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Celgene Restates Drug Risk After EU Prompting


The company restated claims about Revlimid made in a prior press release because European officials didn't think it conveyed the risks.

Usually, big companies are so careful and specific about wording in their press releases that it comes as a bit of a shock when one of them has to restate information at the request of some government folks.

In a statement Thursday morning, Celgene (CELG) says "it is rectifying information in its press release of September 23, 2011, to provide more complete information on the observed risk of cancer and recommended changes to the product label for Revlimid in the EU."

Revlimid is Celgene's most important product. With $2.5 billion in sales last year, it accounted for 70% of the company's total revenue. Drug regulators in Europe asked Celgene to alert the public to potential risks of taking Revlimid. Specifically, patients in clinical trials showed a higher rate of developing other cancers than patients not taking Revlimid. The EU folks didn't think Celgene did a good enough job of spelling out the risks last month. European officials will now review the language for inclusion on Revlimid's label.

Celgene shares dropped 2% to $63 Thursday morning. The stock is up 6% in the past month.

A company spokesman said Celgene was being "too general" by using the term "low incidence" in explaining the concerns about the drug in the September press release. That prior release doesn't appear on the company's website. Celgene also is disclosing for the first time the proposed full language for its Revlimid label in Europe.

Despite the PR misstep, the risks and benefits of Revlimid remain the same. EU officials were concerned about Revlimid after three studies showed the high rates of new cancers in patients with newly diagnosed multiple myeloma who were being treated with the drug, Celgene says. Government investigators ultimately decided that the benefit of Revlimid outweighed the risks of taking the medicine. The drug will continue to be sold in Europe. However, Celgene was told it needed to convey those risks to patients and their doctors.

US officials also are concerned about the issue. In April, the Food and Drug Administration issued a notice saying that it was investigating and will disclose its recommendations at a later date. In addition to multiple myeloma, Revlimid is approved in the US to treat the blood disorder myelodysplastic.

"At this time, there is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated according to the FDA-approved indications," the agency said in April.

All things considered, the recent European decision on Revlimid's benefit is still a net positive.

Twitter: @brettchase
No positions in stocks mentioned.
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