Good news flowed in at
) from Europe when the Committee for Human Medicinal Products
(CHMP) of the European Medicines Agency (EMA) recommended the
approval of its cancer drug Revlimid in the EU for the
myelodysplastic syndrome (MDS) indication. The positive opinion
by the CHMP will be reviewed by the European Commission, which
should issue a final decision in two to three months.
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Celgene is seeking EU approval for the use of Revlimid for
treating patients with transfusion-dependent anemia due to low or
intermediate-1-risk MDS associated with an isolated deletion 5q
cytogenetic abnormality. The patients did not respond adequately
to other therapies for the disease.
The CHMP issued the positive opinion on the basis of encouraging
data from the phase III MDS-004 study (n=205). The study,
conducted across multiple European centers, evaluated the
efficacy and safety of Revlimid versus placebo.
We note that Revlimid, the principal growth driver at Celgene, is
already approved for the MDS indication in many countries
including the US, Canada, Switzerland, Australia, New Zealand,
Malaysia, and Israel apart from several Latin American nations.
The drug is also approved in many countries across the globe in
combination with dexamethasone for treating multiple myeloma
patients who have received at least one prior therapy. Approval
in the EU for the MDS indication would further boost the sales
potential of Revlimid.
Apart from Revlimid, the oncology portfolio at Celgene includes
drugs such as Vidaza, Abraxane, Pomalyst and Thalomid. Celgene
also boasts of an interesting and diversified pipeline. A number
of pipeline-related news is expected in the coming quarters. We
believe that the successful development and commercialization of
the pipeline would boost Celgene's top line further.
Celgene carries a Zacks Rank #2 (Buy) in the short run. Stocks
Cleveland BioLabs, Inc.
) appear to be more attractive. All three companies carry a Zacks
Rank #1 (Strong Buy).