Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,484.02 66.49 0.46%
TOPIX 1,169.43 2.84 0.24%
HANG SENG 22,760.24 64.23 0.28%

Cempra Awarded $58 Million Contract to Develop Antibiotic for Pediatric Use and Biodefense by Biomedical Advanced Research and



 Cempra Awarded $58 Million Contract to Develop Antibiotic for Pediatric Use
   and Biodefense by Biomedical Advanced Research and Development Authority
                                   (BARDA)

- Cempra to Host Conference Call and Webcast at 8:30 a.m. EDT, Tomorrow, May
29, 2013 -

PR Newswire

CHAPEL HILL, N.C., May 28, 2013

CHAPEL HILL, N.C., May 28, 2013 /PRNewswire/ -- Cempra, Inc. (Nasdaq: CEMP), a
clinical-stage pharmaceutical company focused on developing differentiated
antibiotics, today announced that the Biomedical Advanced Research and
Development Authority (BARDA) has awarded Cempra with a five year contract
valued up to $58 million for the development of solithromycin to treat
infections in pediatric populations and for the treatment of infections by
bioterror threat pathogens.  Solithromycin, Cempra's lead product candidate,
is a fourth generation macrolide antibiotic in the fluoroketolide family that
is currently in Phase 3 development for community-acquired bacterial pneumonia
(CABP) in adults.  The company will host a conference call and webcast at 8:30
a.m. EDT, tomorrow, May 29, to discuss the agreement.

"We are delighted that BARDA has recognized solithromycin as a potentially
safe and effective treatment for the pediatric population," said Prabhavathi
Fernandes, Ph.D., chief executive officer of Cempra. "Macrolides have
traditionally been favored for use in pediatrics because of their safety and
efficacy.  Solithromycin's approval would be the first orally administered
antibiotic approved in decades, and azithromycin (Zithromax^® or Z-Pak) was
the last macrolide approved, which was in 1991.  We view BARDA's funding of
this project as recognition of the potential of solithromycin to have broad
utility in all age groups."

The upfront contract is for a two year base period with guaranteed funding of
$17.7 million and is extendable up to five years bringing the value of the
total contract to $58 million.  The contract is expected to fund a variety of
activities that are planned to lead to the Pediatric as well as the Animal
Rule New Drug Applications (NDA) for use of solithromycin against bioterror
threat pathogens. The full funding, if received, will support Phase 1, Phase
2, and the majority of the Phase 2/3 studies on a pediatric oral suspension,
oral capsules and the intravenous formulation for CABP. The contract should
also fund non-human primate pilot studies of activity against biothreat
pathogens, anthrax and tularemia, placing Cempra's lead product on the pathway
to other indications.

This project will be funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201300009C.

Conference Call and Webcast
The conference call may be accessed by dialing 877-377-7553 for domestic
callers and 253-237-1151 for international callers. Please specify to the
operator that you would like to join the "Cempra, Inc., BARDA Contract Award
Conference Call, conference ID#: 77304813." The conference call will be
webcast live under the investor relations section of Cempra's website at
www.cempra.com, and will be archived there for 30 days following the call.
Please visit Cempra's website several minutes prior to the start of the
broadcast to ensure adequate time for any software download that may be
necessary.

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.  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.

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

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 of our studies and clinical trials; our
need to obtain additional funding and our ability to obtain future funding on
acceptable terms; the results of studies and trials of our product candidates
conducted by others; 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.

 

SOURCE Cempra, Inc.

Website: http://www.cempra.com
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement