Josua Lottering stepped out the airport doors in the Bangladesh capital, Dhaka, and doubled over in coughing spasms. Cystic fibrosis has sharply reduced his lung capacity, and the humid, smoggy air hit him hard.
Yet even as coughs shook his body, he was delighted. Josua, 18, had made the long journey from the Western Cape in South Africa, to Dhaka, with his mother to purchase a year’s supply of a new generic version of a drug that has transformed the lives of cystic fibrosis patients in North America and Europe but that he and his family cannot afford back home.
That drug, Trikafta, produced by Boston-based Vertex Pharmaceuticals, has made it possible for people with cystic fibrosis to breathe easily and live longer. Vertex sells a year’s supply of it for about $346,000 in the United States.
The company has a monopoly on transformative cystic fibrosis drugs; Trikafta has brought it $49 billion in revenue since launching in 2019. However, Vertex has not registered the drug for sale in many lower-income countries, and has blocked measures to produce lower-cost generic versions, a tactic not uncommon among drug companies seeking to protect their ability to charge higher prices in wealthy markets.
Now a Bangladeshi company has reverse engineered Trikafta and is using a loophole in global patent law to sell its version, called Triko, for a fraction of Vertex’s price.
Last week, the Lotterings joined a small group of other cystic fibrosis patients and their families who traveled to Dhaka to buy the first boxes of Triko that rolled off the production line of Beximco Pharmaceuticals.
Heather Nichols, a spokeswoman for Vertex, said that Trikafta is available in 75 countries — through sales or donations — and that the company provides it free in 15 countries; more than 7,000 people have received it at no charge.
But there are thousands more patients not covered by those programs, who have tried a variety of strategies to get the drug, including taking Vertex to court and petitioning their governments to allow a generic version of the drug to be imported or made locally, under a process known as compulsory licensing.
The Bangladeshi version gives those patients another option. Triko, costs $6,350 a year for children, double that, for an adult dose. That’s still far too expensive for some people but low enough to be life-changing for others.
Because Bangladesh is classified as a least-developed country, it is exempt from the World Trade Organization’s patent infringement laws. The country is home to a thriving pharmaceutical industry that takes advantage of this exemption by reverse-engineering patented drugs and exporting generics to countries where the drugs have no patent.
Most countries also have an exemption that permits a person to carry a generic version of a medication into a country where it is patented or, in some cases, to import a generic by mail, if it is for personal use. That’s what brought Josua and his mother from their home near Cape Town to Dhaka.
Triko has been approved by Bangladesh’s national drug regulator, but not by regulators in any other country. Beximco produces other drugs that have U.S. Food and Drug Administration and World Health Organization regulatory approval.
After Gilead Sciences began marketing a cure for hepatitis C in 2013, at a price of $84,000, Beximco produced a generic for a tenth of that price.
During the Covid-19 pandemic, Beximco made cheap versions of the antivirals remdesivir, Paxlovid and molnupiravir and exported them around the world. That caught the attention of cystic fibrosis patients and their families, who approached the company about making Trikafta.
Rabbur Reza, Beximco’s chief operating officer, said he was moved by the stories of parents who had heard cystic fibrosis patients in the United States and England describe how their lives had transformed on Trikafta, knowing they could not get the medication.
“I said, ‘If we are capable of manufacturing this, I am committing we will do this for you,’” Mr. Reza said.
Mr. Reza describes his company’s business model — reverse-engineering breakthrough medications in defiance of patents on intellectual property — as an equalizer in the huge disparities in access to treatments between high- and low-income countries.
Ms. Nichols, the Vertex spokeswoman, did not respond to questions specifically about the Bangladeshi product. “Trikafta’s safety and efficacy have been tested for more than a decade in over 200 clinical trials across 24 countries — a level of investment that generic manufacturers have not made,” she said. Generic drug producers do not typically conduct late-stage clinical trials since they are reproducing a product that has already been approved.
Beximco has done an initial production run of a two-year supply of Triko, for a few dozen patients, Mr. Reza said, and will see what market emerges. A cystic fibrosis buyers club, that began with parents in Britain before Trikafta was available in that country, has partnered with an Indian company with experience shipping small quantities of medications internationally.
It is a model that may have growing relevance as patients in lower-income countries seek out therapies that they know are changing lives in higher-income countries.
Aayyush Goyal, the founder of a pharmaceutical supply company, Eudaico Health, in Delhi, said his company has been fielding a half-dozen calls a day from patients asking how soon they will ship Triko, since they listed it on their platform, Medspartner, a few months ago.
