AstraZeneca’s (AZN) biologics unit, MedImmune, recently announced that the Antiviral Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted against the approval of motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.
Motavizumab is a next-generation product that is being developed to drive sales of the company’s RSV franchise. Synagis, a monoclonal antibody for the prevention of respiratory syncytial virus in children, is the key product in the company’s RSV franchise. Synagis sales totaled $1.1 billion in 2009.
The timely approval of motavizumab would have helped accelerate sales of the Synagis/motavizumab franchise for the 2011/2012 RSV season. However, the regulatory process for motavizumab has been rocky.
AstraZeneca has already received a Complete Response Letter for the candidate in December 2008 and we believe that the chance of gaining approval at the upcoming FDA action date is bleak given the concerns raised by the agency regarding side effects and lack of sufficient data. While the FDA is not required to follow the committee’s advice, it usually does so.
Besides motavizumab, AstraZeneca has other candidates in its pipeline that are being developed for RSV. These include vaccines like MEDI-534, MEDI-560, and MEDI-559 among others.
RSV is a common respiratory infection occurring during infancy or childhood. It is the leading cause of lower respiratory tract infections in infants in the United States. It is estimated that up to 125,000 infants are hospitalized with severe RSV infections in the U.S.
The successful development and launch of AstraZeneca’s RSV pipeline candidates would help drive sales of the Infection franchise which came in at $2,631 million in 2009.
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