Bedaquiline Fumarate

The new price in South Africa matches the figure Johnson & Johnson charges the Global Drug Facility for Sirturo, according to South Africa's Competition Commission. A storm of scrutiny relating to Johnson & Johnson’s pricing and patenting of its tuberculosis med bedaquiline (branded as Sirturo) is clearing up after reaching a fever pitch last year. South African antitrust authorities have dropped (PDF) an investigation they opened into J&J last summer after the drugmaker and its Janssen subsidiary filed for a secondary patent that sought to fend off generics until 2027. The country’s Competition Commission decided not to move forward with a complaint after “extensive engagements” with the Sirturo maker, the commission said in a press release. Along with J&J's prior commitment to not enforce its Sirturo patent in 134 low-and middle-income countries (including South Africa), the company agreed to slash the South African government's procurement price by 40%. The new price matches the figure that J&J offers to the Stop TB Partnership’s Global Drug Facility (GDF), according to the commission. GDF supplies the med to “the majority of low-and middle-income countries,” J&J has said. Last year, J&J cut its Sirturo prices for GDF by 55% in what the organization called a “historic price reduction.” However, the GDF deal left out several countries with a high burden of multidrug-resistant tuberculosis, including South Africa, Belarus and Ukraine, global health initiative Unitaid said at the time. Soon after disclosing its GDF partnership, J&J widened its pact and pledged to not enforce Sirturo patents in certain low-and middle-income countries, allowing generics makers to sell their own versions of the med if they are “of good quality, medically acceptable” and used only in the appropriate countries. The move came after several advocacy groups, such as Unitaid and Médecins Sans Frontières, pressed the company to expand access to the drug. Sirturo scored an accelerated approval from the FDA in 2012, becoming the first tuberculosis med to offer a novel mechanism of action in more than 40 years. Since then, the drug has become a staple of worldwide tuberculosis treatment and is listed in the World Health Organization’s recommended treatment guidelines. Earlier this week, regulators in the U.S. and Europe granted Sirturo full approvals, converting their prior conditional approvals.

South Africa's Competition Commission has decided not to move ahead with prosecuting allegations of anticompetitive conduct against Johnson & Johnson and its Janssen unit after the company agreed to cut the price of its tuberculosis (TB) drug Sirturo (bedaquiline) by about 40% in the country.The probe, which began last September, examined accusations that Johnson & Johnson had filed a secondary patent for Sirturo, potentially restricting generic competition until 2027 and enabling the company to charge "excessive" prices to South Africa's National Department of Health."The decision to non-refer the complaint of alleged anti-competitive conduct... to the Competition Tribunal for prosecution, follows extensive engagements with the two companies," according to a statement by the Competition Commission. "The companies, in turn, have agreed not to enforce the bedaquiline patent in 134 low- and middle-income countries, including South Africa."After backlash from advocacy groups against the decision to enforce patents on Sirtuto in several markets, the drugmaker confirmed its intention last year to forgo patents in those countries.South Africa's Competition Commission noted that the discounted price aligns with what Johnson & Johnson offers to the Global Drug Facility, the world's largest procurer of TB medicines and diagnostics.The decision coincides with a pair of regulatory milestones for Sirturo. Earlier this month, the drug received full approval in the US and EU for the treatment of multidrug-resistant pulmonary tuberculosis in adults and children aged 5 and older.