While it’s hard to quantify the benefit of the new incentives intended to promote more antibiotic drug development, Rib-X Pharmaceuticals has something of an answer: $67.5 million. That’s how much the company raised in a series 2 preferred stock financing whose first of two tranches closed last month.
“I give partial credit to the more favorable environment that now exists post-passage of GAIN in being able to close that financing,” Rib-X CEO Mark Leuchtenberger, told GEN. “It really may be more dramatic than going faster. It’s the difference between going forward and not going forward.”
GAIN stands for Generating Antibiotic Incentives Now—a series of antibiotic drug incentives folded into the Food and Drug Administration Safety and Innovation Act (FDASIA)—the formal name for the fifth authorization of the Prescription Drug User Fee Act enacted in July by President Obama. Among incentives in the law is the “qualified infectious disease product” (QIDP) designation, entitling recipient drug developers to faster FDA reviews and five additional years of market exclusivity.
Rib-X was among the first companies to win QIDP status. FDA granted the designation in September for the broad spectrum fluoroquinolone delafloxacin for both acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). delafloxacin is set to enter Phase III trials for ABSSSI in 2013. The following month, Rib-X won QIDP for the oxazolidinone radezolid, for both oral and intravenous use against ABSSSI and CABP.
Since then, Durata Therapeutics achieved QIDP status for Dalbavancin, a once-weekly antibiotic drug candidate for acute bacterial skin and skin structure infections that reported preliminary Phase III results on Dec. 11. Earlier this month, Cubist won QIDP for two Phase III antibiotic candidates—CXA-201 (ceftolozane/tazobactam) for complicated intra-abdominal infections and complicated urinary tract infections caused by Pseudomonas aeruginosa and other Gram-negative bacterial infections; and CB-315 for Clostridium difficile-associated diarrhea (CDAD).
In interviews, leaders of three QIDP-winning companies praised the GAIN incentives as being just the right medicine for antibiotic drug development—namely, by boosting investor confidence that new treatments will reach the market, and sooner.
Among companies planning to pursue QIDP status is PolyMedix. Nicholas Landekic, the company’s president & CEO, told GEN his company plans to pursue QIDP status for its most advanced defensin-mimetic antibiotic in clinical development, brilacidin (formerly PMX-30063) for acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus (including MRSA) and Streptococcus pyogenes. PolyMedix is planning a Phase IIb trial for brilacidin, incorporating direction received last month in a Type B meeting with FDA.
“If we are able to further advance them into development, we also hope to pursue QIDP status for our other defensin-mimetic compounds currently in preclinical development, such as for Gram-negative bacteria, and, with funding, potentially new programs such as tuberculosis,” Landekic said.