The FDA has granted approval of Molecular Biosystems Inc.'sultrasound contrast imaging agent for diagnosis of heart disease,sending the San Diego-based company's stock up 26 percent Monday.Molecular Biosystems developed the imaging agent, called Albunex,and will market it in the U.S. under an agreement with MallinckrodtGroup Inc., of St. Louis.With FDA approval, Molecular Biosystems receives milestonepayments of $8 million from Mallinckrodt and $700,000 from Norway-based Hafslund Nycomed AS, which has manufacturing and marketingrights for Albunex in Europe.The imaging agent is registered in Sweden and Nycomed is seekingapproval in the U.K. Albunex also is on the market in Japan, where it isdistributed by Shionogi & Co. Ltd.Under terms of the agreement with Mallinckrodt, MolecularBiosystems will receive another $3 million for its first Albunexshipment, which is expected in the next 60 to 90 days, and then receive40 percent of gross sales. In the first marketing year, the deal entitlesMolecular Biosystems to 140 percent of sales up to $30 million.Kenneth Widder, Molecule Biosystems' chairman, said Albunex is thefirst ultrasound contrast imaging agent approved by the FDA and thefirst "left heart" contrast imaging agent. Prior imaging agents, Widdersaid, worked only in the right side of the heart, but Albunex goesthrough the lungs and into the left side, the main pumping chamber ofthe heart.It also is Molecular Biosystems' first major product on the market inthe U.S. The FDA approval, which took six years following the start ofclinical trials, sent the company's stock (NYSE:MB) up $2.50 Mondayto close at $12.38 a share.Mallinckrodt's stock (NYSE:MKG) closed at $33.25 a share, up 63cents.Albunex consists of air-filled albumin microspheres. They are injectedinto a vein and are used in ultrasound imaging of the heart to enhanceidentification of endocardial borders and to assess blood flow in thecardiac chambers. n
-- Charles Craig
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