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Janssen Wins Prestigious International Prix Galien Award for MDR-TB Treatment
Ground breaking therapy offers hope for people with Multi-Drug Resistant Tuberculosis (MDR-TB)

PARIS, France, Dec. 8 2016, Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), is proud to accept the prestigious International Prix Galien, recognizing excellence in scientific innovation to improve human health.

The award is presented every two years to a medicine that has previously won a national Prix Galien, in recognition of the pharmaceutical industry's outstanding achievement in the development of new therapies. It is considered the highest accolade for pharmaceutical research and development.1,2 The development of Johnson & Johnson’s treatment for MDR-TB marks an essential step toward arresting the global antimicrobial resistance threat. The award is particularly meaningful since it represents the first time a treatment for a neglected disease such as tuberculosis has been recognized by the Prix Galien.

“Johnson & Johnson is honored to receive the International Prix Galien award for our work in the MDR-TB arena. This achievement is a testament to the tireless efforts of our research scientists and to our global partners,” said Wim Parys, M.D., Head, R&D Global Public Health, Johnson & Johnson. “MDR-TB is a critical part of Johnson & Johnson’s new Global Public Health (GPH) organization and underscores our commitment to ensuring essential medicines and care for the world’s most vulnerable and neglected populations.”

Tuberculosis (TB) is the world’s leading infectious disease killer, affecting an estimated 10.4 million people around the world annually and killing more than 4,900 people each day.6 In 2015, there were an estimated 480,000 new cases of multidrug-resistant TB (MDR-TB) and an additional 100,000 people with rifampicin-resistant TB (RR-TB), who were also newly eligible for MDR-TB treatment.6 Globally, 132,120 cases of MDR-TB and RR-TB were detected and notified in 2015, and nearly 125,000 were enrolled on treatment.

Johnson & Johnson’s MDR-TB treatment was initially approved in the United States in 2012 as part of a combination therapy in the treatment of adults with pulmonary MDR-TB.3 It was the first medication with a novel mechanism of action in over 40 years to be approved for the treatment of adult patients with TB, and the first drug ever to be approved for adult patients with pulmonary MDR-TB.3,4,5 Before the introduction of Johnson & Johnson’s MDR-TB treatment, fewer than 50 percent of patients with MDR-TB were treated successfully.5

Johnson & Johnson’s strong commitment to global health is reflected in the work that Janssen is undertaking to develop innovative pharmaceutical products that address significant worldwide unmet medical needs, as well as unique partnerships to ensure vital medicines reach vulnerable and neglected populations. With TB, these efforts include an existing collaboration with the United States Agency for International Development (USAID) to support the 4-year Bedaquiline Donation Program, through which Janssen will provide up to 30,000 treatment courses for use in more than 100 low and middle-income countries around the world; longstanding partnerships with the Union, Harvard University and TB Alliance; and a more recent partnership with FIND.

This latest International Prix Galien award is Janssen’s fifth international award. Janssen is now one of the most awarded companies in the 46-year history of the Prix Galien, having been previously in 2014, 2012, 2006 and 1996.


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About Johnson & Johnson
Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 128,000 employees at more than 265 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

About Prix Galien1,2
The Prix Galien was created in France in 1970, to promote significant advances in pharmaceutical research. The judging panel consists of clinicians, toxicologists, pharmacologists and pharmacists. The award is an opportunity to give credit to the most important drugs introduced into the public market and the best research teams. It is considered the industry’s equivalent of the Nobel prize and the highest accolade for pharmaceutical research and development. Following its success in France, the Prix Galien was taken up in other countries. The 14th International Prix Galien is being awarded to Johnson & Johnson’s MDR-TB treatment.

About MDR-TB6
MDR-TB is a form of TB characterized by resistance to at least two of the standard four-drug, anti-TB drugs. People who do not receive the correct drug combinations for TB treatment or those who do not take their drugs consistently are at higher risk for developing MDR TB, which they can transmit to others. An estimated 80,000 new cases of MDR-TB, and 100,000 new cases of rifampicin-resistant TB (RR-TB) were reported in 2015, 45% of which were accounted to India, China and the Russian Federation.


References
1. Prix Galien Press Release. Available at: http://www.prixgalien.com/en/. Last Accessed December 2016.
2. Prix Galien. Introduction and Background. Available at: http://www.prixgalien.com/en/01/introduction.htm Last Accessed December 2016
3. J&J Press Release. SIRTURO® (bedaquiline) Receives Conditional Approval in the European Union for the Treatment of Multi-Drug Resistant Tuberculosis. Available at: https://www.jnj.com/media-center/press-releases/fda-grants-accelerated-approval-for-sirturo-bedaquiline-as-part-of-combination-therapy-to-treat-adults-with-pulmonary-multi-drug-resistant-tuberculosis Last Accessed December 2016.
4. J&J Press Release. FDA Grants Accelerated Approval for SIRTURO™ (bedaquiline) as Part of Combination Therapy to Treat Adults with Pulmonary Multi-Drug Resistant Tuberculosis. Available at: https://www.jnj.com/media-center/press-releases/sirturo-bedaquiline-receives-conditional-approval-in-the-european-union-for-the-treatment-of-multi-drug-resistant-tuberculosis Last Accessed December 2016.
5. WHO. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis, Interim Policy Guidance. 2013. Available at: http://apps.who.int/iris/bitstream/10665/84879/1/9789241505482_eng.pdf Last Accessed December 2016.
6. WHO. Global Tuberculosis Report 2016. Available at: http://apps.who.int/iris/bitstream/10665/250441/1/9789241565394-eng.pdf?ua=1 Last Accessed December 2016
7. Diacon AH, Pym A, Grobusch MP et al. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med. 2014;371(8):723-32.
8. EMA. SIRTURO® (bedaquiline) SmPC. March 2014.Availabel at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002614/WC500163209.pdf Last Accessed December 2016.


Media Contact:
Seema Kumar
+1 (908) 405-1144
skumar10@its.jnj.com