Cempra

Cempra, Inc. was a clinical-stage pharmaceutical company established in 2006, with a strategic focus on developing novel antibiotics to combat drug-resistant bacterial infections in both acute care and community settings. The company was founded by Dr. Prabhavathi B. Fernandes, who also served as its President and CEO. Dr. Fernandes brought extensive experience to the venture, with a career spanning over three decades in anti-infective discovery and development at major pharmaceutical firms like Bristol-Myers Squibb and Abbott Laboratories. Her scientific background is rooted in microbiology, holding a Ph.D. from Thomas Jefferson University and having helped develop the highly successful antibiotic Biaxin while at Abbott.

Cempra's business model revolved around identifying, developing, and securing regulatory approval for new antibacterial agents. Its revenue strategy was based on achieving development milestones and future commercialization royalties through strategic partnerships. The company's two lead product candidates were solithromycin (CEM-101) and fusidic acid (marketed as Taksta, or CEM-102). Solithromycin, a next-generation macrolide antibiotic, was developed in both oral and intravenous forms to treat community-acquired bacterial pneumonia (CABP) and was designed to be effective against bacteria resistant to older macrolides. Fusidic acid was being developed as a high-dose oral monotherapy for acute bacterial skin and skin structure infections (ABSSSI), including those caused by MRSA.

A significant milestone for Cempra was the 2012 IPO and its listing on the Nasdaq exchange, which facilitated raising over half a billion dollars for its research and development programs. However, the company faced a major setback in late 2016 when the U.S. FDA issued a Complete Response Letter for solithromycin, citing concerns over liver toxicity and requesting a larger safety study. This regulatory hurdle, followed by the withdrawal of its European marketing application, led the company to initiate a strategic review. In August 2017, Cempra announced a definitive merger agreement with Melinta Therapeutics, a private anti-infectives company. The all-stock transaction was structured as a reverse merger, with the combined entity operating under the Melinta Therapeutics name and Melinta shareholders holding a majority 52% stake. This move effectively concluded Cempra's journey as an independent entity, merging its pipeline and assets with Melinta's to create a larger, commercial-stage anti-infectives company.

Keywords: anti-infectives, antibiotic development, drug-resistant bacteria, solithromycin, fusidic acid, clinical-stage pharma, reverse merger, Prabhavathi Fernandes, community-acquired bacterial pneumonia, bacterial skin infections