Novo Nordisk on Monday said it is suing online telehealth provider Hims & Hers for mass marketing cheaper, unapproved copies of the drugmaker’s new Wegovy obesity pill and injections in the U.S.
Novo is asking the court to permanently ban Hims from selling compounded versions of its drugs that infringe on the company’s patents and is seeking to recover damages.
“This is a complete sham, and it has been a sham since the shortage ended,” said John Kuckelman, Novo’s group general counsel of global legal, intellectual property and security, in an interview.
“The fact is that their medicines are untested, and they’re putting patients at risk,” he added, referring to how the safety, efficacy and quality of compounded medicines are not verified by U.S. regulators.
The move escalates the feud between Novo and Hims, which said on Saturday it will stop offering its new copycat obesity pill after facing scrutiny from federal regulators and legal threats from the Danish drugmaker. Hims had planned to offer the oral drug for as little as $49 for the first month, roughly $100 less than Novo’s approved Wegovy pill.
In a statement on Monday, Hims said the lawsuit is “a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care” and is another case of Big Pharma “weaponizing the US judicial system to limit consumer choice.”
Hims added it has a “long history of providing safe access to personalized healthcare” to patients.
Novo Nordisk’s Copenhagen-listed shares climbed more than 3% on Monday, while Hims’ NYSE-listed stock fell more than 27%.
The lawsuit comes as Novo works to reclaim market share in the booming obesity drug market and fend off competition from both Eli Lilly and a wave of compounded alternatives. Those copycats have proliferated under a regulatory loophole that allows companies like Hims to sell compounded versions of patent-protected drugs when branded treatments are in short supply.
Semaglutide — the active ingredient in Novo’s pill and its blockbuster injections — is no longer in shortage in the U.S., thanks to the company’s efforts to ramp up manufacturing capacity. There are no shortages reported for the Wegovy pill, which has had an explosive launch since it entered the U.S. market in early January.
Even so, Novo estimated in January that as many as 1.5 million Americans are using compounded GLP-1 drugs.
Hims has said its compounded pill and other GLP-1 products contain semaglutide, despite the ingredient being protected by U.S. patents through 2032. Hims has said its versions are legal because they are “personalized” in dosage.
But Novo said it does not directly or indirectly sell semaglutide for copycats, and accused Hims of engaging in illegal mass compounding.
“I would just say we do want an end to mass compounding, to unlawful mass compounding,” Kuckelman said, noting that Novo is not trying to stop all compounding practices.
He said compounding has to be based on legitimate grounds, “as opposed to you producing mass stocks of what you’re calling a personalized medicine, which is really just a dosage variation.”
Compounded drugs can be produced on a case-by-case basis when a doctor determines it is medically necessary for a patient, such as when they can’t swallow a pill or are allergic to a specific ingredient in a branded drug.
On Friday, the Food and Drug Administration announced it planned to take legal action against Hims for the pill, including restricting access to the ingredients and referring the company to the Department of Justice over potential violations.
Kuckelman said some telehealth platforms, such as Ro, “are doing the right things” by transitioning to providing patients with real FDA-approved products from Novo and its competitors.
But “some won’t, and the only way it appears that we’re going to get Hims and others to stop this is through hopefully government enforcement actions and through lawsuits like the one that we’ve filed today,” he said.
Novo and Lilly have aggressively cracked down on compounding pharmacies over the past two years as they benefit from the soaring popularity of their weight loss and diabetes drugs. Novo has so far filed around 130 lawsuits dealing with 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 U.S.
Read the original article here