Celgene Corp. Enters into Strategic Immuno-Oncology Collaboration with AstraZeneca to Develop PD-L1 Inhibitor Program for Pat...
April 24 2015 - 1:04AM
Business Wire
Program to Focus Initially on Non-Hodgkin’s
Lymphoma, Myelodysplastic Syndromes and Multiple Myeloma
Studies Planned to Start in Second Half
2015
Celgene International II Sàrl, a wholly owned subsidiary of
Celgene Corporation (NASDAQ:CELG) today announced that it has
entered into a strategic collaboration with MedImmune Limited, a
wholly owned subsidiary of AstraZeneca PLC, to develop and
commercialize an anti-PD-L1 inhibitor, MEDI4736, for hematologic
malignancies. Approximately 1.75 million patients globally suffer
from blood cancer and many are in need of new treatment
options.
MEDI4736 is a human monoclonal antibody directed against
programmed cell death ligand 1 (PD-L1), which helps tumors avoid
detection by the immune system. Tumor cells use PD-L1 to turn off
the immune system just as it begins to mount a response against
them. MEDI4736 helps turn the immune system back on, allowing it to
continue its attack on cancer.
“The potential of rationally combining immunotherapies such as
MEDI4736 with existing and novel hematology compounds creates new
opportunities for patients with blood cancers to live longer,
better lives,” said Jacqualyn A. Fouse, Ph.D., President, Global
Hematology and Oncology for Celgene. “This strategic collaboration
leverages the deep expertise of AstraZeneca/MedImmune in
immuno-oncology along with the experience of Celgene in the study
and treatment of blood cancers. This collaboration advances
Celgene’s already deep, diverse scientific platform to include
checkpoint inhibitors, an area of significant promise in
hematology.”
Dr. Bahija Jallal, Executive Vice President at MedImmune, said:
“We are excited about our strategic collaboration with Celgene, a
globally recognized leader in treatments for hematological cancers.
This agreement is a great example of how we are accelerating the
development of medical innovation in our portfolio in collaboration
with other experts, in order to bring life-enhancing new medicines
to patients faster. Together with Celgene, we are designing a
programme for our anti-PD-L1 that will explore its full clinical
potential as a game-changing treatment that could activate the
patients’ immune system to fight and change the course of blood
cancers in this area of high unmet need.”
Under the terms of the agreement, Celgene will collaborate with
AstraZeneca to develop the anti-PD-L1 antibody MEDI4736 in
hematology and make an upfront payment of $450 million. Celgene
will lead clinical development across all new clinical trials
within the collaboration and be responsible for all costs
associated with these trials until December 31, 2016, after which
it is responsible for 75% of these costs. Celgene will also be
responsible for the global commercialization of approved MEDI4736
indications in hematology, and will receive royalty rates starting
at 70 percent of worldwide sales from all uses in hematology.
Royalty rates will decrease gradually to 50 percent over a period
of fours after the first date of commercial sales. This
collaboration agreement will become effective upon the expiration
or termination of the applicable waiting periods under all
applicable antitrust laws.
This strategic collaboration will initially focus on the
development of MEDI4736 as combination therapy with Celgene’s
pipeline of products and other novel agents for hematologic
disorders. Over time, the collaboration could expand to include
other assets.
MEDI4736 is not approved in any country for any indication.
About MEDI4736
MEDI4736 is a human monoclonal antibody directed against
programmed cell death ligand 1 (PD-L1), which helps tumors avoid
detection by the immune system. MEDI4736 is currently being
evaluated in several disease states, including lung, melanoma and
head and neck cancer.
About Hematologic Malignancies
The World Health Organization estimates that 1.75 million
patients had a hematologic malignancy in 2012. These diseases
include lymphoma, leukemia, multiple myeloma and myelodysplastic
syndromes. The global incidence of blood cancers continues to rise.
By 2030, the incidence of blood cancer overall is predicted to rise
by 46 percent, and that of non-Hodgkin’s lymphoma and multiple
myeloma by 50 and 60 percent, respectively.
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 gene and protein regulation. For more information, please
visit www.celgene.com. Follow us on Twitter @Celgene, and on
Pinterest and LinkedIn.
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. We 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 our control. 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 Celgene
Corporation’s Annual Report on Form 10-K and other reports filed
with the Securities and Exchange Commission.
All registered trademarks are owned by Celgene Corporation.
CelgeneInvestors:+1-908-673-9628ir@celgene.comorMedia:+1-908-673-2275media@celgene.com
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