Businessweek

Elan Corporation, plc operates as a neuroscience-focused biotechnology company. The company engages in the research, development, and commercial activities for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease, and autoimmune diseases, including multiple sclerosis (MS). Products Tysabri Tysabri is an alpha-4 integrin inhibitor and a therapy for MS, a neurological disorder involving central nervous system dysfunction among adults. Tysabri is approved in approximately 65 countries. Tysabri is approved in the United States as a monotherapy for relapsing forms of MS, for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In Europe, it is approved for relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS. In the United States, Tysabri is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to, tolerate conventional CD therapies and inhibitors of TNF-a. The company sells Tysabri primarily to drug wholesalers. Tysabri – Secondary Progressive MS: In 2012, the company and Biogen Idec, Inc. announced a global Phase 3b study, ASCEND, which is being conducted to evaluate the effectiveness of Tysabri as a treatment for secondary progressive MS. The trial is ongoing. ELND005 ELND005 is an orally bioavailable small molecule that is being investigated by the company for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes b-amyloid anti-aggregation and regulation of brain myo-inositol levels. A clinical program of Phase 1 and Phase 2 Alzheimer’s disease studies has been completed with ELND005 to support clinical development, including the published Phase 2 study ELND005-AD201 in Alzheimer’s disease. ELND005 – Bipolar Disorder: In 2012, the company commenced a Phase 2, placebo-controlled, safety and efficacy study of oral ELND005 as an adjunctive maintenance treatment in patients with Bipolar I Disorder (BPD 1) to delay the time to occurrence of mood episodes. BPD 1 is a severe form of bipolar disorder, also commonly known as manic depressive illness. ELND005 – Agitation/Aggression in Alzheimer’s Disease: In 2012, the company announced that it had enrolled the first patient in a Phase 2 clinical trial of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer’s disease. Dispositions In February 2013, the company sold Alkermes plc. Government Regulation The company is subject to Section 6002 of the Affordable Care Act, commonly known as the Physician Payment Sunshine Act, which regulates disclosure of payments to certain healthcare professionals and providers. Patents and Intellectual Property Rights Tysabri is covered by issued patents and pending patent applications in the United States and other countries. A primary U.S. patent covering the humanized antibody expires in 2020. Outside the United States, patents and pending patent applications covering Tysabri, methods of using Tysabri and methods of manufacturing Tysabri expire between 2013 and 2024. Competition Tysabri competes primarily with Avonex marketed by its collaborator Biogen Idec, Inc.; Betaseron marketed by Berlex (an affiliate of Bayer Schering Pharma AG) in the United States and sold under the name Betaferon by Bayer Schering Pharma AG in Europe; Rebif marketed by Merck Serono and Pfizer Inc. in the United States and by Merck Serono in Europe; Copaxone marketed by Teva Neurosciences, Inc. (Teva) in the United States and co-promoted by Teva and Sanofi-Aventis in Europe; and Novartis AG’s Gilenya, an oral treatment for relapsing MS. History Elan Corporation, plc was founded in 1969. The company was incorporated in Ireland in 1969.