- New Collaboration Builds on Agios Research
Platform and Leverages Celgene Capabilities; Agios to Receive $200
Million Upfront Payment -
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) and Celgene Corporation
(NASDAQ:CELG) today announced an agreement creating a new global
strategic collaboration focused on metabolic immuno-oncology, an
emerging field of cancer research focused on altering the metabolic
state of immune cells to enhance the body’s immune response to
cancer. The goal of the collaboration is to discover, develop and
commercialize novel therapies based on Agios’ innovative cellular
metabolism research platform. Agios will receive an upfront cash
payment of $200 million plus the potential for additional payments
if certain development and regulatory milestones are achieved.
Agios will host a conference call for investors today at 5 p.m. ET.
“The immune system's ability to attack tumors is highly
regulated by cellular metabolism. This emerging discipline of
metabolic immuno-oncology has great potential to provide novel
insights and targets for cancer immunotherapy in solid and
hematologic malignancies,” said Rob Hershberg, M.D., Ph.D., chief
scientific officer at Celgene. “This strategic agreement combines
Agios’ scientific leadership in cellular metabolism with Celgene’s
expertise and growing efforts in immuno-oncology and builds upon
the extremely productive partnership and working relationship that
exist between our two companies.”
“Metabolic immuno-oncology is an exciting new area of research
for Agios that holds tremendous promise for patients and builds on
our strength in cellular metabolism,” said David Schenkein, M.D.,
chief executive officer at Agios. “Following our successful cancer
metabolism partnership, we look forward to continuing our work with
Celgene in this new field. This strategic alliance will allow Agios
to quickly expand our existing research platform into a third core
area while leveraging Celgene’s capabilities and broad portfolio of
immuno-oncology assets.”
Also announced today, the companies modified certain rights from
their 2010 collaboration (the “2010 Agreement”). First, Agios,
which previously held U.S. rights for AG-120, gained global
development and commercialization rights to the program from
Celgene. As of August 15, 2016, neither party will have financial
or other obligations to each other related to AG-120. There are no
other changes to the existing IDH partnership between Agios and
Celgene. Second, the companies agreed that rights to two cancer
metabolism programs discovered under the 2010 Agreement, including
a program focused on MTAP (methylthioadenosine phosphorylase)
deleted cancers, will advance under the structure of the new
research collaboration outlined below. Following the expiration of
the discovery phase of the 2010 Agreement on April 14, 2016, all
other cancer metabolism programs discovered at Agios will remain
wholly owned by Agios.
New Metabolic Immuno-Oncology Collaboration
Metabolic immuno-oncology is a rapidly evolving scientific area
focused on altering the metabolic state of immune cells, or the
tumor microenvironment, to enhance the body’s immune response to
cancer. There is increasing evidence that metabolism plays an
important role in the regulation of immune cells and their response
to tumors. The collaboration aims to discover novel metabolic
pathways and their modulators that affect the metabolic state of
immune cells, which may serve as potent anticancer therapies. In
addition, Agios will focus on discovering molecular markers in
order to identify patients who are most likely to respond to
therapies.
Scope:
- Agios will receive an upfront cash payment of $200 million for
the initial four-year research term. Celgene has the option to
extend the research term for up to two years for a pre-specified
amount.
- Exploratory research, drug discovery and early development will
be led by Agios.
- Generally, collaboration programs may be designated by Celgene
when preclinical studies begin, and Celgene will then have an
option on each program up through Phase 1 dose escalation for at
least a $30 million fee.
Economic Terms on Optioned Programs:
- For metabolic immuno-oncology programs, Celgene and Agios will
enter into a global co-development and co-commercialization
agreement with a worldwide 50/50 cost and profit share. Agios is
eligible for up to $169 million in clinical and regulatory
milestone payments for each program.
- The two cancer metabolism programs from the 2010 Agreement,
including a program focused on MTAP deleted cancers, are eligible
for the same global co-development, co-commercialization and
milestone structure described above.
- Celgene will have a one-time opportunity to select a metabolic
immuno-oncology program for which costs and profits will be shared
65 percent by Celgene and 35 percent by Agios. Agios may also
receive up to $209 million in clinical and regulatory milestone
payments for this program.
- For any inflammation or autoimmune programs that may result
from the collaboration, Celgene has the option to enter into an
exclusive worldwide license agreement and lead worldwide
development and commercialization. For any such licensed products,
Agios may receive up to $386 million in clinical, regulatory and
commercial milestone payments, as well as double-digit tiered
royalties on any net sales.
Development and Commercial Rights:
- Agios and Celgene will alternate leadership of all 50/50
programs in the U.S. territory, with Agios making the first program
selection.
