Biotech Values

[DewDiligence]

Sanofi’s Multaq for AF Reduces Cardio
Hospitalizations in Phase-3 Study

[The primary endpoint, a composite of cardio hospitalizations and deaths, was hit with flying colors, but essentially all of the observed benefit was in the hospitalizations component of the endpoint.]

http://www.reuters.com/article/marketsNews/idINL1583926820080515

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Thu May 15, 2008 1:11pm EDT
By Ben Hirschler

LONDON, May 15 (Reuters) - Patients with a common heart arrhythmia are less likely to end up in hospital if given Sanofi-Aventis's (SNY) experimental drug Multaq, scientists said on Thursday.

The news boosts the chances of success for the product, which the French drugmaker plans to submit for marketing approval in the third quarter and sees as a potential blockbuster.

It is a rare piece of good news for the world's third biggest drugmaker, which has suffered a series of pipeline and patent setbacks recently. Sanofi shares rose 2 percent in New York after the news.

Multaq reduced hospitalisations in people with atrial fibrillation by 25 percent, although it did not result in a statistically significant fall in total mortality, according to results of a 4,628-patient clinical study presented at the American Heart Rhythm Society meeting in San Francisco.

The primary endpoint of the study was cardiovascular hospitalisation or death from any cause, where there was a reduction of 24 percent.

Dr. Stuart Connolly, director of cardiology at Canada's McMaster University and one of the trial investigators, told Reuters the findings showed Multaq was a promising new drug.

"Although it hasn't shown a reduction in mortality... keeping people out of hospital is a very important outcome," he said in a telephone interview.

TROUBLED HISTORY

Given Multaq's troubled history, analysts had viewed the study as make-or-break for the product.

An earlier trial of the drug showed excess mortality -- a result that added to widespread unease about the value of using anti-arrhythmic drugs to treat atrial fibrillation.

Left untreated, the condition can cause blood to pool in the upper chambers of the heart, potentially triggering a stroke. But there has been a debate as to whether this risk is greater than the serious side effects of existing medicines.

"This is an important result because for the first time in 20 years we have a new anti-arrhythmic drug that looks likely to get approved in patients with atrial fibrillation that is both safe and effective," Connolly said.

Sanofi research head Marc Cluzel said Multaq had the potential to change the face of atrial fibrillation management.

Atrial fibrillation is estimated to affect about 4.5 million people in Europe and 2.5 million in the United States. Their risk of suffering a stroke increases sharply as they get older.

Analysts at Deutsche Bank said in a note before release of the data that a positive outcome, showing a reduction in hospitalisation but not mortality, could lead it to double its sales forecast for Multaq to 500 million euros ($775 million) by 2012.

The additional 250 million euros would be equivalent to around 2 percent upside in earnings per share, it added.

The brokerage had not expected a total mortality benefit and Connolly said the study would have needed to be twice as big to detect an improvement in all-cause mortality. He noted that there was, however, a 45 percent reduction in arrhythmic death and a 30 percent decline in cardiovascular death.
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