Novo claims first victories in legal fight against compounded semaglutide

Published: Feb 12, 2024

By Tristan Manalac

BioSpace

Two Florida courts last week ruled in Novo Nordisk’s favor in its legal battle against wellness clinics and compounding pharmacies for marketing counterfeit or compounded versions of its popular weight-loss drug semaglutide.

Judge Beth Bloom in a Miami court in the Southern District of Florida issued a permanent injunction against Ekzotika Corporation, ordering it to stop using Novo’s trademarks for any purpose including advertising, or insinuating that any of its compounded drugs are authentic, contain genuine semaglutide or are approved by the FDA.

In addition, Ekzotika should for the next 12 months “prominently disclose” in any of its adverts or promotional materials that its compounded products have not been approved or reviewed by the FDA.

Senior Judge William Stafford of the Northern District Court of Florida, Tallahassee Division, provided a similar ruling against Effinger Health. Stafford likewise permanently enjoined Effinger from advertising or suggesting that any of its unapproved compounded products are genuine, carry therapeutic benefits or are in any way associated with Novo.

Effinger was ordered to let its customers know that none of its compounded products have fulfilled the FDA’s standards for safety, efficacy and quality.

In both rulings, the judges agreed that the defendants have—without the consent of Novo Nordisk—falsely suggested that their products are “genuine Novo Nordisk, semaglutide-based medicines, and achieve or have been proven to achieve certain clinical or therapeutic results,” Stafford wrote in his eight-page decision.

Novo has reached confidential settlements with both Ekzotika and Effinger, and the judges did not include awards in their respective rulings.

The Danish pharma first launched its legal fight against counterfeit and compounded products in June 2023, filing several lawsuits against medical and wellness spas as well as weight-loss clinics, alleging that they were falsely marketing compounded or outright fake versions of semaglutide.

At the time, Novo said that these “unlawful legal marketing and sales practices” could lead to a “high risk of consumer confusion and deception as well as potential safety concerns.”

Semaglutide belongs to a class of peptide therapeutics called GLP-1 receptor agonists, which mimic the GLP-1 hormone to induce the pancreas to release insulin into the bloodstream in response to blood glucose. These medicines have taken the industry by storm, particularly Novo’s Ozempic and Wegovy, indicated for type 2 diabetes and weight management, respectively.

Eli Lilly is also a dominant developer of GLP-1 receptor agonists with its tirzepatide, which is approved as Mounjaro for type 2 diabetes and as Zepbound for obesity.

GLP-1 receptor agonists are in short supply all over the world, allowing counterfeit products to flood the market. The World Health Organization last month put out a warning against these fake products, which could lead to toxic reactions in patients.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at [email protected] or [email protected].

Source: BioSpace