FORT COLLINS, Colo. & PRINCETON, N.J. & HYDERABAD, India: Dr. Reddy’s Laboratories Ltd. and CHD Bioscience Inc., a privately-held biopharmaceutical company, announced a global licensing agreement for the clinical development and commercialization of Dr. Reddy’s Phase III clinical trial candidate, DFA-02.
It is intended to be used for the prevention of surgical site infections, following non-emergency, elective colorectal surgery. Phase II studies for DFA-02 have been successfully completed, and the product will be transitioning to pivotal Phase III registration studies.
Under the terms of the agreement, Dr. Reddy’s would receive equity in CHD valued at $30 million upon an IPO of CHD or a minimum of $30 million in cash within 18 months of execution of the agreement. Dr. Reddy’s will also receive additional milestone payments of $40 million upon USFDA approval. In addition, CHD will pay Dr. Reddy’s double-digit royalties on sales and commercial milestones.
Commenting on the signing of the agreement, Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma, a wholly owned subsidiary of Dr. Reddy’s, said, “We are pleased to announce our partnership with CHD Bioscience. We feel that the needs of patients undergoing surgery will be well served by CHD, given their strong focus on offering targeted solutions for surgical site infections. DFA-02 has demonstrated promising results in clinical studies, and we are excited about the prospect of CHD undertaking further development and commercialization of the asset.”
“This transaction advances our strategy to become a world leader in the targeted prevention and treatment of drug-resistant infections. Building on our development work with VERIOX™ in orthopedics and wound care, DFA-02 potentially extends our ability to help patients in the surgical setting who may be at high risk of infections without exposing the patient to large amounts of systemic antibiotics,” said Michael Handley, director and chief executive officer of CHD Bioscience. “DFA-02 fits our strategy of targeting the site of the infection rather than the whole patient, and we are pleased to be continuing the great work that Dr. Reddy’s has started.”
DFA-02, Gentamicin and Vancomycin Sterile Gel for surgical wound administration, is a novel bioresorbable extended release phospholipid-based gel intended to be applied within the surgical incision at the time of closure to potentially reduce the risk of surgical site infection (SSI). The gentamicin component is intended to provide coverage for Gram-negative organisms and the vancomycin component is intended to provide coverage for Gram-positive organisms. Further, the gel is intended to provide a high concentration of gentamicin and vancomycin locally at the surgical site with limited systemic exposure.
In preclinical studies, DFA-02 has demonstrated promising properties. Pharmacokinetics in these preclinical studies have demonstrated high local tissue concentrations (greater than four times the minimum inhibitory concentration [MIC] for sensitive organisms) and systemic concentrations at or below recommended levels after use during closure of surgical incisions. Preclinical models have also demonstrated efficacy in reducing infection in surgical incisions as measured by bacterial counts. No adverse histopathological findings or evidence of interference in wound healing were observed.
Clinically, two human studies have been completed in abdominal surgery. No safety or tolerability concerns were observed and systemic gentamicin and vancomycin levels were within acceptable limits. Further, on post hoc analysis, DFA-02 demonstrated a statistically (p = 0.05) significant reduction (60%) in surgical site infections in inflammatory bowel disease patients receiving the treatment over patients in the control arm receiving standard of care.