Cempra (CEMP) Receives Milestone Payment from Toyama Chemical Relating to Solithromycin Phase 3s
- Donald Trump Sworn in as 45th U.S. President
- Wall Street ends higher as Trump becomes president
- Walgreens Boots Alliance (WBA) Said to Face Antitrust Concern for Rite Aid (RAD) Fix - Bloomberg
- Bristol-Myers Squibb (BMY) Says It Won't Pursue Accelerated U.S. Regulatory Pathway for Opdivo Plus Yervoy in Lung Cancer
- Apple (AAPL) Sues Qualcomm (QCOM) Over Patent Royalties in Antitrust Case - Bloomberg
News and research before you hear about it on CNBC and others. Claim your 2-week free trial to StreetInsider Premium here.
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.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Bristol-Myers Squibb (BMY), Ono Enter Settlement and License Agreement with Merck (MRK) to Resolve PD-1 Antibody Patent Litigation
- Minerva Neurosciences (NERV) Reports Additional Data Analyses From Phase IIb Trial of MIN-101 in Schizophrenia
- Perma-Fix (PESI) Names S. Robert Cochran to Board of Directors
Create E-mail Alert Related CategoriesCorporate News, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!