Navigation Links
Cempra Awarded $58 Million Contract to Develop Antibiotic for Pediatric Use and Biodefense by Biomedical Advanced Research and Development Authority (BARDA)
Date:5/28/2013

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Cempra, Inc. Signs Exclusive License and Development Agreement for Solithromycin with Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation in Japan
2. Cempra to Present Data on Solithromycins (CEM-101) Potential Against Urogenital Infections and Multidrug-Resistant Pathogens at ECCMID
3. Cempra, Inc. Reports First Quarter 2013 Financial and Operating Results
4. Cempra, Inc. to Present at 12th Annual Needham Healthcare Conference
5. Cempra, Inc. to Report First Quarter 2013 Financial and Operating Results, and Host Conference Call and Webcast on April 25, 2013
6. Cempra, Inc. to Present at Cowen and Company 33rd Annual Health Care Conference
7. Cempra, Inc. to Report Fourth Quarter and Full Year 2012 Financial and Operating Results, and Host Conference Call and Webcast on February 28, 2013
8. Grant Awarded to Study Novel Therapies for Muco-Obstructive Diseases Includes Studies on Cempras Solithromycin (CEM-101) in a Cystic Fibrosis Anti-inflammatory Model
9. Cempra, Inc. to Present at Oppenheimer 23rd Annual Healthcare Conference
10. Cempra, Inc. to Present at the Jefferies 2012 Global Healthcare Conference in London
11. Cempra, Inc. to Report Third Quarter 2012 Financial and Operating Results, and Host Conference Call and Webcast on November 8, 2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from PsychTests.com reveals that behind the tendency to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
(Date:6/24/2016)... New York, NY (PRWEB) , ... June 24, ... ... lifestyle publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as ... believes that “the most beautiful women in the world, and the most handsome ...
(Date:6/24/2016)... ... ... Venture Construction Group (VCG) sponsors Luke’s Wings 5th Annual ... Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event raised funds ... been wounded in battle and their families. Venture Construction Group is a 2016 Silver ...
Breaking Medicine News(10 mins):