Listed dietary supplements company Promisia Integrative is being prosecuted by the Ministry of Health, which claims its joint health supplement Arthem is an unlicensed medicine and that some marketing activities have breached the Medicines Act 1981.
The company told the NZX there are nine charges, all based on the ministry’s view that Arthrem has been sold and advertised for therapeutic purpose to patients, often with arthritis, and is thus a medicine.
The prosecution comes on top of warnings a year ago from Ministry of Health regulatory body Medsafe that Arthem may cause liver damage.
In a statement to NZX about the recent prosecution the company says: “Promisia disputes all charges and will defend them vigorously.”
“Arthrem is not a medicine. It is a dietary supplement. Promisia has always ensured that its advertising is approved under the dietary supplement category,” it says, adding that it has used the Therapeutic Advertising Pre-vetting Service to this end.
“Promisia will update the market as this matter progresses but notes that further information may be affected by the legal process.”
Penny dreadful stock Promisia, which in the five years since it listed has never traded above 6 cents a share, raised $1.35 million from a 3-for-1 rights issue over the Christmas/New Year period. At that time the family trust of major shareholder and director Tom Brankin kicked in another $250,000, increasing its stake to 51.3 percent. This provided sufficient working capital for it to remain in business.
Promisia’s own health has been in doubt since February last year when MedSafe warned Arthrem may cause liver damage, a warning repeated in November when MedSafe said that 25 cases of liver toxicity had been reported to the Centre for Adverse Reaction Monitoring by Sept. 30.
Promisia claims Arthem is not behind those adverse reactions. Instead, the company says they are caused either by higher dose competing products, or by other drugs or supplements.
A rival product, Go Arthri-Remedy 1-A-Day, was withdrawn from sale after the February Medsafe alert, but Promisia’s product is still sold in about 1,000 New Zealand pharmacies and about 900 pharmacies in Australia.
The Go Arthri-Remedy product contained twice the dosage of Promisia’s product.
Promisia shares dropped 0.1 of a cent to 0.1 cents, matching the rights issue offer price. They haven’t traded above 1 cent in more than a year.