ADVISORY/CEO of Biodefense Drug Maker EluSys Available for Commentary and Interviews on New FDA Policy; FDA Streamlines Anti-terror Drug Approval Process: What Does It Mean for Biotech?

Business Editors, Health/Medical Writers

ADVISORY...

--(BUSINESS WIRE)

      WHO: Steven Sudovar, CEO of EluSys Therapeutics, a
        biopharmaceutical company focused on developing treatments for
        blood-borne diseases including treatments for biowarfare
        threats such as anthrax and smallpox. EluSys provided comment
        to the FDA when it proposed the amendment three years ago.

          Mr. Sudovar is a pharmaceutical industry veteran with
        extensive experience leading research companies and bringing
        successful products to market. Before joining EluSys, Mr.
        Sudovar was president of Roche Laboratories, Inc. Mr. Sudovar
        served on the biodefense taskforce of BIO, the Biotechnology
        Industry Organization. He represented the industry at
        November's CSIS special session, "Biowarfare Threats to
        Civilian Populations: National Strategy to Develop New
        Vaccines and Therapeutics;" and has addressed congressional
        committees and individual members on biological warfare
        defense research and development programs.

      WHAT: The FDA has just amended its regulations to allow for
        approval of certain therapies based on animal studies when
        human efficacy studies are not possible or ethical. This new
        rule facilitates the development of drugs and therapeutic
        treatments for biowarfare diseases such as anthrax, smallpox
        and Ebola virus, which cannot be ethically tested on humans.
        This is an important development for companies engaged in
        biodefense research and development.

      WHY:

      --  The FDA amendment eliminates a major barrier to the
        development of treatments for agents of biowarfare by allowing
        research based on animal data so that humans are not exposed
        to lethal agents.


      --  Mr. Sudovar believes that the amendment could allow EluSys to
        speed development of its unique technology. The EluSys
        Heteropolymer System is designed to treat diseases by
        cleansing the blood of toxins, such as anthrax, within
        minutes.

      --  The FDA's amendment is an essential component of government
        support for the biotech (and pharmaceutical) industry's
        research against biological pathogens.