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 Celgene Corporation CELG and Acceleron Pharma Inc. XLRN today announced that they have completed target enrollment in the 
 MEDALIST and BELIEVE Phase 3 studies of luspatercept in patients with 
 myelodysplastic syndromes (MDS) and beta-thalassemia. The Companies 
 expect to report top-line results from the clinical trials in the middle 
 of 2018. Luspatercept is being developed to treat a range of hematologic 
 diseases including MDS, beta-thalassemia, and myelofibrosis as part of a 
 global collaboration between Acceleron and Celgene.
 
 
 "We are excited to have completed target enrollment in our MEDALIST and 
 BELIEVE Phase 3 studies of luspatercept, ahead of schedule, and look 
 forward to reporting top-line results in the middle of next year," said 
 Michael Pehl, President, Hematology and Oncology for Celgene. "Patients 
 suffering from both diseases have limited treatment options to improve 
 their underlying anemia. We believe that luspatercept may be a 
 potentially paradigm-changing treatment option for patients and 
 physicians alike."
 
 
 "The rapid pace of patient recruitment in our global Phase 3 trials 
 reflects the clear need for new MDS and beta-thalassemia therapies that 
 can significantly reduce or eliminate dependence on red blood cell 
 transfusions,&#34; said Habib Dable, President and Chief Executive Officer 
 of Acceleron. "We are grateful for the support and dedication of the 
 MEDALIST and BELIEVE study investigators, our patient advocacy partners, 
 and most importantly the more than 500 patients and their families who 
 are participating in our studies. I would also like to acknowledge the 
 strong collaborative effort of the Celgene and Acceleron teams that led 
 to this important achievement."
 
 
 The MEDALIST Phase 3 trial has enrolled 210 patients with lower-risk 
 MDS. The BELIEVE Phase 3 trial has enrolled 300 patients with 
 transfusion dependent beta-thalassemia. Patients who are currently in 
 screening remain eligible for randomization into both Phase 3 studies. 
 The trials will remain blinded for both the primary and secondary 
 endpoints until the end of the 48-week treatment period for all 
 randomized patients.
 
 
 About the MEDALIST Study
 
 
 The MEDALIST Phase 3 trial is a randomized, double-blind, 
 placebo-controlled, global study designed to evaluate the efficacy and 
 safety of luspatercept in patients with ring sideroblasts (RS+), 
 lower-risk MDS with a baseline RBC transfusion burden of at least 2 
 units per 8 weeks over the 16-week period prior to treatment. The 
 primary endpoint of the study is the proportion of patients who are red 
 blood cell (RBC) transfusion independent over any consecutive 8-week 
 period through week 24. Secondary endpoints include duration of RBC 
 transfusion independence and proportion of patients achieving a modified 
 hematologic improvement – erythroid (HI-E) per the International Working 
 Group over any consecutive 8-week period during treatment. Patients were 
 randomized 2:1, luspatercept to placebo treatment, administered 
 subcutaneously every 3 weeks for 48 weeks. The MEDALIST study is being 
 conducted at 74 investigational sites in 11 countries.
 
 
 About the BELIEVE Study
 
 
 The BELIEVE Phase 3 trial is a randomized, double-blind, 
 placebo-controlled, global study designed to evaluate the efficacy and 
 safety of luspatercept in patients with transfusion dependent 
 beta-thalassemia. The primary endpoint of the study is the proportion of 
 patients achieving a ≥ 33% reduction in red blood cell (RBC) transfusion 
 burden from Week 13 to Week 24 compared to the baseline 12-week period 
 prior to treatment. Secondary endpoints include reductions in RBC 
 transfusion burden from Week 37 to Week 48 compared to baseline. 
 Beta-thalassemia patients in the trial had a baseline RBC transfusion 
 burden of 6 to 20 units over the 24-week period prior to treatment. 
 Patients were randomized 2:1, luspatercept to placebo treatment, 
 administered subcutaneously every 3 weeks for 48 weeks. The BELIEVE 
 study is being conducted at 73 investigational sites in 15 countries.
 
