Agios Announces MTAP Pathway Research Program as Development Program and Development Candidate Under Master Research and Coll...
March 13 2017 - 7:30AM
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) today announced that
Celgene Corporation has designated the development candidate
focused on MTAP (methylthioadenosine phosphorylase) deleted cancers
as a development candidate under the master research and
collaboration agreement (the “Agreement”) dated May 17, 2016.
Under the terms of the Agreement, Celgene will pay Agios an $8
million designation fee for the MTAP pathway program. Exploratory
research, drug discovery and early development on the MTAP pathway
program is led by Agios, and Celgene will have an opt-in right on
the program up through Phase 1 dose escalation for at least a $30
million fee. Upon opt-in, Celgene and Agios will have global
co-development and co-commercialization rights with a worldwide
50/50 cost and profit share on the MTAP pathway program, and Agios
will be eligible for up to $169 million in clinical and regulatory
milestone payments.
“We are pleased that Celgene has designated this fourth
development candidate discovered and developed at Agios since the
beginning of our research collaboration with them in 2010,” said
Scott Biller, Ph.D., chief scientific officer at Agios. “We have
clearly demonstrated our ability to translate novel Agios
discoveries into important precision medicines in areas of high
unmet need with our IDH portfolio. We look forward to
exploring the potential of our MTAP program in patients following
our expected IND submission by the end of this year.”
MTAP-deletions are present in approximately 15 percent of all
cancers. As described in a 2016 Cell Reports publication, Agios
discovered a novel pathway in MTAP-deleted tumors which, when
inhibited, results in robust anti-tumor activity in animal models.
This pathway can be modulated by small molecule inhibitors, as
demonstrated in a preclinical data presentation at the Keystone
Tumor Metabolism meeting in Whistler, British Columbia on March 9,
2016. The presentation can be found under Publications in the
Research section of the Agios website (www.agios.com).
The $8 million designation fee is expected to be received in the
second quarter of 2017.
About Agios Agios is focused on discovering and
developing novel investigational medicines to treat cancer and rare
genetic diseases 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 Agios/Celgene CollaborationEnasidenib and
AG-881 are part of Agios' global strategic collaboration with
Celgene Corporation focused on cancer metabolism. Under the terms
of the 2010 collaboration agreement, Celgene has worldwide
development and commercialization rights for enasidenib. Agios
continues to conduct clinical development activities within the
enasidenib development program and is eligible to receive
reimbursement for those development activities and up to $95
million in remaining payments assuming achievement of certain
milestones and royalties on net sales. Celgene and Agios intend to
co-commercialize enasidenib in the U.S. Celgene will reimburse
Agios for costs incurred for its co-commercialization efforts. 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. The program
focused on MTAP deleted cancers is part of a 2016 global
co-development and co-commercialization agreement with Celgene
focused on metabolic immuno-oncology. Celgene has the option to
participate in a worldwide 50/50 cost and profit share with Agios,
under which Agios is eligible for up to $169 million in clinical
and regulatory milestone payments for the program.
Agios 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 Agios’ plans, strategies and expectations for its and
its collaborator’s preclinical, clinical and commercial advancement
of its drug development programs; the potential benefits of Agios'
product candidates; and the potential benefit of its strategic
plans and focus. The words “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,”
“could,” “potential,” “possible,” “hope,” “strategy,” “milestone,”
“will,” 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 Agios'
current expectations and beliefs. For example, there can be no
guarantee that any product candidate Agios or its collaborator,
Celgene, is developing will successfully commence or complete
necessary preclinical and clinical development phases, or that
development of any of Agios' product candidates will successfully
continue. There can be no guarantee that any positive developments
in Agios' business 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: Agios' 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; Agios' ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its planned clinical trials; unplanned cash requirements and
expenditures; competitive factors; Agios' ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates it is developing; Agios'
ability to maintain key collaborations, such as its agreements with
Celgene; and general economic and market conditions. These and
other risks are described in greater detail under the caption "Risk
Factors" included in Agios' Annual Report on Form 10-K for the year
ended December 31, 2016, and other filings that Agios may make with
the Securities and Exchange Commission in the future. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Agios expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
Contacts
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:
Holly Manning, 617-844-6630
Associate Director, Corporate Communications
Holly.Manning@agios.com
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