- Enasidenib (AG-221) NDA Submitted for IDH2m
Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) -
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields
of cancer metabolism and rare genetic metabolic diseases, today
outlined key 2017 milestones in conjunction with its presentation
at the 35th Annual J.P. Morgan Healthcare Conference in San
Francisco. The presentation will outline important milestones as
Agios evolves into a commercial stage company, including potential
launches for enasidenib and AG-120 in R/R AML, pivotal development
for its second wholly owned asset, AG-348 in pyruvate kinase (PK)
deficiency, and an investigational new drug (IND) application
submission for the company’s next development candidate, focused on
MTAP deleted cancers. The company will webcast its presentation on
Monday, January 9, 2017 at 10:00 a.m. PT (1:00 p.m. ET) at
www.agios.com.
“This is the year Agios will evolve into a commercial-stage
organization with the anticipated launch of enasidenib for patients
with R/R AML, followed by the NDA submission of AG-120 and AG-348
preparing to enter a pivotal trial in PK deficiency,” said David
Schenkein, M.D., chief executive officer of Agios. “We believe
these milestones will enable us to achieve our vision of delivering
important medicines with the potential to transform patients’
lives. Additionally, our robust research engine continues to be
highly productive with an IND submission for the company’s sixth
development candidate in eight years anticipated by the end of
2017.”
The company expects to achieve the following key milestones by
the end of 2017:
- Potential approval of enasidenib in the United States for IDH2m
positive R/R AML in collaboration with Celgene.
- Submit a new drug application (NDA) to the U.S. FDA for AG-120
by the end of 2017. AG-120 is a wholly owned, first-in-class, oral,
selective, potent inhibitor of IDH1m, in IDH1m positive R/R
AML.
- Initiate a global, registration-enabling Phase 3 study
combining AG-120 and VIDAZA® in frontline AML patients with an IDH1
mutation ineligible for intensive chemotherapy in the first half of
2017.
- Finalize design and operational activities for a global pivotal
trial of AG-348 to initiate in the first half of 2018. AG-348 is a
wholly owned, first-in-class, oral activator of both wild-type
(normal) and mutated pyruvate kinase-R (PKR) enzymes, in PK
deficiency.
- File an IND application for the MTAP pathway development
candidate by the end of 2017.
The company also provided an update on the following 2016
milestones achieved in December:
- Supported Celgene’s submission of an NDA for enasidenib in
IDH2m positive R/R AML.
- Initiated a global, registration-enabling randomized Phase 3
trial for AG-120 in IDH1m positive cholangiocarcinoma. The FDA also
granted AG-120 Fast Track Designation for the treatment of patients
with previously treated, unresectable or metastatic
cholangiocarcinoma with an IDH1 mutation.
- Selected a development candidate focused on the MTAP pathway to
enter IND-enabling studies.
2016 Year-End Cash and Guidance
Agios ended 2016 with approximately $574 million of cash, cash
equivalents and marketable securities. Based on its current
operating plans, the company expects that its existing cash, cash
equivalents and marketable securities as of December 31, 2016,
together with anticipated interest income, and anticipated expense
reimbursements under its collaboration agreements
with Celgene, but excluding any additional program-specific
milestone payments from Celgene, will enable the company to
fund its anticipated operating expenses and capital expenditure
requirements through at least the end of 2018.
Presentation at 35th Annual J.P. Morgan Healthcare
Conference
Agios will webcast its corporate presentation from the 35th
Annual J.P. Morgan Healthcare Conference in San Francisco on
Monday, January 9, 2017 at 10:00 a.m. PT (1:00 p.m. ET). A live
webcast of the presentation can be accessed under "Events &
Presentations" in the Investors and Media section of the company's
website at agios.com. A replay of the webcast will be archived on
the Agios website for at least two weeks following the
presentation.
About Agios
Agios is focused on discovering and developing novel
investigational medicines to treat cancer and rare genetic
metabolic 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 the
company’s knowledge of metabolism, biology and genomics. For more
information, please visit the company's website at
www.agios.com.
About Agios/Celgene Collaboration Enasidenib
and AG-881 are part of Agios' global strategic collaboration with
Celgene Corporation focused on cancer metabolism. Under the terms
of the 2010 collaboration, 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 up to $120 million in payments
assuming achievement of certain milestones and royalties on net
sales. Additionally, Agios and Celgene intend to co-commercialize
enasidenib in the U.S. 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 (methylthioadenosine
phosphorylase) deleted cancers is part of a 2016 global
co-development and co-commercialization agreement with Celgene
focused on metabolic immuno-oncology with a worldwide 50/50 cost
and profit share between Agios and Celgene, under which Agios is
eligible for up to $169 million in clinical and regulatory
milestone payments for the program.
Vidaza® is a registered trademark of Celgene Corporation.
Cautionary Note Regarding Forward-Looking
Statements
This 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 including enasidenib, AG-120, and
AG-348; the potential benefits of Agios' product candidates; its
key milestones for 2017; its financial guidance regarding the
period in which it will have capital available to fund its
operations; 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' Quarterly Report on Form 10-Q for the
quarter ended September 30, 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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