Israel-based Teva Pharmaceutical announced today that the FDA has granted the Fast Track designation to laquinimod, its investigational treatment for relapsing-remitting multiple sclerosis (RRMS). Laquinimod is a once-daily treatment administered orally. Teva licensed the compound from Swedish developer Active Biotech in 2004.
The first phase III clinical trials--Allegro--were completed in November 2008 and Teva is now enrolling patients globally for Bravo, the second Phase III study. Teva said that with the FDA's decision, the drug could enter the market as soon as late 2011. "We are pleased that the FDA has awarded laquinimod with a Fast Track designation, and are hopeful it will be part of our growing portfolio of innovative therapies," Moshe Manor, Vice President, Global Innovative Resources Group at Teva, said in a statement.
Shares of Teva rose 75 cents to $43.88 in afternoon trading on Thursday, while Active Biotech's shares jumped $3.40 to $38.30.
- read the Teva release
ALSO: It seems that Teva is trying to make 2009 the year of generics. The company's new campaign, "Year of Affordable Healthcare," employs social media--including YouTube, Twitter and possibly Second Life-- and various other tools to build its largest ever PR campaign. Teva tells PRWeek that 2009 is "a critical year for the future of both healthcare in America and the generic drug industry." Report