|Applicable indicator||Not applicable|
Cempra is a biopharmaceutical company that has recently merged with Melinta, selected for having a pipeline that targets priority pathogens. It was evaluated in the area of Research & Development only. Its R&D investment in antibiotic drug development in 2016 amounted to USD 82 million. It is a mid-performing company compared to the biopharmaceutical companies in scope. Cempra’s pipeline consists of one novel drug candidate and one adaptation, both in clinical- stage development. The company engages in public-private partnerships and agreements with various organisations to develop its antibiotic candidates. Cempra reported no information on having any access or stewardship provisions in place for its late-stage clinical R&D projects.
Cempra, founded in 2006, was a biopharmaceutical company focussing on the development of differentiated anti-infectives for acute and community care settings. In 2017, the company announced it would merge with Melinta Therapeutics, Inc., a biopharmaceutical company also in scope of the Benchmark. The merger was completed in November 2017.
Cempra was formed by in-licensing Optimer Pharmaceuticals’ macrolide programme, with the aim of developing a superior macrolide, with less toxic properties than the recently introduced telithromycin—the first ketolide antibiotic to enter clinical use. This led to solithromycin, currently in clinical stage of development, in both intravenous and oral formulations, for the treatment of community-acquired bacterial pneumonia and gonorrhoea. Prior to merging with Melinta, Cempra had no products on the market. In 2013, it received five-year funding from the Biomedical Advanced Research and Development Authority (BARDA) for approximately USD 60 million to develop solithromycin. The company was considering additional indications for this compound, for example, for the treatment of malaria, tuberculosis, H. pylori gastritis and various infections in cystic fibrosis patients. The company was also investigating compounds from its macrolide platform, which have the potential to treat bacteria typically responsible for human skin and lung infections, as well as respiratory disease in animal health. Cempra was listed on the NASDAQ stock exchange in 2012, raising approximately USD 47.7 million. Prior to this, between 2006 and 2009, company investors included Intersouth Partners, Aisling Capital, Optimer Pharmaceuticals and Quaker Bioventures, among others.
Cempra does not have any products on the market.
A. Research & Development
3 projects ,3 target priority pathogens
A.2.1-2.2 One new medicine and two adaptations in the pipeline.
Biopharmaceutical companies in scope were selected based on their pipelines that target priority bacteria. Cempra invested USD 82 million in antibiotic drug development in 2016. The company has three projects in its antimicrobial R&D pipeline, all targeting priority bacteria. Its antibiotic candidate, solithromycin, is a macrolide developed for community-acquired bacterial pneumonia (CABP). The medicine was submitted to the FDA in 2016 for market approval, but was rejected due to inadequate characteristics of liver toxicity, and detected deficiencies in the manufacturing facilities of the company’s manufacturing contractors (Wockhardt Limited and Hospira, Inc.). A similar EMA application has subsequently been withdrawn. Additionally, solithromycin is in Phase III clinical development for the treatment of gonorrhoea. Cempra is also developing a new and proprietary regimen of fusidic acid (Taksta™), an existing antibiotic with activity against methicillin-resistant S. aureus (MRSA). The compound is in development exclusively for the US market and is currently in Phase III clinical trials for acute bacterial skin and skin structure infections (ABSSSI) and prosthetic joint infections.
A.3 One R&D project being developed with public partners.
Cempra is developing one R&D project in its priority pathogen pipeline through public-private partnership. It has received financial support from BARDA for the development of solithromycin. This began in 2013 and will last for five years. The BARDA grant provides Cempra with funding for the clinical development of the compound for the treatment of bacterial infections in paediatric populations. The most recent funding instalment (March 2016 to mid-2018) amounted to USD 25.5 million, for the conclusion of Phase II/III studies on intravenous, oral capsule and oral suspension formulations for paediatric patients with community-acquired bacterial pneumonia (CABP).
A.4 No information on access or stewardship provisions.
Cempra reports no information on access or stewardship provisions for its two antibiotic candidates in late-stage development. It has signed the Davos Declaration, which includes a general commitment to ensuring access to antimicrobial medicines and vaccines, and to support the appropriate and responsible use of these products.
Pipeline targeting priority pathogens
B. Manufacturing & Production
As a biopharmaceutical company with no products on the market, Cempra was not eligible for this Research Area.
C. Appropriate Access & Stewardship
As a biopharmaceutical company with no productson the market, Cempra was not eligible for this Research Area.
* Merged with Melinta Therapeutics, Inc. in 2017