In an arrangement that grants first negotiation rights to its lead product as well, Acorda Therapeutics Inc. entered a co-development and co-promotion deal with Teva Pharmaceutical Industries Ltd. for the anticonvulsive agent valrocemide.
"It has completed a small early Phase II study," said Tierney Saccavino, director of corporate communications for privately held Acorda, of New York. Twenty-one patients were tested in Europe, and "we'll be looking to ramp up the Phase II program in 2004," she added.
Financial terms were not disclosed.
Valrocemide - described as a broad-spectrum drug with potential in treating epilepsy, bipolar disease and neuropathic pain - was developed in cooperation with Yissum Research and Development Company of the Hebrew University of Jerusalem, where Teva also is located.
The drug has been selected by the epilepsy branch of the National Institutes of Health in Bethesda, Md., as a candidate with potential and is being pursued in that indication first.
Meanwhile, Acorda's front-runner is Fampridine-SR for chronic spinal cord injury and multiple sclerosis. An oral, sustained-release formulation of 4-aminopyridine, it's a twice-daily potassium channel blocker aimed at the channels in demyelinated nerves. Myelin is the fatty, proteinaceous membrane sheath that wraps around the axons of nerve fibers.
Fampridine-SR is in Phase III trials to evaluate its efficacy in relieving spasticity in people with chronic SCI. Secondary endpoints include bladder, bowel and sexual function. The trial has two arms, with 180 patients in each arm. The drug also is in Phase II trials testing how much it improves walking and muscle strength in MS.
"We'll be expecting data [from Phase II and Phase III trials] staggered through the last part of the first quarter of 2004," Saccavino said. Further back in the pipeline are two preclinical products for remyelination in MS.
Fampridine-SR was "a component" in the talks regarding valrocemide, she said. "Teva expressed some interest if we pursue a marketing partner," she said. "We were delighted because they're such a force in MS marketing."
Teva has the "C" drug in the ABCR regimen that often is used to treat MS: Copaxone (glatiramer acetate for injection). Others are 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.; and Rebif (interferon beta-1a), from Geneva, Switzerland-based Serono SA.
Teva's stock (NASDAQ:TEVA) fell $1.76 Wednesday to close at $58.17.