Cempra's Solithromycin (CEM-101) Receives Qualified Infectious Disease Product Designation From the U.S. Food and Drug Administration
CHAPEL HILL, N.C., Sept. 6, 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 that the U.S. Food and Drug Administration (FDA) has designated oral Solithromycin (CEM-101), as a Qualified Infectious Disease Product (QIDP) for the indication of community-acquired bacterial pneumonia. The QIDP designation is expected to enable Cempra (CEMP) to benefit from certain incentives for the development of new antibiotics, including priority review, and a five year extension of new chemical entity (NCE) exclusivity. An oral formulation of solithromycin is currently being evaluated in a Phase 3 trial for the treatment of community-acquired bacterial pneumonia (CABP). Cempra is planning to initiate an intravenous-to-oral Phase 3 step-down Phase 3 trial during the second half of 2013.
"FDA recognition of solithromycin for QIDP designation highlights the recognition of pneumococcus as a Qualified Infectious Disease Pathogen and the potential differential value of our antibiotic candidate to treat CABP, which is one of the most common bacterial infections that can lead to hospitalization," said Prabhavathi Fernandes, president and chief executive officer of Cempra. "In addition, solithromycin is active against several other proposed or designated Infectious Disease Pathogens including Streptococcus pyogenes, Streptococcus agalactiae, Staphylococcus aureus, Neisseria meningitides, Campylobacter, Enterococcus, Neisseria gonorrhoeae, and Mycobacteria species. We look forward to the potential benefits of QIDP designation of solithromycin as a treatment for CABP as well for other indications so we may bring solithromycin to patients who could benefit from it."
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 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. Both 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, timing, costs and regulatory review, and other analyses, 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; 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.email@example.com Andreas Marathovouniotis Russo Partners LLC (212) 845-4235 Andreas.firstname.lastname@example.orgSource: Cempra, Inc. 2013 GlobeNewswire, Inc.