Novo Nordisk says “there is still room for improvement” in the development and delivery of insulin as it awaits FDA approval of its challenge to Lantus.
The drug company, headquartered in Denmark, recently announced it was celebrating the 90th anniversary of its insulin in the treatment of diabetes and, according to Novo Nordisk spokeswoman Katrine Sperling, “there is still room for improvement” in both therapy and delivery method.
She told in-Pharmatechnologist.com that “a major issue today is compliance with therapy, which is not 100% due to many factors, of which the fear of injections and the interruption of daily routines are amongst the most important.”
Sperling’s words come as Novo Nordisk prepares to launch its new insulin therapy Tresiba in the UK and Denmark, before pushing it out to the rest of Europe later this year having been approved for use in the EU last year.
However, Tresiba has been hit by US regulatory hurdles and it still awaits approval from the FDA (US Food and Drug Administration). Last month the company received a Complete Response Letter from the FDA, refusing to approve the therapy until it is tested further in trials for cardiovascular effects.
This delay may hurt Novo Nordisk as though the firm is a pioneer in insulin development, an increase in demand has led to other players entering the market with innovative therapies and administering devices.
At present Novo Nordisk claims to produce almost half of the world’s insulin but competition from Sanofi has caused them to play second fiddle to the French Pharma company with regards to revenue.
Sanofi’s lead therapy Lantus is a long-acting insulin therapy and a topseller accumulating sales of over $5bn in 2011, according to Bloomberg , and a recent investment of €44m ($57m) in its production of Lantus demonstrates the importance of the product to Sanofi.
With potentially the need of thrice-weekly injections and less austerity in timing of the administration, Tresiba has the potential to offer diabetes sufferers greater flexibility and comfort than Lantus which comes in daily injections.
A reduction in “the number of injections” is an important factor in moving insulin delivery forward, said Sperling, as is the possibility to develop technology to “eliminate injections completely.” She added that as well as Tresiba Novo Nordisk “has a once weekly insulin in clinical development” as well as an oral insulin (both in Phase I).