Today, Senator Richard Blumenthal (D-Conn.) formally announced that Rib-X Pharmaceuticals is the first company in the nation known to receive "Qualified Infectious Disease Product" designation under his recently passed, bipartisan GAIN Act legislation, which provides major incentives for the development of antibiotics to fight superbugs. Blumenthal proposed the GAIN Act last October and it was approved by Congress and signed by the President this year.
The special designation Rib-X received under the GAIN Act -- the Generating Antibiotic Incentives Now (GAIN) Act -- will allow the company to benefit from certain incentives for the development of two of its new drugs, including an additional five years of data exclusivity, and priority FDA review and eligibility for fast-track status.
"This Connecticut company is at the forefront of fighting super germs by developing new antibiotics to conquer increasingly resistant infections," Blumenthal said. "Using incentives provided by the new GAIN Act legislation, Rib-X can invent cutting edge biotech cures that save lives and cut health care costs."
Rib-X received "Qualified Infectious Disease Product" designation for Delafloxacin, which is for indications of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, and for Radezolid, which is for long-term treatment of antibiotic resistant infections such as MRSA.
Antibiotic resistant superbugs have been increasing over the last decade, with the rate of antibiotic-resistant Staph infections approaching 50 percent. Currently, antibiotic-resistant MRSA infections are responsible for over 17,000 deaths in the United States each year, and between 1999 and 2005, MRSA infection-related hospitalizations doubled from approximately 127,000 to 278,000. The Centers for Disease Control and Prevention found that late-onset MRSA infections increased 300 percent in neonatal intensive care units from 1995-2004, increasing average stay by 40 days at an increased cost of $160,000 per patient.