Pretoria compounding pharmacy iDexis, which was raided by the regulator and the Pharmacy Council last month, will come up against Danish pharma giant Novo Nordisk in the Gauteng High Court next week over its weight loss jabs, reports Business Day.
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 – but no generic versions have been registered by the South African Health Products Regulatory Authority (SAHPRA).
Novo Nordisk’s legal action hits at the heart of the legal framework governing compounded medicines, made by licensed pharmacists 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 – being advertised directly to the public (and) offered to doctors – which was not coming from a source we were aware of,” said Novo Nordisk South Africa manager Sara Norcross.
iDexis is already 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 the products, including reflux, nausea, constipation, headaches and, on rare occasions, acute kidney problems. It did not specify how many complaints it had received.
The regulator 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 that 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 has responded 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 like 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 customers buying 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.
Detained and denials
Last month, the day after SAHPRA had carried out a raid at the iDexis pharmacy, former Blue Bulls rugby team doctor Dr Tommie Smook and his partner Suzé Steyl had been detained at OR Tambo Airport after a trip to China, reports Rapport.
This came amid the growing investigation into compounded weight-loss jabs, the origin of the raw materials used to make them, and the network of pharmacies, suppliers and medical practices through which they are distributed.
Smook and his legal representatives have denied that he – or his practice – is acting unlawfully.
Several GLP-1 and GIP injectable products had been confiscated when SAHPRA and the South African Pharmacy Council raided the iDexis raid.
Dr Ruaan Louw of iDexis confirmed Smook was among several doctors who have sent prescriptions for patients to his company.
Louw said iDexis compounds injectable treatments that combine semaglutide and tirzepatide into a single product when prescribed by a doctor. He said Smook was “one of thousands of doctors in this country who prescribe this product”; that iDexis has already processed prescriptions for more than 200 000 patients using these medicines, and that about 3 000 doctors and pharmacies order products from the company.
SAHPRA and the Pharmacy Council said their inspections at iDexis revealed “critical regulatory non-compliance”.
They also said reports had been received of adverse reactions, including hospitalisation. iDexis was instructed to recall affected products already in circulation.
Louw has disputed the findings, saying iDexis sourced its raw materials from a traceable manufacturer, imported them with certificates of analysis, and tested them in South Africa before any compounding took place. He said the documentation would be made available in court.
However, SAHPRA Regulatory Compliance Manager Mokgadi Fafudi said no one has been authorised to import semaglutide or tirzepatide raw materials into South Africa for the purpose of manufacturing compounded products, and the products were thus illegal.
Fafudi added that a doctor’s prescription or involvement of a compounding pharmacy does not, in itself, make a product legal if the active pharmaceutical ingredient has not been properly approved.
Rapport previously reported that Smook’s so-called “RxME injection” is promoted on social media by several celebrities, who refer followers to Smook and his practice, RxME, headed by Steyl.
See more from MedicalBrief archives:
SAHPRA and drug companies flag risks of compounded weight-loss drugs
Court case looms as pharmacy challenges SAHPRA raid