Recently, Celgene Corporation (CELG) announced that its lead drug Revlimid has been approved by the Swiss agency for Therapeutic Products (Swissmedic). The surveillance authority for medicines and medical devices in Sweden cleared Revlimid for treating transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndrome (MDS) associated with a deletion 5q cytogenetic abnormality (with or without additional cytogenetic irregularities). The disorder refers to a rare form of blood cancer.
Approximately 300,000 people are affected by MDS across the globe. We remind investors that the Marketing Authorization Application (MAA), submitted by Celgene in Sweden for the MDS indication, was based on the safety and efficacy data from a late-stage study (MDS-004) and a mid-stage study (MDS-003). The studies evaluated Revlimid in patients suffering from low-or intermediate-1 risk MDS with a deletion-5q cytogenic abnormality.
Apart from Sweden, Celgene is approved for the MDS indication in other countries such as the US, Canada, Malaysia, Israel and many Latin American nations. Moreover, the drug is under review for MDS in many other countries.
Besides the MDS indication, Celene’s key growth engine, Revlimid is approved in approximately 70 nations across the globe in combination with dexamethasone for treating multiple myeloma (MM) patients who have received at least one prior therapy.
Even though Celgene is a key player in the global MM market, competition in the MM space is fast catching up with the potential approval of Onyx Pharmaceuticals Inc.‘s (ONXX) carfilzomib.
Revlimid Trial in Prostrate Cancer Terminated
Celgene, which is evaluating Revlimid in other indications as well, received a setback when it decided to halt a late-stage study (MAINSAIL). The study, which was evaluating Revlimid in patients suffering from castrate-resistant prostate cancer, was halted following the recommendation of the data monitoring committee. Revlimid was not found to be more effective than placebo according to the analysis conducted by the committee.
Our Recommendation
We continue to have an Outperform recommendation on Celgene. We believe that Celgene, driven by its impressive oncology portfolio, expansion efforts, strong balance sheet and robust pipeline, will continue to outperform the broader market in the coming quarters.
Our optimism is justified by the Zacks #1 Rank (Strong Buy rating) carried by the stock in the short run.
