Cempra's Solithromycin (CEM-101) Receives Qualified Infectious Disease Product Designation From the U.S. Food and Drug

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 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
proposedor designatedInfectious 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.flamm@russopartnersllc.com
        
         Andreas Marathovouniotis
         Russo Partners LLC
         (212) 845-4235
         Andreas.marathis@russopartnersllc.com
 
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