Molecular Biosystems Can Test Its Ultrasound Agent
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SAN DIEGO — Molecular Biosystems has been given the green light by the U.S. Food and Drug Administration to begin clinical testing of its ultrasound contrast agent, Albunex, a product that the company believes could find a multimillion-dollar market.
Consisting of microscopic, albumin-coated air bubbles called “microspheres” that are as small as blood cells, Albunex is injected into the blood stream during an echocardiogram, an ultrasound-imaging test administered by cardiologists that enable them to view the movement of the heart.
The bubbles deflect ultrasound signals, creating an image on electronic monitors as they go through the bloodstream, that helps doctors quantify blood flow. If approved, Albunex would be the first non-radioactive contrast agent to show blood coursing through the heart, company Chairman Kenneth Widder said.
If the tests are successful, Albunex would then be used in a significant percentage of the 4.5 million echocardiograms administered yearly, Widder predicted. MBI will charge cardiologists about $100 per vial of Albunex, Widder said.
Clinical tests of the product will take about two years to complete, Widder said. Testing of Albunex, which the FDA classified as an “investigational device,” will take much less time than if the FDA had classified it a drug.
If the testing goes well, MBI could introduce the product on the U.S. market in 1990. The first phase of testing will be carried out at University of Chicago, Widder added.
The clinical-testing process will cost the company up to $4 million, a cost the company can readily absorb, given the $14 million in cash it has on hand, Widder said. MBI plans to manufacture and market Albunex itself for the U.S. market.
For the European market, however, MBI is looking to form a joint venture with a company that will finance clinical tests and share in manufacturing and marketing costs. Widder said MBI plans to form the joint venture over the next month.
Molecular Biosystems stock closed up $.50 at $13.375 per share in over-the-counter trading Friday.
