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Re: frrol post# 70108

Friday, 09/19/2014 8:55:26 PM

Friday, September 19, 2014 8:55:26 PM

Post# of 403134
Frrol, I totally understand your concern. I continue to dig and it seems that the incentives that are available are meant to encourage development of drugs such as B.

***I really think Leo is telling big Pharma "we don't need you and your stink bids... We have options"

Check this out: http://www.medicalcountermeasures.gov/barda/cbrn/broad-spectrum-antimicrobials.aspx


The U.S. Department of Health and Human Services has a requirement to develop broad spectrum antimicrobials for the following biological threat agents: Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Rickettsia prowazekii, orthopoxviruses, filovirus, and Arenavirus (Junin virus). The Biomedical Advanced Research and Development Authority (BARDA) is expanding its role in the development of these medical countermeasures (MCMs) by concurrently providing funding for the development of novel therapies that will address the public health issue of naturally occurring antibiotic/antiviral resistance.

Broad Spectrum Antimicrobials Medical Countermeasure Efforts

The 2010 PHEMCE Review stated that "Our Nation must have a nimble, flexible capacity to produce MCMs rapidly, in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease."

In order to help achieve this vision, BARDA's Broad Spectrum Antimicrobials (BSA) Program was established in January 2010 and is focused on developing novel antibacterial and antiviral drugs for the treatment or prevention of disease caused by currently defined and future biological threats. BARDA also recognizes that new antimicrobials are needed immediately to address the increasingly prevalent public health threat of antibiotic resistance, as well as the likelihood that antimicrobial resistance will complicate standard treatment of a wide array of infections. BARDA hopes to revitalize the antimicrobial pipeline by providing incentives for pharma and biotech companies to engage (or reengage) in antimicrobial development.

The BSA Program's non-dilutive funding strategy provides our partners with capital to support product development and supplement existing equity. BARDA is establishing public-private partnerships with industry partners for the development of novel antimicrobials and anticipates a long term commitment to this market. Through these partnerships, BARDA will support concurrent development of candidate products for biodefense and commercial indications based on strategic and funding priorities outlined in our BAA.

This strategy helps ensure that novel antimicrobials will progress through the development pipeline to approval for a clinically prevalent indication. It increases the likelihood that novel antimicrobials will be added to the arsenal of possible treatments available to counter resistant infections. Approval of a candidate for a commercial indication also helps establish a human safety database and a warm base manufacturing capability for the drug should it be needed in a public health or biothreat emergency scenario.

By engaging with BARDA in a contract our industry partners are able to receive funding and technical consulting support from BARDA for preclinical studies, clinical studies (Phase 1-3), manufacturing, and regulatory activities.


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