Cempra Inc., a clinical-stage pharmaceutical company with no drugs on the market, announced Monday that Toyama Chemical Co., a subsidiary of Fujifilm Holdings Corp., began Phase 3 clinical trials with its pneumonia-fighting drug in Japan, the world’s second-largest antibiotic market.
“We are excited and encouraged to see Toyama commencing their Phase 3 program and moving another step closer to the potential approval of solithromycin in Japan, where already high antibiotic resistance in pneumococcus strains is rising, highlighting the urgent unmet medical need for new therapies,” said Prabhavathi Fernandes, chief executive officer of Cempra, in a statement.
Chapel Hill-based Cempra created an antibiotic to treat pneumonia that outweighs the risk of liver injury, an advisory panel to the U.S. Food and Drug Administration concluded in a 7-6 vote on Nov. 4. N.C. Business News Wire’s full coverage of Cempra can be found here.
Earlier this year, Toyama completed a Phase 2 study of 135 Japanese patients with bacterial pneumonia. The study compared the drug in consideration, solithromycin, with an already approved pneumonia-fighting antibiotic, levofloxacin, and the outcome favored solithromycin. Toyama owns exclusive rights to develop and commercialize solithromycin in Japan.
In November, Cempra announced it had received a $10 million payment when Toyama decided to progress to Phase 3 studies. Cempra has received $40 million in payments from Toyama 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.
Cempra shares were trading around $7.85 Monday, up 3.97 percent.
Note: This story is from the North Carolina Business News Wire, a service of UNC-Chapel Hill’s School of Media and Journalism