From the ASPR Blog: PHEMCE-supported drug achieves FDA approval

Diversifying our medical countermeasures portfolio gives us more options to treat people if an attack ever happens. Developing a diverse medical countermeasures portfolio takes a lot of strong partnerships. Find out how partnerships within the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and between BARDA and private industry are making a more diverse portfolio of medical countermeasures a reality. Learn More >>

HEMCE-supported drug achieves FDA approval

Author: Dr. Richard Hatchett, Acting Director of ASPR’s BARDA
Published Date: 3/21/2016 10:12:00 AM
Category: Medical Countermeasures; Public Health Preparedness;

Today, the FDA licensed the monoclonal antibody drug Anthim, developed by Elusys Therapeutics of Pine Brook, New Jersey, to treat inhalational anthrax. This drug’s approval not only diversifies our available medical countermeasures for use after an anthrax attack but also further demonstrates the effectiveness of partnering among federal agencies through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and the success of BARDA’s model of partnering with private industry.

Bridging the “Valley of Death” in Drug Development

HHS established the coordinated interagency PHEMCE group to define and prioritize requirements for the countermeasures our nation needs, focus research and development activities to address those needs, and procure and establish strategies to deploy and use the medical countermeasures that are in the Strategic National Stockpile.

Before BARDA existed, companies with drugs identified as promising countermeasures in early research often lacked the necessary funding, technical support and services necessary to advance the products through the development pipeline to FDA licensure.

Unlike drugs for common medical conditions, many drugs developed as medical countermeasures do not have a commercial market. Companies with promising medical countermeasures in early development often lacked the needed funding to push their products through late-stage development, which sometimes is referred to as the “valley of death” in drug development, to FDA licensure.

In 2006, Congress recognized that to have medical countermeasures available in a disaster meant the federal government needed to bridge this gap, and created BARDA to do it. The National Institutes of Health (NIH) supports studies of potential medical countermeasures in the earlier stages of development, and BARDA picks up the baton to support products as they move into clinical studies, develop commercial scale manufacturing, and make regulatory submissions. The agencies coordinate through the PHEMCE to transition products smoothly between agencies.

Anthim stands as the twenty-third medical countermeasure BARDA has supported to achieve FDA approval. The support the manufacturer received from PHEMCE partners proved vital reaching this milestone.

Partnerships lead to greater national health security

We continue to collaborate with private sector partners to advance the development of promising drugs, vaccines and other medical products to help ensure our nation is better protected during a disaster or public health emergency.

Companies seeking to further the development of countermeasures for chemical, biological, radiological and nuclear agents can apply for BARDA funding through one of our broad agency announcements, or BAAs. We also provide funding to advance medical countermeasures for pandemic influenza through a separate BAA.

We also provide funding to private partners to help develop new and innovative medical countermeasure technologies.

BARDA created the TechWatch program to help companies, private organizations and academic institutions determine whether they have products or technologies that could qualify for funding. Through TechWatch, participants have an opportunity to meet with scientific subject matter experts as well as project management staff. During TechWatch meetings, participants present their products and development plans, and receive feedback about their products or technologies, suggestions about techniques and strategies to meet technical and regulatory challenges, insight on how a product or technology might address BARDA's objectives, and information about BARDA’s mission and programs.

To learn whether BARDA could help advance the development of a medical countermeasure or innovative technology that your company or organization is working on, request a TechWatch meeting to present your ideas to medical countermeasure development experts.