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Reduced-Duration Tuberculosis Treatment: Tuberculosis (TB) is caused by Mycobacterium tuber- administered for six to eight months, often under the culosis, slow-growing bacteria that thrive in areas of direct observation of a health-care provider. The four- the body that are rich in blood and oxygen. TB in the drug regimen consists of isoniazid, rifampin, pyrazin- lungs is easily spread to other people through cough- amide, and ethambutol. There is a real need for new ing or laughing. M. tuberculosis infects one-third of the treatments that are less expensive, of shorter duration, world’s population, resulting each year in nine mil ion new cases of active TB and two mil ion deaths, 90 per- Moxifloxacin is an antibiotic that was first ap- cent of them in developing countries. China and India proved in 1999 and is currently used in 104 countries alone account for 35 percent of al estimated new TB to treat certain bacterial respiratory, skin and intra-ab- cases each year. An estimated one bil ion people wil dominal infections. The antibiotic has been used by be newly infected between 2000 and 2020; 200 mil- more than 47 million patients worldwide. It is gener- lion wil fal il and 35 mil ion wil die. TB is a leading ally well tolerated but treatment may result in certain cause of death among people living with HIV/AIDS, usually mild side effects, including nausea, diarrhea, and multi-drug resistant strains are spreading at a rate and dizziness. In vitro and in vivo studies have dem- of 300,000 newly diagnosed cases a year. onstrated moxifloxacin activity against M. tuberculosis. Investigators at Johns Hopkins discovered that substi- tution of moxifloxacin for isoniazid in the TB treat- THE R&D cHAllEngE
ment regimen reduced treatment time by two months The TB drug market wil require sufficient incentives in mice. The treatment regimen included rifampin, to support the research needed to develop a pipeline pyrazinimide, and either moxifloxin or isoniazid.2 of continual y improving drugs. Even with the market In October 2005, the TB Alliance and Bayer potential y reaching US$700 mil ion by 2010, it is Healthcare AG3 announced a partnership to coor- concentrated in poor countries, and no single industry dinate a global clinical development program to player has been able to pursue the ful development of study the potential of moxifloxacin to shorten the an anti-TB drug. The Global Al iance for TB Drug standard six-month treatment of TB by two to three Development (TB Al iance)1 was designed by the in- months. The trials will evaluate whether the substi- ternational community as the primary instrument to tution of moxifloxacin for one of the standard TB fil this vacuum and to ensure that new anti-TB drugs drugs (ethambutol or isoniazid) eliminates TB in- are affordable and accessible in endemic countries. fection faster than the current standard therapy. If Current TB therapy is based on four drugs for successful and approved by the respective regulatory preventing multi-drug-resistant TB. These drugs agencies, a new, shorter regimen could be available were discovered 40 or more years ago and must be MIHR/PIPRA. 2007. Reduced-Duration Tuberculosis Treatment: TB Alliance and Bayer HealthCare. In Executive Guide to In- tellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.
Editors’ Note: This case study was prepared by MIHR members of the Technology Managers for Global Health (TMGH), a special interest group of the Association of University Technology Managers (AUTM) (see www.tmgh.org) and adapted for this Executive Guide. The original version was published as part of a collection of case studies: MIHR/TMGH. 2007. Aca- demic Licensing to Global Health Product Development Partnerships (ed. U Balakrishnan). MIHR: Oxford, U.K.
2007. MIHR/PIPRA. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncom- mercial purposes is permitted and encouraged.
