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Sandoz eyes early Canada entry after semaglutide patent

expiry

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CEO sees supply constraints for unbranded GLP-1 medicines

(Adds background and details from interview throughout)

By Bhanvi Satija and Maggie Fick

LONDON, Nov 12 (Reuters) - Generic drugmaker Sandoz

expects unbranded versions of Novo Nordisk's

blockbuster diabetes drug Ozempic to launch in Canada by the end

of June next year after a key patent expires, its CEO told

Reuters on Wednesday.

Sandoz hopes to be one of the first entrants in the Canadian

market where Novo's patent for semaglutide - the active

ingredient in Ozempic - will expire for diabetes in January. No

so-called biosimilar versions have been approved yet, but the

regulatory process is underway for Sandoz.

"It's unlikely people will launch in January next year, to

be brutally honest. I think it'll probably be quarter one,

quarter two," said Richard Saynor in an interview.

DEMAND EXPECTED TO EXCEED SUPPLY

Saynor said Canada would be a testing ground for unbranded

versions of Ozempic, which shares the same active ingredient as

Novo's weight-loss injection Wegovy and is sometimes used as an

unofficial "off-label" substitute.

"This is a 10, 15-year journey. Everyone's super excited

because of Canada. But Canada is just one market," Saynor said,

adding that Sandoz would only be addressing diabetes patients.

Novo loses key patents for semaglutide in several countries

starting next year, including large markets such as Canada,

India and China. Its U.S. patents for both Ozempic and Wegovy

expire in 2032.

The patent expiries add to troubles for the Danish drugmaker

which is losing ground to rival Eli Lilly ( LLY ) in a $150

billion market for weight-loss treatments that has been

revolutionised by their new GLP-1 class of injections.

Saynor declined to comment on launch preparations such as

volumes.

"This is a complicated product. It's a cold chain. There's

storage issues, transport issues. It's a device. And no one's

ever launched a GLP in a regulated market. So no one's got a

clue how big the market is," Saynor said.

Saynor expects that the demand for unbranded GLP-1 medicines

will exceed supply, much like constraints seen with Novo's and

Eli Lilly's ( LLY ) products in recent years.

"I genuinely think the product will be constrained. I don't

think there is enough capacity," he said.

Sandoz has not provided any sales forecasts for unbranded

Ozempic. "I know whatever I say is going to be wrong," Saynor

said.

The U.S. is the biggest market for obesity drugs and

Americans already get some prescription medicines from Canada

because they tend to be cheaper there.

The launch of low-cost Ozempic copies could raise U.S.

regulatory concerns about cross-border biosimilar imports, even

after Novo and Eli Lilly ( LLY ) agreed landmark U.S. deals last week to

slash GLP-1 drug prices and secure Medicare coverage.

"I have no desire to be litigated by an originator for

trying to sell off-label or off-country," Saynor said.