Molecular Biosystems Inc. of San Diego announced thatAlbunex, its cardiac ultrasound agent, has been approved formarketing in Sweden. Although this represents the firstEuropean approval of the agent, Albunex was approved for saleand distribution in Japan last November. The companysubmitted a premarket approval application to FDA inSeptember 1990.
Albunex consists of air-filled albumin microspheres, thecompany said. It is used during echocardiography to enhanceidentification of endocardial borders and assess blood flowwithin the cardiac chambers.
The agent will be marketed in Europe by Hafslund Nycomed ASof Oslo, Norway. Nycomed has filed marketing applications forAlbunex in other European countries, including the UnitedKingdom. In Japan the product is marketed by Shionogi & Co.Ltd. The U.S. marketing rights are held by Mallinckrodt MedicalInc.
Molecular Biosystems chief financial officer and vice presidentof finance Sherry Mesman told BioWorld that Albunexrepresents the first approved contrast agent for ultrasound inthe left heart. (An agent used in the right heart is marketed inGermany by Schering AG, Germany, she said.) Alex Zisson, ananalyst with Hambrecht & Quist, has said Albunex has thepotential to generate several hundred million dollars in yearlyrevenue. Although the company received a favorablerecommendation from an FDA advisory committee in mid-1992, requests for additional data that the agency sent to thecompany last December have delayed approval and appear tobe cutting the company's lead time against a second generationof competing agents. Sonus Pharmaceuticals Inc. of Costa Mesa,Calif., for example, is in Phase I development of QW 3600,another imaging agent for echocardiography that couldultimately compete with Albunex.
Molecular Biosystems' stock (NYSE:MB) closed at $19.38 onWednesday, the day the approval was announced, up $1.25.
-- Karl A. Thiel Associate Editor
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