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Celgene (NASDAQ:CELG) shares lost over 8% in regular trading to close at $55.64 on Monday after the company released clinical data for its multiple myeloma drug, Revlimid, at the American Society of Hematology (ASH) over the weekend. The stock lost another 3% after hours.

Revlimid is by far Celgene’s biggest selling product as well as major growth driver. In the third quarter, it accounted for 70% of total revenues, helping to drive YoY sales up 31% to $910 million.

The main concern brought up at ASH was data suggesting prolonged use of Revlimid increased the risk of developing secondary malignancies. Data presented from a study of Revlimid in long-term maintenance therapy showed 15 cases of secondary malignancies in Revlimid patients compared to six cases of secondary cancer in placebo patients. Perhaps more damaging was a pooled analysis of three studies involving 1060 patients compiled by ISI Group biotech analyst Mark Schoenebaum. Patients on long-term Revlimid treatment were associated with 32 secondary cancers, or 5.9%, compared to 9 secondary cancers, or 1.7%, in patients on placebo.

Growth in Revlimid sales has been driven in large part by progressively longer average use per patient. If this trend is stopped or reversed, sales will be negatively affected.

Meanwhile, analysts remained bullish on Celgene, maintaining the number of secondary cancers found in placebo patients seemed low for multiple myeloma patients. Thomas Wei of Jefferies for one continues to believe "Revlimid maintenance could become part of the gold standard treatment strategy for front-line myeloma."

In the mid to long term, the company is on track to file for Revlimid as front-line therapy in Europe by year-end and as front-line and maintenance therapy in the US next year. Analysts estimate such expanded usage may increase sales potential by 50%.

Disclosure: I amlong CELG.

Source: Celgene Plunges on Revlimid Data