USA — Johnson & Johnson (J&J) recently made a significant announcement, revealing its decision not to enforce secondary patents on a crucial drug used in the treatment of multidrug-resistant tuberculosis (MDR-TB).

This move by the pharmaceutical giant is part of its ongoing efforts to improve the affordability and accessibility of bedaquiline, marketed as Sirturo, in low- and middle-income countries (LMICs).

J&J has been actively engaged in initiatives aimed at ensuring that bedaquiline becomes more accessible to LMICs.

In July, the company granted the Global Drug Facility (GDF) a license to tender, procure, and supply generic versions of the drug from generic manufacturers. This move followed the expiration of J&J’s primary patent on bedaquiline at the end of July.

In August, J&J took another significant step by agreeing to supply bedaquiline to the GDF at approximately half of its previous price, reducing the cost of a 6-month treatment course from US$289 to US$130 for nearly 100 LMICs.

However, concerns were raised by TB activists and organizations like Medecins Sans Frontieres (MSF) regarding some countries with a high burden of MDR-TB that do not procure drugs through the GDF.

These countries would have had to pay a higher price for bedaquiline. Consequently, calls were made for J&J to stop enforcing secondary patents on the drug in those countries.

J&J officials have refuted these claims and stated that their recent announcement aims to reassure current and future generic drug manufacturers that they can produce and sell generic versions of bedaquiline without fear of patent enforcement.

This permission is granted as long as the generic versions meet quality standards, are medically acceptable, and are intended for use exclusively in LMICs.

Howard Reid, J&J’s head of Global Public Health & Social Impact, emphasized the intention behind this decision to dispel any misconceptions about limited access to their medicine.

He also highlighted J&J’s decade-long investments in collaborative efforts to expand access to MDR-TB treatment.

Bedaquiline is a vital component of two World Health Organization (WHO)-recommended treatment regimens for rifampicin-resistant and MDR-TB.

These regimens, known as BPaL (bedaquiline, pretomanid, and linezolid) and BPaLM (bedaquiline, pretomanid, linezolid, and moxifloxacin), offer a more effective, less toxic, and significantly shorter treatment duration compared to previous regimens.

Christophe Perrin, a pharmacist with MSF’s Access Campaign, welcomed J&J’s announcement as a victory for TB activists, highlighting the potential for unfettered access to affordable generic versions of bedaquiline for all individuals in LMICs who require the drug.

This news coincides with a recent announcement from diagnostics company Cepheid and its parent company, Danaher, about a 20% reduction in the cost of Cepheid’s Xpert test cartridges. These cartridges play a critical role in the rapid diagnosis of MDR-TB.

In the face of the alarming global burden of drug-resistant TB, with an estimated 450,000 cases diagnosed annually, affordable and accessible treatments and diagnostics are paramount.

The collective efforts of pharmaceutical companies and diagnostic firms to lower costs and enhance accessibility hold significant promise in the fight against this curable disease, which continues to claim 1.6 million lives each year.

As Christophe Perrin aptly stated, “People with TB cannot afford to wait any longer.”

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