Headquarters: Summit, NJ
Year Established: 1986
Revenues: $11,229 (+21%)
Net Income: $1,999 (+25%)
R&D: $4,470 (+21%)
TOP SELLING DRUGS
|Revlimid||multiple myeloma, mantle cell lymphoma||$6,974||20%|
|Abraxane||breast, lung, pancreatic cancer||$973||1%|
Coming off a successful 2016, results for 1Q17 were equally impressive, with revenues up 18% to nearly $3.0 billion. Celgene’s three top-selling drugs, Revlimid, Pomalyst and Otezla, climbed 20%, 33%, and 24%, respectively. The new year also began with positive Phase II data of ozanimod in Crohn’s disease and Phase III trials planned by year-end. Ozanimod, an immunomodulatory drug, is also in Phase III trials in relapsing multiple sclerosis (RMS), which met the primary endpoint in reducing relapse rate compared to weekly interferon (Avonex), and demonstrated significant reductions in brain atrophy compared to Avonex. An NDA to the FDA, based on the trials for RMS, is expected by the end of this year.
In other R&D news, Celgene’s NDA for enasidenib in relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation was granted Priority Review and given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 2017. Also, the FDA approved an expanded indication for Revlimid as a maintenance treatment for multiple myeloma following autologous hematopoietic stem cell transplant, making it the first and only treatment to receive FDA approval for maintenance following auto-HSCT.
When it comes to alliances, Celgene is known for its costly pursuit of drug development partnerships, which has thus far led to a diverse pipeline appealing assets. At the start of this year, Celgene acquired Delinia, Inc. for $300 million upfront and as much as additional $475 million, expanding its pipeline of potential next-gen medicines for autoimmune disorders. The transaction expands Celgene’s inflammation and immunology pipeline with Delinia’s lead program, DEL106, as well as related programs with potential to treat systemic lupus erythematosus and rheumatoid arthritis.
Entering the immunotherapy race, a global immuno-oncology alliance with BeiGene aims to advance a PD-1 inhibitor program for solid tumor cancers. This set Celgene back $263 million and a $150 million equity investment. The deal complements Celgene’s partnership with AstraZeneca to develop durvalumab in hematological malignancies and expand its presence in China’s cancer market.
Other recent deals include a TriNKET platform pact with Dragonfly to develop natural killer cell-based immunotherapies. Celgene has the exclusive option to license as many as four candidates with potential to treat acute myeloid leukemia, multiple myeloma, and additional hematological malignancies.