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August 23, 2016
Cempra Announces European Medicines Agency Validates MAA for Solithromycin for Treatment of CABP
Formal review of solithromycin by EMA now underway
CHAPEL HILL, N.C., Aug. 23, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today 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.

"With increasing failure rates of primary antibiotic therapy and increasing hospitalization rates due to CABP in the EU, there is an urgent need for new safe and effective oral and intravenous antibiotic therapies," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.

"The validation of Cempra's MAA brings solithromycin another step closer to meeting this need in the EU and we look forward to continuing to work closely with the EMA through the review process," Fernandes added.

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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Source: press release, 8/23/16. http://investor.cempra.com/releasedetail.cfm?ReleaseID=985245

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Cempra Submits Marketing Authorization Application to EMA for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia
Marketing Authorization Application (MAA) submitted for Europe for intravenous and for oral capsules

CHAPEL HILL, N.C., June 28, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the completion of its submission of the MAA for solithromycin to the European Medicines Agency (EMA) for the treatment of community-acquired bacterial pneumonia (CABP). The MAA is for the intravenous and oral capsule formulations.

"The submission of this application to the EMA represents an important achievement in Cempra's effort to bring a potentially important new antibiotic treatment option to critically ill patients in the EU with CABP, where it could help to offset the rising problem of bacterial resistance," stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We look forward to working with the EMA in the coming months with the goal of bringing this potent intravenous and oral treatment to patients in need."

The recent referendum vote in the UK to leave the EU over the next two years is not expected to affect the review of our submission.

This submission in Europe follows the completed submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration in late April this year. Both regulatory submissions include safety and efficacy data from two Phase 3 studies of solithromycin in the treatment of CABP. The first study was a pivotal Phase 3 clinical trial of solithromycin oral capsules, and the second was a global, pivotal Phase 3 clinical trial of IV solithromycin progressing to oral solithromycin. Positive topline results were announced for both Phase 3 trials during 2015.
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Source: press release, 6/28/16. http://investor.cempra.com/releasedetail.cfm?ReleaseID=977301

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Solithromycin CAPInfectious DiseaseCommunity acquired pneumonia (CAP)Fluoroketolide antibioticBacterial ribosome

Mechanism of action: Solithromycin is a next-generation oral and intravenous fluoroketolide. Ketolides are a variation on the existing class of antibiotics known as macrolides. The defining differentiating characteristic of the ketolides as opposed to other macrolides is the removal of the neutral sugar, L-cladinose from the 3 position of the macrolide ring and the subsequent oxidation of the 3-hydroxyl to a 3-keto functional group. These modifications give ketolides much broader spectrum than other macrolides and activity against resistant strains. Ketolides block protein synthesis by binding to ribosomal subunits and may also inhibit the formation of newly forming ribosomes. Solithromycin's activity against resistant strains is driven by its ability to interact with three sites on the bacterial ribosome, compared to one for current macrolides. The binding to three ribosomal sites is expected to limit resistance development.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2017-09-15

Results: Pending