Good news flowed in at Celgene Corporation (CELG - Free Report) 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.
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 such as UCB SA , Athersys, Inc. (ATHX - Free Report) and Cleveland BioLabs, Inc. appear to be more attractive. All three companies carry a Zacks Rank #1 (Strong Buy).