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 News Release - January 22, 2014

Janssen Announces New Group Targeting Unmet Global Health Needs

Janssen Global Public Health to Oversee R&D and Access Strategy Development for Growing Portfolio of Transformational Medicines

BEERSE, Belgium, Jan. 22, 2014 -- (Healthcare Sales & Marketing Network) -- Janssen, the pharmaceutical companies of Johnson & Johnson, today announced the formation of Janssen Global Public Health (Janssen GPH), an important new group unifying Janssen's commitment to research, develop, and deliver transformational medicines to address the world's greatest unmet public health needs. Janssen GPH will align the company's groundbreaking science and innovative access models under a single entity to drive better health outcomes, improve quality of life for patients, and sustainably advance health for people all over the world.

"To solve today's greatest public health challenges, it's essential that we emphasize the needs of the developing world in equal measure to those of the developed world," said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman of Janssen. "With this new group, we've adopted a more focused approach to further develop and introduce our most promising medicines, and with other like-minded organizations, we look forward to advancing a sustainable platform that will make a significant impact on the lives of people around the world."

Janssen GPH is one part of Janssen and Johnson & Johnson's shared response to the world's global public health challenges. Other organizations and operating companies within the Company have launched and continue to support comprehensive efforts toward strengthening the health of communities, improving maternal and child health, and preventing the spread of infectious and preventable diseases worldwide through vaccination. Janssen GPH will partner with other organizations within the Company as appropriate to advance global public health goals. Adrian Thomas, M.D., Vice President of Global Market Access, Global Commercial Strategy Operations, and Global Public Health, and Wim Parys, M.D., Vice President, R&D Global Public Health, will jointly lead Janssen GPH.

Janssen GPH will be responsible for clinical and product development and creating and implementing innovative new access strategies for a growing portfolio of pharmaceuticals, diagnostics, and services for diseases significantly impacting resource-limited countries and emerging markets, and includes:

SIRTURO® (bedaquiline): Janssen GPH is overseeing the development and implementation of a global access framework for SIRTURO®, approved by the US Food and Drug Administration (FDA) as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis (MDR-TB) in December 2012 and by Russian regulatory authorities in October 2013. In June 2013, the World Health Organization (WHO) published interim policy guidance on the medicine's use following a rigorous review process by internal and external TB experts convened by the WHO within six months of its US approval.

Long-acting rilpivirine (TMC278-LA, RPV-LA): Janssen GPH will continue to invest in clinical research toward the development of a long-acting, injectable version of the HIV medicine rilpivirine, a delivery method allowing less frequent dosing. In September 2013, Janssen entered into a licensing agreement with PATH, an international non-profit organization that transforms global health through innovation, for the early development of rilpivirine in a long-acting injection as potential pre-exposure prophylaxis (PrEP) against HIV infection. This novel approach has the potential to significantly improve treatment outcomes in hard-to-reach areas of the developing world.

Dapivirine microbicidal ring: Janssen GPH will continue to work with the International Partnership for Microbicides (IPM), a non-profit organization dedicated to developing new HIV prevention technologies for women in developing countries, toward the development of the investigational HIV medicine dapivirine for use as a monthly vaginal microbicidal ring designed to prevent sexual transmission of HIV – the first product of its kind. The ring is now being studied in two parallel efficacy trials in multiple African countries, with results expected in 2015.

Reformulated flubendazole: Janssen entered into a non-exclusive, royalty-free preclinical data sharing agreement with the not-for-profit Drugs for Neglected Diseases initiative (DNDi) for the preclinical research of a reformulated form of flubendazole, a potential new treatment against parasites that cause lymphatic filariasis (elephantiasis) and onchocerciasis (river blindness), two of the most difficult-to-treat neglected tropical diseases.

Reformulated mebendazole:Janssen GPH is developing a new, chewable formulation of VERMOX® (mebendazole) that will facilitate treatment of intestinal worms in younger children. Mebendazole, a Janssen-developed molecule, is currently used in school-age children over the age of five as a solid, oral tablet. As part of the 2012 London Declaration on Neglected Tropical Diseases, Janssen is donating 200 million doses of mebendazole each year to over 30 countries through 2020.

UNITE Project: UNITE is a consortium between Janssen and several partners with expertise in HIV/AIDS, including the Grameen Foundation, the Indian Institute of Technology, the Bill & Melinda Gates Foundation, the Johns Hopkins Center for Clinical Global Health Education, and ten HIV clinics in India, working to improve health outcomes for people living with HIV via the use of mobile technologies (mHealth). The consortium aims to find solutions to facilitate access to appropriate care for patients via their cell phone, leveraging a simple tool that is proven to improve health outcomes.

"The world's major global health challenges call for products and practices designed specifically to address the real world needs of people living with disease in underserved regions of the world," said Wim Parys, M.D. "As dedicated researchers, we recognize this unmet need. We also have the ability to leverage our R&D skills and expertise in collaborations that support innovative solutions for the developing world, specifically developed for places in need and appropriate for local contexts. Through Janssen GPH, we hope to create more targeted medicines for treating and preventing disease."

Beyond research and development, Janssen GPH will cultivate and help implement innovative pricing and results-based financing models that improve access to these medicines for patients in resource-limited and emerging markets, while also creating sustainable, long-term solutions based on country ownership and accountability for health services and outcomes. These new strategies will be integrated with those developed by Janssen's Global Access and Partnerships Program (GAPP), which currently ensures affordable and sustainable access to the company's portfolio of HIV medicines in resource-limited countries.

Janssen GPH recognizes the need for enhanced collaborations to better address unmet public health needs around the world. Janssen GPH will be the central point of contact for continued collaboration with global public health stakeholders and invites innovative, international, and multi-sectorial collaborations to tackle key challenges in global public health, such as MDR-TB. Janssen GPH also will work with stakeholders to ensure that public health policies are developed to maximize access to our portfolio of medicines needed by patients around the world.

"We are applying our expertise where we can make the biggest impact," said Adrian Thomas, M.D. "Our goal is to address seemingly intractable health challenges in new and unexpected ways."

About the Janssen Pharmaceutical Companies of Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and Prostate Cancer), immunology (e.g., rheumatoid arthritis, inflammatory bowel disease and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. To learn more, visit

About Janssen Pharmaceutica

Janssen Pharmaceutica NV is a worldwide center for excellence for integrated R&D, production and general services. The company has four sites in Belgium (Beerse I & II, Geel and Olen), which together employ nearly 4,000 people.

More than eighty medicines registered to the company are used worldwide in human medicine and material protection. The company operates in a wide range of pathological areas, such as neurosciences, oncology and infectious diseases.

Source: Janssen Global Public Health

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