COPENHAGEN (Dow Jones)--Shares in Danish pharmaceutical firm Novo Nordisk A/S (NVO) rose on Monday after the company released late-stage data, which confirmed the positive potential of its new generation insulin Liraglutide.
Novo Nordisk, the world's largest producer of insulin, said Liraglutide provided statistically significantly better glucose control than GlaxoSmithKline PLC's (GSK) and Sanofi-Aventis S.A.'s (SNY) oral anti-diabetes drugs Avandia and Amaryl in combination with other oral anti-diabetes drugs.
It also said Liraglutide cut patients' body weight by between two and four kilograms more than Avandia and Amaryl.[This statement is somewhat misleading, IMO, because the comparator drugs are not known for causing weight loss.]
The positive data - from the second and third of a total of five phase three trials on Liraglutide - reassured investors of the drug's potential. At 0742 GMT Novo Nordisk shares traded up 2.6% at DKK582, outperforming a higher Nordic market.
Novo Nordisk has previously said that Liraglutide sales could reach more than $1 billion a year if the drug is approved.
Sydbank analyst Rune Majlund Dahl said the results were good, but in line with expectations, since they show the same result as the first, already announced, phase three study. He added it is still too early to say if Liraglutide could also be used against obesity, for which it is in mid-stage trials. Majlund Dahl has an overweight recommendation on the share.[Doesn’t an “overweight” rating suggest it won’t work for obesity? :-) ]
Liraglutide belongs to a new class of diabetes drugs called GLP-1 solutions, where a hormone triggers the release of insulin in the pancreas.
Eli Lilly & Co.'s (LLY) and Amylin Pharmaceuticals Inc.'s (AMLN) Byetta in another GLP-1 solution, but while Liraglutide is taken once a day, Byetta is taken twice-daily.
The two 26-week studies are part of the Liraglutide Effect and Action in Diabetes, or LEAD, program and included 2,132 patients in total. The studies investigated the effect of different doses of Liraglutide in combination with the two oral diabetes drugs metformin and Amaryl.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "The encouraging clinical results from the two new trials confirm the positive effect of Liraglutide on blood glucose control, body weight and hypoglycemia risk seen in previous studies and leave us confident that we are on track to submit for regulatory approval mid-2008."
The competition in the attractive U.S. diabetes market has increased sharply during the past two years, with the launch of Byetta and Pfizer Inc.'s (PFE) inhalable insulin Exubera last year.[Huh? Exubera has had close to nil impact on the diabetes market.]
Novo Nordisk last November said it will add 700 people to its U.S. sales force, raising its number to around 1,900.
Novo Nordisk expects to announce headline results from the remaining two phase three studies of Liraglutide during the second half of 2007 and the first quarter of 2008. <<
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