Sanofi Q4 net up 21 pct, sees H2 Acomplia launch
PARIS, Feb 24 (Reuters) Sanofi-Aventis said on Friday its timetable for launching anti-obesity pill Acomplia had slipped to the second half of 2006 as it reported fourth quarter net profit up 20.8 per cent thanks to merger savings.
The French company -- the world's third-largest drug maker -- had originally hoped to launch its biggest new product hope in the United States in the second quarter but said this was now more likely in the second half.
A week ago, the U.S. Food and Drug Administration issued an ''approvable'' letter for Acomplia, asking Sanofi for extra information on the drug before giving it the marketing go-ahead as an obesity treatment. It rejected it as an anti-smoking aid.
Sanofi head of research and Vice President Gerard Le Fur said the FDA wanted the company to undertake a further clinical trial to test Acomplia's ability to suppress the desire to smoke tobacco, but had not asked for a further clinical trial of Acomplia's fat-fighting properties.
''We will meet the FDA in March to respond to their questions,'' said Le Fur, who will join the Sanofi board as a director in May.
''We still think it's possible to launch the product between now and the end of the year,'' he added.
For this year, Sanofi said adjusted earnings per share should rise around 10 per cent, but declined to provide an outlook for sales.
''I don't have a forecast because it's hard to see how the global pharmaceutical market will develop,'' Sanofi Chief Financial Officer Jean-Claude Leroy told reporters.
He said there appeared to be a slight slowdown under way in the United States, and generic competition was also ''on the radar''.
He added, however, that the company was confident of meeting its goal of achieving 1.6 billion euros (.9 billion) in savings following its 2004 merger with Aventis already in the first half.
POSITIVE PIPELINE Net profit in the fourth quarter of 2005, adjusted for Sanofi's takeover of Aventis in 2004, rose 20.8 per cent year on year to 1.444 billion euros -- slightly above the average forecast in a Reuters poll of analysts for 1.426 billion euros.
However, operating profit before exceptional items increased 4 per cent to 2.020 billion euros, below the consensus for 2.183 billion euros.
Analysts at Dresdner Kleinwort Wasserstein said the numbers were in line with their estimates.
Leroy said the company's performance in the fourth quarter was marked by competition from generic products and heavier than expected investment, including preparing for the launch in Japan of its blood thinner Plavix and Acomplia.
Le Fur sounded upbeat about the company's product pipeline, saying it now had 17 products in Phase III clinical trials and 18 in Phase IIb.
By the end of 2008 the company aimed to have submitted 11 new pharmaceutical compounds and seven new vaccines for approval, not including those, like Acomplia, already submitted and adaptations to existing products, he said.
However, the group has dropped two experimental drugs from development for the treatment of small cell lung cancer and Alzheimer's disease.
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