Novo Nordisk to file Lantus rival Degludec in US after EU
This article was originally published in Scrip
Novo Nordisk has filed in the EU its ultra-long acting basal insulin analogue Degludec (insulin degludec) and its insulin combination analogue Degludec Plus (70% Degludec, 30% Novo Nordisk's NovoLog (insulin aspart). The company expects to file approval documentation on its potential rivals to Sanofi-Aventis' Lantus (insulin glargine) in the US within two weeks.
The filings are based on the results from the BEGIN and BOOST trial, which showed that Degludec effectively lowers blood glucose levels and demonstrated a lower rate of hypoglycaemia compared with Lantus. The trials also showed that Degludec can be administered once daily at any time of the day according to patient need, without affecting glycaemic control or compromising safety. Lantus must be administered at the same time every day.
The company expects approvals in late 2012 or early 2013. "There are only benefits and no weak spots ... We don't think there is any cause for concern with regulators, but we know they have questions," said Mr Thomsen.
Novo Nordisk expects the two products will eventually push the company to the top of the basal insulin market, which is currently dominated by Lantus. "At the moment we are a distant second with Levemir," said Mads Krosgaard Thomsen, the company's CSO. In the US, Levemir takes around 16% of the volume market, while Lantus takes around 70%.
Mr Thomsen declined to comment on what he expects the products to be worth, but he said they would be key to achieving double digit growth of the firm's diabetes business.
Nevertheless, class domination will take time because the market is conservative: patients already used to one brand do not tend to switch, said Mr Thomsen. "At first it will be a question of getting new patients ... but there will also be patients who switch." Because patients do not have to take Degludec every day, it offers them better quality of life, he explained. Meanwhile, dosing intervals for Lantus are very rigid and must be taken the same time every day.
Similarly, the company is hopeful that it will eventually convince payers about the drugs' benefits, ie, better efficacy and safety and enhanced convenience. Health economic research markers were built in to both Phase II and III and the company believes it can will be able to offer health technology assessment bodies and providers a strong value proposition.
Mr Thomsen thinks that the firm will be seeking a "modest" price premium of between 10 and 30% compared to today's modern insulins. "We know we can prove value, but we also know there has been a lot of reform. We don't expect a big price premium. In the old days it would have been higher".