A CMI Solar Receiver Will Equip the World's Tallest Solar Tower in Dubai

CMI Energy awarded a contract for the Mohammed bin Rashid al Maktoum solar park in Dubai
SERAING, Belgium-Tuesday 4 December 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- After its commercial success in China for the design and supply of a thermal solar receiver at Haixi, CMI has just been awarded a new contract for engineering and supplying a receiver for the Mohammed bin Rashid al Maktoum solar park (Dubai).

This huge concentrated solar power (CSP) project named after the Emir of Dubai, is the centerpiece of Dubai's ambitious goal of generating 75% of the Emirate’s electricity demand from renewable energy by 2050. When completed in 2030, the Solar Park will have an installed capacity of 5,000 MW from an investment of approximately 12 billion euros. Launched in 2013, the Solar Park’s first three phases are dedicated to producing photovoltaic power (PV). Phase 4, known as the DEWA project for Dubai Electricity and Water Authority, is expected to cost over 3.3 billion euros. ACWA Power, one of the world’s largest developers of CSP projects, won the development contract for Phase 4. ACWA Power has selected Shanghai Electric as EPC. CMI Energy was awarded the contract for the solar receiver in October 2018.

Phase 4 includes a 100 MW solar tower. Thousands of sun-tracking mirrors will spread over several square kilometers around a 260-meter high tower. They will focus the sun’s energy onto a 30-meter-high CMI receiver installed at the top of the tower and that will heat molten salts above 560°C. The heat transfer fluid may then be sent to energy storage tanks for later use or used immediately to produce high-temperature steam that will flow through a steam turbine to produce electricity.

Power around the clock

CSP and the use of molten salts have two significant advantages over conventional wind and solar PV projects. First, high-temperature molten salts permit energy storage, so power may be generated 24-hours a day. Second, the power output of a CSP plant is dispatchable, which means electricity production may be controlled to match grid demand, unlike wind and solar PV.

About Cockerill Maintenance & Ingénierie

CMI, Cockerill Maintenance & Ingénierie, designs, integrates, modernises and maintains equipment for energy, defence, iron and steel, the environment and industries in general. CMI Energy is an international supplier of HRSGs, industrial boilers and steam generators for CSP with thermal storage.



View source version on businesswire.com: https://www.businesswire.com/news/home/20181203006035/en/

Contacts
Laurence PETIT
CMI ENERGY
laurence.petit@cmigroupe.com
https://www.cmigroupe.com/


https://www.aetoswire.com/news/a-cmi-solar-receiver-will-equip-the-world39s-tallest-solar-tower-in-dubai/en

Char Popp Joins PSB as Senior Vice President and Global Head of Qualitative Research

WASHINGTON-Saturday 1 December 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- PSB, a global research-based consultancy, announced today that Char Popp has joined the firm as Senior Vice President and Global Head of Qualitative Research to oversee the growth and development of the firm’s Qualitative Research offerings. She is based in Seattle and holds global responsibilities.

Popp is a veteran in strategic research and marketing strategy, having worked both in-house and as adviser to the technology industry for nearly 20 years. Her expertise lies in qualitative research where she has been responsible for driving customer, product and market strategy across a broad range of clients and industries via new methods and new research modes – including facilitated co-creation and product design sessions – all with a focus on end results that drive business impact. Popp’s hire is part of an approach to marry PSB’s depth of expertise in data analytics with high-impact qualitative research.

“I’m excited to unlock our qualitative capabilities for our clients in new and different ways with Char at the helm,” said Mike Pettingill, PSB’s Chief Operating Officer, to whom Popp will report. “She has a tremendous mind for the consumer and goes beyond the norm to get to the unanticipated root of an issue.”

Before PSB, Popp spent more than seven years at Schireson Associates where she served as Partner and led its qualitative research business. Prior to Schireson, she spent four years in product planning at Microsoft, where she led the product planning efforts for multiple components of Office, including the final customer validation for Office Online. Earlier in her career, she was with Hitachi Consulting and HP in program and product management capacities.

“PSB has long been expert at delivering strategic, data-driven insights to clients across a range of industries,” said Popp. “I’m thrilled to be able to bring my passion and expertise for customer intimacy and understanding to bear for PSB’s clients and to further develop our ability to deliver innovative qualitative research across the organization.”

Popp received her undergraduate degree in Theatre and Business from Baldwin-Wallace College and a MBA degree in marketing, strategy, management and technology from the University of Washington Foster School of Business.

