A high-stakes legal battle between Danish pharmaceutical manufacturer Novo Nordisk and compounding pharmacy iDexis over weight loss jabs is set to be heard in the high court in Pretoria on June 10. Novo Nordisk has asked the court to interdict iDexis from manufacturing, advertising and distributing products containing semaglutide pending the outcome of regulatory investigations, alleging it is illegally compounding and selling a knock-off version of its drugs that poses a public health risk. Novo Nordisk has registered two medicines containing semaglutide in South Africa ― Ozempic for treating type 2 diabetes and Wegovy for weight loss. No generic versions have been registered by the South African Health Products Regulatory Authority (Sahpra).Novo Nordisk’s legal action has potentially far-reaching implications as it goes to the heart of the legal framework governing compounded medicines. These are products that licensed pharmacists make for patients who require a dose or combination tailored to their specific needs that is not commercially available.“We started this case because we were getting a lot of queries about a version of semaglutide that was being advertised direct to the public (and) offered to doctors which was not coming from a source that we were aware of,” said Novo Nordisk South Africa manager Sara Norcross. iDexis is under scrutiny from Sahpra, which last month ordered it to issue a product recall for its jabs containing semaglutide and tirzepatide on the grounds that it was importing these ingredients illegally and had not complied with good manufacturing practices. iDexis resisted, saying it had supplied these products to more than 200,000 patients with no reports of adverse events.Sahpra subsequently told Business Day it had received reports of adverse events associated with iDexis’ products, including reflux, nausea, constipation, headaches and, on rare occasions, acute kidney problems. It did not specify how many complaints it had received. “We have received several whistleblower reports and upon our investigation we discovered that iDexis has been manufacturing products in the guise of compounding, which is a contravention of the Medicines and Related Substances Act,” it said. Sahpra is cited as a respondent in the case brought by Novo Nordisk but has not filed a response.In its papers, Novo Nordisk said it manufactures its own semaglutide and is not supplying it to any compounding pharmacies in South Africa. Nor has it authorised any companies to import the drug substance. Tests on iDexis’ semaglutide showed it contained impurities that could affect its efficacy and safety, Novo Nordisk said.It alleges iDexis is manufacturing compounded medicines containing semaglutide at scale, in breach of section 14(4) of the Medicines Act. The sales volume claimed by iDexis in its court papers, of 84,500 units a month, is more than the sales volume of Ozempic and Wegovy combined, Novo Nordisk said in its papers.Novo Nordisk argues the semaglutide base in iDexis’ product is chemically synthesised and is therefore not the same as that in its registered medicines, which are biologically derived. iDexis is therefore using an unregistered and illegal form of semaglutide in its products, it said.iDexis said in its response that it is lawfully compounding and supplying products containing semaglutide because the drug substance it uses contains the same 31 amino acids, linked in the same sequence, as the semaglutide used by Novo Nordisk in its medicines. iDexis also argues that the South African population has a right to access GLP-1 receptor agonists such as semaglutide, which it said Novo Nordisk has been unable to supply in sufficient quantities to meet demand. iDexis has supplied patients treated by Drs Smook & Partners with a compounded semaglutide product that starts at R1,250, while those people purchasing its products via Medi-Lean are paying upwards of R4,312, according to Novo Nordisk’s papers. Novo Nordisk’s semaglutide products start at R1,438 a month, according to the Medicine Price Registry, which tracks private sector medicine prices.