* Xultophy combines long-acting insulin deguldec and Victoza
* Novo expects to launch in first EU markets in H1 2015
* Shares in Novo rise 1.6 percent
(Adds company comment on launch in first half 2015, latest
By Ben Hirschler
LONDON, July 25 A Novo Nordisk drug
combining its long-acting insulin degludec with its type 2
diabetes treatment Victoza has been recommended for approval in
Europe, in an important boost for the Danish company.
The European Medicines Agency said on Friday it had issued a
positive opinion for Xultophy, previously known as IDegLira,
implying the medicine is likely to be formally approved by the
European Commission within three months.
Novo said it planned to launch Xultophy in the first
European markets in the first half of 2015.
Jakob Riis, executive vice president of marketing and
medical affairs at Novo Nordisk, said Britain, Germany and
Denmark were likely to be among the first launch markets for the
Clinical trial results have shown that the once-daily
injection lowers blood sugar more than each medicine taken on
its own, setting a new standard for sugar control in diabetic
Prospects for degludec - already on sale separately in
Europe under the brand name Tresiba - and the new combination
with Victoza are critical for Novo, which is the world's biggest
Shares in Novo gained 1.6 percent on news of the favourable
European decision, outperforming the European drugs sector
which slid 0.3 percent by 1200 GMT.
Victoza has been a major growth driver for the group in the
past few years but its sales are now rising more slowly, and
Novo suffered a major setback in 2013 when U.S. regulators
demanded more data on the safety of Tresiba before approving it.
With diabetes affecting 382 million people worldwide and the
number of cases expected to rise to 592 million by 2035,
according to the International Diabetes Federation, the disease
represents a huge market for pharmaceutical companies.
Novo's main rivals in the space are Sanofi and Eli
Lilly, which are also major suppliers of insulin.
Combination therapies for the growing type 2 diabetes health
crisis are becoming increasingly common as patients continually
require additional medicines as the disease progresses.
In addition to good blood sugar control, patients taking
Xultophy also tend to lose weight. Weight loss is a particularly
beneficial effect as obesity is a leading cause of type 2
diabetes and insulin tends to cause weight gain.
(Additional reporting by Ole Mikkelsen; Editing by David