Cempra, Inc. Receives $10M Milestone Payment From Toyama Chemical Co. Triggered By Solithromycin's Clinical Development Progress In Japan

Cempra, Inc.

today announced the receipt of a $10 million milestone payment from Toyama Chemical Co., a subsidiary of FUJIFILM Holdings Corporation, triggered by Toyama's progress of its solithromycin clinical development program in Japan, the world's second largest antibiotic market. The payment was made following Toyama's receipt of regulatory clearance to begin a Phase 2 trial of solithromycin in Japan following successful completion of a Phase 1 study. Key points: Toyama owns exclusive rights to develop and commercialize solithromycin in Japan for respiratory tract infections and other indications in adults and pediatric patients. Cempra received a $10 million upfront payment when the agreement was signed and can earn up to $60 million in milestone payments from Toyama based on the achievement of certain objectives, including the $10 million just received. Tiered royalties that will be adjusted based on sales would be paid to Cempra following launch of solithromycin in Japan. Japan is the world's second largest antibiotic market with annual sales of about $4 billion. Macrolides, which account for about $700 million in sales in Japan, have been widely used in Japan because of their safety, efficacy and spectrum and availability for adults and children. Marcrolide resistance has been increasing in Japan; currently 78% of pneumococcal strains are resistant in Japan, leaving physicians with limited oral therapeutic options http://www.ncbi.nlm.nih.gov/pubmed/23483982. Solithromycin shows potent antibacterial effects against pneumococci and Mycoplasma pneumoniae strains that are resistant to older macrolides such as azithromycin and clarithromycin. In Toyama's Phase 1 single and multi-dose studies in adult volunteers, solithromycin was well tolerated and demonstrated pharmacokinetics that reflected what was seen in Cempra's U.S. clinical studies. Quote: Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra said, "We are very pleased with our partner, Toyama Chemical Company, a leading antibacterial company that has several decades of experience in developing and commercializing novel antibiotics in Japan, the second largest antibiotic market in the world. We are pleased with our strong relationship and have benefited from frequent information and data exchange because of Toyama's strong antibiotic drug development experience. This milestone payment illustrates the progress Toyama is making toward bringing this important and needed antibiotic option to patients in Japan. We look forward to their continued progress in their clinical program which will complement our own."