Full Description

Acorda Therapeutics, Inc. (Acorda), incorporated in 1995, is a commercial-stage biopharmaceutical company engaged in the identification, development and commercialization of therapies that improve neurological function in people with multiple sclerosis (MS), spinal cord injury (SCI), and other disorders of the central nervous system (CNS). The Company’s marketed product, Zanaflex Capsules, is approved by the United States Food and Drug Administration (FDA) for the management of spasticity. The Company’s product candidate Fampridine-SR, has completed two positive Phase III clinical trials for the improvement of walking ability in patients with MS. The research and development programs for the Company include Remyelination Programs and Chondroitinase Program.

Zanaflex Products

Zanaflex Capsules and Zanaflex tablets are short-acting drugs approved by the FDA for the management of spasticity. These products contain tizanidine, one of the two treatments for the management of spasticity. During the year ended December 31, 2008, there are 12 generic versions of tizanidine tablets on the market. The clinical trials conducted by Elan Pharmaceuticals, Inc. (Elan) demonstrated that Zanaflex Capsules, when taken with food, produce average peak levels of tizanidine in a person's blood that are lower and rise more gradually compared to the peak levels following a similar dose of the tablet form. Zanaflex Capsules are available in two milligram, four milligram and six milligram doses, while tablet formulations are only available in two milligram and four milligram doses.

Fampridine-SR

Fampridine-SR is a small molecule drug contained in a sustained-release tablet form. Laboratory studies have shown that fampridine, the active ingredient in Fampridine-SR, improves impulse conduction in nerve fibers in which the myelin sheath has been damaged. Fampridine is not currently FDA-approved for use in MS or any other indications. Fampridine-SR is a sustained release formulation of fampridine that produces lower peak and more sustained blood levels than immediate-release formulation. The Company have conducted a series of clinical trials to establish the safety, pharmacokinetics and optimal dosing of Fampridine-SR in MS and SCI, as well as to assess its efficacy. The second Phase III clinical trial (MS-F204) was initiated in March 2007.

Remyelination Programs

The remyelination programs include two distinct therapeutic approaches to stimulate repair of the damaged myelin sheath in MS, neuregulins/GGF2 and remyelinating antibodies. These two approaches address remyelination by different and complementary routes. Both programs require finalizing production of clinical-grade material and completion of preclinical toxicology tests before moving into clinical development.

The neuregulins form a family of growth factors related to epidermal growth factor. These molecules bind to erbB receptors, which translate the growth factor signal to the cell and cause changes in cell growth, protein production and gene expression. Neuregulins have been shown in published studies to have a range of effects in protection and repair of cells both in the nervous system and in the heart.

Neuregulins covered in the portfolio from CeNeS Pharmaceuticals plc. (CeNeS) have a number of potential applications. Neuregulins and their erbB receptors are essential for cardiac development and have been shown to protect cardiac muscle cells from stressors that can lead to congestive heart failure, including myocardial infarction. Additionally, neuregulins have been shown to protect the heart and brain from the toxicity of commonly used chemotherapeutic agents, such as anthracyclines. The remyelinating antibodies program is based on research performed at Mayo Foundation for Medical Education and Research (Mayo Clinic).

Chondroitinase Program

The Company has developed a program based on the concept of breaking down the matrix of scar tissue that develops as a result of an injury to the CNS. The Company is conducting a research program to develop second generation approaches to overcoming the proteoglycan matrix. These include enzyme molecules and alternative approaches to blocking matrix formation.