| From the preliminary S-1:
Acorda Therapeutics is a late-stage biopharmaceutical company dedicated to the identification, development and commercialization of novel therapies that improve neurological function in people with spinal cord injury, multiple sclerosis and related disorders of the central nervous system, or CNS. Our current product candidates target the treatment of a wide range of disorders affecting individuals with chronic spinal cord injury, referred to as SCI, and multiple sclerosis, referred to as MS, including spasticity, muscle weakness, loss of bowel and bladder control and sexual dysfunction.
Approximately 500,000 people in the United States suffer from SCI and MS and we believe that the combined annual cost of treatment for these conditions exceeds $9 billion. Our goal is to become a fully integrated biopharmaceutical company commercializing multiple therapeutic products for these large and underserved markets while continuing to augment our product pipeline and to identify new applications for our core technologies.
Our Product Candidates
Our lead product candidate, Fampridine-SR, is an oral, small molecule drug contained in a sustained release tablet form. Laboratory studies have shown that fampridine, the active molecule of Fampridine-SR, improves impulse conduction in nerve fibers in which the insulating layer of the spinal cord, called myelin, has been damaged. This damage may be caused by physical trauma, in the case of SCI, or by the body's own immune system, in the case of MS. We are developing Fampridine-SR for use by people with SCI or MS.
Clinical trials of Fampridine-SR are the first, to our knowledge, that have demonstrated improved neurological function in people with chronic SCI or MS. In cooperation with Elan Corporation plc, or Elan, we have conducted a series of clinical trials during the past six years evaluating Fampridine-SR. Approximately 550 people have been treated with Fampridine-SR in 14 clinical trials, including eight clinical trials for SCI and six clinical trials for MS. In Phase 2 clinical trials, treatment with Fampridine-SR has been associated with a variety of neurological benefits in people with SCI or MS.
We are currently conducting two Phase 3 clinical trials in people with SCI for the reduction of muscle stiffness, referred to as spasticity, and one late Phase 2 clinical trial in people with MS for the improvement of walking speed. Our goals are to submit a New Drug Application, or NDA, to the United States Food and Drug Administration, or the FDA, for Fampridine-SR for the treatment of spasticity in SCI in 2004 and for the treatment of lower extremity motor dysfunction in people with MS in 2005. We plan to commercialize Fampridine-SR ourselves in the United States and Canada and with partners in various other markets throughout the rest of the world. We have received Orphan Drug designation from the FDA for Fampridine-SR for the treatment of both SCI and MS.
Our second most advanced product candidate is valrocemide, which is currently in Phase 2 clinical trials for the treatment of epilepsy. Valrocemide is a small molecule drug with early Phase 2 clinical evidence of safety and efficacy as an add-on therapy for partial seizures, a type of epilepsy, and pre-clinical evidence of activity in animal models of epilepsy and neuropathic pain. We plan to move valrocemide into late Phase 2 clinical trials for epilepsy and early Phase 2 clinical trials for bipolar disorder in 2004. We may also pursue
clinical development of valrocemide for the treatment of neuropathic pain. Valrocemide is being co-developed and co-promoted with Teva Pharmaceutical Industries Ltd., or Teva, and its affiliates in the United States.
We have a robust pipeline of pre-clinical programs targeting neurological dysfunction. These programs include two distinct myelin restoring therapies, Glial Growth Factor 2, which we refer to as GGF-2, and remyelinating antibodies. GGF-2 has been shown in various published studies to stimulate remyelination in animal models of MS and to have a variety of other effects in neural protection and repair. Our remyelinating antibody program involves monoclonal antibodies that have demonstrated the ability to stimulate repair of myelin in three different animal models of MS. We have also developed a chondroitinase program based on the concept of breaking down scar tissue that forms as a result of injury, which is believed to limit the regeneration of nerve fibers in the CNS. In addition, we have initiated a regenerative antibody program to identify novel approaches to stimulate nerve fiber regeneration in CNS. To support our research and development efforts, we have substantial laboratory capabilities employing both tissue culture methods and predictive animal models of SCI repair. These capabilities allow us to rapidly screen and validate potentially useful therapeutic approaches to SCI.
Our product development programs include a patent portfolio comprised of 24 U.S. patents and 40 U.S. patent applications and numerous foreign counterparts, of which we are the assignee or have in-licensed.
Our Focus
Our core initial focus on the development of treatments for SCI has led, and we believe will continue to lead, to the identification and development of therapies applicable to other CNS disorders. Since many of the mechanisms of tissue damage and repair in SCI are shared by other conditions, such as MS, stroke and traumatic brain injury, our core technologies have potentially broad applicability for these and other CNS indications.
Our strategy is to focus on the identification, development and marketing of a broad range of CNS therapeutics, using our scientific and clinical expertise in SCI as a strategic point of access. In order to implement this strategy, we plan to pursue the following initiatives:
complete the clinical development of, and obtain regulatory approval for, Fampridine-SR in SCI, MS and other neurological disorders;
complete the clinical development of, and obtain regulatory approval for, valrocemide in epilepsy, bipolar disorder and other neurological disorders;
continue to develop and advance our pipeline of other product candidates and programs to treat neurological disorders;
continue to in-license preclinical and clinical programs;
expand sales and marketing capabilities; and
pursue additional commercial alliances.
To keep us apprised of the latest technological advances and help us identify and evaluate business development opportunities, we have established an advisory team and network of well-recognized scientists, clinicians and opinion leaders in the fields of SCI and MS. In addition, we have recruited 80 SCI rehabilitation centers and 24 MS rehabilitation centers in the United States and Canada to conduct our clinical trials. Our clinical management team has extensive experience in the areas of SCI and MS and works closely with this network. |
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