Encouraging news flowed in at
) from Europe with the European Commission (EC) amending the
company's marketing authorisation for Revlimid and approving the
drug for an additional indication.
The EC cleared Revlimid, the principal growth driver at
Celgene, for treating patients suffering from
transfusion-dependent anaemia due to low or intermediate-1 risk
myelodysplastic syndromes (MDS) associated with an isolated
deletion 5q cytogenetic abnormality. The patients did not respond
adequately to other therapies for the disease. The EC approved
the drug on the basis of encouraging data from the MDS-004 and
Following the approval, Celgene intends to launch Revlimid for
MDS in each of the member states of the EU depending on local
needs. The drug is expected to be available for the new
indication first in the German market. The European approval did
not come as a surprise since in Apr 2013, the Committee for Human
Medicinal Products of the European Medicines Agency had
recommended the approval of Revlimid in the EU for the MDS
We note that Revlimid 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 been treated at
least once for the disease. Approval in the EU for the MDS
indication would further boost the sales potential of
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
Celgene carries a Zacks Rank #3 (Hold). Stocks such as
Biogen Idec Inc.
Jazz Pharmaceuticals Public Limited Company
Anika Therapeutics Inc.
) appear to be more favorably placed. All three companies carry a
Zacks Rank #1 (Strong Buy).
ANIKA THERAPEUT (ANIK): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
CELGENE CORP (CELG): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
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