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Beximco Pharmaceuticals today formally handed over TRIKO, a low-cost generic version of the breakthrough cystic fibrosis (CF) treatment Trikafta, to patients and their representatives from six countries at a ceremony held at the company's manufacturing facility here.
The medicine, a combination of elexacaftor, tezacaftor and ivacaftor, also known as ETI, was handed over to selected patients and representatives from the United States, United Kingdom, Slovakia, Qatar, South Africa and Bangladesh, said a press release.
According to the company, the handover marks the first time an affordable generic alternative to the cystic fibrosis medicine has been made available to CF patients globally.
The initiative was publicly announced at the North American Cystic Fibrosis Conference (NACFC) in Seattle, Washington, on October 23 last year, by a coalition of parents of children living with CF. The ceremony marked the implementation of that commitment.
Cystic fibrosis is a rare genetic disorder characterised by the build-up of thick mucus in the lungs and digestive system, severely affecting respiratory function.
Approximately 160,000 people worldwide are living with the disease, while an estimated 80,000 additional cases are believed to be undiagnosed, with 82 percent of those cases in low- and middle-income countries.
Trikafta, developed by US-based Vertex Pharmaceuticals, has significantly improved treatment outcomes and survival rates for CF patients.
However, its US list price of US$ 370,000 per year has limited access for many patients globally, while patent protection has prevented the availability of generic versions.
Beximco Pharma said Bangladesh's status as a Least Developed Country (LDC) under the United Nations classification, along with provisions under the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), allows the manufacture and export of generic versions of patented medicines.
TRIKO, the company's generic version of the ETI combination therapy, has been priced at US$ 12,750 per year for adults and US$ 6,375 per year for children, representing a 96 percent reduction compared with the US list price of the originator product.
At that price, the company said 58 children can receive treatment for the cost of treating one child with the branded medicine.
BEXDECO, Beximco Pharma's separately launched generic version of ivacaftor, one of the three active components of Trikafta, is also available at US$ 5 per tablet for patients who require the component as a standalone therapy.
For the initial period following the launch, supply will be managed on a named-patient basis through the CF Buyers' Club, with plans to expand access gradually as manufacturing capacity increases.
Campaign Lead of Right to Breathe and CF parent and patient advocate from the United Kingdom Gayle Pledger said access to life-saving treatment is a fundamental human right and that currently available breakthrough medicines remain prohibitively expensive for many CF patients worldwide.
She said Beximco Pharma responded to requests from CF patients and advocacy groups globally and had undertaken the initiative on humanitarian grounds.
Beximco Pharma Chief Operating Officer Rabbur Reza said the company has consistently sought to address unmet medical needs, particularly in treatment areas with limited access.
He said the company was proud to be part of the initiative and believed that wider access to the treatment would have a transformative impact on thousands of CF patients who are currently unable to receive treatment because of the high cost.
