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Johnson & Johnson agrees not to enforce patents on a key tuberculosis drug in dozens of poor countries

Johnson & Johnson Confirms Intent Not to Enforce Patents for SIRTURO® (bedaquiline) for the Treatment of Multidrug-Resistant Tuberculosis in 134 Low- and Middle-Income Countries

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Oct 03 (The Justice Now) —The Company is still focused on removing perceived obstacles to access and redirecting global efforts towards the biggest impediment to access: the undiagnosis of the illness.
The decision results from more than a decade of company investments in collaboration efforts to assist countries sustainably expand access to treatment and help people suffering from multidrug-resistant tuberculosis (MDR-TB) to medicines.

Johnson & Johnson (the “Company”) (NYSE: JNJ) has today announced its intention not to enforce the patents that it owns and monitors on SIRTURO(r) (bedaquiline) in the treatment of tuberculosis that is multidrug-resistant (MDR-TB) in 134 low and middle-income nations.

The goal of the decision is to ensure current and future generic manufacturers that they can produce and sell high-quality versions generic of SIRTURO(r) without worry about whether the Company will be able to enforce its bedaquiline patents if the versions generic of SIRTURO(r) manufactured or offered through generic manufactures are of excellent quality, are medically acceptable, and utilized exclusively in the 134 countries of low and middle-income countries.

“Underdiagnosis remains the most significant barrier to treatment, with nearly two-thirds of the 450,000 people who develop MDR-TB each year not diagnosed and enrolled in treatment,” said Howard Reid, Global Head, Global Public Health & Social Impact, Johnson & Johnson. “This is a way to dispel any misconception that the availability of our treatment is restricted or limited. It is a result of our ten years of investment in collaboration efforts to help countries sustainably increase access and help bring those in MDR-TB the treatment .”

Johnson & Johnson introduced SIRTURO(r) (bedaquiline), the first targeted tuberculosis (TB) medicine that has an innovative method of activity in over 40 years, in 2012 following years of concentrated expenditures in R&D. In collaboration with a variety of other companies the Company has spent the last decade investing in vital TB system capacity including healthcare professionals education, testing for resistance, surveillance, as well as security in the supply chain to aid in the process of bringing people to treatment while maintaining the effectiveness as resistance to drugs increases across the globe.

Today, thanks to years of investments, collaboration, and responsible use of our intellectual property, bedaquiline is the backbone of World Health Organization-recommended treatment guidelines for drug-resistant TB, and three of every four MDR-TB patients on treatment are receiving a bedaquiline-containing regimen.
Recently, Johnson & Johnson granted the Stop TB Partnership’s Global Drug Facility (GDF) authorization, which allowed GDF to solicit and acquire generic forms of SIRTURO(r) (bedaquiline) to the vast majority of the countries with low and middle incomes. The Company will continue to invest in surveillance, innovative capacity building, and initiatives to find patients that will improve access to and the appropriate utilization of bedaquiline.

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