US FDA approves Xolair
Years of drug development by and legal bickering among a trio of disinclined collaborators finally ended happily when the US Food and Drug Administration (FDA; Rockville, MD) approved Xolair (omalizumab), a humanized monoclonal antibody for the treatment of allergic asthma, on June 20. Xolair, which blocks immunoglobulin E, is the first product approved in the US for Tanox (Houston, TX, USA), a company with $223.1 million in cash and a $30 million burn rate. Although Xolair was approved in Australia in June 2002, the US market is much larger and could generate $750 million annually in sales. Xolair will be comarketed by Genentech (S. San Francisco, CA, USA) and Novartis AG (Basel, Switzerland), and Tanox will receive 10% of sales. Xolair's development has a long, troubled history, highlighted by Tanox's successful lawsuit against Genentech for theft of trade secrets in 1993, after which the three companies agreed to go forward with the antibody that eventually became Xolair. According to Wendell Ray Guffey, Tanox's vice president of intellectual property, the Xolair saga reinforces the importance of maintaining absolute control over confidential information. PL
This is a preview of subscription content, access via your institution