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/Anti-InfectiveDrugsAdvisoryCommittee/ucm496389.htm.
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.
About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra's two lead product candidates are currently in advanced clinical development. Solithromycin has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia and applications for approval for both intravenous and oral capsule formulations have been accepted for review by the FDA and the EMA. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin is also in a Phase 3 clinical trial for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is contracted with BARDA for the development of solithromycin for pediatric use. Three formulations, intravenous, oral capsules and a suspension formulation are in a Phase 1b trial in children from birth to 17 years of age. Fusidic acid is Cempra's second product candidate, which is being developed for acute bacterial skin and skin structure infections (ABSSSI) and is also in an exploratory study for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra has also synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com.
Please Note: This press release may contain forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our and our strategic commercial partners' ability to obtain FDA and foreign regulatory approval of our product candidates, including solithromycin; results of our pre-clinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; and the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.