By Ben Hirschler and Mette Fraende
LONDON/COPENHAGEN (Reuters) - Novo Nordisk's ultra long-acting insulin Tresiba has been recommended for approval by the European Medicines Agency in an important boost for the Danish drugmaker's key new product.
The European endorsement, announced by the London-based agency and the company on Friday, follows regulatory delays for the diabetes treatment in the United States, where the bulk of future sales are expected to be generated.
Tresiba, or degludec, is central to Novo's aim of ending Sanofi's dominance of the long-acting insulin market and the group said it expected to launch it in several European markets early next year, subject to final approval.
Diabetes is on the rise worldwide, fuelled by increased rates of type 2 diabetes, which is linked to obesity, making the disease a major target for drug company investment.
The International Diabetes Federation estimates that 366 million people had diabetes in 2011 and it projects this figure will rise to 552 million by 2030.
Mads Krogsgaard Thomsen, Novo's chief science officer, said he expected Tresiba to win over the majority of new patients, given its improved qualities and slow absorption rate, which provides a long-lasting and stable effect.
"Our ambition is that this product will be the biggest long-acting insulin in the market within the next eight to nine years," he told Danish television.
Novo, the world's largest insulin maker, also won a green light for Ryzodeg, which combines degludec with insulin aspart, and this product is expected to go on sale around a year after Tresiba.
Recommendations for marketing approval by the European agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within around two months.
"This is extremely important for Novo Nordisk," said Sydbank analyst Soren Lontoft. "(Tresiba) is a good product, a flexible product which will be capable of taking on rival Lantus from Sanofi."
Lontoft estimated peak annual sales of Tresiba at around 22 billion Danish crowns ($3.9 billion) worldwide and around 6 billion in Europe.
Ending Sanofi's 10-year dominance would be a coup for Novo, whose long-acting insulin Levemir has failed to seriously dent the French drugmaker's grip on the market.
Shares in Novo rose 1.3 percent by 1340 GMT (0940 EDT), outperforming a flat European drugs sector, although analysts cautioned the positive decision in Europe did not provide an automatic read-through in the all-important U.S. market.
"Although the CHMP decision - as well as September's Japanese approval - is validation of approvability, at this stage it is impossible to fully rule out the FDA (Food and Drug Administration) requiring additional safety data or analyses prior to approval," said Deutsche Bank analyst Tim Race.
The FDA said three months ago it was convening an advisory committee meeting on November 8 to assess Tresiba. It convenes such panels when it wants independent expert advice on scientific, technical and policy matters relating to new drugs.
Competition is heating up in the multibillion-dollar market for long-lasting insulins. While Novo hopes Tresiba can trump Lantus, Eli Lilly is also developing a rival drug that is a few years behind.
Worldwide, Lantus has some 80 percent of the market for long-acting, or basal, insulins and the product had sales of around $5 billion last year.
(Editing by Kate Kelland and David Holmes)