Novo Nordisk leans on Victoza as competition increases
- Novo Nordisk's overall sales are up by 3% in local currencies and diabetes and obesity care sales are up by 10%, driven by increases of 149% for Tresiba (insulin degludec). Meanwhile, liraglutide sales grew by 18% in diabetes (Victoza) and 90% in obesity (Saxenda).
- "Although the formulary negotiations in the USA reflect the tough competitive environment, we remain confident that our long-term financial growth targets are achievable," said CEO Lars Fruergaard Jørgensen.
- Victoza remains Novo Nordisk's biggest seller, at DKK11.5 billion ($1.8 billion) in the first half of 2017, making up 24% of the diabetes and obesity total sales, as well as 20% of the company's overall sales.
The biggest driver of sales growth at Novo Nordisk in the first half of 2017 was the diabetes and obesity care sector, behind 240% of the share of growth. The new-generation insulins Tresiba, Xultophy (insulin degludec/liraglutide), Ryzodeg (insulin degludec/insulin aspart) and Fiasp (ultra-fast acting insulin aspart) grew by 155% and contributed 144% of the share of growth.
Novo Nordisk has submitted an application for including SWITCH trial data in the U.S. This was due to get a decision in the third quarter of 2017, but has now been pushed back to the first quarter of 2018 in order to review the information in the context of the results from the DEVOTE trial.
"Our optimism for the label update is unchanged; it's just the timing that is changed," said Lars Fruergaard Jørgensen, president and CEO.
Novo Nordisk remains particularly dependent on sales of Victoza, which got an update to its EU label during the quarter to include cardiovascular data. While sales are still growing at 18% in local currencies, this does demonstrate how much focus Novo Nordisk retains in Victoza, and the risk that holds in the light of the potential competitive threat from the long-acting GLP-1 drugs in the U.S. and Japan.
Victoza's U.S. GLP-1 volume market share has dropped to 46% from over 60% in May 2014, whereas Eli Lilly's Trulicity (dulaglutide) has grown to a 34% U.S. market share since its launch in September 2014. There is a generic threat too – Teva Pharmaceutical Industries Ltd. filed an abbreviated New Drug Application to market its generic version of liraglutide six months ago.
"Victoza is growing in the emerging markets where the long-acting GLP-1 drugs have not yet been launched," said Jørgensen. "We have also just got reimbursement for Victoza in China."
Novo Nordisk expects a U.S. regulatory decision and an opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for the once weekly use of semaglutide, the Victoza follow-on, in diabetes by the end of 2017. In a Phase 2 obesity study of semaglutide, the drug reduced weight by an average of 16.2% or 17.8 kg for those who completed the course, and by 13.8% including those who discontinued the drug.
"At the two highest doses we saw a 15 to 17 kg weight loss over one year, which we believe is a new level of efficacy for this class. Semaglutide was well tolerated and we expect to begin a Phase 3 trial of a weekly dose in obesity in the first half of 2018," said Mads Krogsgaard Thomsen, EVP and CSO.
Novo Nordisk confirmed that formulary negotiations with pharmacy benefit managers and managed care organizations in the U.S. are progressing, and that it expects that average prices after rebates are likely to be lower, Jørgensen has said that the company is not going to comment further on price where formularies are concerned.
"We are not going to go into pricing guidance details. We don't believe that it is meaningful as the pricing is a product of the volume and the mix. We believe that last year's long-term financial guidance is still valid," said Jørgensen. "The market access is anticipated to remain broadly unchanged across the diabetes portfolio at a level similar to 2017."
Victoza has been left off several major formulary lists in recent years in favor of GLP-1 offerings from competitors.
- Novo Nordisk Statement
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