(Bloomberg) -- Gilead Sciences Inc. is facing pressure to speed up its plans to bring an experimental HIV prevention drug to market after new data further underscored how useful the medicine could be in the fight against AIDS.
On Wednesday, the drugmaker presented details from a key study at the AIDS 2024 conference in Munich showing that people in the trial who took different therapies to prevent HIV in some cases still contracted the virus because they didn’t stick to their regimens. Gilead had announced in June that its twice-yearly shot prevented 100% of HIV cases in a trial of women and adolescent girls in Africa, which was hailed as a major scientific win.
Gilead’s drug, which has been likened to an HIV vaccine, is a “miracle product,” said Asia Russell, executive director of advocacy group Health GAP. “This is a vastly superior prevention product.”
The accolades didn’t last long.
The drug needs to get to patients as quickly as possible, Russell said. “And that’s not what Gilead is putting forward.”
HIV activists say the company is withholding access to a much-needed preventative by not immediately filing for regulatory approval for use in women.
Activists with posters bearing the words “Gilead’s Greed Kills” descended on the company’s stand at the conference this week, reminiscent of the early days of the HIV epidemic when access to treatments was limited in many countries in Africa and elsewhere.
Foster City, California-based Gilead said it’s working quickly to get the new drug to people but that they’re waiting for data from another trial that includes men and transgender people, which aren’t expected until late this year or early next.
Adding to HIV advocates’ concern is the high price of the drug. Gilead’s prevention drug is currently available in the US as a treatment for people with multidrug-resistant HIV under the brand name Sunlenca. The current list price in the US is $42,250 for the first year and $39,000 a year after that.
Winnie Byanyima, the UNAIDS executive director, said in an interview that the company should license the drug now to generic companies for use in preventing HIV so those companies can have it ready when approval is granted. “They seem to want to drag it out so they first maximize profits in rich markets,” she said.
Gilead is in talks with potential partners that could produce low-cost versions of the prevention drug once it is approved, a spokesperson said in an email. The company said it is committed to pricing that will make it widely accessible and that the cost won’t be based off of Sunlenca’s price.
“We are moving with urgency to negotiate these contracts,” the spokesperson said. Until partners start producing low-cost versions of the drug, Gilead says it will produce dedicated supply of the drug for countries where need is greatest.
New research shows the drug, also known as lenacapavir, could be profitably produced as a generic for just $40 a year, with the manufacturers making a 30% profit margin.
One of the authors of the study, the University of Liverpool’s Andrew Hill, said it could take another six months before results from Gilead’s second trial emerge. “In this time, another 650,000 people are likely to become infected with HIV.”
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