Solithromycin Proves Safe, Makes Cempra A Deal Target
This article was originally published in The Pink Sheet Daily
The antibiotic showed promising results in a late-stage study of the oral formulation, setting the company up as a potential target for acquirers and partnering opportunities – though for now it is signaling its intent to go it alone.
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Expecting approval for CABP before the end of 2016, Cempra says solithromycin will offer a significant treatment-resistance edge over the earlier macrolide antibiotic azithromycin.
Antibiotic-focused biotech can earn $58 million over five years under the government contract, which provides for testing of the novel macrolide in pediatric indications and for protection against bioterror-threat pathogens.
The Anti-Infective Drugs Advisory Committee's failure to agree on a preferred approval pathway for antibiotics to treat community-acquired bacterial pneumonia opens the door for FDA to offer several options to industry.