Cempra Inc (NASDQ:CEMP) announced that Toyama Chemical Co., Ltd.(Toyama) a subsidiary of FUJIFILM Holdings Corporation, has begun Phase 3 clinical trials with solithromycin in Japan, the world’s second largest antibiotic market, for patients with community-acquired bacterial pneumonia (CABP) and other respiratory infections.

Earlier this year, Toyama completed a Phase 2 multi-center, randomized, double-blinded study of 135 Japanese patients with mild to moderate 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. These data, and the data from Cempra’s studies, were reviewed by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) before finalizing the Phase 3 study protocol.

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

In November 2016, Cempra announced it had received a $10 million milestone payment when Toyama decided to progress to Phase 3 studies. Cempra has received $40 million of upfront and milestone 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.

“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 and other CABP pathogens is rising, highlighting the urgent unmet medical need for new therapies,” said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra.

“We are also pleased that the Toyama Phase 3 trial will be against levofloxacin as the comparator, which is the fluoroquinolone used most frequently in outpatient CABP treatment,” Fernandes added. (Original Source)

Shares of Cempra are up nearly 5% to $7.94 in pre-market trading Monday. CEMP has a 1-year high of $32.31 and a 1-year low of $5.70. The stock’s 50-day moving average is $22.20 and its 200-day moving average is $20.63.

On the ratings front, CEMP stock has been the subject of a number of recent research reports. In a report issued on November 21, Cowen analyst Ritu Baral downgraded CEMP to Hold. Separately, on the same day, Needham’s Alan Carr downgraded the stock to Hold .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ritu Baral and Alan Carr have a yearly average return of 1.5% and 6.0% respectively. Baral has a success rate of 36% and is ranked #1421 out of 4240 analysts, while Carr has a success rate of 43% and is ranked #529.

Sentiment on the street is mostly neutral on CEMP stock. Out of 10 analysts who cover the stock, 6 suggest a Hold rating , 2 suggest a Sell and 2 recommend to Buy the stock. The 12-month average price target assigned to the stock is $6.50, which implies a downside of 14% from current levels.

Cempra, Inc. engages as a clinical-stage pharmaceutical company, which focuses on the development of antibacterials to meet critical medical needs. Its antibiotic candidates includs Solithromycin and Taksta.