Sanofi-Synthelabo is planning an aggressive clinical trial program to expand labeling for its pair of cardiovascular products co-promoted with Bristol-Myers Squibb in the U.S., Plavix and Avapro.

For Plavix (clopidogrel), a study is planned for primary prevention of atherothrombotic events in patients with two or more risk factors, exec VP-Scientific Affairs Gerard Le Fur told an analysts briefing in London Feb. 23.

The global patient population for such an indication would be over 100 mil. patients, he indicated.

In addition, the company has designed the MATCH study to assess clopidogrel plus aspirin in 7,500 patients for secondary prevention after stroke or transient ischemic attack in high-risk patients, Le Fur added. The potential patient population is about 41 mil.

Plavix was approved early in 1998 to reduce secondary atherosclerotic events in patients who have had recent stroke, myocardial infarction or peripheral artery disease. That indication includes 19 mil. patients, Le Fur said.

Plavix sales for 1999 were $636 mil. an increase of 367%, although the product was not launched in Europe until the third quarter of 1998. U.S. sales were $455 mil. (up 282%).

Bristol-Myers Squibb records the majority of revenues from Plavix in the U.S. Of the $636 mil. sales, Sanofi-Synthelabo retains $199 mil. (31%).

Other trials for Plavix include the COMMIT trial in acute MI, which compares clopidogrel and aspirin to aspirin alone. It is planned for 30,000 patients. WATCH is assessing Plavix for prevention of ischemic events in congestive heart failure, compared with aspirin, in 4,500 patients. Both began in 1999.

The CURE and CLASSICS trials began in 1998 and are examining unstable angina and coronary stenting (¹ Also see "Sanofi-Synthelabo/Bristol Plan Avapro Heart Failure Program" - Pink Sheet, 13 September, 1999.).

The 1,000-patient CLASSICS study is complete and demonstrated similar efficacy and superior safety to ticlopidine (Sanofi's Ticlid, marketed by Roche in the U.S.), Le Fur said.

Avapro/Aprovel (irbesartan) sales were $386 mil. for 1999, an increase of 114%, aided by the May launch in the U.S. of a combination with hydrochlorothiazide.

Sanofi-Synthelabo booked $195 mil. (50.5%) of Avapro sales. U.S. sales were $153 mil. (up 125%).

The angiotensin II inhibitor is being assessed in the PRIME study in 610 type 2 diabetics with hypertension and 1,715 patients with diabetic nephropathy. An NDA supplement is expected in early 2001.

Ambien/Stilnox (zolpidem) is performing better than expected in the U.S., Chief Operating Officer Herve Guerin said. Sales increased 16% to $616 mil. worldwide, including $487 mil. in the U.S., a gain of 18%.

Ambien is co-marketed with Searle under the Lorex joint venture, and Sanofi-Synthelabo booked $395 mil. (64%) in sales.

"We were wondering six months ago what would be the impact of competition in this market" with Wyeth-Ayerst's Sonata (zaleplon), Guerin said. At the end of 1998 the company doubled its U.S. promotional expenditure for Ambien in preparation for Sonata.

Sanofi-Synthelabo sales were up 3% to $5.36 bil. in 1999, and net profit was up 21% to $626 mil., Guerin reported. The company's U.S. market share is 1.2% (including the full value of Plavix, Avapro and Ambien). U.S. sales of all products developed by Sanofi were $1.37 bil. in 1999, the company said.

The Sanofi/Synthelabo merger closed in July and the reorganization of the two sales forces finished at the end of 1999.

In the U.S., Sanofi-Synthelabo has over 800 sales reps with plans to add another 300 by the end of 2000. There are 1,400 Searle reps detailing Ambien.

Asked about sales capability in the U.S., Sanofi-Synthelabo CEO Jean-Francois Dehecq commented that "if you look at the products it is clear that in Europe, we need a [general practitioner] sales force. With the new products in the U.S., it is a market of specialists."

To support the upcoming Sanofi portfolio, "you don't need thousands of sales force," he maintained.

Bristol/Sanofi Plavix Sales Triple In U.S.; Avapro Doubles

More from Archive

More from Pink Sheet