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November 4, 2016
Cempra Stock Trading Halted Today; FDA Advisory Committee to Discuss Solithromycin
CHAPEL HILL, N.C., Nov. 04, 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 NASDAQ has halted trading of the company's common stock.

The U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) is meeting today to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).

The Advisory Committee meeting is scheduled to begin at 8:30 a.m. ET and is scheduled to end at 5:00 p.m. ET. The FDA briefing materials for the meeting can be found at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/A....

Solithromycin was granted qualified infectious diseases product (QIDP) designation which entitled the new drug applications (NDAs) to eight month priority reviews, resulting in PDUFA dates of December 27, and December 28, 2016, respectively, for the oral and intravenous NDAs.
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Source: press release, 11/04/16. http://investor.cempra.com/releasedetail.cfm?ReleaseID=997697

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Cempra to Present Solithromycin at FDA Antimicrobial Drugs Advisory Committee Meeting on November 4, 2016
FDA currently reviewing NDAs for IV and oral solithromycin for community-acquired bacterial pneumonia, with PDUFA dates in late December
CHAPEL HILL, N.C., Aug. 30, 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 U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Antimicrobial Drugs Advisory Committee on November 4, 2016 in Silver Spring, Maryland to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).

Cempra conducted two pivotal Phase 3 global registration trials of solithromycin. The first study was conducted with solithromycin oral capsules, and the second study tested intravenous (IV) solithromycin progressing to oral solithromycin. Both Phase 3 studies met their primary endpoints that were aligned with FDA guidance.

Solithromycin was granted qualified infectious diseases product (QIDP) designation which entitled the new drug applications (NDAs) to eight month priority reviews, resulting in PDUFA dates of December 27, and December 28, 2016, respectively, the oral and intravenous NDAs.

"Antimicrobial resistance is an urgent public health threat and we believe that the strong data we have seen with solithromycin in clinical trials supports its approval as a new IV and oral antibiotic that would meet an important unmet need in the treatment of both in-patient and out-patient CABP," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.

"We look forward to the November 4 discussion with the advisory committee, and continued dialogue with the FDA, as we progress towards the solithromycin PDUFA dates at the end of the year," Fernandes added.
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Source: press release, 8/30/16. http://investor.cempra.com/releasedetail.cfm?ReleaseID=987074

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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 FDA: Advisory Committee Meeting

Dates: 2016-11-04

Results:

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November 4, 2016
FDA Advisory Committee Votes That Efficacy Results of Cempra's Solithromycin Outweigh Risks for Community-Acquired Bacterial Pneumonia
—FDA PDUFA dates December 27 & 28, 2016—

CHAPEL HILL, N.C., Nov. 04, 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 majority of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra's solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP).

Members of AMDAC voted unanimously (13-0) that there was substantial evidence of the efficacy of solithromycin for CABP. The committee also voted (12-1) that the risk of hepatotoxicity with solithromycin had not been adequately characterized and discussed a variety of potential approaches to further characterize the existing liver safety information on solithromycin.

"We appreciate the meaningful discussion from today's panel. Their supportive view and thoughtful comments on approaches to ensuring appropriate use are consistent with Cempra's commitment to make solithromycin available to the right patients for a five to seven day course of an oral and/or IV macrolide as monotherapy for CABP," said Prabhavathi Fernandes Ph.D., president and chief executive officer of Cempra.

"Antibiotic resistance is reaching alarming rates across the globe. In the U.S. alone, pneumonia is the leading cause of death due to infectious disease and rates of pneumococcal resistance to current macrolides for the treatment of CABP can exceed 50 percenti. We believe solithromycin has the potential to offer patients and physicians an important new treatment option and we look forward to continuing to work with the FDA as it completes its review," Fernandes added.

The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is December 27 and 28, 2016 for the oral and IV filings, respectively.

The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, solithromycin would be the first new macrolide antibiotic with an oral and IV formulation in over 20 years.
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Source: press release, 11/04/16. http://investor.cempra.com/releasedetail.cfm?ReleaseID=997840

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