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.<\/p>\n
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\u2019s 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.<\/p>\n
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\u2019s supply of it for about $346,000 in the United States.<\/p>\n
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.<\/p>\n
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\u2019s price.<\/p>\n
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.<\/p>\n
Heather Nichols, a spokeswoman for Vertex, said that Trikafta is available in 75 countries \u2014 through sales or donations \u2014 and that the company provides it free in 15 countries; more than 7,000 people have received it at no charge.<\/p>\n
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.<\/p>\n
The Bangladeshi version gives those patients another option. Triko, costs $6,350 a year for children, double that, for an adult dose. That\u2019s still far too expensive for some people but low enough to be life-changing for others.<\/p>\n
Because Bangladesh is classified as a least-developed country, it is exempt from the World Trade Organization\u2019s 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.<\/p>\n
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\u2019s what brought Josua and his mother from their home near Cape Town to Dhaka.<\/p>\n
Triko has been approved by Bangladesh\u2019s 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
Rabbur Reza, Beximco\u2019s 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.<\/p>\n
\u201cI said, \u2018If we are capable of manufacturing this, I am committing we will do this for you,\u2019\u201d Mr. Reza said.<\/p>\n
Mr. Reza describes his company\u2019s business model \u2014 reverse-engineering breakthrough medications in defiance of patents on intellectual property \u2014 as an equalizer in the huge disparities in access to treatments between high- and low-income countries.<\/p>\n
Ms. Nichols, the Vertex spokeswoman, did not respond to questions specifically about the Bangladeshi product. \u201cTrikafta\u2019s safety and efficacy have been tested for more than a decade in over 200 clinical trials across 24 countries \u2014 a level of investment that generic manufacturers have not made,\u201d she said. Generic drug producers do not typically conduct late-stage clinical trials since they are reproducing a product that has already been approved.<\/p>\n
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<\/a>, 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n \u201cParents are very impatient, which I can understand because it\u2019s the treatment for their child,\u201d he said. The company charges a 10 percent markup and a $50 shipping fee to handle the importation paperwork, which varies by country.<\/p>\n 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.<\/p>\n