An agreement between the Stop TB Partnership and pharmaceutical giant Johnson & Johnson (J&J) will expand access to a key component of the shorter drug regimen for multidrug-resistant tuberculosis (MDR-TB).
Under the agreement, which was announced last week, J&J granted Stop TB Partnership's Global Drug Facility (GDF) licenses that will enable it to "tender, procure, and supply" generic versions of Sirturo (bedaquiline) for most low- and middle-income countries (LMICs), including those in which the drug is still under patent. Bedaquiline is part of the 6-month regimens that are recommended by the World Health Organization (WHO) for treating MDR-TB.
"This is an important agreement that will support our common goal of ending TB," Stop TB Partnership said in a statement.
Deal could bring down costs, ensure secure supply
Brenda Waning, PhD, MPH, chief of the GDF, which was created in 2001 to promote equitable access to TB drugs and diagnostics, said that the agreement will cover all LMICs except 11 and include most of the countries that have a high burden of MDR-TB. She framed the negotiations, which have been going for more than a year, as part of an ongoing discussion with J&J about ensuring equitable access to bedaquiline at the best possible price.
"This is what we ended up with as a way forward," Waning told CIDRAP News.
Waning said that while it's unclear how much the agreement will bring down the price of bedaquiline, which currently costs $272 for a 6-month treatment, there are other important benefits in having generic versions of the drug. One of those is drug supply security.
"It's always dangerous to have all your eggs in one basket, to have one supplier be the only one in the world who can make a product," she explained. "The last thing you want is to not have bedaquiline available, because it's a core TB medicine that can't be easily replaced by something else."
The 6-month, all-oral treatment regimens that include bedaquiline (along with pretomanid, linezolid, and moxifloxacin) have been considered a game-changer for MDR-TB patients. In addition to having a much higher cure rate, the regimens are significantly shorter and less toxic than previous regimens, which lasted up to 2 years and included painful injectable drugs with significant side effects.
"Bedaquiline is a life-saving medication for people living with drug-resistant TB, and it spares them the misery and side effects of a daily injection," Jennifer Furin, MD, PhD, an infectious disease clinician at Harvard Medical School, told CIDRAP News.
According to the WHO's most recent report, MDR-TB cases rose by 3% in 2021, with 450,000 cases reported worldwide. In addition, treatment for MDR-TB declined during the COVID-19 pandemic amid a reduction in essential TB services.
Critics want more from J&J
The agreement comes amid criticism of J&J from groups like Medicins Sans Frontieres (MSF), which says the company has been blocking access to cheaper versions of the drug by filing for secondary patents in countries with a high burden of MDR-TB. That criticism has picked up in recent weeks on social media.
Bedaquiline was approved by the US Food and Drug Administration for the treatment of patients with MDR-TB in 2012. The company's main patent on the drug expires this year, but it has filed for secondary patents in some countries for small changes to the molecule that would extend the patent to 2027. In March, the Indian Patent Office rejected the company's application for a secondary patent. India has one the highest burdens of MDR-TB in the world.
Bedaquiline is a life-saving medication for people living with drug-resistant TB, and it spares them the misery and side effects of a daily injection.
In response to the agreement, which was announced on July 13, MSF said the deal still offers only a short-term solution for LMICs and doesn't cover all countries with high MDR-TB burdens.
"We reiterate our call on J&J to publicly announce it will not enforce any secondary patents on bedaquiline in any country with a high burden of TB and withdraw and abandon all pending secondary patent applications for this lifesaving drug," Christopher Perrin, PharmD, MPH, a pharmacist with MSF's Access campaign, said in an MSF press release.
Furin called the agreement a "step in the right direction," but said she would also like to see J&J stop filing secondary patents and commit to non-enforcement of any secondary patents it already has, along with making the standing license for generics that was granted to the GDF last in perpetuity.
"I am a TB physician, and have worked in the field for almost three decades. I have witnessed first-hand how access to bedaquiline can transform the lives and health of those with drug-resistant TB," she said. "I am chagrined at the monopoly J&J continues to seek to assert over this public good."
Furin said the cost savings from cheaper, generic bedaquiline could be used by cash-strapped TB programs around the world to diagnose and support people on treatment.
J&J, in a statement posted on Twitter, said it is false to suggest that its patents are being used to prevent access to bedaquiline.
"Unfortunately, the most significant barrier to treatment access for patients today is the fact that millions of patients with TB go undiagnosed every year," the company said. "This is a challenge that we have invested significant resources to overcome and must all get behind if we are to achieve the global goal of ending TB."
Stop TB Partnership says it will invite generics manufacturers to submit bids within the next few weeks. Waning said that she hopes the deal, which allows the GDF to seek out an unlimited number of generics suppliers for bedaquiline, can provide a model that could be used to improve equitable access to other drugs.
"It's an interesting way of managing things that we haven't seen to date in global health," she said.
