Novo Nordisk faces off in court with South African weight-loss drug compounder

By Nqobile Dludla

PRETORIA, June 10 (Reuters) - Danish drugmaker Novo Nordisk headed to court in South Africa on Wednesday to try to halt the sale of unapproved copies of semaglutide, the active ingredient in its blockbuster weight-loss and diabetes drugs Wegovy and Ozempic.

Novo Nordisk South Africa filed a High Court application seeking to prevent local compounding pharmacy iDexis from manufacturing, advertising, distributing and selling "unregistered and untested" weight-loss products containing a semaglutide base, pending the court's consideration on the matter.

"Our concerns relate to patient safety, product quality and regulatory oversight," Novo Nordisk said in a statement. 

Compounding, or the practice of mixing or altering drug ingredients for individual patients, is tightly restricted in South Africa. Large-scale manufacturing or the sale of unregistered medicines is not permitted - a legal boundary central to the case that is being heard in the High Court in Pretoria.

The arguments by legal representatives of both companies also concern whether the active ingredient, responsible for the therapeutic effect of the drug, used by iDexis is exactly the same or similar to semaglutide, which would need to be registered for approval to be sold lawfully.

The compounder, iDexis, has rejected Novo Nordisk's claims as unsubstantiated, and has asked the court to compel the company to produce evidence supporting its allegations, Senior Counsel Stefan Maritz, representing iDexis, said.

He also said there have been no reports of adverse reactions or conditions from using iDexis products.

The judge has yet to deliver a judgment, saying he would do so as soon as possible.

BROADER RESISTANCE AGAINST COMPOUNDED SEMAGLUTIDE

Novo Nordisk's legal action reflects wider efforts by drugmakers to curb compounded versions of GLP-1 drugs. 

In the United States, Novo Nordisk has taken action against pharmacies and telehealth platforms offering copies of semaglutide, saying they circumvent regulatory safeguards and pose safety risks.

Demand for GLP-1 ​drugs, widely used for diabetes and weight loss, surged in South Africa last year following the launch of Eli Lilly's blockbuster Mounjaro and subsequently Novo's Wegovy. 

The cost for the lowest injected dose of Wegovy has dropped from 3,090 rand ($183) to 1,873 rand, while the cost of the highest dose ‌has fallen 27% to 3,746 rand. 

Unable to afford the drugs, some patients switched to compounded copies of the medication, opening up a grey market for many pharmacies and local producers.

A joint inspection by the South African Health Products Regulatory Authority and the South African Pharmacy Council found  last month iDexis was producing GLP-1 medicines, including tirzepatide, for broader commercial distribution - beyond that allowed by regulations.

Inspectors cited serious deficiencies in quality, safety and compliance. Authorities seized products and ordered a recall of medicines distributed via healthcare providers and pharmacies.

"Unlawful manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight loss is a serious violation of the law and a direct threat to public safety," Vincent Tlala, CEO of the SAPC, said.

iDexis said at the time its compounding processes complied with legal requirements and it would defend itself in court.

(Reporting by Nqobile Dludla, Editing by Louise Heavens and Barbara Lewis)