Americans pip Dutch to the post in heart medicine registration

Photo: Depositphotos

Dutch cardiologists say a Slovakian pharmaceutical company has “hijacked” their research into the benefits of an existing medicine against gout for heart patients, the Volkskrant reported on Monday.

The case revolves around colchicine, an off patent anti-inflammatory drug which has been used for years to treat patients with gout but was found to help heart disease as well.

In 2020, following lengthy research supported by government money and investment from generic medicine companies, cardiologists from the Netherlands and Australia published proof the medicine could also reduce the chance of another heart attack or stroke in heart patients by 30%.

Registration of the medicine for heart patients would have been the next logical step but wranglings over money got in the way, the paper said.

A request by drugs companies Teva and Tiofarma to the Dutch health ministry to grant them exclusivity for a few years to earn a return on their investment by upping the original price of colchicine from €3 to €9 a month for heart patients was turned down. Both gout and heart patients were given the same pill, the ministry said, precluding a price difference.

‘So what we should have done was cheat,” Hans Waals, director of Dutch pharmaceutical frim Tiofarma, told the paper, referring to the practice of tweaking the composition of medication that has been found to help other conditions and then increasing the price a hundredfold. “That is exactly what we wanted to prevent,” Waals said.

The Slovakian drugs firm, Agepha Pharma, however, did exactly that, reducing the amount of colchicine in the drug for the US market and gaining FDA approval and citing the Dutch and Australian research in its press release.

It is not yet known how much Lodoco, “shamelessly” named after the Dutch/Australian patient research project, will cost but the company has already said it will support patients who cannot afford it.

“That tells you all you need to know,” Jan Hein Cornel, professor of cardiology at Nijmegen University, told the paper. In the Netherlands the medicine would have cost just €113 a year.

If Dutch manufacturers has been able to come to an agreement about a return on their investment three years ago the medicine would have been registered in Europe, Waals said. “We simply left it too late.”

The Dutch companies are now exploring legal ways of preventing Agepha from registering the medicine in Europe.

Meanwhile, Aegpha told the Volkskrant it was an “honour” to name the revised drug after the research and said it is in “contact” with the Australian research team. That contact, the Volkskrant said, is one email.

Dutch News has contacted Aegpha in both Slovakia and the US for comment.

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