- Celgene will lead ex-U.S. development and commercialization for
all programs. Celgene will lead worldwide development and
commercialization for the 65/35 program.
Global Rights for AG-120 Transferred to
Agios
Agios now has full global development and commercial rights for
AG-120, a first-in-class, oral, potent inhibitor of mutant
isocitrate dehydrogenase 1 (IDH1). Agios is studying AG-120 in AML
in multiple clinical trials, including as a single agent in the
relapsed/refractory setting as well as in combination with standard
chemotherapy regimens in the frontline setting. Additionally, Agios
plans to initiate pivotal trials in AML and is exploring the use of
AG-120 in several solid tumors, including cholangiocarcinoma and
glioma.
“We are excited to consolidate the full worldwide rights for
AG-120, providing us with another wholly owned investigational
therapy discovered by Agios scientists to develop and commercialize
along with our rare genetic disorders programs,” said Dr.
Schenkein. “We know that people with AML have limited treatment
options today, and we are committed to bringing AG-120 through
pivotal development as quickly as possible.”
AGIOS CONFERENCE CALL INFORMATIONAgios will
host a conference call and live webcast with slides for investors
today at 5 p.m. ET. To participate in the conference call, please
dial (877) 377-7098 (domestic) or (631) 291-4547 (international)
and refer to conference ID 15115720. The live webcast can be
accessed under “Events & Presentations” in the Investors &
Media section of the company's website at www.agios.com. The
archived webcast will be available on the company's website
beginning approximately two hours after the event.
About the Agios-Celgene IDH Program
AG-221 and AG-881 remain part of Agios’ global strategic
collaboration with Celgene Corporation, and there are no
changes to these programs. Under the terms of the 2010
Agreement, Celgene has worldwide development and
commercialization rights for AG-221 (CC-90007). Agios continues to
conduct clinical development activities within the AG-221
development program and is eligible to receive up to $95
million in payments on achievement of certain milestones and
royalties on any net sales. For AG-881, the companies have a joint
worldwide development and 50/50 profit share collaboration, and
Agios is eligible to receive regulatory milestone payments of up
to $70 million.
About Agios Agios is focused on discovering and
developing novel investigational medicines to treat cancer and rare
genetic metabolic disorders through scientific leadership in the
field of cellular metabolism. In addition to an active research and
discovery pipeline across both therapeutic areas, Agios has
multiple first-in-class investigational medicines in clinical
and/or preclinical development. All Agios programs focus on
genetically identified patient populations, leveraging our
knowledge of metabolism, biology and genomics. For more
information, please visit the company's website
at www.agios.com.
About CelgeneCelgene 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, FaceBook and YouTube.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding the potential benefits of, and plans relating to the
collaboration between Agios and Celgene; the potential of IDH1/IDH2
as therapeutic targets; the potential benefits of product
candidates targeting IDH1/IDH2 or other genetic mutations,
including AG-221, AG-120, and AG-881; and the benefit of each
company’s strategic plans and focus. The words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “would,” “could,” “potential,” “possible,”
“hope” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Such statements are
subject to numerous important factors, risks and uncertainties that
may cause actual events or results to differ materially from
current expectations and beliefs. For example, there can be no
guarantee that any product candidate will be successfully developed
or complete necessary preclinical and clinical phases, or that
development of any product candidates will successfully continue.
There can be no guarantee that any positive developments will
result in stock price appreciation. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other important factors, including: results of clinical
trials and preclinical studies, including subsequent analysis of
existing data and new data received from ongoing and future
studies; the content and timing of decisions made by the U.S. FDA
and other regulatory authorities, investigational review boards at
clinical trial sites and publication review bodies; the ability to
obtain and maintain requisite regulatory approvals and to enroll
patients in its planned clinical trials; unplanned cash
requirements and expenditures; competitive factors; the ability to
obtain, maintain and enforce patent and other intellectual property
protection for any product candidates; the ability to maintain key
collaborations; and general economic and market conditions. These
and other risks are described in greater detail under the caption
"Risk Factors" included in each company’s public filings with the
Securities and Exchange Commission. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and neither company has any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
CONTACTS
Agios Pharmaceuticals:
Investors:
Kendra Adams, 617-844-6407
Senior Director, Investor & Public Relations
Kendra.Adams@agios.com
Renee Leck, 617-649-8299
Senior Manager, Investor & Public Relations
Renee.Leck@agios.com
Media:
Dan Budwick, 973-271-6085
Senior Vice President, Media Relations
Pure Communications Inc.
dan@purecommunicationsinc.com
Celgene Corporation:
Investors:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
Media:
Brian P. Gill, 908-673-9530
Vice President, Corporate Communications
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