Celgene specializes in the development and marketing of new drugs for cancer and inflammatory diseases. Its first marketed product, Thalomid, was approved for multiple myeloma in May 2006. Its second blockbuster product is Revlimid, an analog of Thalomid with improved efficacy and safety that was approved by the FDA in December 2005 for the subgroup of patients with myelodysplastic syndrome (MDS) characterized by an abnormality in the 5q-chromosome. Data from another trial showed that Revlimid is active in the broader group of lowand intermediate-risk MDS patients. For the larger indication of relapsed/refractory multiple myeloma, Revlimid received approval in June 2006. In late 2007, late 2009, and early 2010, the company presented strong data in newly diagnosed multiple myeloma patients who are eligible and ineligible for transplant, which should substantially increase the market opportunity of Revlimid. Together, multiple myeloma and MDS represent a multi-billion-dollar worldwide market opportunity for Revlimid. Results from studies in other hematologic malignancies, such as chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, are showing promise, and late-stage trials that could generate label expansions for these important indications began in 2009.

The 2007 acquisition of Pharmion gave Celgene worldwide rights to Vidaza for high-risk MDS. The product has shown striking survival data and we expect it to be the leading drug for this indication. In addition, the 2010 acquisition of Abraxis gave Celgene an entrée into the solid tumor area with Abraxane, on the market in the US and Europe for metastatic breast cancer and with a potential approval in the US for non-small cell lung cancer in 2012. Other Thalomid analogs are in development which could target different malignancies and inflammatory disorders. These include Apremilast, in Phase III trials in patients with psoriasis and psoriatic arthritis. The company receives royalties on sales of Ritalin and Focalin (ADHD) from Novartis.

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