Novo's Ozempic launch kicks into gear ahead of oral semaglutide FDA decision

Novo Nordisk has suffered some well-documented insulin woes, but now the company has not just two, but three GLP-1 drugs stepping up to drive growth. And if all goes well at the FDA, another big approval is on tap this year.

Novo’s blockbuster Victoza, obesity med Saxenda and newcomer Ozempic together pulled in $2.63 billion during the first half of the year, a 29% jump at constant exchange rates. And Ozempic accounted for a hefty $562 million of that, up from last year's tally of about $40 million.

Launched last year, Ozempic is storming ahead and expanding the overall GLP-1 market, Novo execs said on a Friday conference call. Only 25% of patients taking the drug, approved for Type 2 diabetes, are coming from another GLP-1 drug such as Victoza or Eli Lilly’s Trulicity, they said. The remainder are new to the class. 

Ozempic is now capturing 35% of new GLP-1 patients in the U.S., Novo says. Together with Victoza, the company holds 53% of the new-to-brand share in the key market.

Meanwhile, the obesity drug Saxenda—with the same active ingredient as Victoza, liraglutide—took a 56% leap in the first half to $401 million. That, together with Ozempic's strong rollout helped lift the company beyond its sinking insulin sales to overall sales and profit growth—enough to hike its full-year guidance.

While the injectable Ozempic presses on, the company has big hopes for the oral version of the drug now under FDA review, with a decision in Type 2 diabetes expected September 20, execs said. It's also up for approval to reduce major cardiovascular events in diabetes patients with heart disease, with that decision on tap for January 20.

Novo execs declined to get into details about payer negotiations for the forthcoming rollout, but CEO Lars Fruergaard Jørgensen said on the call his company is "confident" in the product's profile and the company's ability to "obtain access to have meaningful launch." 

Speaking with FiercePharma, Jørgensen said he believes Novo is in the "strongest position of all players" in diabetes. After oral semaglutide’s expected approval, the company will be able to offer a highly efficacious daily injectable in Victoza, a weekly option in Ozempic and a daily tablet in oral semaglutide, plus insulins. 

With oral semaglutide, Novo aims to treat type 2 diabetes patients earlier in their disease progression and "hopefully take share from some of the existing oral medications," Jørgensen said. About 70% of type 2 diabetes patients are currently treated with tablets, he said, adding that patients tend to push off seeking treatment through injectables.

Jørgensen acknowledges the forthcoming med will cannibalize Novo’s own offerings to some degree, but he’s confident the drug will help the company move into a larger patient population and grow sales overall. Meanwhile, even after oral semaglutide launches, Jørgensen believes Ozempic can keep growing sales because there will still be patients who need higher efficacy from an injectable.

With its oral semaglutide launch expected in early 2020, Novo is gearing up supply. Just this week, it purchased a pill manufacturing plant from embattled opioid maker Purdue Pharma for an undisclosed sum.

Outside of GLP-1 drugs, insulin sales came to $4.54 billion for the first half, down 1% at constant exchange rates from last year’s first half. Overall, the company grew sales 5% at constant exchange rates to $8.9 billion and grew operating profits 6% to $4.16 billion. With the performance, Novo raised its full-year guidance. It's now expecting sales and operating profit growth of 4% to 6%. 

During the second quarter, the company kicked off four late-stage trials for oral and injectable semaglutide in type 2 diabetes patients with associated complications such as cardiovascular disease, diabetic retinopathy and chronic kidney disease.