Novo Nordisk's oral GLP-1 Rybelsus rollout isn't yet showing up on its earnings reports, but, behind the scenes, the drugmaker is busy mapping out its key launch.
The med, a follow-up to Novo's older Victoza that shares the same active ingredient as injectable Ozempic, won U.S. approval in September as the first GLP-1 diabetes drug in pill form. While it’s still early, there’s a “keen interest” in the new option, as it offers the efficacy of injectables in convenient oral form, Novo CEO Lars Fruergaard Jørgensen told FiercePharma
It's now about a month since the FDA nod, and Novo's team is working with specialists and key opinion leaders to educate them about the drug. Alongside that effort, Novo is negotiating for access with payers. After the drugmaker inks contracts with payers, Novo plans to go into “strike mode” and support the rollout with a full field force followed by advertising, he said.
Analysts have said the drug will grow to blockbuster sales, but some have expressed concern that payers may seek to limit spending as the new med expands the GLP-1 drug class.
For his part, Jørgensen said there’s still “ample opportunity” for growth in the class as payers realize savings from lower pricing in insulins and elsewhere. In the long run, spending on GLP-1 meds in an “attractive” option, he said. Novo's Victoza and Ozempic pulled in $2.47 billion and $1 billion in the first nine months of 2019, respectively.
Outside the U.S., Novo expects potential Rybelsus approvals in Europe and Japan next year. A Novo exec said on a Friday conference call it's "no secret" the drugmaker is gearing up for rollouts in those markets.
The Rybelsus ramp-up comes as the injectable version of the drug, Ozempic, reached blockbuster status for the first time in the first nine months of 2019. The med’s sales of $1 billion in the first nine months beat analyst expectations by 5%, according to a note from Jefferies analyst Peter Welford.
Looking ahead, Novo Nordisk anticipates a label expansion early next year outlining Ozempic’s cardiovascular benefits. It’s also applied for a CV nod for Rybelsus. Jørgensen said “one of the biggest trends” in diabetes treatment is that drugs that also provide cardiovascular benefits are moving up in treatment guidelines, so those approvals will be key as the drugs look to compete with heart-helping members of the rival SGLT2 class.
In the first nine months, Novo’s revenue of $13.4 billion beat analyst estimates by 11% thanks to Ozempic and an outperformance by the company's biopharma group. Victoza came up short of analyst expectations in the U.S., and insulins continue to struggle under pricing pressure.