Celgene and Juno Announce Celgene Exercised Option to Develop and Commercialize CD19-directed Product Candidates

April 11, 2016 at 9:09 AM EDT

-- $50 million opt-in payment for CD19 program to Juno --

SUMMIT, N.J. & SEATTLE--(BUSINESS WIRE)--Apr. 11, 2016-- Celgene Corporation (NASDAQ: CELG) and Juno Therapeutics, Inc. (NASDAQ: JUNO) today 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.

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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.

“Our CD19-directed portfolio of drug candidates has shown encouraging efficacy and manageable toxicity in trials to date across a range of B cell malignancies, and we are pleased that Celgene has decided to opt in to the CD19 program. Celgene’s development and commercial expertise, particularly in hematologic malignancies, make them our ideal partner and will accelerate our global development capabilities for patients with ALL, CLL, and NHL,” said Hans Bishop, Juno’s President and Chief Executive Officer. “The long-term collaboration with Celgene is an important component of our plan to develop our engineered T cell platform rapidly and effectively for the benefit of patients around the world, and we are encouraged by the progress we are making together.”

"Our decision to move forward with the Juno CD19 program underscores our commitment to the long-term collaboration with Juno and our strong desire to deliver important new treatment options to patients with serious hematologic malignancies,” said Robert Hershberg, M.D., Ph.D., Chief Scientific Officer for Celgene. “CD19-based CAR T therapies hold great promise in B cell malignancies including acute lymphoblastic leukemia, non-Hodgkin lymphoma, and chronic lymphocytic leukemia. Further, the lessons learned from CD19 will inform additional targets and approaches as the Celgene-Juno collaboration evolves.”

About Juno

Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno's long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world's leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children's Research Institute, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19 directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene and Juno undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in the public reports of each company filed with the Securities and Exchange Commission.

Source: Juno Therapeutics, Inc.

Juno Therapeutics
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Celgene Corporation
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Patrick Flanigan
908-673-9969
pflanigan@celgene.com
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