PROMISIA, the publicly-listed New Zealand manufacturer of joint supplement Arthrem, is staunchly defending a prosecution by NZ regulator Medsafe, which has alleged the company breached the NZ Medicines Act 1981.
The case kicked off last Fri in the Wellington District Court, with Medsafe alleging sales of Arthrem were illegal because of claims it is an unlicensed medicine.
Promisia said it had always maintained that Arthrem was a dietary supplement, not a medicine.
Earlier this month Promisia published its financial statements and annual report for the year to 31 Dec, with a "significant" NZ$2.2m loss due largely to a Medsafe Alert (PD 19 Feb 2018) about potential adverse liver toxicity events in connection with Artemesia Annua (sweet wormwood) extract.
Promisia said the alert had caused an immediate collapse in sales in NZ, and also overshadowed the launch of Arthrem in Australia.
The company reiterated concerns about the accuracy of the adverse reaction reports, and a "lack of investigation" by Medsafe to confirm the information provided.
"It is clear that in a number of the reported adverse reactions the offending product was unlikely to have been Arthrem due to the dose size and number of capsules taken daily...these are likely to have been competing products that have subsequently been withdrawn from sale in pharmacies," Promisia said.
In relation to the Medsafe prosecution over promotion of an unlicensed product, Promisia also noted that all of its marketing and advertising material had been approved by NZ's Therapeutic Goods Advertising Pre-Vetting Service before being published.
Despite the controversy, the company said Arthrem was now stocked in about 600 pharmacies in Australia, "mainly in most of the major pharmacy groups".
The case has been set down for a further hearing on 29 Mar.
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