Hims & Hers has abandoned plans to sell a compounded version of Novo Nordisk\u2019s Wegovy (semaglutide) pill, though Novo and the US Food and Drug Administration (FDA) have already set wheels in motion for a legal challenge.<\/p>\n
In a 7 February statement on X, Hims & Hers stated: \u201cSince launching the compounded semaglutide pill on our platform, we\u2019ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment. We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalised care.\u201d<\/p>\n
Shares in Novo rose 7.3% to DKr 317.05 ($50.36) at market open on 9 February, up from a market close of DKr 295.5 on 6 February. The Danish drugmaker has a market cap of DKr 1.4tn.<\/p>\n
Compounded drugs are custom-made and unbranded medications that contain the same active ingredient as a marketed drug, such as semaglutide, pursuant to a prescription. While they are not FDA-approved, they can be made in certain situations, such as shortages or under personalised regimens. However, there are blurred legislative lines on telehealth companies undertaking mass-compounding.<\/p>\n
Despite Hims & Hers conceding, Novo announced it had filed a lawsuit against the telehealth company for infringing on its semaglutide patent on 9 February.<\/p>\n
\u201cWe\u2019ve taken legal action to protect the American public and our intellectual property and will continue to work with regulators, law enforcement and other key stakeholders to ensure patients have access to FDA-approved safe and effective medicines,\u201d said John Kuckelman, Novo\u2019s group general counsel of global legal, IP and security.<\/p>\n
Novo has had to battle erosion in the obesity market<\/a> amid pressure from drugs developed by Eli Lilly and compounded products being sold by telehealth providers. A main component of Novo\u2019s growth strategy relies on sales for its recently launched Wegovy pill in the US.<\/p>\n In a statement to Pharmaceutical Technology, Hims & Hers said: \u201cNovo Nordisk\u2019s lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalised care. Once again, big pharma is weaponising the US judicial system to limit consumer choice. This lawsuit attacks more than just one medication or company \u2013 it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer.\u201d<\/p>\n Novo\u2019s legal challenge follows a similar move by the US Department of Health and Human Services (HHS) to hold Hims & Hers accountable. HHS general counsel Mike Stuart said the company had potentially breached US law.<\/p>\n On 6 February, Stuart said: \u201cBased on a review of the applicable facts, earlier today referred Hims & Hers Health, the Department of Justice for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.\u201d<\/p>\n In a research note, BofA Securities analyst Allen Lutz said: “Because the FDA did not make a distinction between oral and injectable products, we believe this could extend beyond the API for oral GLP-1s and include APIs for Hims & Hers’ injectable semaglutide.”<\/p>\n The legal saga comes as Hims & Hers pressed ahead with airing a commercial at the Super Bowl on 8 February. The 60-second ad, called People Live Longer, draws attention to the widening wealth gap in health outcomes across the US.<\/p>\n