HANDBOOK OF BEST PRACTICES: EXECUTIVE GUIDE | CS 43 The Phase II and III clinical trial program involves Funding has been provided to the TB Al iance by: countries in four continents and will enroll close to • the Bill and Melinda Gates Foundation 2,500 patients with TB. The trials will be carried out in • the U.S. Agency for International Development Brazil, Canada, South Africa, Spain, Tanzania, Uganda, the United States, and Zambia. If the trials are success- ful, the partnership aims to register moxifloxacin for a PRogRESS, cURREnT STATUS, AnD goAlS
TB indication. Upon regulatory approval, the partner- Goals of the TB Alliance are: ship is committed to making it affordable and acces- • to devise, coordinate, and support a global sible in developing countries, where the disease is most clinical-development program to register a moxifloxacin-based regimen for shortening the For this project, Bayer will donate moxifloxa- time required for treatment of TB, at an afford- cin for each trial site and will cover the costs of able price (to be carried out in parnership with regulatory filings, and the TB Alliance will coor- dinate and help cover the costs of the trials, seek- • to carry out clinical trials compliant with ICH ing to leverage support from the U.S. Centers for Disease Control and Prevention (CDC), the Orphan • to create a unified global safety database Products Development Center of the U.S. Food and Drug Administration (FDA) and the European and • to provide affordable treatment for patients Developing Countries Clinical Trials Partnership (EDCTP). In May 2006, the TB Alliance received a US$104 million grant from the Bill and Melinda Gates Foundation. The grant will be used in part to • CDC TBTC Study #27: Moxifloxacin replaces fund Phase II and III trials of moxifloxacin with the ethambutol. United States, Canada, Uganda, goal of showing the efficacy of moxifloxacin in reduc- and South Africa. 336 patients. Status: com- ing TB treatment times by two months by 2010. • CDC TBTC Study #28: Moxifloxacin replaces isoniazid in United States, Canada, Uganda, THE BEnEFITS
South Africa, Brazil, and Spain. 410 patients. Public health experts note that a shorter TB regimen Status: Enrollment initiated February 2006.
would help ease the economic burden of the disease, • JHU: Moxifloxacin replaces ethambutol. Brazil. estimated at US$16 billion a year, and enable health- 170 patients. Status: Trial initiated in February care workers to treat more patients. A shorter treat- ment protocol may improve patient adherence to • UCL-BMRC: Moxiflaxacin replaces ethambu- therapy and, thereby, help save lives. When patients tol; moxifloxacin replaces isoniazid. Tanzania, complete treatment successfully, there is less chance of South Africa, and Zambia. 1500 patients. relapse or of the emergence of drug resistance.
Licensing deals include the following terms: Major partners in the TB treatment project are: • pharmaceutical company Bayer HealthCare • payments/royalties: to be made available in developing countries at cost, for use against • nonprofit organization the Global Alliance for • patent strategy: patents previously issued n • government entities the U.S. Centers for Disease Control and Prevention, the FDA, and For further information, please contact: gloBal allianCe For tB drug deVeloPMent (tB
Clinical studies would be carried out by the fol- allianCe), Maria Freire, CEO & President, 80 Broad
Street, 31st Floor, New York, NY 10004, U.S.A. maria. • Tuberculosis Trials Consortium (TBTC) of the freire@tballiance.org Bayer healthCare, Staci Gouveia, 400 Morgan Lane, West
Haven, CT 06516, U.S.A. staci.gouveia.b@bayer.com Bayer healthCare, Michael S. Diehl. Leverkusen,
Germany 51368, Leverkusen. michael.diehl@bayerhealth- No commercialization plan for the improved care.com CS 44 | HANDBOOK OF BEST PRACTICES: EXECUTIVE GUIDE 1 Global Alliance for TB Drug Development (TB Alliance): 2 Nuermberger EL, T Yoshimatsu, S Tyagi, K Williams, I Rosenthal, RJ O’Brien, AA Vernon, RE Chaisson, WR Bishai and JH Grosset. 2004. Moxifloxacin-Containing Regimens of Reduced Duration Produce a Stable Cure in Murine Tuberculosis. Am J Respir Crit Care Med. 3 Bayer HealthCare AG: www.bayer.com. See also Chapter 11.6 William T. Tucker and Gavin S. Ross, titled Use of Trademarks in a Plant-Licensing Program, p. 1059.

Source: http://www.iphandbook.org/handbook/case_studies/csPDFs/casestudy19.pdf

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