UPDATE 2-Novartis wins EU backing for Tasigna, Galvus combo

(Adds detail on Tasigna, clinical data on diabetes treatment)

LONDON, Sept 21 (Reuters) - Novartis AG's NOVN.VX experimental leukaemia drug Tasigna -- a follow-up to its second biggest-seller Glivec -- has been recommended for approval in Europe for patients who no longer respond to Glivec.

The European Medicines Agency also said on Friday it had backed a new tablet, called Eucreas, combining the Swiss group’s Galvus pill with the older medicine metformin as a treatment for diabetes.

Eucreas will be the first single-tablet combination of a DPP-4 inhibitor drug and metformin in Europe.

Tasigna works in about half of those patients who develop resistance to Glivec, the market-leading drug for the most common type of chronic myeloid leukaemia, or CML, which had worldwide sales last year of $2.6 billion.

Its path to market has been rapid. A team of Novartis scientists only created Tasigna in August 2002, one year after the launch of Glivec.

The new drug will be battling for market share with Bristol-Myers Squibb's BMY.N rival product Sprycel, designed to treat the same group of patients.

Recommendations for marketing approval by the agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

Tasigna won its first approval in Switzerland in July 2007 and a regulatory decision in the United States is expected by the end of the year. Approval is also pending in Japan.


The green light for the combination of Galvus and metformin marks an advance for Novartis in its battle with Merck & Co MRK.N in treating diabetes.

Galvus works in a similar way to Merck’s Januvia, which is already cleared for use in combination with metformin in the United States but not in Europe. Merck markets its combo pill as Janumet in the United States.

Galvus itself won a positive recommendation in Europe in July and may be formally approved by European authorities later this month or in October.

The new two-in-one drug should help patients who are not reaching their blood-sugar goals on metformin alone.

Data presented at the European Association for the Study of Diabetes congress this week showed patients inadequately controlled on metformin were four times more likely to hit blood-sugar goals with the addition of Galvus compared to placebo.

Galvus’s path to market in the key U.S. market has been delayed by worries over skin toxicity. Merck’s big lead means Novartis may be at a disadvantage when its drug is finally approved in the world’s biggest drugs market, according to some industry analysts.

Both Galvus and Januvia are so-called DPP-4 inhibitors, which are designed to enhance the body’s own ability to lower elevated blood sugar and could become an important new way to control type 2 diabetes, the most common form of the disease.