Cempra's lead oral antibiotic meets main goal in late-stage trial
By Natalie Grover and Vidya L Nathan (Reuters) - Cempra Inc moved a step closer to approval for its lead antibiotic, solithromycin, after an oral version of the potential blockbuster met the main goal in a late-stage trial. Investment by Big Pharma in antibiotic research has revived as bacteria grow increasingly resistant to existing drugs, leading Merck & Co to bid for Cubist Pharmaceuticals Inc and casting other antibiotic drug developers as potential targets. Shares of Cempra, among a clutch of smaller companies developing treatments to fight super-bugs, rose as much as 18 percent to $27.10 in early trading on Monday. Up to Friday's close, the company's shares had gained 43 percent since Merck's announcement on Dec .8. At Monday's high, Cempra was valued at about $970 million. Cempra Chief Executive Prabha Fernandes, speaking on a call with analysts, reiterated that the company was not looking for partners. The drug is a next-generation version of a class of oft-prescribed antibiotics called macrolides, which are used to fight pathogens that cause community-acquired bacterial pneumonia (CAPB). CAPB is the leading cause of death from infection and is characterized by shortness of breath, cough and fever. About 5-10 million cases are recorded in the United States annually. An oral formulation of solithromycin was as effective as Bayer AG's moxifloxacin 72 hours after dosing, Cempra said on Sunday. WBB Securities' Steve Brozak raised his price target on the stock to $40 from $25, estimating that solithromycin was worth about $1.4 billion to Cempra. On the call, a company executive said there were no signs of any serious adverse reactions in the solithromycin study. Prior-generation macrolides have triggered safety concerns. Sanofi SA's telithromycin, for example, was associated with liver toxicity, while Pfizer Inc's azithromycin was linked to heart risk. The unparalleled rate at which the oral version of solithromycin is absorbed in the blood, or its oral bioavailability, differentiates it from standard treatments, Fernandes told Reuters in an interview in November. North Carolina-based Cempra is also evaluating an intravenous formulation of solithromycin for CAPB. Cempra expects to update investors on the study in April 2015, Fernandes said. The drug is also the first pediatric antibiotic-in-development in nearly three decades, she said. Solithromycin is commercially licensed to Fujifilm Holdings Corp in Japan. (Editing by Simon Jennings and Ted Kerr)
