Encouraging news flowed in at Celgene Corporation (CELG - Analyst Report) 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 MDS-003 studies.
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 indication.
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 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 #3 (Hold). Stocks such as Biogen Idec Inc. (BIIB - Analyst Report), Jazz Pharmaceuticals Public Limited Company (JAZZ - Analyst Report) and Anika Therapeutics Inc. appear to be more favorably placed. All three companies carry a Zacks Rank #1 (Strong Buy).