Molecular Biosystems has received approval from the US Food and Drug Administration to sell Albunex to improve contrast in echocardiography. It is the first contrast agent to be approved for ultrasound there, and will be sold by Mallinckrodt. About 10 million echocardiograms are performed annually in the USA, and a significant proportion of these could be enhanced by the use of Albunex, said MB. The drug is injected intravenously and travels to the heart where it makes first the right and then the left chambers of the heart opaque to ultrasound waves, improving the definition of the ultrasound image.
Shares in MB rose on the approval, but analysts expressed surprise at this because the approval has been anticipated since April, when MB received an "approvable" letter from the FDA. Analysts also noted that other ultrasound contrast agents will soon be approved. Sven Borho of Mehta & Isaly said the market for ultrasound contrast agents could reach $500 million-$1 billion by the end of the decade, but that Albunex' potential share is limited by both the compound's characteristics and the pending entry of competing products.
Mr Borho noted that Albunex is a first-generation product with a very short half-life, enhancing the image for just 12 seconds. Longer-lasting and more general- purpose agents are coming from Schering and Sonus, he said. While it is good that Albunex has reached the market first, it is not going to be the product which drives the market, said Mr Borho. It has been launched in Japan for three quarters but has not performed as well as expectations.
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