SangStat Gets Favorable Ruling In Novartis SangCya Flap
Dow Jones Newswires
3/31/2000
FREMONT, Calif. -- SangStat Medical Corp. (SANG) said a British court upheld the U.K. marketing authorization of its SangCya product, thwarting Novartis AG's (Z.NOV) attempt to have the approval revoked.
In a press release Friday, biopharmaceutical company SangStat said Novartis has been trying to have the the U.K. marketing authorization of its SangCya Oral Solution cyclosporine product overturned.
SangCya is used to prevent organ transplant rejection.
The court ruled that the U.K.'s Medicines Control Agency acted properly in granting SangCya's approval, and it ordered Novartis to pay the agency's legal costs in defending the action.
SangStat said the British court also denied Novartis' request to appeal its decision.
The SangCya drug, the generic equivalent of Novartis' Neoral product, has been sold in the U.K. since April, 1999.
The Food and Drug Administration approved SangCya as a drug equivalent in October, 1998, and Novartis subsequently sued the FDA.
In part of that suit, Novartis fought against the requirement that it change the labeling of its Neoral drug after SangCya's approval.
As reported in December, 1999, a U.S. district court ruled against Novartis' motion for a preliminary injunction related to the labeling issue.
In February, 1999, Switzerland-based Novartis sued SangStat for patent infringement in the U.S. and later brought a similar suit in the U.K.
Novartis representatives weren't immediately available for comment.
Will cut into profits, but not sure how much.
Jack |
