Drug developer Oscient Pharmaceuticals Corp. has withdrawn its application with European regulators to market its antibiotic Factive as a therapy for certain strains of pneumonia and bronchitis.
The company said the June 17 withdrawal was “based on the view ... that data submitted does not allow” for the European Medicines Agency to endorse the application for the treatments outlined. Oscient, based in Waltham, Mass., sought an endorsement to sell Factive as a treatment for community acquired pneumonia of mild severity as well as acute chronic bronchitis.
The application was submitted on behalf of Oscient by Factive sublicensee Menarini International Operations Luxembourg S.A.
Oscient (Nasdaq: OSCI) entered into its licensing agreement with Menarini, which can sell Factive tablets in the European Union, in December 2006.
In July 2008, Oscient received notice from the U.S. Food and Drug Administration to revise the usage and warning labels of Factive due to recently discovered risk factors affecting specific patient populations.
The company said the risk factors include tendon ruptures and tendonitis among patients over the age of 60 as well as kidney-, heart- and lung-transplant recipients.
At the time, Oscient said three cases of tendon-related side effects were linked to Factive patients. Those cases included a patient with a tendon disorder, another case of tendonitis and one case of tendon rupture.
For 2008, Oscient said Factive sales accounted for around 20 percent of its $86.3 million in revenue.
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