UPDATED: Celgene hits new bump in extending Revlimid sales

Celgene's blood cancer drug Revlimid was cruising in the first half of 2013. In February, the drug scored a Chinese approval that came with an import license, signifying a launch there was on the way. Then, in June, the FDA approved Revlimid as a supplemental treatment for mantle-cell lymphoma. Now, the U.K.'s cost-effectiveness watchdog has put up a roadblock, but some new positive trial data might keep the setback from taking too much wind out of Revlimid's sails.

Thursday, Britain's National Institute for Health and Care Excellence (NICE) in its draft guidance deemed the drug unworthy of its price tag as a treatment for myelodysplastic syndromes. According to Reuters, the cost agency cited uncertainty over whether Revlimid can extend the lives of patients with the serious bone marrow disorders.

Now, a consultation process will ensue. If the draft guidance is confirmed, Revlimid will not be recommended for use in Britain's National Health System, and U.K. patients will be down a treatment option for the condition, which can lead to potentially deadly diseases like leukemia, Reuters says. But NICE has grown increasingly harder to please.

Revlimid is Celgene's ($CELG) key drug, and it generated more than $1 billion in the first quarter--up 16.5% compared with the same period a year ago. And Celgene also announced some good news Thursday that should ease the blow from the setback in the U.K. The company revealed late-stage trial data showing that Revlimid improved survival in newly diagnosed multiple myeloma patients, an indication the company is after. Right now, the drug is approved for use in tandem with dexamethasone in patients who have tried at least one other therapy, but based on the study results, Celgene said in a statement that it intends to apply for expanded approval in the U.S., Europe and other markets.

- read the Reuters story
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Special Report: Celgene: The house that Revlimid built - The Biggest R&D Spenders in Biotech

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