New Study Reveals Limitations of a Complex and Challenging Global Tuberculosis Drug Marketplace

First comprehensive study of market dynamics offers insights into what will be needed to get new, faster and better TB drugs to patients

NEW YORK, May 14, 2007 /PRNewswire-USNewsire/ -- The Global Alliance for TB Drug Development (TB Alliance), a not-for-profit, product development partnership accelerating the discovery and development of new TB drugs, today released results from the first comprehensive study of the dynamics of the global TB drug market that offers a detailed analysis of how today's TB medicines reach patients around the world, and an estimate of the value of the global market for first-line TB treatments.

The study, Pathway to Patients: Charting the Dynamics of the Global TB Drug Market, reveals the variability and complexities faced at all levels of the TB drug supply chain; the highly fragmented nature of the global marketplace in terms of purchase, supply and delivery; the important role of local and national governments in procurement and distribution; and the limited commercial market potential for new TB drugs.

"The absence of a viable commercial market has clearly held back TB drug research for decades," said Maria C. Freire, CEO and President of the TB Alliance. "This groundbreaking study reaffirms the mission of the TB Alliance to develop new, faster and better TB drugs, and the importance of working to ensure these lifesaving new cures reach all those who need them."

Pathway to Patients studied the TB drug market in ten strategically selected countries, including high burden, emerging and high income markets (Brazil, China, France, India, Indonesia, Japan, the Philippines, South Africa, the United Kingdom and the United States) to obtain country specific market data and provide a comprehensive understanding in eight key countries of procurement and distribution systems.

The study projects an estimate of the global market for first-line TB drugs of approximately US$315 million per year, including high income country sales of the four first-line drugs commonly used to treat drug susceptible disease. Although researchers found that a number of factors limited the ability to estimate the global market for treatment for drug resistant disease, they were able to determine that US$54 million is spent annually on the more expensive, second-line treatments in the ten countries studied.

"Understanding how drugs actually reach patients is critical," said Nina Schwalbe, TB Alliance Director of Policy. "We know that desperately needed new cures that shorten and simplify TB treatment will only be effective if they are available to those who need them. This research offers valuable insights into what we at the TB Alliance and others will need to do to get new drug regimens to patients."

The TB Alliance is driving the advancement of the most comprehensive portfolio of TB drugs ever, and is accelerating discovery, preclinical and clinical research of known and novel classes of antibiotics to shorten and simplify TB treatment. The Alliance is committed to making all drugs developed by its research partnerships affordable, universally adopted, and available to all who need them.

The research for Pathway to Patients was conducted in partnership with IMS Health, Inc., a global strategic consulting group focused on the pharmaceutical and health care industries. The project was financed by a grant from the Netherlands Ministry of Foreign Affairs' Department of Development Cooperation (DGIS) and with the support of the Bill & Melinda Gates Foundation.

About TB Disease

Tuberculosis (TB), although curable, continues to kill someone somewhere in the world every 20 seconds -- about 4,400 people every day, or 1.6 million in 2005 alone, according to the latest estimates from the World Health Organization (WHO). TB is second only to HIV as the leading infectious killer of adults worldwide. It accounts for more deaths among women than all other causes of maternal mortality combined and is the leading infectious cause of death in people with HIV/AIDS. The global economic toll of TB is at least $12 billion each year. The bacteria that cause TB, known as Mycobacterium tuberculosis (M.tb), can reside latent in the human body for many years, but once active, attack the respiratory system, and are easily spread through the air like the common cold -- by coughing and sneezing. The WHO estimates that one third of the world is infected with M.tb.

The last class of TB drugs was developed and approved in the 1960s, and the lengthy treatment (6-9 months) required by the old regimen is hindering the progress of TB control. Public health experts agree that a faster-acting TB cure would improve compliance, lower relapse rates, reduce the growth of drug resistant TB, reduce health care costs and save millions of lives. Novel new TB drugs also are needed to be compatible with antiretroviral drugs used to treat HIV for the rising number of those co-infected with TB and HIV, as well as to work against the deadly climb in drug resistant TB.

About the Global Alliance for TB Drug Development

The Global Alliance for TB Drug Development (TB Alliance) is a not-for- profit, product development partnership accelerating the discovery and/or development of new TB drugs that will shorten treatment, be effective against susceptible and resistant strains, be compatible with antiretroviral therapies for those HIV-TB patients currently on such therapies, and improve treatment of latent infection.

Working with public and private partners worldwide, the TB Alliance is leading the development of the most comprehensive portfolio of TB drug candidates in history, and is committed to ensuring that approved new regimens are affordable, adopted and available to those who need them.

The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, Irish Aid, the Netherlands Ministry of Foreign Affairs (DGIS), the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID). For more information on TB drug development and the TB Alliance, please visit http://www.tballiance.org.

    Contact:


    Al Hinman

    TB Alliance

    

    +1-212-227-7540 ext 209

    +1-917-657-5222 (mobile)


    Cuyler Mayer

    TB Alliance

    

    +1-212-227-7540 ext 202

    +1-646-673-7305 (mobile)


    Sarah Smedley

    For TB Alliance

    

    +1-212-229-8488

    +1-917-656-9262 (mobile)

al.hinman@tballiance.org cuyler.mayer@tballiance.org ssmedley@ccapr.com

CONTACT: Al Hinman, +1-212-227-7540 ext 209, Mobile: +1-917-657-5222,, or Cuyler Mayer, +1-212-227-7540 ext 202, Mobile:+1-646-673-7305, , both of TB Alliance; or SarahSmedley, +1-212-229-8488, Mobile: +1-917-656-9262, , forTB Alliance al.hinman@tballiance.org cuyler.mayer@tballiance.org ssmedley@ccapr.com

Web site: http://www.tballiance.org/

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Posted: May 2007

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