September 4, 2008 / 12:26 PM / 10 years ago

UPDATE 2-BioMS multiple sclerosis drug gets FDA fast track

(Adds detail. Figures in U.S. dollars unless noted)

OTTAWA, Sept 4 (Reuters) - Canadian biotechnology company BioMS Medical Corp MS.TO said on Thursday its lead drug for the treatment of multiple sclerosis was granted fast-track designation from the U.S. Food and Drug Administration.

Fast-track designation could help development and speed the review process of dirucotide, for the treatment of secondary progressive MS, now being evaluated in a U.S. Phase 3 trial.

The designation is reserved for products intended to treat serious or life-threatening conditions with the potential to address unmet medical needs. Multiple sclerosis is caused by an immune attack against normal components of the central nervous system.

About 510 patients have been recruited for the company’s U.S. trial at 68 sites and will receive either dirucotide (MBP8298) or a placebo intravenously every six months for two years.

BioMS signed a licensing and development deal with Eli Lilly (LLY.N) in December for dirucotide, sending its shares 50 percent higher.

The arrangement gives Lilly worldwide rights to dirucotide and BioMS an upfront payment of $87 million with potential milestone payments of up to $410 million and escalating royalties on sales if the drug is approved.

The companies said they would collaborate on development of dirucotide, with Lilly responsible for future research and development, manufacturing and marketing.

BioMS Chief Executive Kevin Giese told Reuters that it hoped for approval of the compound in Canada and Europe by 2011 and in the United States by 2012.

Shares in BioMS closed at C$3.21 on the Toronto Stock Exchange on Wednesday. So far this year, the stock has dropped about 19 percent. ($1=$1.06 Canadian) (Reporting by Susan Taylor, Editing by Frank McGurty)

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