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Sanofi-aventis Announces Second Quarter 2009 Results
Date:7/29/2009
e date of this report, the FDA has not granted final approval to any of the generic manufacturers.
On July 1, 2009, the FDA approved Multaq((R)), the first anti-arrhythmic to be approved in the United States with a clinical benefit in reducing cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter. Multaq((R)) was launched in the United States on July 28. The submission for approval of Multaq((R)) in the European Union is currently being reviewed, with approval expected during the second half of 2009.
Worldwide presence of Plavix((R))/Iscover((R))
Second-quarter sales of Plavix((R)) were up 9.6%, driven by a good performance in the United States (where net sales are consolidated by Bristol Myers Squibb) and in the Other Countries region. In Europe, which represents less than 25% of sales, Plavix((R)) saw a slight decline (of 3.2%) due to competition from clopidogrel besylate in the monotherapy segment in Germany, where Plavix((R))/Iscover((R)) had a market share of around 66% in June (IMS Pharmatrend, week ended June 26, 2009). Plavix((R)) continued its success in Japan, with net sales rising by 61.8% to euro 85 million. First-half sales of Plavix((R)) were up 9.1% at euro 3,482 million, with sales in Japan up 73% at euro 155 million.
On May 29, 2009, the CHMP announced that positive opinions had been adopted recommending approval of applications for marketing authorization of clopidogrel filed through the centralized procedure in the European Union. Some of these applications are for formulations of clopidogrel with a different salt (e.g. besylate) from that used in Plavix((R)) (clopidogrel hydrogen sulphate). When applications for generics are filed under the EMEA centralized procedure, the scientific opinion issued by the CHMP is followed by a decision-making process at European
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