ADA: Novo Nordisk touts oral semaglutide's pivotal win as Ozempic launch revs up

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Novo Nordisk unveiled important new data this weekend on its oral GLP-1 candidate, a follow-up to its weekly injectable, Ozempic. (Novo)

Novo Nordisk’s next big hope is an oral version of its latest launch, semaglutide, and the data in its favor just keeps piling up. After trouncing its predecessor Victoza and rival Jardiance in two data releases last week, the oral med delivered on the nitty-gritty details in a study unveiled at the American Diabetes Association meeting over the weekend.

The daily semaglutide pill beat placebo at cutting blood sugar and helping patients lose weight, with patients on the high dose seeing a 1.5% decline in HbA1C, a standard measure of blood glucose, compared with 0.1% for placebo. And 44% of them lost at least 5% of their body weight, compared with 16% in the placebo arm.

That pivotal study data, from a trial known as Pioneer 1, will go to the FDA when Novo’s ready to file for the oral med’s approval, expected early next year, with a potential nod in 2020. Ozempic, the weekly injectable form of semaglutide, launched earlier this year in the U.S.

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Compared with last week’s head-to-heads against Victoza and Jardiance, however, the oral semaglutide details didn’t generate as much buzz at ADA. But after an analyst briefing Sunday, Bernstein’s Wimal Kapadia said the company’’s commentary, plus chats with physicians, “leave us increasingly comfortable with the product’s clinical profile.”

RELATED: Novo Nordisk results show GLP-1s are job 1. Can its crucial Ozempic launch deliver?

For one thing the weight-loss benefit, scored in the Pioneer 1 release at 26 weeks, looks as if it’ll grow when measured after a full year, Kapadia said. The data curves “look to be on a nice downward trend,” suggesting that weight loss of more than 5kg “looks realistic.” And compared with Victoza as it was in Pioneer 4 data relased last week, oral semaglutide’s weight loss benefit looks as if it has more staying power. Given that weight loss is one of the top priorities for most diabetes patients, that sort of advantage could be a nice marketing edge.

Ozempic and oral semaglutide are two key launches for Novo Nordisk, which has suffered from the payer pressure that’s now routine in diabetes. Victoza, its daily GLP-1, is losing share to Eli Lilly’s weekly Trulicity, and Ozempic is Novo’s answer to taking some of it back. The daily oral added to the mix could return Novo to the GLP-1 dominance it enjoyed before Trulicity came along.

Because Novo is so focused on diabetes—unlike rival diabetes giants Eli Lilly, Sanofi and Merck, which all have broad portfolios—the pressure is especially acute. Coupled with the Medicare changes that put pharma on the hook for bigger “donut hole” discounts, the formulary hardball has forced cost cuts that reportedly are set to accelerate.

The company cut 1,000 jobs back in 2016 after cutting its profits guidance twice; this time around, the company said early this year that it’ll need to cut costs to compensate for the Medicare discounts, and over the weekend said it’s sticking to its long-term targets. A report in Borsen earlier this month said the company is considering job cuts of up to 3,000, but the company says it’s still weighing the details.

Meanwhile, Novo said at ADA that Ozempic has amassed 10.6% of the new-to-brand scripts in its class, Kapadia said in Monday's note. With plans for a bigger marketing push, and the oral med looking good, the hit to Novo's sales when Victoza goes off patent could be cushioned more than market watchers might expect, the analyst noted.

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