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Moscow, Russia, March 02, 2018 – Today, Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, signed a Memorandum of Understanding with a view to have Pharmstandard Ufimsky Vitamin Plant, one of the leading Russian pharmaceutical manufacturers, appointed as an additional toll manufacturer for Janssen for Sirturo® (bedaquiline), a medicine for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults. The collaboration will help to provide additional manufacturing capacity for bedaquiline.
We are proud to expand our partnership with Pharmstandard which should ultimately help more MDR-TB patients around the world access bedaquiline,” said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson. “At J&J, we have a legacy of developing and responsibly deploying innovative treatments to combat drug-resistant infections. Collaboration across, and within, the public and private sectors has been critical factor in this effort, changing the trajectory of health for thousands of people living with TB and other potentially life-threatening infections.”
This collaboration will expand an existing partnership between Janssen and Pharmstandard. Under a licensing agreement signed in 2012, Janssen granted commercial rights to bedaquiline to Pharmstandard for use in the treatment of MDR-TB in the Russian Federation and a number of other countries in the region, including the Commonwealth of Independent States (CIS). Janssen also transferred certain technology and production know-how for bedaquiline to Pharmstandard. That same year, Pharmstandard became the Marketing Authorization Holder for bedaquiline in Russia.
In 2015, Janssen and Pharmstandard partnered on a Bedaquiline Donation Program to provide up to 5,800 courses of treatment over four years in Pharmstandard’s territory. This program was recently expanded to include an additional 3,800 treatments for CIS countries through April 2019. This commitment built upon and strengthened agreements with the Stichting International Dispensary Association, the Stop TB Partnership’s Global Drug Facility’s procurement agency and the United States Agency for International Development (USAID) to donate up to 30,000 courses of treatment for use in more than 100 Global Fund-eligible countries worldwide.
Russia has shown strong leadership in the fight against TB. In November last year, the Russian Federation hosted the first-ever WHO Global Ministerial Conference on Ending TB. The expanded collaboration with Pharmstandard is another important contribution the country is making to combat this life-threatening disease,” said Ekaterina Pogodina, Managing Director, Janssen, Russia & CIS.
Today’s announcement builds on nearly 20 years of TB research and development by Johnson & Johnson. Bedaquiline received accelerated regulatory approval in the United States in 2012 as part of a combination therapy in adults (≥ 18 years) with pulmonary MDR-TB. It was the first medication with a novel mechanism of action against TB to be approved in the United States in over 40 years. The drug is now included on the World Health Organization (WHO) Essential Medicines List. Since its approval, more than 43,000 courses of bedaquiline have been delivered for patients in need in 95 countries around the world.
According to the WHO, there were an estimated 490,000 new cases of MDR-TB and 240,000 deaths caused by MDR-TB related complications in 2016. Later this year, global leaders will convene in New York for the first-ever United Nations High-Level Meeting on Tuberculosis to discuss strategies for advancing progress against TB and achieving the Sustainable Development Goal and WHO End TB Strategy target of ending the disease by 2030.
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At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. www.jnj.com
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We are focused on tackling some of the world’s most pressing public health challenges such as HIV, TB and mental health and committed to achieving transformational health outcomes for the world’s most vulnerable people. Taking a holistic approach we are developing integrated, evidence-based solutions aimed to ensure that crucial innovative medicines and products are accessible and delivered to those in need. And bringing to bear our deep expertise, talent, operational excellence, community engagement and partnerships with governments, donors, non-profits and multilateral institutions globally and locally we are accelerating these efforts. Learn more at www.jnj.com/global-public-health and follow us @JNJGlobalHealth.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements," as defined in the Private Securities Litigation Reform Act of 1995, regarding a collaboration to provide additional manufacturing capacity and supply of bedaquiline. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceutica NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including under the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.