Anticipating the wrap-up of a safety review on Revlimid later this week, analysts are figuring the matter concerning the Celgene ($CELG) cancer treatment will be settled in the company's favor. European regulators had launched the safety probe--under Article 20--to weigh concerns the multiple myeloma drug might boost the risk of developing other cancers.
A European Commission advisory panel meets this week to talk about the review, and as Reuters reports, a decision is expected as early as Friday. And the word is the watchdogs will determine Revlimid's benefits outweigh its risks. And that, in turn, could take the brakes off Celgene's European applications for new indications for Revlimid as a first-line treatment and as a maintenance therapy.
"We expect favorable resolution of the Article 20 review near term, removing an overhang and perhaps signaling (European) receptivity toward front-line/maintenance label expansion early next year," Wells Fargo analyst Brian Abrahams said in a research note (as quoted by Reuters).
The company plans to apply for the first-line and maintenance indications in the U.S. later this year. But even without those uses, the drug is Celgene's growth machine, The Street points out. The drug's second-quarter sales grew by 35% to $795 million, inspiring Revlimid to raise its 2011 forecast for the drug to a range of $3.15 billion to $3.25 billion.