Celgene and Juno Announce Celgene Exercised Option to Develop and Commercialize CD19-directed Product Candidates
April 11 2016 - 9:08AM
Business Wire
-- $50 million opt-in payment for CD19
program to Juno --
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160411005739/en/
Juno TherapeuticsInvestor Relations:Nicole
Keith206-566-5521nikki.keith@junotherapeutics.comorMedia:Julie
Normart, W2O Group415-946-1087jnormart@w2ogroup.comorCelgene
CorporationInvestor Relations:Patrick
Flanigan908-673-9969pflanigan@celgene.comorMedia:Greg
Geissman908-673-9854ggeissman@celgene.com
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