UPDATE 1-Sanofi plans late-stage diabetes pen tests in 2014

Mon Jun 24, 2013 9:35am EDT

* Plans to start late-stage LixiLan tests in H1 2014

* Aims to file U300 insulin with regulators in H1 2014

By Elena Berton

PARIS, June 24 (Reuters) - French drugmaker Sanofi said it aims to start late-stage tests in the first half of 2014 for a pen-shaped device that combines two diabetes treatments and could help patients better control blood sugar levels.

Sanofi said in May it was stepping up development of the LixiLan pen combining Lantus and Lyxumia after an earlier setback with a similar device to take advantage of the delayed U.S. launch of rival Novo Nordisk's Tresiba insulin.

Lyxumia, discovered by Denmark's Zealand Pharma, is part of a new class of diabetes treatments called GLP-1 analogues which prompt the body to release insulin when a diabetic's blood sugar level climbs too high.

Combined with Lantus insulin, the companies say it could help diabetics control blood sugar levels better than each therapy used alone.

"This is important because ... the expected landscape in the U.S. has changed and this should ... allow LixiLan to be the first fixed-ratio combination of basal insulin and GLP-1 in the U.S. market," Hugo Fry, who heads the development programme for Lyxumia at Sanofi, told investors on Monday.

Sanofi also said it expects to seek regulatory approval for its next-generation U300 insulin in the United States and Europe during the first half of 2014, following the results of two further late-stage tests expected by the end of this year.

U300 reported encouraging results at the American Diabetes Association congress on Saturday, and Sanofi diabetes head Pierre Chancel said the company could be in a position to start selling it in 2015.

The improved version of Sanofi's blockbuster Lantus insulin has shown it is better at controlling blood sugar lows at night, a common side effect in diabetics treated with insulin.

Berenberg analysts wrote in a note to clients that U300 would help mitigate any threat from Novo Nordisk's Tresiba.

Lantus, a synthetic insulin developed in the 1990s, is currently Sanofi's top-selling product. Last year it grew almost 20 percent to generate 5 billion euros ($6.6 billion) in sales, but it is set to lose patent protection in 2015.

The successful launch of U300 and LixiLan could strengthen Sanofi's position as it defends its No. 2 spot in the $43 billion diabetes market from rival drugs.

Shares in Sanofi were trading 1.6 percent lower at 76.16 euros at 1322 GMT, roughly in line with Paris' blue-chip CAC 40 index.

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