Factive (gemifloxacin) will get an expanded label in pneumonia, according to an FDA approvable letter, and orBec (oral beclomethasone) is entering the regulatory review process.
Oscient Pharmaceuticals Corp., the maker of Factive, doesn't believe any additional clinical trials are required to get the antibiotic approved as a five-day treatment for community-acquired pneumonia (CAP) of mild to moderate severity. Investors liked the news, boosting the Waltham, Mass.-based company's stock (NASDAQ:OSCI) on Friday by 13 cents, or 13 percent, to $1.12.
According to the letter, Oscient is required to provide clarification and additional interpretation regarding certain data included in its supplemental new drug application. The company intends to respond in the coming weeks, and the FDA typically responds to resubmissions within two months.
Factive already is approved as a seven-day CAP treatment and for the five-day treatment of acute bacterial exacerbations of chronic bronchitis. The submission for the five-day treatment of CAP included Phase III data that demonstrated strong clinical response rates at follow up in patients who received five- or seven-day treatment courses with 320 mg of the drug once a day.
More recently, the product was rebuked by the FDA's Anti-Infective Drugs Advisory Committee, which voted against expanding its label for acute bacterial sinusitis in the absence of an additional study to demonstrate its superiority. The agency, which has until Dec. 15 to make a final decision on Factive's use in that indication, typically follows the advice of its committees. (See BioWorld Today, Sept. 13, 2006.)
DOR Gets NDA On File For orBec
DOR BioPharma Inc. filed for FDA approval of orBec in gastrointestinal graft-vs.-host disease, the most common life-threatening complication of allogeneic hematopoetic stem cell transplantation.
A two-pill system, it employs the topically active corticosteroid beclomethasone to specifically target and treat the condition in the upper and lower GI tract. Because it would reduce the need for immunosuppressive treatment, patients would have fewer systemic immunosuppressive side effects.
OrBec has fast-track and orphan designation from the FDA in this indication, for which there are no approved products, and the Miami-based company expects that it could qualify for priority review.
Data underlying the new drug application demonstrated that orBec provides a lowered risk of mortality above the current standard of care, and a lowered exposure to systemic corticosteroids following allogeneic transplantation.
In a pivotal Phase III trial, patient survival at the pre-specified endpoint of 200 days post-transplant showed a 66 percent reduction in mortality among patients randomized to orBec (p=0.0139), and that mortality benefit was corroborated in a retrospective analysis of the Phase II study in which there was a 55 percent reduction in mortality at 200 days post-transplant.
The company plans to file for European approval in November. On Friday, DOR's shares (OTC BB:DORB) gained 2 cents to 28 cents.