COPENHAGEN (Reuters) - Novo Nordisk reported solid growth for its new diabetes drug on Friday and said it would submit a tablet version, a key growth hope, for U.S. approval in the first quarter, lifting the Danish drugmaker’s shares.
Shares in Novo rose almost 4 percent, boosted by a revised 2019 outlook and forecast-beating sales of its new once-weekly Ozempic GLP-1 drug. The world’s top maker of diabetes drugs expects 2019 sales growth of 2-5 percent and operating profit growth of 2-6 percent, both measured in local currency.
Novo faces pressure on prices from competitors and lawmakers in the United States and is pinning its growth hopes on a once-weekly injection and tablet version of its GLP-1 drug semaglutide for diabetes, as well as anti-obesity treatments.
A potential “hard Brexit”, with Britain leaving the European Union without a deal, represents another political headache for Novo, which said it had more than doubled inventories to around 16 weeks and also ensured cool flight transportation to ensure a supply of insulin for British diabetics.
Fourth-quarter operating profit came in below forecasts, but the miss was partly due to Novo’s acquisition of a priority review voucher for oral semaglutide, Jefferies analysts said.
Novo said it would use the so-called priority review voucher when submitting its oral semaglutide drug for U.S. approval around the end of this quarter to speed up the process.
The potential launch of its GLP-1 semaglutide drug as a pill is seen as a major trigger as it overcomes the aversion many diabetics have to injections.
“Now we expect to shorten the review time with the FDA which means that the time we can start making contracts in the U.S. has also advanced,” Chief Executive Lars Fruergaard Jorgensen told journalists, adding that he expected the review time to be shortened to around six months.
The U.S. FDA grants priority review to drugs that seem likely to provide significant improvements in safety or effectiveness or prevention of a serious condition.
Jorgensen declined to comment on the pricing of the tablet, citing competitive reasons.
High prescription drug costs have consistently polled as a top voter concern and have been a top priority of the administration of U.S. President Donald Trump.
Novo’s fourth-quarter operating profit of 10.8 billion Danish crowns (1.27 billion pounds) was below an average 11.3 billion crowns forecast in a Reuters poll of analysts.
Reporting by Stine Jacobsen; Editing by Jacob Gronholt-Pedersen, Jane Merriman and Alexander Smith