Hawthorne, NY July 28, 2004 – Acorda Therapeutics announced today that it has acquired rights to Zanaflex® (tizanidine) from Elan Pharmaceuticals, Inc., a subsidiary of Elan Corporation, plc (NYSE: ELN). Under the terms of the agreement, Acorda has acquired all sales, marketing and distribution rights in the United States to the Zanaflex® tablet, which is currently on the market, as well as to a new, FDA-approved capsule formulation. Elan will supply Acorda with the capsule, for which Elan has retained manufacturing rights. Financial terms were not disclosed.
Ron Cohen, M.D., President and CEO of Acorda, commented, “We are delighted to be able to bring a recognized spasticity treatment to people with spinal cord injuries or multiple sclerosis, as well as to those with related conditions such as traumatic brain injury and stroke. Zanaflex® is an ideal strategic fit for Acorda, given our expertise and ongoing clinical and research programs in these therapeutic areas. It launches the commercial stage of the company and extends our commitment to deliver therapies to the spinal cord injury and multiple sclerosis communities.”
David Apple, Jr., M.D., Medical Director of the Shepherd Center in Atlanta, Georgia, said, “Spasticity is one of the most common and disabling conditions associated with spinal cord injury and multiple sclerosis, and Zanaflex® is an important treatment for this serious quality of life problem. The new capsule formulation increases physicians' options in managing this condition.” The National Institute on Disability and Rehabilitation Research (NIDRR) has designated the Shepherd Center as one of the 16 Model Systems Centers of Care for the treatment of spinal cord injury.
About Zanaflex® (tizanidine)
Zanaflex® is indicated for the management of spasticity. It is thought to reduce spasticity by blocking nerve impulses through pre-synaptic inhibition of motor neurons, resulting in decreased spasticity without a reduction in muscle strength.
Zanaflex® is approved in tablet and capsule formulations. The tablet is available in 2mg and 4mg strengths. The multi-particulate capsule formulation has received FDA approval and will be available in 2mg, 4mg and 6mg strengths. Acorda plans to launch the capsule formulation in early 2005.
The new Zanaflex® capsule formulation can give physicians and patients greater flexibility in managing spasticity. The capsule has a different pharmacokinetic profile than the tablet when taken with food. Some patients may find capsules easier to take than tablets and, for patients who have an impaired ability to swallow, a capsule offers the opportunity to sprinkle the particles in liquids or soft foods. In addition, the 6mg dose, which is not available in the tablet form, may provide the opportunity for patients to take fewer pills per day. The most frequent adverse events reported by patients taking Zanaflex® are dry mouth, sedation, asthenia and dizziness, and are most often considered mild to moderate.
About Spasticity
Spasticity refers to the often painful involuntary tension, stiffening or contractions of muscles. This condition occurs when the nerve cells in the spinal cord become disconnected from controlling centers in the brain, and therefore transmit unregulated impulses to the muscles. Spasticity is common in neurological disorders where portions of the nervous system that control voluntary movement have been damaged, such as spinal cord injury (SCI), multiple sclerosis (MS), stroke and traumatic brain injury. Up to 75% of people with chronic SCI, and the majority of people with MS, experience some form of spasticity. While the incidence of spasticity is not known with certainty, it is estimated to affect over half a million people in the United States alone, and over 12 million worldwide.
About Acorda Therapeutics
Acorda Therapeutics, a privately-held biotechnology company, is developing therapies for SCI, MS and related nervous system disorders. In addition to Zanaflex®, the Company's lead clinical-stage product is Fampridine-SR, which is being developed in human clinical trials for both MS and SCI. The Company's clinical pipeline also includes valrocemide, which it is developing with Teva Pharmaceutical Industries Ltd. for the treatment of epilepsy and bipolar disorder. Acorda's preclinical pipeline includes multiple products for regeneration and repair of the spinal cord and brain.