Approval is usually the hard part. Aspen Pharmacare told the JSE on Monday that its Canadian arm had won Health Canada clearance for Aspen-Semaglutide, a generic version of Novo Nordisk's Ozempic, which is essentially the same medicine sold without the brand name. It is cleared for adults with type 2 diabetes, to improve blood sugar control alongside diet and exercise. Then, in the very next line of the same announcement, Aspen said it cannot say when it will actually sell any.
The bottleneck is the ingredient
The working compound in the drug, the bit that produces the therapeutic effect, comes from India's Dr Reddy's Laboratories, and Aspen's launch date depends entirely on getting hold of it. Earlier this month Dr Reddy's said an impurity problem had halted production of new batches, leaving its own generic unavailable in India and supply into Canada disrupted until at least late October. Aspen pointed shareholders straight at those disclosures rather than around them.
A queue is already forming
Novo Nordisk's Canadian patent on the ingredient has expired, and the door is now open to several drugmakers with copies of their own. Apotex got there first: the Canadian company's Sevmia, a generic of Novo's weight-loss brand Wegovy, was authorised in June. Aspen had told the market it expected to be one of the first to market in Canada, and had been counting on the Canadian launch to help it recover from the loss of a major manufacturing contract. Chief executive Stephen Saad said in March that Aspen would make its generics at its South African and French plants, with the larger multi-dose pen volumes coming out of South Africa and single-dose autoinjectors from France.
Investors took the approval and left the asterisk where it lay. Aspen shares closed 3.11% higher on Monday, valuing the group at about R69bn, and are up more than a third so far this year, helped along by the sale of its Australian business.
Late October is the date to circle. Until Dr Reddy's restarts, Aspen holds a Canadian approval it cannot act on, and every week of waiting is a week its rivals get to fill shelves it cannot reach.
