Lyndra Therapeutics, the Watertown biotech startup that wants to develop long-acting medicines to replace daily pills, has signed a $15 million deal with Gilead Sciences to help the giant California biotech develop HIV drugs that would be taken weekly.
Gilead, the leading maker of HIV medications — and a frequent target of criticism for its high prices — had already contributed to a recent $60.9 million fund-raising round for Lyndra. Other investors included the Bill & Melinda Gates Foundation.
Lyndra was set to announce on Tuesday that Gilead, based in Foster City, Calif., will pay it $15 million upfront to develop an HIV pill that could be taken once a week in the hopes of helping patients stick to their medication regimens.
“Gilead is a world leader in HIV treatment,” said Amy Schulman, the CEO and cofounder of Lyndra, who plans to step down in September and become executive chairwoman of the startup’s board of directors. “We’re delighted to be working with them.”
Gilead will have exclusive rights to any product resulting from the collaboration, and Lyndra has pledged not to work with any other drug maker on HIV medicines, Schulman said. The partners haven’t settled on a particular drug, approved or in the pipeline, to try to turn into a weekly pill.
Gilead’s HIV products include Truvada, a blockbuster medicine that was approved in 2004 to treat the virus that causes AIDS. In 2012, the Food and Drug Administration also approved the pill as the first preventive medicine for healthy people who are at high risk of acquiring HIV through sexual activity.
But the company has been denounced by activists for its pricing of Truvada. The pill, whose use as a preventative measure is sometimes called PrEP — “Pre-exposure Prophylaxis” — costs about $1,675 a month, or $20,000 a year.
Gilead was sued in May in federal court in San Francisco by consumers who claimed that the company conspired with other drug makers to stymie competition in generic medicines, even after its patents expire. Gilead has sued several rival companies that have tried to introduce generic versions of Truvada in the United States.
Truvada is expected to lose its US patent protection in 2021.
If Gilead reformulates the drug so that people could take it once a week, the company could seek patent protection for that innovation in the hopes of prolonging its monopoly on the medicine.
“This is exactly what pharmaceutical companies do,” said Bruce Sunstein, a Boston intellectual property lawyer who has represented drug makers but isn’t involved in this matter. “They’re always interested in thinking of methods for extending their position.”
A top Gilead executive said that its partnership with Lyndra marks an important step in his company’s effort to treat HIV and prevent its spread.
“Gilead is committed to advancing therapies for all people living with or at risk for HIV, including potential strategies for long-acting regimens that would reduce pill burden,” said John McHutchison, Gilead’s chief scientific officer.
Created in 2015 after being spun out of the MIT lab of Robert Langer, the prolific inventor and entrepreneur, Lyndra wants to make long-acting medicines for conditions ranging from schizophrenia to Alzheimer’s disease.
A weekly pill could be particularly helpful to treat mental illnesses, experts say, because patients often resist taking pills daily, especially if they cause side effects.
The privately held company has designed a capsule that contains a star-shaped structure. The star’s six arms unfold inside the stomach and steadily release ingredients over an extended period; the star stays in the stomach until the arms break off and leave the body like undigested food.
Last month, Lyndra said Patricia Hurter, a recently retired and high-ranking executive at Boston-based Vertex Pharmaceuticals, will succeed Schulman as CEO.