National Editor

Providing solid cash backbone for its ongoing Phase III trial with a therapy for spinal cord injury, Acorda Therapeutics Inc. said it raised $55.3 million in the third largest U.S. biotechnology financing this year.

"We were already well funded, but this gives us the opportunity to plan our business on at least a three-year basis," said Mark Pinney, chief financial officer of Hawthorne, N.Y.-based Acorda.

He declined to say how much cash the privately held company has, but noted the Acorda's Series I financing more than two years ago, a $33.7 million round that left the firm with $48 million on hand. (See BioWorld Today, Jan. 10, 2001.)

"We still have resources from that," Pinney said.

Acorda's lead product is Fampridine-SR, in Phase III studies for spasticity in spinal cord injury patients and in Phase II against multiple sclerosis. Secondary endpoints in the Phase III study include bladder, bowel and sexual function.

The trial has two arms, with 180 patients in each arm.

"We're expecting to get data at the end of the year or early into the first quarter" of next year, Pinney said.

The drug is an oral, sustained-release formulation of 4-aminopyridine, a potassium channel blocker aimed at channels in demyelinated nerves. Myelin is the fatty, proteinaceous, membrane sheath that wraps around the axons of nerve fibers. Fampridine-SR is designed for twice-daily dosing.

In the MS trial, the drug is being tested for safety and efficacy in treating impaired walking and improving leg strength.

"Based on the data we're aware of, a compound like this might suitably be complementary to the ABCR drugs," Pinney told BioWorld Today. The ABCRs consist of Avonex (interferon beta-1a), from Biogen Inc., of Cambridge, Mass.; Betaferon/Betaseron (interferon beta-1b), from Berlex Laboratories Inc., of Montville, N.J., and Chiron Corp., of Emeryville, Calif.; Rebif (interferon beta-1a), from Geneva, Switzerland-based Serono SA; and Copaxone (glatiramer acetate for injection), from Teva Pharmaceuticals Industries Ltd., of Jerusalem.

Acorda also has a pair of technologies for renewing myelin. One approach involves a class of remyelinating monoclonal antibodies. Another uses a neuregulin, glial growth factor 2 (GGF2). Both are in preclinical development.

"We hope to move GGF2 into the clinic next year," Pinney said. "We've also been working for some time on a compound called M1, [a monoclonal antibody] which has similar effects, for people with MS."

Licensed from the Mayo Clinic in Rochester, Minn., M1 is at a "roughly similar" stage as GGF2, though the latter is likely to go into the clinic first, "to be fiscally prudent," Pinney said.

The company also has an exclusive, worldwide license to neuregulin 2, which has shown promise in repairing nerves and is in the early stages of development.

"We have a very active in-licensing program under way," Pinney said. "We're earnestly looking to expand our late-stage pipeline with a central nervous system therapeutic," on which Phase I and Phase II trials have been completed.

"We've been in negotiations on a number of different fronts," he said, and expect to disclose progress on that front "through the balance of this year."

The latest private venture round was led by Easton Hunt Capital Partners, of New York. Other major investors were ABN AMRO Capital, of Amsterdam, the Netherlands; Cross Atlantic Partners, of New York; JP Morgan Fleming Asset Management, of New York; and Techno Venture Management, of Boston.

Pinney said the company is "very excited by the way our venture capital relationships have expanded," with strong representation from new and old investors.

"I'm not seeing evidence of an [initial public offering] window opening in the foreseeable future," he said. "There may be other hybrid financing techniques, but for the most part, the venture capital route is the way for us to go."