After allowing generic competition and slashing the price of its multidrug-resistant tuberculosis (MDR-TB) med Sirturo (bedaquiline) in low- and middle-income countries, Johnson & Johnson has taken its access efforts a step further by committing to not enforce secondary patents on the treatment in 134 countries.
Now, generic makers in low-and middle-income countries can sell their own versions of Sirturo if they are “of good quality, medically acceptable” and used only in the 134 countries, a company said in a release.
“This addresses any misperception that access to our medicine is limited or restricted and builds on our decade of investments in collaborative efforts to help countries sustainably scale up access and bring people living with MDR-TB into treatment,” J&J’s head of global public health and social impact, Howard Reid, said in a statement.
While the drug’s primary patent expired over the summer, some secondary patents don't expire 2027.
The move comes after several advocacy groups called on the pharma giant to increase access to the drug.
Last week, the global health initiative Unitaid pressed J&J to expand its efforts beyond price cuts. In an open letter to CEO Joaquin Duato, Unitaid’s executive director Dr. Philippe Duneton expressed the organization's “disappointment” that J&J “ignored the public health community’s calls” and continued to enforce its secondary patents in many countries with a high burden from MDR-TB.
The pricing agreement, which discounted Sirturo by 55%, left the med only accessible for purchase through the Global Drug Facility (GDF), Unitaid noted. This approach excluded several countries, the group said.
The drug serves as the "backbone” of the World Health Organization’s treatment guidelines for the disease, with three out of every four MDR-TB patients on treatment receiving a bedaquiline-containing regimen, according to J&J.
Médecins Sans Frontières (MSF) called the latest pledge a “huge success” and a “sea change” in TB. Now, the group is turning attention to Otsuka’s TB drug delamanid and its secondary patents, it said in a recent statement.