Solithromycin is currently manufactured using clarithromycin, a fermentation–derived antibiotic, as the starting material. Macrolide will partner with Cempra to develop a fully synthetic, cost-competitive manufacturing process for solithromycin, which could provide manufacturing and supplier flexibility by reducing dependence on fermentation-derived starting materials.
Cempra will support research at Macrolide focused on the optimization, scalability and efficiency of a fully synthetic manufacturing approach. Macrolide 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 could occur with validation and approval by the FDA. Financial terms were not 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,” said 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,” stated Lawrence 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.”