Novartis ($NVS) got a recommendation from the European Medicines Agency (EMA) today for the pioneering eye drug that it licensed last year from ThromboGenics in a deal, worth about €375 million ($498 million).
ThromboGenics touted positive results from two Phase III trials of the Belgian biotech's experimental drug for age-related eye ailments.
ThromboGenics came closer to having its first approved drug on the U.S. market, gaining an FDA advisory committee recommendation for its lead drug candidate, ocriplasmin, for combatting vision-impairing vitreomacular adhesion.
The FDA advisory committee echoed some of the safety concerns raised in an agency staff review earlier this week, but members ultimately voted 6-3 that no additional studies of the treatment's impact on the retina were needed prior to approval, Bloomberg reported.
The FDA managed to rattle ThromboGenics' investors yesterday with a warning on the adverse events associated with its eye drug ocriplasmin. With an expert panel review looming tomorrow, the regulatory review cited several serious adverse events, sending the biotech's shares down as much as 19% at one point.
The news at Sweden's BioInvent is all bad. Today it says that one of the two drugs it planned to shift its focus to failed a Phase IIa trial.
Shares at Sweden's BioInvent went into meltdown mode earlier this month when an experimental blood-thinner it was developing in partnership with Thrombogenics failed in a head-to-head study with Xarelto. Today the other foot dropped. BioInvent is reorganizing in the wake of the trial disaster, laying off 21 of its 89 staffers and refocusing on a pair of experimental drugs further down the pipeline.
An increase in bad bleeding incidents among patients on the companies' candidate, TB-402, compared with those on the approved Xarelto prompted the developers to end the mid-stage study and abandon the program altogether.
Belgian biotech ThromboGenics ( $ THR ) has picked up a major partnership with the Alcon unit of Swiss drug giant Novartis ( $NVS ) for its experimental therapeutic for an eye ailment known as symptomatic vitreomacular adhesion, or VMA. And the deal with Alcon, which grants rights to market the eye drug outside the U.S., could be worth up to €375 million ($494 million) to ThromboGenics.
Belgium's ThromboGenics is trying to make its likely New Year's wish a reality: A 2012 commercial launch of ocriplasmin to treat symptomatic vitreomacular adhesion by way of an injection into the