Date: 2016-04-11
Type of information: Exercise of an option agreement
Compound: Chimeric Antigen Receptor Technology (CAR-T) including CD19 and CD22 directed CAR-T product candidates and T Cell Receptor (TCR) technologies
Company: Celgene (USA - NJ) Juno Therapeutics (USA - WA)
Therapeutic area: Autoimmune diseases
Type agreement: development commercialisation
Action mechanism: immunotherapy product/cell therapy/gene therapy/CAR-T cell therapy
Disease:
Details: * On June 29, 2015, Celgene and Juno Therapeutics announced a global collaboration for the development and commercialization of immunotherapies. The two companies will leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on Chimeric Antigen Receptor Technology (CAR-T) and T Cell Receptor (TCR) technologies. Under the terms of the collaboration, Celgene has the option to be the commercialization partner for Juno's oncology and cell therapy auto-immune product candidates, including Juno's CD19 and CD22 directed CAR-T product candidates. B-Cell Maturation Antigen (BCMA) is excluded as a target in this collaboration. For Juno-originated programs co-developed under the collaboration: Juno will be responsible for research and development in North America and will retain commercialization rights in those territories. Celgene will be responsible for development and commercialization in the rest of the world, and will pay Juno a royalty on sales in those territories; and Celgene has certain co-promotion options. Celgene will initially be eligible to select two programs, excluding CD19 and CD22, to be subject to a global profit sharing agreement under which the companies will share worldwide expenses and profits equally, except in China. Additionally, subject to additional obligations, Celgene may select a third program. Celgene will receive the right to nominate a member to Juno's board of directors. During the 10-year term of the collaboration, Celgene will have the right to purchase additional equity in Juno during specified windows and at specified market premiums subject to satisfaction of certain conditions by each party including Juno opting in on select Celgene programs, such that, at a maximum, Celgene could own up to 30% of Juno's common stock then outstanding.
Juno will have the option to enter into a co-development and co-commercialization agreement on certain Celgene-originated development candidates that target T Cells. For any such Celgene-originated programs co-developed under the collaboration: The parties will share global costs and profits with 70% allocated to Celgene and 30% allocated to Juno; and Celgene will lead global development and commercialization, subject to a Juno co-promote option in the US and certain EU territories.
This transaction has been approved by the boards of directors of both companies. Celgene and Juno currently expect to complete the transaction during the third quarter of 2015, subject to the expiration or termination of applicable waiting periods under all applicable antitrust laws and satisfaction of other usual and customary closing conditions.
Financial terms: Upon closing, Juno will receive an upfront payment of approximately $150 million, and in addition Celgene will purchase 9,137,672 shares of Juno's common stock at $93.00 per share. In conjunction with this stock purchase:
Latest news: * On April 11, 2016, Celgene and Juno Therapeutics announced that Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China. With the exercise of this option, Celgene will pay Juno a fee of $50 million and the companies will now share global development expenses for products in the CD19 program. Celgene has commercial rights outside of North America and China and will pay Juno a royalty at a percentage in the mid-teens on any future net sales of therapeutic products developed through the CD19 program in Celgene’s territories. Juno retains commercialization rights in North America and China.
Juno currently has three CD19-directed product candidates in clinical development, including JCAR015, JCAR017, and JCAR014. JCAR015 is in a Phase II trial for adults with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL). JCAR017 is in two separate Phase I trials, one in pediatric patients with r/r ALL and another in patients with r/r non-Hodgkin lymphoma (NHL). JCAR014 is in a Phase I trial in three different indications, adult r/r/ ALL, r/r NHL, and r/r chronic lymphocytic leukemia (CLL), as well as a trial in combination with AstraZeneca’s investigational programmed death ligand 1 (PD-L1) immune checkpoint inhibitor, durvalumab.
