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ADA: Sanofi eyes 2014 submissions for Lantus successor

Releases first phase III data for U300 formulation of insulin glargine

ADA Chicago 2013

Sanofi is planning to submit the successor to its blockbuster insulin Lantus (insulin glargine) to regulators for approval next year. 

U300 is a new, three times more concentrated formulation of insulin glargine that Sanofi said would offer more patient control and adherence benefits due to less frequent, or lower, dosing requirement and a more consistent release than its predecessor. 

When it comes to pricing, something that has so far held back uptake of Novo Nordisk's Lantus rival Tresiba (insulin deguldec), the head of Sanofi's diabetes division Pierre Chancel told PMLiVE "we will make sure price is not an issue".

“We really wanted to bring a new set of value for the physician and the patient, but also for the payers.”

Asked whether U300 would be priced at a premium to Lantus, Chancel said: “The intent is to price it at the level of Lantus, or slightly above Lantus. But, definitely we are not going to price it 50 or 100 per cent above.”

“It's going to be the next generation of insulin. Naturally we will have a cannibalisation of Lantus, but it will help us to expand the people that are eligible for insulin,” Chancel said, adding: “It will have a natural place at the centre of our portfolio.” 

It's premature to say whether U300 will entirely replace Lantus in time, Chancel said, but if the full results of the EDITION programme go the right way for Sanofi he does expect there could be a “substantial” switch from Lantus to U300.

Releasing the product's first phase III data over the weekend at the American Diabetes Association's annual meeting in Chicago, Sanofi said U300 showed equivalent blood sugar control, with fewer night time low blood sugar events. 

In the EDITION I trial there was a 21 per cent reduction in these nocturnal hypoglycaemia events in patients receiving U300 between months three and six, compared to those on Lantus. 

The multi-centre, open-label study randomised patients to mealtime insulin and then either Lantus or U300, and also showed similar reductions in metabolic control in terms of HbA1C levels with the two insulins, 

“The data presented … is in the right direction,” Riccardo Perfetti, VP of medical affairs for the pharma company's diabetes division, said. “We're obviously very encouraged by what we have seen.”

Sanofi doesn't not expect to have to conduct any additional trials of cardiovascular safety - something that caught Novo Nordisk by surprise in the US with Tresiba earlier this year, despite the product winning approval elsewhere.

“It seems to be quite obvious that the molecular activity of U300 is identical to Lantus … so we don't believe there will be any need for a cardiovascular study, because there already is one,” said Perfetti. 

The reference was to Sanofi's ORIGIN study, which last year showed Lantus does not increase the risk of serious cardiovascular and cancer side effects. “In my view ORIGIN covers U300,” Perfetti concluded.

Article by
Dominic Tyer

25th June 2013

From: Sales



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