This excerpt taken from the SNY 6-K filed Apr 29, 2009.
Worldwide presence1 of Plavix®/Iscover®
In the United States, sales of Plavix®, which are consolidated by Bristol Myers Squibb (BMS), recorded strong growth of 13.6%. In Europe, sales held steady despite competition from clopidogrel besylate in the monotherapy segment in Germany, where Plavix®/Iscover® still had volume market share of around 70% in March 2009 (IMS Pharmatrend: week ending March 27, 2009). The success enjoyed by Plavix® in Japan continued, with net sales up 90.2% at 70 million.
On March 31, 2009, findings from the ACTIVE-A study were presented at the American College of Cardiology Scientific Sessions. The findings demonstrated that for patients with atrial fibrillation who were at increased risk of stroke and could not take oral anticoagulant medication, Plavix® plus aspirin significantly reduced major vascular events by 11% over aspirin (6.8% vs. 7.6%, per year, p=0.01). The greatest benefit was seen in the reduction of stroke, by 28% (2.4% vs. 3.3% per year, p<0.001), which is the primary goal of physicians treating patients with atrial fibrillation. Filing for approval is scheduled for the third quarter of 2009.
Page 3 of 21
This excerpt taken from the SNY 6-K filed May 6, 2008.
Worldwide presence1 of Plavix® / Iscover®
In the United States, sales of Plavix® (consolidated by Bristol Myers Squibb BMS) reached $1,142 million in the first quarter, versus $789 million in the first quarter of 2007 when the product was still affected by the presence of a generic version.
In Europe, net sales of Plavix® were up 4.3% at 461 million, though sales are still being affected by Germany.
In addition, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recently issued a positive opinion recommending approval of the 300mg tablet of Plavix®. This positive opinion from the CHMP must be ratified by the European Commission in the coming months before final approval.
In the Other Countries region, Plavix® reported a strong advance in sales of 32.0% to 231 million, supported by the products success in Japan (net sales of 28 million, compared with 4 million in the first quarter of 2007).
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This excerpt taken from the SNY 6-K filed May 3, 2007.
On August 8, 2006, Apotex announced that it had launched a generic version of clopidogrel bisulfate 75 mg tablets in competition with Plavix® in the United States. On August 31, 2006, the U.S. District Court for the Southern District of New York granted the motion filed by sanofi-aventis and Bristol-Myers Squibb for a preliminary injunction and ordered Apotex to halt sales of its generic version of clopidogrel bisulfate. However, the Court did not order the recall of products already sold by Apotex.
This preliminary injunction was upheld by the Court of Appeals for the Federal Circuit in December 2006.
Consequently, U.S. sales of Plavix® rallied strongly in the first quarter of 2007 to 603 million (7.4% down versus the first quarter of 2006) after having been hit hard in the fourth quarter of 2006 (273 million).
Total prescriptions (TRx) of clopidogrel bisulfate rose by 19.5%6 in the quarter thanks to sustained promotional activity. In addition, a recent FDA panel has recommended prolonged treatment for patients with drug eluting stents.
On April 18, 2007, a U.S. subsidiary of sanofi-aventis received a subpoena from the Attorney General of the State of New York requesting the production of certain documents relating to the proposed settlement of the U.S. Plavix® patent litigation against Apotex.
In Europe, first-quarter net sales of Plavix® were up 5.4% at 448 million, despite a further decline in German sales due to a marked slowdown in the market and the effect of parallel imports.
In Japan, the two-week limit on prescriptions imposed by the Japanese authorities will remain in force until May 2007. Quarterly sales of Plavix® totaled 4 million. The application relating to Plavix® as a treatment for acute coronary syndrome was filed with the Japanese authorities at the end of 2006.