Johnson & Johnson JNJ: Dacogen approval for elderly AML in the EU was mentioned in passing but no further discussion
Celgene CELG (transcript via Morningstar)
In the third quarter, Celgene made significant progress advancing our strategies to expand strong global leadership position in the treatment of patients with MDS. Across all global markets, VIDAZA continued to gain share in intermediate-2 and high-risk disease. Global third quarter sales were excellent, a record $220 million, up 9% quarter-on-quarter and 15% year-on-year. In the United States, VIDAZA shared of the hypomethylator market is steady and above 80%. Sales grew 1% quarter-on-quarter and were up 13% year-on-year. International sales grew strongly, led by Australia, France, Germany, Italy and the United Kingdom. VIDAZA sales increased 15% quarter-on-quarter and 16% year-on-year.
We also made progress in the quarter to strengthen the VIDAZA label. We completed patient enrollment in the Phase III registration study in acute myeloid leukemia. Results are expected within one year and if successful should support label expansion to include all patients with AML.
Our clinical and regulatory teams have made excellent progress advancing CC-486, oral azacitidine, to the point where we plan to initiate two special protocol assessments designated Phase III studies by the end of this year. One study will test CC-486 in a subset of low-risk MDS and the other Phase III study will test CC-486 as maintenance therapy in AML. Beyond MDS and AML, investigators in Celgene have developed and are pursuing clinical strategies with CC-486 to enhance the antitumor activity of traditional chemotherapies for lung cancer and pancreatic cancer. We are early in this investigation but we have seen dramatic results in some patients.