Molecular Biosystems Inc. (MB) announced last week that theFDA has requested additional information for its review of thecompany's cardiac ultrasound imaging agent Albunex, which isderived from human albumin.
Although this probably means a delay in FDA's final pre-market approval for the diagnostic, the San Diego company saidit is confident that the product will still be approved.
However, at least one analyst downgraded his recommendation,and the stock (NYSE:MB) tumbled $5.88 a share on Friday to$18.
The FDA's medical device panel raised three concerns: labelingissues, an update on safety and efficacy data, and thecompany's manufacturing process.
The first two were not unexpected, said Sherry Merman, MB'schief financial officer; they had been raised at last July'sRadiologic Devices Advisory Panel meeting (when the panelunanimously recommended approval of Albunex). But the thirdarea, relating to the manufacturing process, came as thesurprise, Merman told BioWorld.
She said, however, that the company was ready to respond."MBI already possesses the necessary information, has initiatedthe required actions and anticipates prompt submission of thePMA (product manufacturing) amendment," Merman said.
Peter Drake, executive vice president and director of equityresearch at Vector Securities International, downgraded hisrating on the MB to "neutral" last week, based on theregulatory uncertainty now facing Albunex. But Drake said that"the approvability of Albunex remains very much intact givenits strong safety and efficacy profile."
He added, however, that "we expect the resulting delay inapproval will push the commercial launch of Albunex back tothe fourth quarter 1993 or possibly the first quarter of 1994."
Market sources said that Smith Barney also downgraded itsrating to a "hold" from a "buy."
Merman added that the delay will hold up $11.7 million inpayments that MB expected to receive from companiesmarketing the product, Mallinckrodt Medical in the U.S. andHasflund Nycomed in Europe.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.