The Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMEA) recently issued a positive
opinion regarding the approval of
) oncology drug, Pomalyst.
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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'
) 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
Celgene, a biopharmaceutical company, currently carries a Zacks
Rank #2 (Buy).
Alexion Pharmaceuticals, Inc.
) appears to be equally attractive in the biopharma space with an
), a specialty biopharmaceutical company, carries a Zacks Rank #1