“Parents are very impatient, which I can understand because it’s the treatment for their child,” he said. The company charges a 10 percent markup and a $50 shipping fee to handle the importation paperwork, which varies by country.
Vertex has patented Trikafta in India, but has not registered it for commercial sale. While the company donates the drug to a small number of Indian patients, it has been fighting in court for years to prevent the government from allowing low-cost generic production.
The genetic variant that causes cystic fibrosis is most common in people of Northern European ancestry. But there are many cystic fibrosis patients in developing countries, including a significant population who are undiagnosed; one analysis found that India alone likely has tens of thousands.
In Dhaka, Aadil Rahman’s parents noticed something was wrong when he was a newborn, but it took them two years of visiting a succession of doctors before they learned he had cystic fibrosis, a disease they had never heard of. Their initial panic eased when they learned about Trikafta, but they soon discovered that Vertex had not registered the drug in Bangladesh, and saw what it cost in the United States.
“No one in Bangladesh can afford that,” Mr. Munshi said. Frantic, they tried to get Aadil, now 6, into clinical trials in India, but he wasn’t eligible as a foreigner. Mr. Munshi cold-called Vertex executives to plead his case.
Aadil grew sicker: He spent weeks in intensive care last year. When he was home, he lay on the chest of his mother, Ayesha Moshumi, and watched from the window as other children walked to school. “He asked me why his life could not be like theirs,” Ms. Moshumi said.
On Monday, Aadil’s parents took him to pick up a first month’s supply of Triko.
Within hours of taking a first dose, Aadil began to expel copious amounts of the mucus that cystic fibrosis causes his body to overproduce.
“I was asking God, you gave me this child and you gave him this disease, and praying, You have to give me a miracle, a way to save him,” Mr. Munshi said.
Purchasing Triko will still be a huge financial strain, he said, but with the help of extended family, they hope Aadil will be able to take it all his life.
At the Bangladeshi factory, Aadil and his family stood beside a father and son who arrived from the other side of the world. Šimon Ševčík, 26, traveled from his home in Slovakia, where the national insurer has agreed to pay for Trikafta for some cystic fibrosis patients, but not those who have his particular genetic mutations.
“When I knew this medication was available and I couldn’t get it from government and the price was extremely high — it was terrible,” he said.
Mr. Ševčí hopes to recover enough that he can work, move out of his parents’ house, and lobby the Slovak government to cover Trikafta for every cystic fibrosis patient. If lobbying doesn’t work, he said, he will move closer to Bangladesh, so it’s easier to purchase Triko regularly.
In South Africa, Vertex patented Trikafta but did not register it for sale for years. When patients took the company to court in 2023 seeking a compulsory license, Vertex settled the case in a sealed deal that got the drug paid for by some health insurance plans. This covered, at most, half of the diagnosed cystic fibrosis patients in the country, but left out lower-income families, including patients who rely on the public health system.
Josua Lottering’s mother, Wilna, had health insurance, but it didn’t cover the drug. A doctor told her it would cost them 2.4 million South African rand, or about $150,000, a year to buy it.
“I could sell my whole house, and it would only buy him half a year,” she said.
South African babies are not routinely screened for the disease, and children may struggle through adolescence before they are diagnosed. Josua was underweight and prone to coughing fits that left him doubled over. Ms. Lottering asked about cystic fibrosis, she said, but doctors did not diagnose him until last year. Googling the disease, she read about Trikafta, and felt huge relief. Then, moments later, the family learned how much it would cost them.
“We would have done anything to get Jos the medication as soon as possible,” Ms. Lottering said, adding: “You’re mourning someone that is still alive, you are watching them deteriorate — it makes you so utterly powerless.”
In online chats for cystic fibrosis families, she learned about the new Bangladeshi drug. At $12,000 a year for the adult dose, it’s still a huge financial burden, but she said it allowed her to think it would be possible to keep her son alive while she figures out the future. She has considered emigrating to a country where the national insurer would pay for the medication.
The Lotterings flew home on Thursday, anxious they might have to explain drug import laws to a suspicious customs official. But they faced no questions. Josua began to take Triko the next day, and in the evening told his mother he was hungry — words she said she had never heard from him. He didn’t cough all day, and he could smell and taste things he hadn’t since childhood.
“It’s a day of a dozen miracles,” Ms. Lottering said.
