June 2 (Bloomberg) -- AstraZeneca Plc failed to win a U.S. panel’s backing to introduce an improved version of its $1 billion-a-year medicine to prevent a respiratory disease that sends 125,000 babies to hospitals each year.
Outside advisers to the Food and Drug Administration recommended against approval of motavizumab for children at risk for complications from respiratory syncytial virus in a 14-3 vote today in Silver Spring, Maryland. While the FDA usually follows the advice of its panels, it isn’t required to do so.
The product was designed to replace Synagis, an older drug for the same virus, before it loses patent protection in 2015. AstraZeneca, based in London, acquired both medicines in its 2007 purchase of MedImmune Inc., a U.S. maker of flu vaccines and biologic drugs. The panel was concerned that motavizumab was linked in studies to more allergic reactions and wasn’t proven to be have any benefit over Synagis.
“We do not know what the true risk is and there’s a signal that it could be significant,” said panel member Michelle Roland, chief of the Office of AIDS at the California Department of Public Health in Sacramento. “Are we comfortable advising you to take the chance of figuring it out in the real world or do we want to error on the side of caution?”
American depositary receipts of AstraZeneca, each representing one ordinary share, rose $1.28, or 3 percent, to $43.59 at 4:01 p.m. in trading on the New York Stock Exchange.
Seeking New Products
AstraZeneca needs new products as its three biggest medicines prepare for generic competition in the next four years. MedImmune has so far failed to meet its stated goal of introducing one new product every year.
Motavizumab was submitted for approval in 2008, and the FDA had undisclosed questions about the application that took AstraZeneca more than a year to answer. Additional concerns raised by FDA staff in a report released last week suggested to investors that today’s meeting may have a negative outcome, said Jeffrey Holford, an analyst at Jefferies International Ltd. in London.
“Market expectations may have to be scaled back as some may have speculated that AstraZeneca could have launched a new superior product at a higher price to drive franchise sales ahead,” Holford said yesterday in a note to clients.
Synagis was approved in 1998 as the nation’s first antibody derived from a single clone of cells targeting infectious disease. The drug brought in $1.08 billion in sales last year.
Common Infection
Almost all babies have been infected at least once with the respiratory syncytial virus by their second birthday, often causing bronchitis or pneumonia, according to the U.S. Centers for Disease Control and Prevention.
Synagis and motavizumab were designed to prevent the virus in high-risk children, including babies born prematurely. Babies with chronic lung disease or congenital heart disease, or with weakened immune systems, also have a greater chance of developing severe illness from the virus.
AstraZeneca said Dec. 24 that it replied to the agency’s concerns with its motavizumab application. The FDA usually takes six months to review these responses and issue a decision.
--Editors: Lisa Rapaport, Andrew Pollack
To contact the reporter on this story: Catherine Larkin in Silver Spring, Maryland, at clarkin4@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
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