Novo Nordisk on Monday mentioned it’s suing on-line telehealth supplier Hims & Hers for mass advertising and marketing cheaper, unapproved copies of the drugmaker’s new Wegovy weight problems capsule and injections within the U.S.
Novo is asking the court docket to completely ban Hims from promoting compounded variations of its medication that infringe on the corporate’s patents and is searching for to get better damages.
“It is a full sham, and it has been a sham for the reason that scarcity ended,” mentioned John Kuckelman, Novo’s group normal counsel of worldwide authorized, IP and safety, in an interview.
“The very fact is that their medicines are untested, they usually’re placing sufferers in danger,” he added, referring to how the protection, efficacy and high quality of compounded medicines usually are not verified by U.S. regulators.
The transfer escalates the feud between Novo and Hims, which mentioned on Saturday it is going to cease providing its new copycat weight problems capsule after going through scrutiny from federal regulators and authorized threats from the Danish drugmaker. Hims had deliberate to supply the oral drug for as little as $49 for the primary month, roughly $100 lower than Novo’s permitted Wegovy capsule.
Novo Nordisk’s Copenhagen-listed shares have been up greater than 5% whereas Hims’ NYSE-listed inventory was down 21% in premarket as of 8 a.m. ET.
The lawsuit comes as Novo works to reclaim market share within the booming weight problems drug market and fend off competitors from each Eli Lilly and a wave of compounded options. These copycats have proliferated beneath a regulatory loophole that permits corporations like Hims to promote compounded variations of patent-protected medication when branded therapies are in brief provide.
Semaglutide — the lively ingredient in Novo’s capsule and its blockbuster injections — is now not in scarcity within the U.S., because of the corporate’s efforts to ramp up manufacturing capability. There aren’t any shortages reported for the Wegovy capsule, which has had an explosive launch because it entered the U.S. market in early January.
Even so, Novo estimated in January that as many as 1.5 million Individuals are utilizing compounded GLP-1 medication.
Hims has mentioned its compounded capsule and different GLP-1 merchandise include semaglutide, regardless of the ingredient being protected by U.S. patents via 2032. Hims has mentioned that its variations are authorized as a result of they’re “customized” in dosage.
However Novo mentioned it doesn’t straight or not directly promote semaglutide for copycats, and accused Hims of partaking in unlawful mass compounding.
“I might simply say we do need an finish to to mass compounding, to illegal mass compounding,” Kuckelman mentioned, noting that Novo just isn’t attempting to finish all compounding practices.
He mentioned compounding needs to be primarily based on authentic grounds, “versus you producing mass shares of what you are calling a personalised medication, which is basically only a dosage variation.”
Compounded medication will be produced on a case-by-case foundation when a health care provider determines it’s medically vital for a affected person, similar to after they cannot swallow a capsule or are allergic to a particular ingredient in a branded drug.
On Friday, the Meals and Drug Administration introduced it deliberate to take authorized motion towards Hims for the capsule, together with limiting entry to the elements and referring the corporate to the Division of Justice over potential violations.
Kuckelman mentioned some telehealth platforms, similar to Ro, “are doing the suitable issues” by transitioning to offering sufferers with actual FDA-approved merchandise from Novo and its rivals.
However “some will not, and the one approach it seems that we’ll get Hims and others to cease that is via hopefully authorities enforcement actions and thru lawsuits just like the one which we have filed at the moment,” he mentioned.
Novo and Lilly have aggressively cracked down on compounding pharmacies over the previous two years as they profit from the hovering recognition of their weight-loss and diabetes medication. Novo has to date filed round 130 lawsuits coping with misleading advertising and marketing practices and client fraud, Kuckelman mentioned.
Lilly has gone via a comparable authorized course of with tirzepatide, the lively ingredient in its weight reduction drug Zepbound and diabetes therapy Mounjaro, which is now not in brief provide within the U.S.
