R&D IN BRIEF
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Barr's adenovirus vaccines constitute its first biologics BLA: Barr's adenovirus types 4 and 7 live oral vaccines carry an FDA user fee date of July 31, 2009, making it the company's first in-house biologics to reach FDA review. Barr, through its Duramed subsidiary, entered into a multi-year agreement in 2001 to develop the vaccines for the U.S. Department of Defense. The vaccine product is administered as an oral enteric-coated tablet with an inner tablet core containing live adenovirus - type 4 or type 7 - surrounded by an outer tablet coat and a final enteric coat. The type 4 and type 7 vaccine tablets are taken together to prevent wild type 4 adenovirus-associated acute respiratory disease and to induce neutralizing antibody to type 7 adenovirus. The BLA is supported by a Phase III placebo-controlled study in more than 4,000 male and female Navy and Army recruits
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UCB antiepileptic Rikelta starts Phase III trials: Belgian biopharmaceutical company UCB announces the initiation of three multinational Phase III trials for antiepileptic Rikelta (brivaracetam) as adjunctive therapy in patients with refractory partial-onset epilepsy. Strong results from two Phase IIb trials, including in patients on fellow UCB antiepileptic cash cow Keppra (levetiracetam), supported the move into Phase III, UCB said. Approval of brivaracetam would fill the hole made by Mylan's plan to launch generic Keppra on Nov. 1, 2008. First results from the Rikelta trials, which are slated to enroll 1,300 patients between 16 and 70 years old, are expected in the third quarter of 2009. Two of the studies will enroll patients whose epilepsy is not fully controlled by one or two other AEDs, while the third, a flexible-dose trial, will assess patients with uncontrolled partial onset or primary generalized seizures...