Novo Nordisk Using Priority Review Voucher To Propel Oral Semaglutide To Market
Executive Summary
Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time for expected approval to six months.
Prospects of a 2020 market arrival for Novo Nordisk AS’s ground-breaking oral GLP-1 diabetes therapy remain on track, propelled by solid clinical trial data and a priority review voucher purchased by the Denmark-based group to speed the process.
Regulatory plans for oral semaglutide were announced along with the company’s fourth-quarter and full-year update for fiscal 2018, which although mixed were generally well-received by investors, and reflect the solid results produced by Novo Nordisk's 10 PIONEER clinical development program for its oral GLP-1 semaglutide as a diabetes treatment.
Full Speed Ahead For Oral Semaglutide
Scrip readers would not have been surprised by the news, however, given that Novo Nordisk's chief science officer said in an interview in November that a priority review voucher could be used to cut approval time by the FDA down from 10 to six months. (Also see "Novo Nordisk May Use Priority Review Voucher To Speed Oral Semaglutide To Market" - Scrip, 26 Nov, 2018.)
Regulatory submissions for the orally taken GLP-1 receptor agonist are also planned the EU during the first half of this year and in Japan during the third quarter.
Some analysts believe FDA approval for oral semaglutide could come as early as the fourth quarter of 2019.
But the oral GLP-1 treatment would not hit the market immediately upon being approved, Novo Nordisk CEO Lars Fruergaard Jørgensen told journalists.
“We expect to shorten the review time in the US for oral semaglutide, so the time frame of making contracts in the US is also advanced. But as seen with [weekly injectable semaglutide] Ozempic, when you launch new products in the US today you will be blocked at launch until you have negotiated contracts. So we have advanced the time frame for when we can start these contract negotiations [for oral semaglutide] but it will still take time before those are completed. We will therefore not be launching upon approval,“ Jørgensen said.
Some analyst believe that when Novo does launch oral semaglutide, pricing is likely to be lower than for its marketed injectable GLP-1 therapies Victoza (liraglutide) and Ozempic, as significant pricing pressure and competition has kept pricing for other orally administered therapies at around $2,000 per year.
But the CEO when asked by Scrip what price oral semaglutide would be launched at declined to say, citing "competitive considerations."
The company did well on the GLP-1 front in the fourth quarter, registering 18% growth year-on-year and reflecting the capture by Ozempic of about 26% of new-to-brand prescription share in the US, offsetting the decline of Victoza and reversing the company's recent loss of market share to Eli Lilly & Co.'s once-weekly Trulicity (dulaglutide).
"We stopped the decline in market share by increasing the capture rate and are gradually turning that picture around," Jørgensen said.
"We expect that based on an even stronger GLP-1 franchise, that that will help to reverse the decline in market share and help us to gain market share and by that also increasing the growth outlook. So we expect our GLP-1 business will keep having double-digit growth rates in 2019,” he said.
CEO Welcomes Trump Rebate Initiative
Novo Nordisk's CEO used the quarterly update to welcome a proposal by the US Department of Health and Human Services calling for an end to the industry practice of offering rebates from manufacturers to pharmacy benefit managers (PBMs).
“Under this proposal, a company like Novo Nordisk could no longer give rebates to PBMs, but instead give it directly to the patients. We applaud initiatives by the Trump administration under which patients actually get access to rebates, and get in a situation where the medicines are more affordable.
“Today we pay on average 68% in rebates today ... which under these latest proposals would be illegal to give to the middlemen and would instead need to be given directly to the patients instead,” Jørgensen told journalists.
“Over the years the downside of not providing access to the patients has grown and accelerated [in the US] so we applaud the proposal. It’s not perfectly clear yet how it could be implemented and it’s by far a done deal … but I think there’s a high likelihood of this happening,” the CEO said, citing among other things the fact the Trump administration has announced it seeks political bipartisanship over the issue.
Hard Brexit Assumed
Meanwhile, the CEO said the company is now planning for the worst-case scenario of Britain exiting the European Union without a negotiated deal. (Also see "Pharma Industry Holds Tight As Disorderly Brexit Approaches" - Scrip, 16 Jan, 2019.)
“We are prepared for a hard Brexit in the sense that we have increased our inventories."
"Our products are to be kept in cool storage so there’s a limit to how large an inventory we can build, but we have now increased our inventory in the UK to around 16 weeks. We have also made plans for bringing in supplies on cooled transportation later in the year, if necessary.”