Cellceutix antibiotic brilacidin gains 'infectious disease' status
This article was originally published in Scrip
The FDA has granted qualified infectious disease product (QIDP) status to Cellceutix's antibiotic brilacidin, which the firm is developing as a treatment for acute bacterial skin and skin structure infections (ABSSSI).
Shares of the Beverly, Massachusetts firm soared as high as 38.5% on 8 December, before closing at $4.49, up $1.14, or 34%.
The rise in Cellceutix's shares may have not solely been from the QIDP status. The stock likely also got a boost from Merck's $9.5bn deal to buy Cubist Pharmaceuticals (scripintelligence.com, 9 December 2014, 9 December 2014).
The FDA has granted the QIDP designation at least 64 times to 43 unique molecular entities.
Drugs holding the status are expected to receive special priority reviews intended to accelerate their regulatory process.
They also are eligible for an additional five years of market exclusivity if they win US approval.
QIDP was created under the Generating Antibiotic Incentives Now Act to incentivize manufacturers to develop medicines against some of the deadliest infections, including MRSA, vancomycin-resistant Staphylococcus aureus, vancomycin-resistant enterococcus, Klebsiella pneumoniae, Pseudomonas aeruginosa, E coli species, multidrug resistant tuberculosis and the notorious Acinetobacter baumannii (scripintelligence.com, 05 June 2014, 17 June 2013, 10 July 2012, 17 June 2011).
Brilacidin, which belongs to a new class of antibiotics called defensin-mimetics, completed a Phase IIb trial in September showing, amongst other things, a single dose of the drug was as effective in treating ABSSSI as a seven-day dosing regimen of Cubist's Cubicin (daptomycin).
Cellceutix said it plans to meet with the FDA this month to discuss the firm's planned Phase III trial of brilacidin in ABSSSI.