Bedaquiline Fumarate

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.

J&J has delivered 845,000 courses of its Sirturo to treat multi-drug resistant tuberculosis patients in more than 160 countries, according to the company. It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods. Regulators on both sides of the Atlantic granted the full approvals based on data from a phase 3 study showing that a Sirturo-containing regimen delivered a “significant improvement” in treatment outcomes compared to other, injectable-containing regimens, according to a recent company press release. The STREAM Stage 2 study was the first large-scale trial to evaluate an all-oral Sirturo-based regimen. J&J filed its bids for the full approvals last year. In Europe, the decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Sirturo first hit the scene in the U.S. in 2012 with an FDA accelerated approval for the treatment of multidrug-resistant tuberculosis (MDR-TB), which was followed by a 2014 conditional nod in Europe. Those approvals were based on a surrogate endpoint of time to sputum culture conversion, a test that measures a patient’s response to tuberculosis treatment. Upon its prior accelerated and conditional approvals, Sirturo became the first tuberculosis med to offer a novel mechanism of action in more than 40 years. The drug is now a staple of worldwide TB treatment and holds a position in the World Health Organization (WHO)’s recommended treatment guidelines. In the decade since the first approvals, J&J has been busy working with communities and governments to “help ensure the medicine is accessible and remains effective for patients today and tomorrow,” the company said in its recent release. The drugmaker’s efforts include investing in “critical TB systems capacity” such as healthcare professional training, resistance testing and surveillance and supply chain security. Last year, Médecins Sans Frontières (MSF) called on the company to commit to not enforcing secondary patents on Sirturo in countries with a high tuberculosis burden. As the main cost driver in the WHO’s recommended six-month treatment regimen, allowing generics could slash treatment costs by two-thirds, MSF said at the time. J&J eventually responded to the swirling pressure from MSF and other advocacy groups with an announcement declaring its intent to not enforce the drug's patents in 134 low- and middle-income countries. Before that, the company had granted the Stop TB Partnership's Global Drug Facility (GDF) a license allowing the GDF to procure and supply generic Sirturo versions to “the majority of” low-and middle-income countries. That approach did cut the med’s price by 55% when purchased through GDF but left many countries out, global health initiative Unitaid said in an open letter to J&J’s CEO last year.