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This excerpt taken from the SNY 6-K filed Apr 29, 2009. Worldwide presence1 of Aprovel®/Avapro®/Karvea®
Aprovel® reported growth of 18.5% in Other Countries region due to sales of active ingredient to our Japanese partners. In the United States, the product continued to face a highly competitive environment. In Europe, Aprovel® posted 4.1% growth. During the quarter, irbesartan generics began to be marketed in the monotherapy segment in Spain and Portugal. In both these countries, as well as in Finland, Norway and some Eastern European countries, irbesartan is not protected by an active ingredient patent. In the main European countries, Aprovel® is protected by an active ingredient patent through August 2012. Net sales of Aprovel® as a monotherapy in European countries with no active ingredient patent were approximately €50 million in 2008. This excerpt taken from the SNY 6-K filed Jul 31, 2008. Worldwide presence1 of Aprovel®/ Avapro®/ Karvea®
Second-quarter worldwide sales of Aprovel®/Avapro®/Karvea® were up 14.7% at €499 million. Over the first half, sales of the product were up 13.0% at €971 million.
1 See Appendix 1 for a definition of financial indicators.
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This excerpt taken from the SNY 6-K filed May 6, 2008. Worldwide presence1 of Aprovel®/ Avapro®/ Karvea®
First-quarter worldwide sales of Aprovel®/Avapro®/Karvea® were up 11.3% at €472 million .
Page 5 of 18
This excerpt taken from the SNY 6-K filed May 3, 2007. Worldwide presence1 of Aprovel®/Avapro®/Karvea®:
In the first quarter of 2007, the worldwide presence of Aprovel®/Avapro®/Karvea® was represented by sales of €443 million , up 11.6%.
6 IMS NPA Q1 2007
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Net sales of the product in the United States rose by 15.0% in the first quarter, largely as a result of higher selling prices. In the same period, total prescriptions of the product were stable6.
On April 18, the Cardio-Renal Advisory Committee of the FDA recommended approval of Avalide® as initial treatment of hypertension. Avalide® is a fixed-dose combination of irbesartan and hydrochlorothiazide that is currently approved for the treatment of hypertension in patients with blood pressure uncontrolled on monotherapy. If approved, the new indication for Avalide® would be the first-line treatment of hypertension in patients who are unlikely to obtain their blood pressure goals on monotherapy.
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