COPENHAGEN Novo Nordisk <NOVOb.CO said on Thursday it could launch its new long-acting insulin Tresiba, a crucial future growth driver for the Danish company, at the start of 2016 in the United States.
The world's top insulin maker is battling to maintain strong profit growth after the U.S. Food and Drug Administration refused to approve Tresiba due to heart-risk concerns and the company lost contracts to supply a U.S. pharmacy chain.
Investors were likely to welcome the more detailed timetable for Tresiba in the United States. Novo Nordisk had previously said it would have additional data ready by mid-2015, without outlining further steps.
"They have moved the (Tresiba) data six months forward, which is certainly not unimportant for Novo. It looks like there are no problems with the study, so it is a very positive signal," said analyst Michael Friis Jorgensen of Alm Brand, which has a "buy" rating on Novo Nordisk shares.
The FDA told Novo Nordisk to conduct extra tests and the company now says the data should be complete by the end of the year or the start of 2015, allowing it to submit an analysis in the first half of 2015.
"If we calculate the best possible scenario then we could see an approval by the end of the year, meaning a launch into the beginning of 2016," Novo Nordisk Chief Executive Lars Rebien Sorensen told journalists on a call.
He was speaking after the company reported second-quarter results that were more or less in line with analyst expectations and maintained a 2014 forecast for a 7-10 percent rise in sales and around 10 percent growth in operating profit.
It said operating profit reached 8.73 billion Danish crowns($1.57 billion) in the second quarter compared to expectations of 8.56 billion crowns, on revenues of 21.63 billion crowns against a consensus forecast of 21.7 billion crowns.
Shares in Novo Nordisk rose as much as 1.5 percent before retreating to stand 0.75 percent higher at 254.70 crowns each. The main Copenhagen stock exchange index was down a touch.
U.S. PRICING PRESSURE
Novo Nordisk has been under pressure in the United States, its largest market, due to competition from generic drugs and broader pricing pressure. Last year it lost two contracts to supply Express Scripts Holding Co. representing some 40-45 million U.S. customers.
Sales of Victoza, used for patients with type 2 diabetes who can still generate some insulin themselves, rose 15 percent in North America and Novo increased its market share in the GLP-1 sector to 69 percent from 65 percent.
But Victoza was one of the products hurt by the loss of Express Script contracts and its sales growth did not satisfy all analysts, including those from Nordea and Berenberg.
"Victoza sales ... were 3 percent below consensus and the GLP-1 market growth rate continues to struggle. The category is now seeing tougher competition from oral drugs such as the DPP-IVs and SGLT-2 inhibitors," Berenberg analyst Alistair Campbell said in a note.
Sorensen conceded that the U.S. market was a challenge for Novo Nordisk after rivals Sanofi and Eli Lilly both reported growth in their diabetes segments.
"It is clear that the situation which occurred toward the end of 2013 is persisting into 2014, with increasing pricing pressure in almost all segments," Sorensen said.
In the year to date, Novo Nordisk shares are up over 28 percent, outperforming Sanofi's 3 percent and Eli Lilly's 20 percent increase.
(1 US dollar = 5.5691 Danish crowns)
(Additional reporting by Teis Jensen; writing by Sabina Zawadzki; editing by Tom Pfeiffer)