The FDA has given preliminary marketing approval to MolecularBiosystems Inc.'s Albunex contrast imaging agent for use withultrasound, expanding the select group of biotechnology companiesthat have successfully brought products to market. This is the first timean agent of this type has been approved for marketing.Molecular's stock (NYSE:MB) rose $2 on Thursday after theannouncement, but dropped 50 cents on Friday to close at $17.50 pershare."We are obviously very pleased," said Kenneth Widder, chairman andCEO of the San Diego company. "We've been waiting for thisapproval and we are optimistic that the product will do very well.""It's about time," said Mary Ann Gray, a vice president with KidderPeabody Group Inc, of New York. "It's been a very long time since theapplication was filed." Gray said the FDA had raised a succession ofrelatively minor questions that dragged the approval process out sinceSeptember 1990. She said Albunex has good prospects.Albunex is an injectable product intended to aid ultrasound contrastenhancement of the heart chambers, and to improve endocardial borderdefinition in patients with suboptimal echocardiograms. Widder said itwill help physicians get diagnostically useful information in cases inwhich a technician is having difficulty visualizing the heart withconventional methods.Widder said 9 million echocardiograms are done each year in the U.S.Of these, he estimated that there is suboptimal visualization in about 15percent of the cases, all of which will be candidates for Albunex.Widder said Albunex makes it possible to visualize the right and leftventricles and provide better visualization of the heart chamber,allowing accurate measurement of where the endocardial borders are.He said it is also useful in ischemia because assessment of the motionof the heart wall is dependent on accurate endocardial borderdefinition.The FDA's approval is conditional on revisions in labeling and someother specifications, and requires Molecular Biosystems to performcertain studies after final approval, including studies related to thenature and frequency of any reported "adverse device effects." Thecompany said it had already agreed to these studies and believes theywere requested for informational purposes because Albunex is the firstproduct of this kind to be approved. The company said it hopes forfinal approval "in the near future."Some analysts have qualified their optimism about Albunex by notingthat competitive products are in development, in particular those ofGermany's Schering AG and Seattle-based Sonus Pharmaceuticals Inc.Widder told BioWorld that he thought these rival products were still inearly stages of development and that it would be at least two to threeyears before Schering's product is on the market. Widder said Sonus'drug is a second-generation product and several years away fromdevelopment.Meanwhile, he said, his company hopes to file an investigational newdrug application for its own second generation version of Albunexbefore the end of the year. According to Widder, in animal studies, thedrug allows myocardial perfusion to be visualized and increases theutility of the product. The drug is injected into the arm and allowsblood flow within the cardiac muscle to be seen. He said it can showareas of decreased myocardial perfusion as a result of significantcoronary lesions."If a patient is admitted with chest pain and you don't know if theyhave a severe obstruction this type of product can be helpful.Sonographers would be able to see blood flow in real time within theheart muscle, and would be a better alternative to the use of thallium, aradioactive compound," Widder said.Albunex will be marketed and distributed in the U.S. by MallinckrodtMedical Inc., a division of Mallinckrodt Group Inc. (NYSE:MKG), ofSt. Louis, Mo. Albunex is already being marketed in Japan where it isdistributed by Shionogi and Co. Ltd. It has also been approved formarketing in Sweden. Hafslund Nycomed AS (NYSE:HN) hasmarketing rights in Europe.
-- Philippa Maister
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