Promising new TB drug given special status by US and European regulators

October 24, 2007

What: Approximately one-third of the world's population is infected with Mycobacterium tuberculosis, the bacterium that causes TB, and an estimated 1.6 million people died of the disease in 2005. Currently, TB patients must adhere to a complex treatment regimen over a six- to nine-month period. This demanding schedule often results in patients skipping treatment doses, which has given rise to drug-resistant strains of M. tuberculosis, including multi-drug-resistant (MDR) and, more recently, extensively drug-resistant (XDR) TB.

SQ109, an antimicrobial agent developed through a partnership between the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, and the biotech company Sequella, Inc., has recently been granted "orphan drug" status by the U.S. Food and Drug Administration and the European Medicines Agency for development against drug-susceptible and drug-resistant TB. This orphan designation will help accelerate clinical testing of the drug; SQ109 (in combination with other TB drugs) may help establish simpler and more effective treatment regimens for the disease.

Recent events have underscored the immense problem of antimicrobial resistance, including the growing threat of MDR-TB, according to NIAID Director Anthony S. Fauci, M.D. The advancement of SQ109 to a clinical candidate, he says, demonstrates the key role that public-private partnerships can play in developing new interventions to improve public health.

SQ109 was discovered by NIAID scientists in 1999 and developed with grant and contract support from NIAID and contributions by the National Cancer Institute/NIAID Inter-Institute Program for the Development of AIDS-related Therapeutics. NIAID licensed the SQ109 technology to Sequella in March 2006 under a Cooperative Research and Development Agreement.
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Spokespersons: Anthony S. Fauci, M.D., NIAID Director, and Christine F. Sizemore, Ph.D., chief of the Tuberculosis and other Mycobacterial Diseases Section in the NIAID Division of Microbiology and Infectious Diseases.

Contact: To schedule interviews, contact the NIAID News and Public Information Branch, (301) 402-1663, http://www.niaid.nih.gov.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)--The Nation's Medical Research Agency--includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

NIH/National Institute of Allergy and Infectious Diseases

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