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Preclinical Study Suggests That Solithromycin May Provide an Effective Antimicrobial Approach for Prevention and Treatment of Intrauterine Infections in Pregnancy

Cempra's Solithromycin Demonstrates Clinically-Relevant Fetal Blood Levels in a Sheep Pregnancy Model

Presentation at the 8th World Congress on Developmental Origins of Health and Disease (DOHaD), Nov. 18, in Singapore

CHAPEL HILL, N.C., Nov. 18, 2013 (GLOBE NEWSWIRE) -- Cempra, Inc., (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced results of an in vivo preclinical study suggesting that solithromycin (CEM-101) may provide an effective antimicrobial approach for the prevention and treatment of intrauterine infections during pregnancy. Intravenous administration of solithromycin in pregnant sheep, a validated model for human pregnancy, resulted in effective concentrations of the drug in fetal plasma and amniotic fluid. The study will be presented at the 8th World Congress on Developmental Origins of Health and Disease (DOHaD) Conference on Nov. 18, in Singapore. The research has also been accepted for publication in Antimicrobial Agents and Chemotherapy and it is currently available online.

According to the U.S. Centers for Disease Control and Prevention, the U.S., preterm delivery rate, defined as less than 37 weeks gestation, is approximately 12% of all births, or roughly half a million a year. Preterm births account for 75% of perinatal mortality and more than half of these babies face long-term morbidities, including increased risk of neurodevelopmental and other impairments. Bacterial infection of the amniotic cavity is associated with preterm birth (PTB). It is estimated that infection may be implicated in as many as 40% of PTB cases. In a 2007 study, bacterial vaginosis was shown to approximately double the risk of PTB and miscarriages were six times more likely. According to the March of Dimes, in 2005, labor, delivery, medical and healthcare costs due to preterm birth were estimated at $18.8 billion in the U.S.

To prevent PTB, maternally delivered antibiotics are prescribed to high risk patients. However, these agents, mainly azithromycin and erythromycin, face challenges, namely, penetration into the placenta, fetal plasma, and amniotic fluid. In addition, antibiotics indicated for infections during pregnancy, erythromycin, metronidazole and clindamycin, do not reduce the risk of PTB. New treatment options are urgently needed.

"Ureaplasma, mycoplasma and Group B Streptococcus are serious infections in pregnant women and can result in adverse outcomes for the developing fetus," said Jeffrey Keelan, professor, School of Women's and Infant's Health, University of Western Australia and presenter of the study. "A challenge has been to identify safe and effective antibiotics that can be administered maternally but reach effective concentrations in fetal blood so that the infection can be effectively treated. Solithromycin, which has demonstrated in vitro activity against bacterial pathogens relevant for this patient population, can reach clinically-relevant fetal blood concentrations based on this animal model and, thus, appears to be a promising antibiotic to treat these currently difficult infections."

Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra, said, "This study is another example of the broad use potential in special populations of our fourth-generation macrolide, the first fluoroketolide antibiotic, solithromycin, further differentiating solithromycin from other antibiotics in development as well as generic antibiotics, and trying to meet a large medical need in this special population group."

Presentation information:

1:30 – 3 p.m. SGT, Monday, Nov. 18

Abstract # DOHaD13-1392, posterboard # 076; A Novel Antibiotic for the Treatment of Intrauterine Ureaplasma and Mycoplasma Infection: Pharmacokinetic Studies in the Pregnant Sheep Model

Jeffrey A Keelan, professor, School of Women's and Infants' Health, University of Western Australia

About Cempra, Inc.

Founded in 2006, 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 (CEM-101) is in a Phase 3 clinical trial for community-acquired bacterial pneumonia (CABP) and is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. TAKSTA™ (CEM-102) is Cempra's second product candidate currently in a Phase 2 clinical trial for prosthetic joint infections. TAKSTA was recently granted orphan drug designation for this indication. Both product candidates seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company also intends to use its series of proprietary lead compounds from its novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Additional information about Cempra can be found at www.cempra.com.

Please Note: This press release contains 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: the results of studies of our product candidates conducted by others; the results, timing, costs and regulatory review of our studies and clinical trials; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our anticipated capital expenditures and our estimates regarding our capital requirements; our ability to obtain FDA approval of our product candidates; our dependence on the success of solithromycin and Taksta; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; and innovation by our competitors. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

CONTACT: Investor and Media Contacts: Robert E. Flamm, Ph.D. Russo Partners, LLC (212) 845-4226 Robert.flamm@russopartnersllc.com Andreas Marathovouniotis Russo Partners LLC (212) 845-4235 Andreas.marathis@russopartnersllc.comSource:Cempra, Inc.