FDA advisors back Sanofi vaccine

NEW YORK (CNNMoney.com) -- FDA advisors on Thursday suggested that the agency approve a Sanofi-Aventis vaccine for children, which they deemed effective and safe for the U.S. market.

Pentacel, a vaccine to prevent diphtheria, tetanus, whooping cough and other diseases, is already available in Canada and Europe, and the French drugmaker Sanofi-Aventis is trying to get it approved in the U.S.

The advisors voted today in favor of the vaccine, according to Sanofi-Aventis, and that non-binding vote would be taken as a suggestion to the Food and Drug Administration when it makes the final decision. The FDA follows the advice of its advisors most of the time.

"We think that's an appropriate decision," said Sanofi spokesman Dr. Michael Decker. "Canadians have enjoyed the benefit of this vaccine for nearly a decade, and it's time for Americans to enjoy it also."

But even if the vaccine wins FDA approval, it's unlikely to have much of an impact on sales for the Paris-based Sanofi-Aventis (down $0.53 to $45.68, Charts).

Sales for Sanofi-Aventis, the biggest drugmaker in Europe, totaled $35.6 billion in 2005, the most recent period for full-year statistics. Assuming that Pentacel wins FDA approval, sales are expected to grow to $300 million by 2010, from an estimated $46 million in 2006, according to estimates from the investment firm Sanford C. Bernstein.

In other words, the sales projections for Pentacel suggest that it would garner less than 1 percent of Sanofi's annual revenues.

Sanofi-Aventis is the biggest drugmaker in Europe, and the No. 3 drugmaker in the world in terms of sales, behind Pfizer (down $0.46 to $26.36, Charts) and Johnson & Johnson (down $0.33 to $66.68, Charts).

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