Nordisk on Monday said he is suing an online telehealth provider him and her to mass market cheaper, unapproved copies of the drugmaker's new anti-obesity pill and injections Wegovy in the US.
Novo is asking the court to permanently ban Hims from selling compounded versions of its drugs that infringe the company's patents and seeks to recover damages.
“This is a complete travesty, and it has been a travesty since the shortage ended,” John Kuckelman, general counsel for security, intellectual property and global legal at the Novo group, said in an interview.
“The fact is that their drugs are untested and are putting patients at risk,” he added, referring to how American regulators do not verify the safety, effectiveness and quality of compounded drugs.
The move intensifies the dispute between Novo and Hims, which said Saturday it will stop offering its new anti-obesity pill after facing scrutiny from federal regulators and legal threats from the Danish drugmaker. Hims had planned to offer the oral drug for just $49 for the first month, about $100 less than Novo's approved Wegovy pill.
In a statement Monday, Hims said the lawsuit is “a blatant attack by a Danish company on millions of Americans who rely on compounded medications to access personalized care” and is another case of Big Pharma “weaponizing the U.S. court system to limit consumer choice.”
Hims added that he has a “long history of providing safe access to personalized healthcare” to patients.
Novo Nordisk shares listed in Copenhagen rose more than 3% on Monday, while Hims shares listed on the New York Stock Exchange fell more than 18%.
The lawsuit comes as Novo works to regain market share in the booming obesity drug market and fend off competition from both. Eli Lilly and a wave of compound alternatives. Such copycats have proliferated under a regulatory loophole that allows companies like Hims to sell compounded versions of patent-protected drugs when brand-name treatments are in short supply.
Semaglutide, the active ingredient in Novo's pill and its successful injections, is no longer in short supply in the United States, thanks to the company's efforts to increase manufacturing capacity. There have been no reported shortages of the Wegovy pill, which has had an explosive launch since it entered the US market in early January.
Still, Novo estimated in January that up to 1.5 million Americans are using GLP-1 compound drugs.
Hims has said its compound pill and other GLP-1 products contain semaglutide, even though the ingredient is protected by U.S. patents until 2032. Hims has said its versions are legal because they have “customized” dosages.
But Novo said it does not directly or indirectly sell semaglutide to copycats, and accused Hims of participating in illegal mass preparation.
“I would just say that we want to put an end to mass compounding, illegal mass compounding,” Kuckelman said, noting that Novo is not trying to stop all compounding practices.
He said the compounding must be based on legitimate reasons, “as opposed to producing mass quantities of what we call a personalized medicine, which is really just a variation of the dosage.”
Compounded medications can be produced on a case-by-case basis when a doctor determines that it is medically necessary for a patient, such as when they cannot swallow a pill or are allergic to a specific ingredient in a brand-name medication.
On Friday, the Food and Drug Administration announced it planned to take legal action against Hims over the pill, including restricting access to the ingredients and referring the company to the Department of Justice for potential violations.
Kuckelman said some telehealth platforms, like Ro, “are doing the right thing” by moving to providing patients with real, FDA-approved products from Novo and its competitors.
But “some won't, and the only way it looks like we're going to get Hims and others to stop this is through government action and lawsuits like the one we've filed today,” he said.
Novo and Lilly have cracked down on compounding pharmacies over the past two years as they benefit from the growing popularity of their weight loss and diabetes medications. So far, Novo has filed about 130 lawsuits related to deceptive marketing practices and consumer fraud, Kuckelman said.
Lilly has gone through a similar legal process with tirzepatide, the active ingredient in its weight-loss drug Zepbound, and diabetes treatment Mounjaro, which is no longer in short supply in the US.
