Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Chicago Tribune - May 28, 2004
Bruce Japsen, Tribune staff reporter
The Deerfield-based medical products giant said the agency was concerned that it had not displayed "appropriate language" about side effects or supporting information in printed marketing materials about the drug, Advate.
Although the FDA would not disclose the specific nature of the warning, Baxter said it has "complied with the FDA's request to stop disseminating the specific promotional materials."
The materials are largely disseminated to doctors' offices, Baxter said.
The warning does not relate to Advate's performance, clinical data or processing, so patient safety is not an issue, Baxter said.
Still, the marketing problems come at a critical time for Baxter, which has high hopes for Advate.
Baxter is in a financial turnaround and hopes Advate eventually will do as well as an older blood-clotting drug that is the company's top-selling product, Recombinate, which generated nearly $1 billion in sales last year.
Advate was launched in the United States in August.
Baxter is now trying to convince physicians and other medical-care providers to use Advate, the first genetically engineered clotting treatment made without added animal and human proteins.
Researchers who have studied the drug say they believe Advate is safer than other drugs in treating hemophilia patients vulnerable to blood-borne viruses such as HIV or hepatitis.
Baxter cut prices for Advate this spring amid industry pricing pressures prompted by stiff competition, causing the company to revise sales projections for the year to between $200 million and $300 million for 2004. Earlier first-year estimates were for $300 million in sales for this year.
"We are working closely with the FDA to make sure we resolve the issues," Baxter spokeswoman Cindy Resman said. "We have stopped use of all the promotional materials that they addressed as a concern."
Wall Street took the news in stride. Baxter shares rose nearly 3 percent, or 82 cents, Thursday, to $31.53 a share.
"When they did the advertising material or little handouts [to doctors], they might not have positioned the warnings as prominently as the FDA wanted," said Ben Andrew, analyst with William Blair & Co. in Chicago. "That is the kind of thing the FDA would get cranked up about. This thing happens every once in a while."
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