The High Court battle which started this week between pharmaceutical giant Novo Nordisk and a Pretoria pharmacy shone the spotlight on GLP-1 drugs and the frenzied market demand that has resulted in a compounding explosion, and also has implications for pharmacies facing pushback against compounded drugs worldwide.
Novo Nordisk – maker of Wegovy and Ozempic – took Pretoria pharmacy iDexis to court yesterday over its use of a patented compound, the outcome of which is likely to affect the fate of numerous South African pharmacies that have begun compounding their own GLP-1 drugs and dispensing them to thousands of patients. In the United States, Novo has already taken action against pharmacies and telehealth platforms offering copies of semaglutide, arguing they circumvent regulatory safeguards and pose safety risks, reports CNBC Africa.
Industry experts have said compounding rules have limits, while the lobby group for SA’s pharmaceutical companies says GLP-1 compounding should, in fact, be banned completely.
The Novo Nordisk-iDexis case was the conclusion of a dispute over the pharmacy’s use and marketing of semaglutide. Novo Nordisk holds South African patents for Ozempic and Wegovy, both of which use semaglutide as their active ingredient.
In May, iDexis, trading as Sentra in Pretoria, was raided by regulators who seized various medications and alleged it was compounding outside the framework of South African law.
The SA Health Products Regulatory Authority (SAHPRA) also alleged that iDexis was compounding in unsafe conditions.
However, the pharmacy denied wrongdoing and said the active pharmaceutical ingredients (APIs) it uses for its compounds were “sourced from reputable, internationally approved pharmaceutical manufacturers and had been tested in independent analytical laboratories for sterility and quality”.
But the Pharmaceutical Task Group (PTG), which represents the majority of the SA pharmaceutical industry by production (above 80%), said SA should follow the trend of leading global regulators and ban GLP-1 compounding by pharmacists completely on safety grounds.
Explosive growth
Demand for GLP-1s has exploded worldwide: in SA alone, the market tripled over the 18 months to end-January, Aspen said in March, with SA’s GLP-1 market worth about R2.2bn a year. Mounjaro has achieved more than 50% market share in SA, Aspen reported in its interim results to end-December.
In May, SAHPRA, in collaboration with the South African Pharmacy Council (SAPC), had announced it was stepping up enforcement against “the unlawful manufacturing and distribution of unregistered GLP-1 and GIP medicines”.
The two conducted a joint investigation inspection at iDexis on 11 May where they allegedly discovered “critical regulatory non-compliance” and seized all GIP/GLP-1 injectable products found onsite.
While compounding is strictly limited to the preparation of medicines for individual patients based on a valid prescription, the facility was found to be manufacturing and marketing GIP/GLP-1-based products, including semaglutide, tirzepatide, and combination formulations, for broader commercial distribution, particularly for weight management purposes, SAHPRA said.
iDexis resists
iDexis challenged the findings, adding that it had dispensed its (semaglutide and tirzepatide), compounded peptide product to 214 406 patients on prescription of their treating clinicians through the practices of their clinicians, or retail pharmacies of choice, “without any reports of adverse reactions or conditions, only reports of success and gratitude”.
The PTG has welcomed the enforcement initiatives.
PTG chair Stavros Nicolaou told News24 that while compounding is permissible under certain conditions, the issue is the flouting of many regulations, leading the US and Australia to completely ban compounding by pharmacists.
“There is already an international precedent where two of the most stringent regulators have acted. So this begs the question: why are our own policies not following suit?” he asked.
He said GLP-1 injectable pens must be manufactured in sterile conditions because they are unlike pills that are swallowed, where the stomach offers a barrier of protection.
The PTG said it was unclear how compounding pharmacies are acquiring their APIs.
“There have been reports that they’ve been brought in under labels such as calcium. I’ve even heard reports of APIs being imported while labelled as cat food,” Nicolaou said.
Patients are also being forced to sign non-disclosure agreements, he added, which is directly at odds with regulations requiring the collection of information about adverse medical events.
“I know of one patient who took these compounded medicines, experienced a severe side effect, and landed up in ICU in Bloemfontein, but couldn’t make disclosures because of a confidentiality agreement.”
CNBC Africa – Novo Nordisk faces off in court with South African weight-loss drug compounder
See more from MedicalBrief archives:
Novo Nordisk sues local pharmacy over alleged ‘knock-off’ weight-loss jabs
Court case looms as pharmacy challenges SAHPRA raid
SAHPRA and drug companies flag risks of compounded weight-loss drugs