With Eli Lilly's Trulicity winning GLP-1 market share by the day, Novo Nordisk has a lot riding on its oral version of semaglutide—and now the drugmaker is putting its approval bid in the fast lane. Novo bought a priority review voucher to cut down on FDA review time and is plotting a filing in a matter of a few months.
Armed with data from its extensive Pioneer trial program, the company plans to submit the drug—which would be the only pill in the fast-growing GLP-1 class—around the end of the first quarter, Novo disclosed (PDF) along with fourth-quarter results. The new timeline could set up a potential approval by the end of the year, analysts with financial group ODDO BHF wrote Friday.
Analysts believe the oral option will disrupt the increasingly competitive diabetes market, grow the entire GLP-1 class and pull in blockbuster sales. Jefferies' Peter Welford wrote in December that an “oral GLP-1 could drive wider penetration of this class, in our view, gaining traction for earlier use.” His team predicted $5 billion in peak worldwide sales. Life science commercial intelligence firm Evaluate previously predicted (PDF) the drug could pull in about $2 billion by 2024.
Additional revenue would come at an important time for Novo as the company has increasingly suffered from U.S. competition and payer pressure. It’s paid growing rebates to middlemen, and that trend will continue into next year, executives said on Friday’s conference call with analysts. In 2018, discounting reached 68% across its U.S. portfolio, executives said. To cope with pricing struggles, Novo has had to cut costs.
One of the main drivers of the pricing trend is the basal insulin market, where “we’ve been paying high rebates to remain on formularies,” one Novo executive said. Still, the company has strong formulary coverage for its products going into 2019, the Novo leadership team said on the call.
Meanwhile, the company is seeking to expand the label for its injectable version of semaglutide, Ozempic, to include cardiovascular benefits after analyzing study results for the oral version. The company is in “constructive dialogue" with the agency, and it hopes to win the label expansion so it can reduce the need for another large cardiovascular outcomes trial.
Overall for 2018, Novo Nordisk turned in DKK 111.8 billion ($17.15 billion) in sales, a 5% increase over 2017 in local currencies. GLP-1 launch Ozempic and weight loss drug Saxenda beat analyst expectations in the fourth quarter, Welford wrote, while insulins fell short.
Novo’s profit fell by 4% for the year, however, and missed analyst expectations because of the purchase of a priority review voucher for oral semaglutide. Novo guided for 2% to 5% sales growth at constant exchange rates, hitting analyst estimates, Welford wrote. The company expects operating profit to grow 2% to 6% next year.