Friday May 24, 5:39 PM EDT
WASHINGTON, May 24 (Reuters) - Promotions for Biogen Inc.'s (BGEN) multiple sclerosis treatment Avonex made false and misleading statements about Serono SA's (SEOZ) rival drug Rebif, U.S. regulators have charged in a letter to the firm.
The Food and Drug Administration, in a letter dated May 9 and posted on the agency's Web site Thursday, told Biogen to stop distributing the materials.
Biogen said the issues raised in the letter related to an ongoing dispute with the FDA over the interpretation of a Serono study of Rebif, which the agency cleared for sale in March. Avonex is Biogen's only commercial product, bringing in $972 million in sales in 2001.
Biogen argues that a 48-week trial showed Rebif's advantage over Avonex did not continue during the second half of the study.
"The data showed that in weeks 25-48, Avonex actually outperformed Rebif," one letter given to doctors said.
The FDA said that statement was "false." "The results of the second 24-week study period supported the data and effects observed in the first 24-week period," the FDA's letter said.
Biogen spokeswoman Kathleen O'Donnell said some of the statements the FDA complained about were made in unapproved promotional materials circulated by company sales representatives.
She said the unauthorized materials had been discontinued but said the company still contends that Serono's study does not show a benefit over Avonex during the second six months.
"The statements made by Biogen are statements that are based on peer-reviewed clinical data," O'Donnell said, adding the company would continue to "vigorously discuss these issues with the FDA."
Biogen shares soared nearly 23 percent Friday to close $9.11 higher
at $49.47 as investors welcomed Thursday's U.S. advisory panel ruling in
favor of the company's experimental psoriasis drug Amevive.
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