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Cempra Pharmaceuticals Inc. Announces Lead Macrolide is Active in vitro Against Clinically Significant Antibiotic-Resistant Pathogenic Organisms

CEM-101 is active against M. pneumoniae, M. hominis and Ureaplasmas, including macrolide-resistant strains


CHAPEL HILL, N.C.--(BUSINESS WIRE)--Apr 28, 2009 - Cempra Pharmaceuticals today announced the publication of new research in the May issue of Antimicrobial Agents and Chemotherapy, a journal of the American Society for Microbiology, demonstrating that its lead compound, CEM-101, is active in vitro against six clinically important human Mycoplasma and Ureaplasma species. The findings suggest that the antibiotic may have clinical utility across a range of difficult-to-treat infections, and that further investigations are warranted.

The study, conducted by researchers at the University of Alabama at Birmingham, showed that CEM-101 was active against azithromycin- and telithromycin-resistant M. pneumoniae, organisms that cause pneumonia, and doxycycline-resistant M. hominis, an organism that can cause urogenital infections such as pelvic inflammatory disease. CEM-101 also demonstrated activity against Ureaplasma species which can cause urogenital and neonatal infections. Cempra, initially targeting moderate to severe community-acquired bacterial pneumonia with CEM-101, expects to begin a Phase 2 trial in this indication in 2009.

CEM-101, which Cempra believes is the most potent macrolide in development to date, has consistently shown activity against organisms with acquired resistance to available macrolides.

“Bacterial drug resistance is a significant problem in treating infections, and addressing this urgent need to develop solutions to drug-resistant bacterial infections is an enormous challenge,” said Dr. Prabhavathi Fernandes, CEO of Cempra Pharmaceuticals. “Additionally, recent global public health threats, such as the re-emergence of swine influenza, point to the importance of research and drug development targeted towards difficult-to-treat respiratory infections. The CDC has cited that severe illnesses, such as pneumonia and respiratory failure, and deaths resulting from these infections, have occurred with influenza. As influenza increases the body's susceptibility to Pneumococcus and Mycoplasma, and bacterial resistance to drugs interferes with our ability to effectively address these infections, it is critically important that we continue to work on new treatments.”

Dr. Fernandes continued by saying, “Cempra's macrolide, CEM-101, has displayed unmatched potency and activity against macrolide-resistant organisms and shows potential to meet important public health needs.”

Macrolides are typically prescribed for the treatment of respiratory tract and soft tissue infections. Their spectrum of activity includes streptococci as well as atypical bacteria such as Mycoplasma and Legionella, and intracellular bacteria such as Chlamydia. A significant percentage of Streptococcus pneumoniae are resistant to currently available antibiotics, which may result in treatment failures.

“We have already seen activity with this compound against bacteria that cause serious respiratory and urogenital infections, and this current study demonstrated that the antimicrobial spectrum of activity for CEM-101 is, in fact, much broader than we could have anticipated,” said Dr. Ken Waites, lead investigator and a professor in the Department of Pathology at the University of Alabama at Birmingham. “It's a very promising compound.”

In addition to CEM-101, Cempra is also developing CEM-102, an oral antibiotic that is active against gram-positive bacteria. CEM-102 is expected to be used to treat patients with staphylococcal infections.

About Cempra Pharmaceuticals, Inc.

Founded in 2006, Cempra Pharmaceuticals, Inc. is a privately-held biotechnology company that discovers and develops well-differentiated medicines to cure bacterial infections and improve the quality of life for those with chronic illnesses. The company strives to meet urgent and rapidly expanding needs to treat patients with drug-resistant bacterial infections. Cempra balances near-term product development opportunities, including the macrolide CEM-101, while investing in future products from new technologies to derive the next generation of antibiotics. Cempra is utilizing its proprietary chemistry technology to develop macrolides without antibacterial activity for non-antibiotic uses. Additional information about Cempra can be found at



Contact: Feinstein Kean Healthcare
Krystle Ficco, 617-761-6702



Posted: April 2009