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 tablet and injections within the U.S.
Novo is asking the courtroom to completely ban Hims from promoting compounded variations of its medication that infringe on the corporate’s patents and is searching for to recuperate damages.
“It is a full sham, and it has been a sham because the scarcity ended,” mentioned John Kuckelman, Novo’s group normal counsel of world authorized, mental property and safety, in an interview.
“The actual 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’s going to cease providing its new copycat weight problems tablet after dealing with 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 authorised Wegovy tablet.
In an announcement on Monday, Hims mentioned the lawsuit is “a blatant assault by a Danish firm on hundreds of thousands of People who depend on compounded drugs for entry to customized care” and is one other case of Large Pharma “weaponizing the US judicial system to restrict client selection.”
Hims added it has a “lengthy historical past of offering protected entry to customized healthcare” to sufferers.
Novo Nordisk’s Copenhagen-listed shares climbed greater than 3% on Monday, whereas Hims’ NYSE-listed inventory fell greater than 27%.
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 underneath a regulatory loophole that enables corporations like Hims to promote compounded variations of patent-protected medication when branded remedies are in brief provide.
Semaglutide — the lively ingredient in Novo’s tablet and its blockbuster injections — is not in scarcity within the U.S., due to the corporate’s efforts to ramp up manufacturing capability. There are not any shortages reported for the Wegovy tablet, 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 People are utilizing compounded GLP-1 medication.
Hims has mentioned its compounded tablet and different GLP-1 merchandise comprise semaglutide, regardless of the ingredient being protected by U.S. patents by means of 2032. Hims has mentioned 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 mass compounding, to illegal mass compounding,” Kuckelman mentioned, noting that Novo will not be attempting to cease all compounding practices.
He mentioned compounding must be based mostly on professional grounds, “versus you producing mass shares of what you are calling a customized medication, which is actually 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, corresponding to once they cannot swallow a tablet 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 in opposition to Hims for the tablet, together with limiting entry to the components and referring the corporate to the Division of Justice over potential violations.
Kuckelman mentioned some telehealth platforms, corresponding to Ro, “are doing the appropriate issues” by transitioning to offering sufferers with actual FDA-approved merchandise from Novo and its opponents.
However “some will not, and the one manner it seems that we’ll get Hims and others to cease that is by means of hopefully authorities enforcement actions and thru lawsuits just like the one which we have filed right this 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 reduction 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 by means of a comparable authorized course of with tirzepatide, the lively ingredient in its weight reduction drug Zepbound and diabetes therapy Mounjaro, which is not in brief provide within the U.S.
