Cempra Inc (NASDAQ:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, and Macrolide Pharmaceuticals, Inc., a preclinical company focused on the development of novel macrolide antibacterials, today announced an agreement where Macrolide will use its novel, proprietary synthesis technology to provide Cempra with a fully synthetic process for its late-stage investigational macrolide antibiotic, solithromycin. Solithromycin has completed Phase 3 clinical trials and a New Drug Application (NDA) is in progress for the treatment of community acquired bacterial pneumonia. Solithromycin is currently manufactured using clarithromycin, a fermentation-derived antibiotic, as the starting material. Based on ground-breaking technology developed by Andrew G. Myers, Ph.D., and colleagues at Harvard University, Macrolide Pharmaceuticals will partner with Cempra with the goal of developing a fully synthetic, cost-competitive manufacturing process for solithromycin. An alternative fully synthetic process could provide manufacturing and supplier flexibility by reducing dependence upon fermentation-derived starting materials.
Under this agreement, Cempra will support research at Macrolide Pharmaceuticals focused on the optimization, scalability and efficiency of a fully synthetic manufacturing approach to solithromycin. To accomplish this, Macrolide Pharmaceuticals will expand its process chemistry efforts to encompass the synthesis of solithromycin. The initial commercialization of solithromycin, if approved, will utilize the semi-synthetic process that begins with clarithromycin. Sometime later, a shift to a fully synthetic process for solithromycin could occur with validation and approval by the FDA. Financial terms of the agreement have not been disclosed.
“We are pleased with the current cost and feasibility of manufacturing solithromycin, but, if this new method is successful, we will have the option of decreasing our dependence on fermentation-derived clarithromycin, which may allow us to manage and control our manufacturing costs even further,” stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.
“We are delighted to work with Cempra on solithromycin, a highly promising antibiotic and the only macrolide in late stage clinical development,” statedLawrence G. Miller, M.D., CEO of Macrolide Pharmaceuticals. “We have demonstrated our capability for a full synthesis of solithromycin, and this partnership will allow us to improve and extend this work.” (Original Source)
Shares of Cempra closed last Friday at $17.23. CEMP has a 1-year high of $46.99 and a 1-year low of $15.43. The stock’s 50-day moving average is $24.60 and its 200-day moving average is $30.66.
On the ratings front, Cempra has been the subject of a number of recent research reports. In a report issued on December 21, Needham analyst Alan Carr maintained a Buy rating on CEMP, with a price target of $48, which implies an upside of 178.6% from current levels. Separately, on December 11, Canaccord Genuity’s Michael Walkley reiterated a Buy rating on the stock and has a price target of $26.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Alan Carr and Michael Walkley have a total average return of 11.1% and 12.1% respectively. Carr has a success rate of 44.1% and is ranked #171 out of 3622 analysts, while Walkley has a success rate of 55.6% and is ranked #36.
The street is mostly Bullish on CEMP stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $37.33, which implies an upside of 116.7% from current levels.
Cempra Inc is a clinical-stage pharmaceutical company. It develops antibiotics for acute care & community settings to meet critical medical needs in treatment of bacterial infectious diseases, respiratory tract & chronic staphylococcal infections.