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Data on Pomalyst Published

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Celgene Corporation (CELG) recently announced that data on its oncology drug Pomalyst (EU trade name: Imnovid) from a phase III study (MM-003: n=455) was published online in the Lancet Oncology.

The trial evaluated Pomalyst in combination with low-dose dexamethasone versus high-dose dexamethasone in relapsed and refractory multiple myeloma (MM) patients, who have received unsuccessfully at least 2 prior therapies (inclusive of Celgene’s key oncology drug Revlimid and Takeda Pharmaceutical Company’s (TKPYY) Velcade administered either as a monotherapy or in conjunction with other therapy/ies) for the disease.

Data revealed that there was significant improvement in progression-free survival and overall survival in patients in the Pomalyst arm. Moreover, the data monitoring committee recommended that MM patients who have not yet responded to treatment by  dexamethasone (high dose) should have access to Pomalyst either in combination with  dexamethasone (low dose) or as a monotherapy.

We note that the drug was approved in the EU for the above indication on the basis of data from the MM-003 study. The EC cleared the drug for treating MM patients whose disease had worsened while on their last therapy.

We note that Pomalyst is already available in the U.S. for the MM indication. The U.S. Food and Drug Administration approved Pomalyst in Feb 2013. The drug is under review in many other countries. Approval in additional markets would boost Celgene’s top line further as the MM market offers significant commercial potential. U.S. sales of the oncology drug in the second quarter of 2013 (its first full quarter in the market) came in at $58 million.

Celgene, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Actelion Ltd. (ALIOF) and Gilead Sciences Inc. (GILD) appear to be well placed in the biopharma space with a Zacks Rank #1 (Strong Buy).

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