AstraZeneca suffered further pipeline setback as the company stops development of its motavizumab drug for the prevention of a serious respiratory disease that affects babies. The company says it will withdraw its pending application for approval and take a charge of $445 million in the fourth quarter. The U.K. drug maker said on Tuesday that the charge would be excluded from “core” earnings and therefore had no impact on guidance for 2010 earnings.
Motavizumab, a humanized monoclonal antibody, was being developed by AstraZeneca’s MedImmune unit for the prevention of respiratory syncytial virus (RSV) infection in high-risk infants. The condition affects around 125,000 infants in the United States each year. Almost all babies have been infected at least once with RSV by their second birthday, often causing bronchitis or pneumonia, according to the U.S. Centers for Disease Control and Prevention.
FDA adviser panel had said they were concerned Motavizumab’s link to allergic reactions and the effectiveness of the new drug to be only as good in reducing RSV hospitalisations as AstraZeneca’s current therapy- Synagis. Motavizumab was designed to replace Synagis before its patent expires in 2015. The U.S. regulator asked in June for more data and AstraZeneca had already indicated that if it ceased development of motavizumab, it would incur a charge of $445m.
AstraZeneca acquired both medicines in 2007 with its $15.2 billion purchase of U.S.- based MedImmune.