Tags: celgene | revlimid | drug

Celgene Pulls Application for Wider Revlimid Use

Thursday, 21 June 2012 11:01 AM

Celgene Corp. said on Thursday it was withdrawing a European application for wider use of its big-selling Revlimid blood cancer drug, sending its shares down sharply.

The U.S. biotechnology company said it planned to resubmit the application with more data. The company has been seeking to expand the use of Revlimid to newly diagnosed patients.

Revlimid, Celgene's most important growth driver with annual sales approaching $4 billion, is currently approved in the United States and Europe in combination with dexamethasone to treat multiple myeloma in patients who have failed at least one prior therapy.

Investors hoped European regulators would endorse wider use of Revlimid at a monthly meeting of the Committee for Medicinal Products for Human Use this week.

"The withdrawal is obviously disappointing," UBS analyst Matthew Roden said in a research note.

The European verdict on Revlimid is particularly important because regulatory approval is needed before the expensive medicine is paid under Europe's reimbursement system. By contrast, Revlimid is already reimbursed in the United States despite lacking an explicit Food and Drug Administration approval for such wider use.

Christopher Raymond, an analyst with Baird Equity Research, said Celgene has an ongoing clinical trial that is due to finish later this year and may serve as the basis for a re-submitted application.

Celgene said it was proceeding with applications for newly diagnosed multiple myeloma in Switzerland, Australia and other markets. In the United States, the company said it was "re-evaluating" its application, but anticipates submitting one next year.

Celgene backed its 2012 and 2015 financial goals despite the withdrawal.

"Some investors wonder if an acquisition will be needed to hit this guidance," RBC Capital Markets analyst Michael Yee said in a research note.

European regulators last September ruled that the benefits of Revlimid for treating multiple myeloma outweighed its risks, a finding seen as potentially clearing the way for the drug to be approved for wider use.

Global sales of Revlimid rose 17 percent to $861 million in the first quarter. Celgene on Thursday backed its expectation for Revlimid net product sales of between $3.75 billion and $3.85 billion this year.

Its shares fell 10.9 percent to $59.85 in premarket trading after the announcement.

Late on Wednesday, FDA advisers backed Onyx Pharmaceuticals Inc's drug Kyprolis for patients who have failed to successfully treat their blood cancer with other medicines, making it likely the drug would secure approval. Onyx shares rose sharply.

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Thursday, 21 June 2012 11:01 AM
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