"Hims & Hers Sued Over 49-Dollar Imitation Wegovy... Stock Plunges 16%"
Novo Nordisk Sues Over U.S. Patent Infringement
Danish pharmaceutical company Novo Nordisk, which manufactures the obesity drug Wegovy, filed a lawsuit on the 9th (local time) against U.S. telehealth company Hims & Hers, claiming that its products have not received approval from the U.S. Food and Drug Administration (FDA).
According to the U.S. District Court for the District of Delaware on the same day, Novo Nordisk asserted in the complaint submitted to the court that Hims & Hers infringed its U.S. patents related to Wegovy's active ingredient, semaglutide.
According to Novo Nordisk, the alleged patent infringement covers not only the pill product that Hims & Hers launched last week and then pulled from sale, but also all of the injectable products it has been selling for some time.
Previously, on February 5, Hims & Hers announced that it would launch a compounded product with the same active ingredient as the Wegovy pill at a much lower price than the original Wegovy product. As the first-month price started as low as 49 dollars per month (about 71,000 won), far cheaper than the original Wegovy product (starting at 149 dollars per month), Novo Nordisk and rival Eli Lilly shares plunged that day, causing a major stir.
Amid heated controversy over the legality and effectiveness of the Hims & Hers products, the FDA sided with Novo Nordisk. FDA Commissioner Martin Makary issued a statement on February 6, declaring that the agency would take firm action to prevent unapproved obesity drug active ingredients from being used in compounded medications that are mass-marketed, and this led to the withdrawal of Hims & Hers' obesity pill launch.
Hims & Hers had been selling an injectable drug containing Wegovy's active ingredient via telehealth prescriptions by invoking an exception for situations in which a medication is in short supply. Even after the shortage was resolved, it continued marketing the injectable product, arguing that its prescription drugs qualified as compounding that customizes the dosage of existing pharmaceutical ingredients to meet individual patient needs, and later sought to launch the new pill product on the same basis.
John Kukelmann, chief legal officer at Novo Nordisk, criticized the launch of Hims & Hers' imitation Wegovy pill in an interview with Bloomberg, saying, "The announcement of the pill launch last week was extremely serious and crossed a red line."
Hims & Hers, on the other hand, said in a statement sent to U.S. CNBC that the lawsuit is "a blatant attack by a Danish company on the millions of Americans who rely on compounded medications to access personalized medical care," and claimed it is "yet another example of a big pharmaceutical company weaponizing the U.S. legal system to limit consumer choice."
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On the New York Stock Exchange that day, Hims & Hers shares closed at 19.33 dollars, down 16.03% from the previous trading session. The stock continued to fall in after-hours trading. Novo Nordisk closed up 3.58% at 49.37 dollars.
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