The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recently issued a positive opinion regarding the approval of Celgene Corporation’s (CELG) oncology drug, Pomalyst.
Celgene is seeking approval for the use of Pomalyst in combination with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma (MM) patients, who have received at least two prior therapies (inclusive of Celgene’s key oncology drug Revlimid and Takeda Pharmaceutical Company’s (TKPYY) Velcade). The disease worsened for the patients while on their last therapy. A final decision from the European Commission is expected within two to three months.
The CHMP’s positive opinion on Pomalyst came on the back of encouraging data from the phase III study (MM-003: n=455). The study evaluated Pomalyst as a combination therapy in relapsed refractory multiple myeloma patients. Data revealed that there was significant improvement in progression-free survival and overall survival in patients in the Pomalyst arm.
We note that Pomalyst is already available in the US for the MM indication. The US Food and Drug Administration approved Pomalyst in Feb 2013. The US approval of Pomalyst has boosted Celgene’s already strong oncology product portfolio. Celgene’s top line would be boosted further in the event of Pomalyst gaining EU approval as the MM market offers significant commercial potential.
Celgene, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). Alexion Pharmaceuticals, Inc. (ALXN) appears to be equally attractive in the biopharma space with an identical rank. Santarus, Inc. (SNTS), a specialty biopharmaceutical company, carries a Zacks Rank #1 (Strong Buy).
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