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TWN Info Service on Health Issues (Oct25/03)
24 October 2025
Third World Network


Buyers club challenges Big Pharma’s monopoly over cystic fibrosis drug

New Delhi, 23 October 2025 — Today, at the North American Cystic Fibrosis Conference (NACFC) in Seattle, a community-run buyers’ club was launched to help patients worldwide access a new generic version of a lifesaving treatment for cystic fibrosis. The generic version will be manufactured by Beximco, a pharmaceutical company based in Bangladesh and is expected to become available by Spring 2026.

TRIKO, a generic version of the triple combination therapy (elexacaftor, tezacaftor and ivacaftor) listed as an essential medicine by the WHO, could extend the life expectancy of a child by  twenty-seven years. It will cost $12,775 for an adult per year and $6,387.50 for a child per year, 96% cheaper than the originator version Trikafta at $325,300, sold by the U.S. company Vertex. Beximco is also separately launching BexDeco, a generic version of ivacaftor, one of the components of TRIKO, which costs $5 per tablet. The treatment consists of two tablets of TRIKO and one of BexDeco every day for adults and one TRIKO and half a BexDeco every day for children.

Gayle Pledger, leading the global Right to Breathe campaign, celebrated the feat in Seattle: “This is a historic moment. We’ve watched children suffer and die while a treatment sat on the shelf, priced out of reach. Today, that changes. We’ve proven that patient power can change when billion-dollar corporations refuse to. Governments must act fast to take all the necessary steps to make this lifesaving drug available for every eligible patient”.

Cystic fibrosis is a rare genetic disorder that disrupts mucus production in multiple organs, particularly the lungs and digestive system, leading to debilitating symptoms, such as serious chronic respiratory issues and malnutrition. Delayed diagnosis and lack of treatment contribute to an average life expectancy of less than 20 years.

As of now, cystic fibrosis affects an estimated 188,336 people globally, of whom only 60% are diagnosed and just 27% receive treatment. Access remains starkly unequal between developed and developing countries. Data is limited, but a 2024 study estimated 82% of those undiagnosed live in low- and middle-income countries (LMIC), and only one LMIC, against thirty-five high-income countries (HICs), had reported patient reimbursement for Trikafta.

Patients were the ones who first led Beximco to develop TRIKO three years ago. “Seeing the meds available in the rest of the world and not to us was an added pressure. And India producing ingredients but Indians not having access to the final product was demeaning and depressing,” said Mallika Gollapudi, mother to a 14-year-old child with cystic fibrosis, when she heard the news. “We see a ray of hope now,” she added.

Third World Network (TWN) worked closely with patient groups in India, where access to cystic fibrosis diagnostics and treatment was virtually nonexistent. Chetali Rao, a scientific researcher with TWN, explained, “When a medicine costs more than life itself, it stops being an innovation, it becomes an exclusion. Trikafta can transform a life-threatening disease like cystic fibrosis into a manageable condition. It must be available and we were determined to find a way to make it affordable.” This urgency drove TWN, together with patient groups Just Treatment in the UK and the global campaign Right to Breathe, to approach Beximco with the proposal to develop an affordable generic alternative.

“As a responsible generic manufacturer, we have always remained firm in our commitment to address the unmet medical needs of patients,” said Beximco in a statement.

On the other end of this spectrum, Trikafta is one of the most expensive medicines in the world. Vertex’s monopoly has generated extraordinary profits: $29.5 billion over ten years (2012–2021), almost entirely derived from the sales of medicines for cystic fibrosis. A 2022 study, however, estimated Trikafta could be produced for $5,700 per patient per year.

Another object of criticism by patients and advocates has been Vertex’s abusive patenting strategies.

Trikafta is a combination of elexacaftor, tezacaftor and ivacaftor (ETI). Vertex’s patents over Trikafta have expired or are near expiry, except for one of its three components. Patent on ivacaftor has expired and the patent on tezacaftor expires in 2027. However, in the last couple of years, Vertex has applied for additional patents on modifications and different forms of these existing compounds to prolong exclusive rights beyond the expiration of the primary patent, a practice known as evergreening. TWN, Just Treatment and Right to Breathe have also filed challenges against Vertex’s patents in India and other countries, seeking to dismantle unjustified barriers.

In a notable development, the Indian Patent Office refused Vertex’s application for a solid dispersion form of tezacaftor last May. The application was rejected under Section 3(d) of the Indian Patents Act, which prohibits the patenting of new forms of known substances unless they demonstrate enhanced efficacy.

Despite applying for multiple patents, on another front of its aggressive monopoly strategy, Vertex has not registered Trikafta in India in a tactic to delay generic competition and extend its monopoly without any consideration for patients suffering, since the lack of registration does not allow for the marketing of the drug in the country.

In response, patients, with the support of TWN, Just Treatment and Right to Breathe, have also petitioned the Karnataka High Court seeking to make the drug available under a government use license. The trial has not concluded. To mitigate public pressure and potential reputational damage, Vertex has started compassionate use programs that might be supplying treatment to around 150 patients in India, according to patient sources.

All of these acts and Beximco’s announcement, triggered by patients and civil society advocacy, represents a critical step towards an affordable alternative and wider access, challenging the monopolistic practices that have long restricted life-saving medicines and upholding the right to health.

Further information will be available on cfbuyersclub.org

 


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