Solithromycin, an oral antibiotic manufactured by Cempra Inc and prescribed against community-acquired bacterial pneumonia (CAPB) has won the approval of health authorities after it performed excellently at its late-stage trial. This success qualifies this drug for approval by the FDA and it might soon hit the market once its approval scales through.

A next generation class of antibiotics known as macrolides, Cempra’s solithromycin has been proven effective at combating CAPB, which has been the leading cause of death from community infections that is characterized by cough and fever, and shortness of breath among others. About 5-10 million people are infected with CAPB annually, and it is a leading health concern for authorities and pharmaceutical companies.

Bayer AG’s moxifloxacin had been effective at combating CAPB, but Cempra’s solithromycin has outperformed moxifloxacin by a slight margin. It is also found to have very low gastrointestinal toxicity, and this marks its safety profile as impressive – causing Baird’s Brian Skorney to raise his price target by $11 to $32 on the stock market.

Macrolides that had been in the market before the manufacture of Cempra’s solithromycin have raised safety concerns among health authorities – and in this regard telithromycin produced by Sanofil SA was linked to liver toxicity and Pfizer’s azthromycin was associated with increased heart risks. But solithromycin is well-tolerated with perfect absorption in the blood, and its oral bioavailability makes it different from other standard treatments.

As if to prove its superior effectiveness and minimal rate of resistance, solithromycin performed with a bioavailability of 80% against azithromycin which performed only 28%; and to this end, Cempra is contemplating producing its intravenous version for treating CAPB.

Commercially licensed to Fujifilm Holdings Corp in Japan, solithromycin is proving a success; and while Cempra values its independence, it would not mind considering other molecules to help out if need be. “We can always get a gram-negative drug — that would be nice to add to the portfolio, to be a really full blown anti-infective company, and then we need to find a partner!” said the company recently.

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