Celgene Corporation CELG and AstraZeneca AZN announced the initiation of the FUSION development program on investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1), durvalumab (MEDI4736), across blood cancers like non-Hodgkin’s lymphoma (NHL), myelodysplastic syndromes (MDS) and multiple myeloma.
The FUSION program comprises four studies – MM-001 (a phase Ib study to determine the recommended dose and regimen of durvalumab as a monotherapy or in combination with pomalidomide, with or without low-dose dexamethasone, in patients with relapsed/refractory multiple myeloma); CC-486-MDS-006 (a phase II study to evaluate the efficacy and safety of CC-486 alone or in combination with durvalumab in patients with MDS, who fail to achieve an objective response to treatment with azacitidine for injection or decitabine); MEDI4736 -NHL-001 (a phase I/II study to assess the safety and tolerability of durvalumab as a monotherapy as well as combination therapy in patients with lymphoma or chronic lymphocytic leukemia); and MEDI4736-MDS-001 (a phase II study to evaluating the efficacy and safety of azacitidine subcutaneous in combination with durvalumab in previously untreated patients with higher-risk myelodysplastic syndromes or in elderly acute myeloid leukemia subjects, who are not eligible for hematopoietic stem cell transplantation).
We remind investors that Celgene and AstraZeneca entered the immuno-oncology deal earlier this year. As per the terms of the agreement, Celgene made an upfront payment of $450 million to AstraZeneca related to durvalumab. Celgene will be responsible for the development of all studies within the collaboration as well as the global commercialization of approved treatments.
In addition to this, all research and development costs will be borne by Celgene until the end of 2016, after which it will take on 75% of these costs. AstraZeneca, on the other hand, will be responsible for manufacturing, booking sales on durvalumab and paying a royalty to Celgene on global sales in hematological indications. The royalty rate will start at 70% and will decrease to about half of the sales of durvalumab in hematological indications over a period of four years.
Celgene has a Zacks Rank #3 (Hold), while AstraZeneca sports a Zacks Rank #1 (Strong Buy). Some well-ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and Baxalta Incorporated BXLT. Both Anika and Baxalta sport a Zacks Rank #1.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment