March 29, 2010 / 11:03 PM / 10 years ago

UK agency backs Sanofi's Multaq, in change of tack

* NICE recommends limited use of atrial fibrillation drug

* Body concludes Multaq linked to fewer adverse events

* Move is boost for Sanofi following slow start for Multaq

By Ben Hirschler

LONDON, March 30 (Reuters) - Sanofi-Aventis’s (SASY.PA) heart drug Multaq has been recommended for limited use on Britain’s state health service, after all, following a change of tack by the country’s healthcare costs board.

The decision by the National Institute for Health and Clinical Excellence (NICE) is a welcome piece of good news for the drug to treat atrial fibrillation, or irregular heartbeat, following disappointing global sales since its launch last year.

Andrew Dillon, chief executive of NICE, said on Tuesday the agency had concluded that Multaq, or dronedarone, did have a role to play because it was likely to result in fewer adverse effects than the older generic drug amiodarone.

“Whilst dronedarone has not been shown to be as effective as existing treatment options in controlling atrial fibrillation, and is more expensive, short term evidence suggests that it is associated with fewer side-effects,” he said.

The latest draft guidance backs limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose condition has not been controlled by initial therapy.

NICE noted Multaq cost 2.25 pounds ($3.36) per day, against just 5 pence for the older generic medicine amiodarone.

Analysts see Multaq, which won approval from European medicines regulators in September and was approved in the United States in July, as a key growth driver for Sanofi to see it through the years when patents expire on multibillion-dollar drugs like cancer treatment Taxotere and blood thinner Plavix.

But sales of the drug have been slower than hoped in the key U.S. market and Multaq also received a low score in an assessment by French authorities, which may limit reimbursement in its home market, according to media reports. [ID:nLDE62L057]

Analysts at Jefferies said last week that Multaq’s slow launch ramp-up suggested it might not reach “blockbuster”, or $1 billion-a-year, status and sales could fall well short of consensus expectations.

Multaq generated revenue last year of just 25 million euros ($33.6 million) but current consensus forecasts suggest this should rise to $1.9 billion by 2014, according to Thomson Reuters data.

Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart beat in an uncoordinated way, which can cause palpitations, shortness of breath and fatigue and raise the risk of more serious heart problems and stroke. (Editing by Sharon Lindores) ($1=.6690 Pound) ($1=.7439 Euro)

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