Molecular Biosystems has received an approval recommendation fromEurope's Committee for Proprietary Medicinal Products (CPMP) forits Albunex ultrasound contrast agent, which will be marketedin Europe as Infoson. Infoson's application will now go to
Molecular Biosystems has received an approval recommendation fromEurope's Committee for Proprietary Medicinal Products (CPMP) forits Albunex ultrasound contrast agent, which will be marketedin Europe as Infoson. Infoson's application will now go to membercountries of the European Union, whose regulatory agencies generallyfollow CPMP recommendations.
San Diego-based MBI took over regulatory responsibility forInfoson after it reacquired European marketing rights to the agentlate last year from Hafslund Nycomed, which had shepherded Infosonthrough European clinical trials. Nycomed apparently wished tofocus on commercial development of its own ultrasound contrastagents, according to MBI president and COO Bobba Venkatadri.
MBI is looking for another marketing partner to handle Infosonin the regions once covered by Nycomed: Europe, Africa, the MiddleEast, India, and the former Soviet Union. MBI is in discussionswith several firms, including U.S. marketing partner MallinckrodtMedical, and hopes to have a deal sewn up by May, Venkatadri said.
