New Delhi: In a significant breakthrough, the nonprofit company Global Drug Facility has reached an agreement with pharma major Johnson & Johnson to supply cheaper, generic versions of the key anti-tuberculosis drug bedaquiline for most low and middle-income countries.TB causes 1.5 million deaths every year, despite being treatable. It is the world’s deadliest infectious disease and among the top causes of death globally. Johnson & Johnson holds the patent for bedaquiline, which has shown remarkably high success in treating drug-resistant TB.In a statement, Stop TB Partnership announced the agreement and called for tenders. The statement said:“Following lengthy negotiations, Johnson & Johnson has granted Stop TB Partnership’s Global Drug Facility’s licenses that enable Global Drug Facility (GDF) to tender, procure, and supply generic versions of SIRTURO (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect.”The “important agreement” will support the goal of ending TB, the organisation said adding that the tender for bedaquiline will be launched by end-July.India’s patent office in March this year rejected a petition from J&J to extend its primary patent, which expires this month. Generic manufacturers will now be able to make their own versions in India at an affordable price that will likely be 80% cheaper for a six-month course.J&J had filed a patent for the fumarate salt of bedaquiline in 2008 to extend its patent till the end of 2027. The move was part of a strategy called patent evergreening, through which companies extend patent rights and keep drug prices high. India has the world’s highest TB burden and the government has announced an ambitious plan to end the disease by 2030 – although there are doubts that the deadline will be met.While the WHO plans to eliminate TB by 2030, the COVID-19 pandemic has delivered a setback in tackling the disease.Brenda Waning, the chief of Global Drug Facility, told Forbes that the agreement gives them the ability to “sell generic versions of the drug in 44 countries — including Mozambique, the Philippines and Zambia”, countries where the patent is active. In 52 countries, Global Drug Facility already sells generic drugs because Johnson & Johnson’s patents have expired there.Waning added that discussions have already taken place with two Indian manufacturers – Lupin and Macleods – to produce the drug. Global Drug Facility will accept bids and select a primary and secondary manufacturer soon.Forbes added that the agreement will not apply to some countries in eastern Europe and Asia, where J&J has established an exclusive agreement with Russian pharmaceutical company Pharmstandard.Johnson & Johnson charges $272 (~Rs 22,000) for the total six-month course needed to treat TB but a study published in 2017 estimated that if generic versions of bedaquiline enter the market, the price would fall to somewhere between $48-$102 (~Rs 4,000 to ~Rs 8,300).
