OTTAWA, Sept 4 (Reuters) - Canadian biotechnology company BioMS Medical Corp
(MS.TO: Quote, Profile, Research, Stock Buzz) 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: Quote, Profile, Research, Stock Buzz) 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.
