Aspen Pharmacare expects Canada entry with Ozempic generic by third quarter

By Nqobile Dludla

JOHANNESBURG, March 3 (Reuters) - Aspen Pharmacare's APNJ.J unbranded version of Novo Nordisk's NOVOb.CO popular diabetes drug Ozempic could be registered in Canada in the second or third quarter of this year, the South African pharmaceuticals group's CEO said on Tuesday.

Aspen hopes to be one of the first to provide generic competition for Ozempic in Canada, where Novo's patent for semaglutide - the active ingredient in Ozempic - expired for diabetes in January.

"We're getting feedback from the regulators. From what we can see, we could have a registration in late Q2 or Q3 of this calendar year, so some time between May and September," Stephen Saad told Reuters.

Novo Nordisk is set to lose key patents for semaglutide in several countries this year, including in large markets such as Canada, India and China.

CANADA TO BE A REFERENCE MARKET FOR EM REGULATORS

The launch will allow Aspen to tap into the booming weight-loss drug market, which is estimated to reach at least $150 billion by the end of the decade as global demand continues for obesity treatments.

Saad said Canada would serve as a reference for regulators in emerging markets, where it has a strong presence.

"Canada is very important for us. Many countries, for example Latin America and even the Middle East, will say to us we need a reference market from a stringent regulator," Saad said.

"So the registration in Canada for us is more than just for Canada. It's very important to help open up some key emerging markets."

ASPEN'S GENERICS TO BE MADE IN SOUTH AFRICA AND FRANCE

Aspen's generics will be manufactured in its South African and French facilities, with the bigger volumes via multi-dose pens set to come out of the South African facility, Saad said.

The France facility will produce single-dose autoinjector medicine.

"I think there will be a really big uptake, particularly in emerging markets. You're going to see a lot of new patients on this product because it's affordable and because they will pay out of pocket," he said.

In South Africa, where it sells Eli Lilly's LLY.N Mounjaro through a contract, Saad expects Mounjaro sales of over 1 billion rand ($60.68 million) this year.

($1 = 16.5749 rand)