2008 Still Possible |
|
| Monday April 21st, 2008 / 15h03 |
|
|
|
(Adds detail)
ZURICH -(Dow Jones)- Novartis AG (NVS) said Monday that significant hurdles remain for launching its generic version of Sanofi-Aventis SA's (SNY) thrombosis drug Lovenox, but that a launch this year is still possible.
"It is always difficult to predict the timing of an FDA approval," said Andreas Rummelt, chief executive of Sandoz, the generics company that's fully owned by Novartis. "But a launch in 2008 is still possible," he added.
Novartis' CEO Daniel Vasella added, that if not in 2008, the drug will be launched in 2009.
Among the obstacles is a pending reply to the U.S. Food and Drug Administration's so-called deficiency letter, which Novartis plans to send in early May, Rummelt said.
Also, an appellate court decision on enoxaparin -the generic name of Lovenox -is still pending. This generic challenge to the Lovenox patent comes jointly from Teva Pharmaceutical Industries Ltd. (TEVA) and Amphastar Pharmaceuticals.
Launching enoxparin in the U.S. is key for Sandoz, which saw U.S. sales decline 2% in local currencies in the first quarter because it didn't launch any important products this year.
"Our growth rates in the U.S. depend on generic Lovenox and metaxalone," Rummelt said.
Metaxalone is the generic name of Skelaxin, a muscle relaxant sold by King Pharmaceuticals (KG) of Bristol, Tenn.
Company Web site: www.novartis.com
-By Anita Greil, Dow Jones Newswires; +41 43 443 8044 ; anita.greil@dowjones.com
|
|
| Monday April 21st, 2008 / 15h03 |
Source : Dowjones Business News |
|
|
|
|
|
|
