* Head-to-head trial finds degludec similar to Lantus
* Trend to less hypoglycaemia, but not significant
* Further degludec results due later this year and 2011
By Ben Hirschler
LONDON, Oct 27 (Reuters) - Rival drugmakers Novo Nordisk (NOVOb.CO) and Sanofi-Aventis (SASY.PA) still have all to play for in the multibillion-dollar long-acting insulin market after a new product from the Danish group failed to show a clear edge.
Degludec, which Novo hopes to launch in 2013, was developed as an improvement over existing long-acting insulins, capable of delivering equivalent or better blood sugar control with fewer episodes of dangerously low blood sugar levels.
In fact, results of a head-to-head study against Sanofi’s Lantus released on Wednesday showed comparable reductions in blood glucose levels and only a trend towards lower risk of hypoglycaemia, which was not statistically significant.
Novo reported the results of the six-month Phase III trial alongside better-than-expected third-quarter results. [ID:nLDE69Q0EC]
Mark Clark, an industry analyst at Deutsche Bank, said the fact degludec and Lantus were essentially equivalent was positive for Sanofi, which generated revenue of 3.08 billion euros ($4.3 billion) from Lantus in 2009.
The French group is particularly reliant on Lantus because it faces a wave of patent expiries on other blockbuster medicines. That big patent “cliff” is a key reason behind its $18.5 billion bid for U.S. biotech group Genzyme GENZ.O, as it hunts additional sources of revenue.
“Although there are further head-to-head studies due to report end-2010 and early-2011, today’s data makes us more confident Lantus has substantial growth ahead of it,” Clark said.
He expects Lantus sales to reach nearly 5 billion euros in 2015, equivalent to some 15 percent of group sales.
Emmanuel Papadakis of Collins Stewart also said the latest clinical trial results would not dispel scepticism over degludec’s prospects.
Novo shares were 1.4 percent higher by 1130 GMT, as results of the degludec study took some of the shine off its impressive financial performance. Sanofi was up 0.3 percent, while the broader European drugs sector .SXDP added 0.4 percent.
The world’s biggest insulin maker, the Danish company is banking on degludec to consolidate its market lead in the years ahead, when it faces the risk of competition from cheaper so-called biosimilar versions of some of its products. [ID:nLDE69I0ZK]
The new insulin is a challenger not only to Lantus but also Novo’s own best-selling long-acting insulin, Levemir.
Novo still has other opportunities to prove it has a better product as results from larger and long-lasting clinical studies come in this year and next.
Editing by David Hulmes