 
 About Luspatercept
 
 
 Luspatercept is a modified activin receptor type IIB fusion protein that 
 acts as a ligand trap for members in the transforming growth factor-beta 
 superfamily involved in the late stages of erythropoiesis (red blood 
 cell production). Luspatercept regulates late-stage erythrocyte (red 
 blood cell) precursor cell differentiation and maturation. This 
 mechanism of action is distinct from that of erythropoiesis-stimulating 
 agents (ESAs), which stimulate the proliferation of early-stage 
 erythrocyte progenitor cells. Acceleron and Celgene are jointly 
 developing luspatercept as part of a global collaboration. Acceleron and 
 Celgene are conducting two Phase 3 clinical trials that are designed to 
 evaluate the safety and efficacy of luspatercept in patients with 
 myelodysplastic syndromes (the "MEDALIST" study) and in patients with 
 beta-thalassemia (the "BELIEVE" study). 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.clinicaltrials.gov&amp;esheet=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=www.clinicaltrials.gov&amp;index=1&amp;md5=5abdd6a3c4debc1c28a789929535ba60" rel="nofollow" rel="nofollow">www.clinicaltrials.gov</a>.
 
 
 Luspatercept is an investigational compound that is not approved or use 
 in any country.
 
 
 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=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=www.celgene.com&amp;index=2&amp;md5=1eead862205107af0fdac7fbfd0d0a5d" 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=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=%40Celgene&amp;index=3&amp;md5=f1ff1064929d5ecccb03ea833cf03cb7" 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=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=Pinterest&amp;index=4&amp;md5=7e51023333090a8e26cfe17b4d7fa2ac" 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=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=5&amp;md5=359d64c14901e7210b465d956304b1f2" 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%2FCelgeneCorp%2F%3Ffref%3Dts&amp;esheet=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=FaceBook&amp;index=6&amp;md5=d7991e12dd6bffd48fea9cca74b751a3" 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=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=YouTube&amp;index=7&amp;md5=2ced33ab2fa3ae0bc5440e731e1884c0" rel="nofollow" rel="nofollow">YouTube</a>.
 
 
 About Acceleron
 
 
 Acceleron is a clinical stage biopharmaceutical company focused on the 
 discovery, development and commercialization of innovative therapeutics 
 to treat serious and rare diseases. Its pioneering research platform 
 leverages the powerful biology behind the body's ability to rebuild and 
 repair its own cells and tissues. This approach to drug discovery has 
 generated four therapeutic candidates that are currently in clinical 
 trials. Acceleron's lead therapeutic candidate, luspatercept, is being 
 evaluated in Phase 3 studies for the treatment of the hematologic 
 diseases myelodysplastic syndromes (MDS) and beta-thalassemia under a 
 global partnership with Celgene Corporation. Acceleron is also advancing 
 clinical programs in the fields of oncology and neuromuscular diseases 
 and has a comprehensive preclinical research effort targeting fibrotic 
 diseases and other serious conditions.
 
 
 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.acceleronpharma.com%2F&amp;esheet=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=www.acceleronpharma.com%2F&amp;index=8&amp;md5=d7fb8fa5aa53efec616e11c79d7a8119" rel="nofollow" rel="nofollow">www.acceleronpharma.com/</a>. 
 Follow Acceleron 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%2FAcceleronPharma&amp;esheet=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=%40AcceleronPharma%C2%A0&amp;index=9&amp;md5=aeabc6fe9797a8f1a44818bad092ccc0" rel="nofollow" rel="nofollow">@AcceleronPharma </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.linkedin.com%2Fcompany-beta%2F31472%2F&amp;esheet=51568105&amp;newsitemid=20170601005744&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=10&amp;md5=d82a4a4a304e2e139430ad27ad72886b" rel="nofollow" rel="nofollow">LinkedIn</a>.
 
 
 Cautionary Note Regarding 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 Acceleron 
 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.
 
 
 Hyperlinks are provided as a convenience and for informational 
 purposes only. Neither Celgene nor Acceleron bears any responsibility 
 for the security or content of external websites.
 
 
 
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