Business And Finance In Brief

Executive Summary

FDA approves Novartis' Extavia for MS: FDA approved on Aug. 17 Novartis' first multiple sclerosis drug Extavia, a branded version of interferon beta-1b, which is sold by Bayer Schering as Betaseron. The approval will enable Novartis to gain experience in the MS market as it prepares to commercialize its more important oral therapy fingolimod (FTY720) (1"The Pink Sheet," Feb. 2, 2009). The drug maker says it will price Extavia lower than other first-line injectable disease-modifying therapies for MS, though it had not released specifics as of Aug. 21. Extavia is approved for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations and also is indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging (MRI). Novartis gained rights to interferon beta-1b from Bayer Schering. It expects to launch Extavia this fall, backed by a patient support program as well as access to a nurse helpline, one-on-one injection training and assistance with insurance coverage