September 25, 2016 3:49 AM ET

Pharmaceuticals

Company Overview of Cempra, Inc.

Company Overview

Cempra, Inc., a clinical-stage pharmaceutical company, focuses on developing antibiotics to meet medical needs in the treatment of bacterial infectious diseases in North America. Its lead product candidates include solithromycin (CEM-101), which is in Phase III clinical trials for the treatment of community acquired bacterial pneumonia, as well as for uncomplicated bacterial urethritis; and Taksta, an antibiotic that has completed Phase II clinical trials for refractory bone and joint infections. The company also produces novel macrolides for non-antibiotic uses, such as the treatment of chronic inflammatory diseases, endocrine diseases, and gastric motility disorders. It has collaborative r...

6320 Quadrangle Drive

Suite 360

Chapel Hill, NC 27517

United States

Founded in 2005

93 Employees

Phone:

919-313-6601

Key Executives for Cempra, Inc.

Founder, Chief Executive Officer, President and Director
Age: 67
Total Annual Compensation: $510.0K
Chief Financial Officer and Executive Vice President
Age: 53
Total Annual Compensation: $350.0K
Chief Commercial Officer and Executive Vice President
Age: 42
Total Annual Compensation: $330.0K
Chief Medical Officer
Age: 58
Total Annual Compensation: $300.0K
Compensation as of Fiscal Year 2015.

Cempra, Inc. Key Developments

Cempra, Inc. Presents at The 2016 Morgan Stanley Global Healthcare Conference, Sep-12-2016 01:05 PM

Cempra, Inc. Presents at The 2016 Morgan Stanley Global Healthcare Conference, Sep-12-2016 01:05 PM. Venue: The Grand Hyatt Hotel, New York, New York, United States.

Cempra, Inc. Announces Publication of its Pivotal Phase 3 Study, SOLITAIRE-IV

Cempra, Inc. announced the publication of its pivotal Phase 3 study, SOLITAIRE-IV, comparing the efficacy and safety of intravenous-to-oral solithromycin to intravenous-to-oral moxifloxacin for the treatment of community-acquired bacterial pneumonia (CABP) in Clinical Infectious Diseases. Cempra’s other pivotal Phase 3 study with solithromycin, SOLITAIRE-ORAL, which evaluated the efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of CABP, also met its primary non-inferiority endpoint and was published in Lancet Infectious Diseases in February 2016. According to the U.S. Centers for Disease Control and Prevention (CDC), CABP is the leading cause of death due to infectious disease in the United States, killing more than 53,000 people annually. Streptococcus pneumoniae (S. pneumoniae) is the leading cause of bacterial pneumonia in the U.S. and drug-resistant S. pneumoniae is responsible for 1.2 million infections a year, according to the CDC. Solithromycin is a highly potent macrolide which has activity against most macrolide-resistant CABP pathogens. In vitro and in vivo studies have shown potent activity against S. pneumoniae as well as an extended spectrum of activity against community-acquired methicillin-resistant S. aureus (CA-MRSA), streptococci, haemophilus, enterococci, Mycobacterium avium and in animal models of malaria. It is also active against atypical bacteria, such as legionella, chlamydia, mycoplasma and ureaplasma, and against gonococci and other organisms that cause genitourinary tract infections. It is eight to 16 times more potent than azithromycin against many bacteria and is active against azithromycin-resistant strains. The activity of solithromycin against resistant strains is driven by its ability to interact with three sites on the bacterial ribosome, compared to the single binding site of first- and second-generation macrolides.

Cempra Announces European Medicines Agency Validates MAA for Solithromycin for Treatment of CABP

Cempra, Inc. announced that the European Medicines Agency (EMA) has validated the company’s marketing authorization application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP, also referred to as community-acquired pneumonia (CAP) in the EU). The EMA’s validation of the MAA confirms that the submission is complete and formally starts the review process. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now begin their assessment of solithromycin through the centralized review procedure. If the CHMP review results in a positive opinion, the next step would be for the European Commission to grant marketing clearance for solithromycin, which would apply to all EU member states. If approved, solithromycin would be the first new oral and IV antibiotic available in the EU in more than 15 years. According to the European Respiratory Society (ERS), more than 3,000,000 cases of community-acquired pneumonia are diagnosed each year in the EU, resulting in approximately 1,000,000 hospitalizations annually. The ERS notes that antibiotic resistance is one of the major threats undermining the treatment of respiratory infections.

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