Novo Nordisk Reports 2018 Profit of DKK 47.2 Billion and Plans FDA Fast-Track Submission for Oral Semaglutide

DiabetesPharmaceutical manufacturer Novo Nordisk announced its 2018 fiscal year report on Friday (February 1), stating that the company plans to submit to the U.S.FDAAccelerate the application to approve its potential blockbuster oral GLP-1Diabetesthe drug semaglutide, and stated that the drug is a key component of Novo Nordisk's long-term strategy.

According to Novo Nordisk’s 2018 annual report, the company’s full-year operating profit amounted to DKK 47.2 billion (approximately RMB 48.8 billion). The change in performance was attributable to severance payments associated with layoffs in the second half of 2018 and fees related to the Priority Review Voucher for the oral antidiabetic drug semaglutide. Calculated in local currency, operating profit increased by 6%.

In November 2018, Novo Nordisk completed itsDiabetesThe remaining two trials of the Phase 3a PIONEER program for once-daily oral semaglutide, PIONEER 6 and 9. The trials demonstrated that the drug’s efficacy surpassedEli LillyThe company’s flagship product, Trulicity (dulaglutide). Data from the Phase IIIa PIONEER 8 clinical trial showed that in patients with type 2 diabetes who had been receiving long-term insulin therapy,DiabetesAmong patients, semaglutide significantly improved glycemic control while demonstratingWeight LossEfficacy.

Semaglutide targets GLP-1, a peptide hormone encoded by the human proglucagon gene and secreted by intestinal L cells. GLP-1 agonists are a novel class of insulin secretagogues. Studies have shown that the glucose-lowering efficacy of this class of agonists is second only to insulin, offering potent glycemic control with a lower risk of hypoglycemia, andWeight LossEfficacy and Advantages in Cardiovascular Benefit. The risk of hypoglycemia induced by this drug is low, primarily because the glucose-lowering effect of GLP-1 acts on pancreatic β-cells in a glucose-dependent manner, promoting insulin gene transcription, increasing insulin biosynthesis and secretion, while its effect is significantly attenuated during hypoglycemia, thereby ensuring safe glucose lowering.

Semaglutide will be submitted to the United States at the end of the first quarter of 2019FDAReview: Novo Nordisk will simultaneously submit a request for priority review, which is expected to accelerate the approval process to six months, compared to the standard 10-month timeline. If approved, external focus will shift to the pricing of semaglutide, as soaring drug prices in the United States could trigger backlash and resistance from patients and politicians. Previous reports on rationing for diabetic patients or insulin pricing have drawn widespread public criticism.

Novo Nordisk has devoted nearly a century of effort to the development and commercialization of semaglutide, but the drug’s momentum has been hindered by intensifying competition and pricing pressures in the U.S. market. “Concerns about future market risks for the drug will drive up pricing for GLP-1 therapies,” Jefferies analysts wrote in a report on Friday. A Novo Nordisk spokesperson declined to comment on the company’s pricing plans for oral semaglutide. Meanwhile, Novo Nordisk is also facing uncertainties surrounding Brexit. The company is the largest insulin supplier in the UK market, but with the final details of the UK’s exit from the European Union still unclear, the pharmaceutical giant has devised contingency plans, including stockpiling sufficient supplies before March 29—the projected date of the UK’s withdrawal from the EU—to ensure uninterrupted normal supply.Bio ValleyBioon.com）