Victoza® (liraglutide) from Novo Nordisk

Novo Nordisk is fighting hard to get liraglutide approved by FDA as soon as possible. The company filed for European and U.S. approval last year and FDA is expected to approve the drug around May 2009. The approval process has been delayed due to FDA’s extended data requirement.

Liraglutide is a human GLP-1 analogue, designed to induce the same effects as a blood sugar-improving hormone and will be competing head on with Eli Lilly/Amylin’s Byetta. FDA has already approved Byetta and the product could hereby profit from a first mover advantage. But Byetta has run into trouble. Byetta has been linked to an increased risk of deadly pancreatic disease. This has forced FDA to strengthen the warnings about life-threatening pancreas when using the product. The FDA says that Byetta and other suspect drugs should be promptly discontinued if pancreatitis is suspected. Novo has not experienced any of the above problems in the clinical trials with liraglutide and it should be easy to discriminate all links to pancreatitis and create a competitive advantage compared to Byetta.

Victoza® (liraglutide) contra Byetta

Liraglutide has three advantages:

• Liraglutide is a once daily injection (Byetta is a twice daily)
• The Lead-6 data has indicated a better efficacy compared to Byetta
• No link between the product and pancreatitis
  

If Novo Nordisk can utilize the once daily version, the better efficacy and Byetta’s impaired reputation , the first mover advantage of Byetta could be effect less and Victoza could quickly meet its blockbuster potential and secure a market leader position.

However Victoza’s success could be short termed. The expected launch of Byetta Lar (once-weekly injections) in mid 2010 will be a serious challenge, due to the impressive results in clinical trials. Byetta Lar has documented a weight loss in the size of 4-5 kg, after one-year treatment – compared to “only” 2-3 kg with Victoza. Byetta Lar could challenge the possible market leader position of Victoza – if the product is approved.

Goldman Sachs has predicted the global sales of Victoza to reach DKK 6,000 million in 2012. In my opinion Novo has to focus on pushing the product and build up a strong market position within the six first months of launch – if not the predicted global sales will be diminished. Novo has to utilize the window of opportunities before Byetta Lar is approved. If they succeed the product could be a future cash cow.