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 Celgene Corporation CELG and Agios Pharmaceuticals 
 AGIO today announced that the U.S. Food and Drug Administration 
 (FDA) has accepted Celgene's New Drug Application (NDA) for enasidenib 
 (AG-221/CC-90007) for the treatment of patients with relapsed or 
 refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 
 2 (IDH2) mutation. The NDA was granted Priority Review and has been 
 given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 
 2017. Celgene completed the NDA submission in late December 2016.
 
 
 "We accelerated this application – submitting the NDA just three years 
 after the first patient was treated in the enasidenib pivotal 
 investigational trial – because we believe that there is a significant 
 unmet need for people with relapsed or refractory AML," said Michael 
 Pehl, president, Hematology/Oncology for Celgene. "The acceptance of the 
 enasidenib NDA is a significant milestone in what we hope will be a new 
 era of molecularly targeted therapies for patients with this devastating 
 disease."
 
 
 Enasidenib is a first-in-class, oral, targeted inhibitor of mutant IDH2. 
 The NDA submission is based on results from AG221-C-001, a single-arm 
 phase I/II study of enasidenib in patients with advanced hematologic 
 malignancies with an IDH2 mutation. Early data from the relapsed or 
 refractory AML patients in this study were presented at the 2015 
 American Society of Hematology (ASH) Annual Meeting.
 
 
 &#34;Having received NDA acceptance and priority review for enasidenib, we 
 look forward to working with our partner Celgene and the FDA to advance 
 a first-in-class therapy for relapsed or refractory AML with an IDH2 
 mutation," said David Schenkein, M.D., chief executive officer at Agios. 
 "We hope that the continued adoption of molecular profiling and 
 availability of new targeted therapies such as enasidenib will have a 
 significant impact on patients living with AML."
 
 
 Additionally, Abbott has submitted a Premarket Approval (PMA) 
 application for the FDA approval of an IDH2 assay on the Abbott m2000 
 RealTime System, a polymerase chain reaction (PCR) molecular 
 diagnostics instrument. IDH2 mutations occur in about 8 to 19 percent of 
 AML patients. Recent publications have highlighted the advances in the 
 understanding of the genetics underlying AML and the need for routine 
 mutational analysis at diagnosis and relapse.
 
 
 Celgene is also evaluating enasidenib compared with conventional therapy 
 in older patients with an IDH2 mutation and relapsed or refractory AML 
 in the ongoing phase III IDHENTIFY trial (NCT02577406).
 
 
 Enasidenib is an investigational drug that has not been approved for any 
 use in any country.
 
 
 About Acute Myelogenous Leukemia (AML)
 
 
 AML, a cancer of blood and bone marrow characterized by rapid disease 
 progression, is the most common acute leukemia affecting adults. 
 Undifferentiated blast cells proliferate in the bone marrow rather than 
 mature into normal blood cells. AML incidence significantly increases 
 with age, and according to the American Cancer Society, the median age 
 of onset is 66. Less than 10 percent of U.S. AML patients are eligible 
 for bone marrow transplant and the vast majority of patients do not 
 respond to chemotherapy and progress to relapsed/refractory AML. The 
 five-year survival rate for AML is approximately 20 to 25 percent. IDH2 
 mutations are present in about 8 to 19 percent of AML cases.
 
 
 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 <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.celgene.com&amp;esheet=51518423&amp;newsitemid=20170301005785&amp;lan=en-US&amp;anchor=www.celgene.com&amp;index=1&amp;md5=4b9a378ef4168d0dd2d15849012a45da" rel="nofollow" rel="nofollow">www.celgene.com</a>. 
 Follow Celgene on Social Media: <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fcelgene&amp;esheet=51518423&amp;newsitemid=20170301005785&amp;lan=en-US&amp;anchor=%40Celgene&amp;index=2&amp;md5=72ab2b5e916af04ab5c209e6cb89daab" rel="nofollow" rel="nofollow">@Celgene</a>, <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.pinterest.com%2Fcelgene%2F&amp;esheet=51518423&amp;newsitemid=20170301005785&amp;lan=en-US&amp;anchor=Pinterest&amp;index=3&amp;md5=6a6011ca7e0a3e7b1b869a74d39102a9" rel="nofollow" rel="nofollow">Pinterest</a>, <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fcelgene&amp;esheet=51518423&amp;newsitemid=20170301005785&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=4&amp;md5=e2916530faf449ab94c06c9643a8e7af" rel="nofollow" rel="nofollow">LinkedIn</a>, <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FCelgene%2F&amp;esheet=51518423&amp;newsitemid=20170301005785&amp;lan=en-US&amp;anchor=Facebook&amp;index=5&amp;md5=dff64a7123c8a761a976b4b0b01789bf" rel="nofollow" rel="nofollow">Facebook</a> and <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.youtube.com%2Fcelgene&amp;esheet=51518423&amp;newsitemid=20170301005785&amp;lan=en-US&amp;anchor=YouTube&amp;index=6&amp;md5=fbd1a5d4c36d7a97ecd775b3fc7fb8a0" rel="nofollow" rel="nofollow">YouTube</a>.
 
 
 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&#39;s 
 website at <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.agios.com%2F&amp;esheet=51518423&amp;newsitemid=20170301005785&amp;lan=en-US&amp;anchor=www.agios.com&amp;index=7&amp;md5=f4ff81eee73c4c63efdd2c436b28696f" rel="nofollow" rel="nofollow">www.agios.com</a>.
 
 
 About Agios/Celgene Collaboration
 
 
 Enasidenib is part of Celgene's global strategic collaboration with 
 Agios 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 $120 million in 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.
 
 
 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 &#34;expects,&#34; &#34;anticipates,&#34; 
 &#34;believes,&#34; &#34;intends,&#34; &#34;estimates,&#34; &#34;plans,&#34; &#34;will,&#34; "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. Neither Celgene nor Agios 
 undertake any 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 each company's 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 the Annual Report on Form 10-K and other reports of 
 each company filed with the Securities and Exchange Commission.
 
 
 
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