QIDP Designation Allows for FDA Priority Review, Fast-Track Designation, and an Additional Five Years of Market Exclusivity for SBG003
QIDP Designation Allows for FDA Priority Review, Fast-Track Designation, and an Additional Five Years of Market Exclusivity for SBG003
TEMPE, Ariz., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Sonoran Biosciences (“Sonoran” or the “Company”, a preclinical-stage pharmaceutical company developing innovative hospital based products for the treatment of surgical site infections and postoperative pain, announced today that the Company’s lead product SBG003 (tobramycin and vancomycin hydrogel) has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food & Drug Administration (FDA) for prevention of post-abdominal surgical site infection.
The QIDP program, part of the FDA’s Generating Antibiotic Incentives Now (GAIN) provisions, provides incentives for the development of new drug products that treat or prevent serious or life-threatening infections, especially those caused by important pathogens. Under the QIDP designation, Sonoran will be eligible to take advantage of substantial incentives including Priority Review, Fast Track designation, and an additional five years of market exclusivity following marketing approval of SBG003. Prior companies to receive this designation for similar indications include Armis Biopharma and PolyPid Ltd (PYPD).
SSI is one of the most common and costly hospital-acquired infections, emerging as a key quality metric under Medicare’s Hospital-Acquired Condition Reduction Program, which links Medicare payments to healthcare quality. SSI is associated with prolonged length of stay, increased treatment costs, morbidity, and risk of death. According to literature reports, patients with a deep or organ space colorectal SSI spent an average of 21 days in the hospital compared to six days for similar patients without SSI.
“We are very pleased to have received QIDP designation from the FDA,” said Dr. Derek Overstreet, Sonoran’s co-founder and Chief Executive Officer. “Receipt of this designation underscores the FDA’s recognition of SSIs as a serious medical problem and one that SBG003 has the potential to play a significant role in preventing. We are currently preparing to advance the clinical development of SBG003 in abdominal surgery as quickly as possible.”
Sonoran plans to initially evaluate SBG003 in colorectal surgery, a subset of abdominal surgery that is associated with the highest incidence of SSI among elective operations. The Company completed a pre-Investigational New Drug (Pre-IND) meeting with the FDA in September 2019. Definitive pre-clinical studies are currently in progress.
About Sonoran Biosciences, Inc.
Sonoran Biosciences is a preclinical-stage pharmaceutical company leveraging its proprietary drug delivery technology to develop innovative hospital-based products for the treatment of surgical site infections and postoperative pain. The Company’s lead product SBG003 is an injectable sustained-release gel containing tobramycin and vancomycin designed for direct application in surgical sites. SBG003 has the potential to become a first-in-class product for prevention of SSI, including after abdominal, colorectal, cardiac, and orthopedic surgery.
Contact:
Derek Overstreet
derek@sonoranbiosciences.com
480-389-6413
