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