Cempra (CEMP) Receives Milestone Payment from Toyama Chemical Relating to Solithromycin Phase 3s

November 1, 2016 7:32 AM EDT

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Cempra, Inc. (Nasdaq: CEMP) announced the receipt of a $10 million milestone payment from Toyama Chemical Co., Ltd. (Toyama) a subsidiary of FUJIFILM Holdings Corporation, triggered by Toyama progressing to Phase 3 studies with solithromycin in Japan, the world's second largest antibiotic market.

Earlier this year, Toyama completed a Phase 2 multi-center, randomized, double-blinded study of 135 Japanese patients with mild to moderate community-acquired bacterial pneumonia (CABP). Patients were randomized to either oral solithromycin or oral levofloxacin for five days. Overall safety and tolerability was similar in both treatment groups and all efficacy outcome measures favored solithromycin.

The Japanese Phase 2 study was similar in design to the Phase 3 CABP studies conducted by Cempra in accordance with guidance from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Toyama owns exclusive rights to develop and commercialize solithromycin in Japan for respiratory tract infections and other indications in adults and pediatric patients.

In addition to the $10 million milestone payment for progressing to Phase 3, Cempra has also previously received $30 million of upfront and milestone payments and can earn an additional $30 million, for a total of $70 million, in payments from Toyama based on the achievement of certain objectives. If approved, Toyama would pay tiered royalties, adjusted based on sales, to Cempra following launch of solithromycin in Japan.

“Physicians in Japan currently have limited therapeutic options for CABP. We congratulate Toyama on their progress and have been very pleased to see the data generated by Toyama in their clinical studies are consistent with the data from Cempra’s clinical trials and support the strong value proposition of solithromycin for patients with CABP,” said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra.

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