About PSB

PSB is a full-service custom research and analytics consultancy that connects data-driven insights with human experience to solve clients’ most critical challenges. With a heritage in political polling, PSB brings the agility of campaign strategy to research and consulting across a range of industries, including technology, healthcare, financial services, and entertainment. PSB is a member of the BCW Group of companies, which is a part of WPP (NYSE: WPP), the world leader in communications services. For more information, visit www.psbresearch.com.

Contacts

Catherine Sullivan
+1.212.798.9501
Catherine.Sullivan@bcw-global.com

Permalink : https://www.aetoswire.com/news/char-popp-joins-psb-as-senior-vice-president-and-global-head-of-qualitative-research/en

Celgene Corporation Announces Results of AUGMENT Evaluating REVLIMID® In Combination with Rituximab (R2) In Patients with Relapsed/Refractory Indolent Lymphoma At ASH 2018

SUMMIT, N.J. -Monday 3 December 2018 [ AETOS Wire ]




Pivotal phase 3 data show investigational R2 significantly extended progression-free survival compared with rituximab plus placebo



Positive trend in overall survival was observed



Regulatory submissions planned for Q1 2019



(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced results of the phase 3 AUGMENT study, which showed that REVLIMID® (lenalidomide) in combination with rituximab (R2) demonstrated superior progression-free survival (PFS) in patients with relapsed/refractory indolent lymphoma compared to patients who received rituximab plus placebo (R-placebo). The data were presented by John Leonard, M.D. in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, C.A. (Abstract #445).



The phase 3 randomized, double-blind, international clinical study evaluated the efficacy and safety of the investigational combination of R2 versus rituximab plus placebo in patients (n=358) with relapsed/refractory follicular (n=295) and marginal zone (n=63) lymphoma.



In the study, the R2 arm demonstrated a highly statistically significant improvement in the primary endpoint of progression-free survival (PFS), evaluated by an independent review committee, versus (vs.) the R-placebo arm. The median PFS was 39.4 months for patients treated with R2 and 14.1 months for those treated with R-placebo (P



“The AUGMENT data, with R2 more than doubling progression-free survival over rituximab monotherapy, represents an important potential new treatment option for patients with relapsed/refractory follicular or marginal zone lymphoma,” said John Leonard, M.D., AUGMENT lead investigator, The Richard T. Silver Distinguished Professor of Hematology and Medical Oncology and director of the Joint Clinical Trials Office at Weill Cornell Medicine, who has also served as a consultant for Celgene.



Overall survival (OS), a secondary endpoint, showed a positive trend for improvement in the R2 arm vs. the control arm (16 vs. 26 death events) (HR: 0.61; 95% CI, 0.33-1.13). Two-year OS rate was 93% for patients receiving R2 and 87% for those receiving R-placebo.



Overall response rate (ORR), another secondary endpoint, was 78% (n=138) in the R2 arm vs. 53% (n=96) in the R-placebo arm, according to the independent review committee. Duration of response (DoR) was significantly improved for R2 vs. R-placebo with median DoR of 37 vs. 22 months, respectively (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79).



The most frequent adverse event (AE) in the R2 arm was neutropenia (58%), vs. 22% in the R-placebo arm. Additional commonly observed AEs in more than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in R-placebo), constipation (26% vs. 14%, respectively), cough (23% vs. 17%), and fatigue (22% vs. 18%), respectively. Adverse events that were reported at a higher rate (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare. No unexpected safety findings were observed in the AUGMENT trial.



“These data represent a potential new treatment strategy for patients with relapsed/refractory indolent non-Hodgkin’s lymphomas,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “We are advancing regulatory submissions in the first quarter of 2019 to bring this important combination to patients as soon as possible.”



REVLIMID® alone or in combination with other agents is not approved for use in follicular lymphoma or marginal zone lymphoma in any geography.



About REVLIMID®



REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)



REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)



REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities



REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib



REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials



Important Safety Information



WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM



Embryo-Fetal Toxicity



Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS® program.



Information about the REVLIMID REMS® program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.



Hematologic Toxicity (Neutropenia and Thrombocytopenia)



REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.



Venous and Arterial Thromboembolism



REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks.



CONTRAINDICATIONS


See full article: https://www.aetoswire.com/news/celgene-corporation-announces-results-of-augment-evaluating-revlimidreg-in-combination-with-rituximab-r2-in-patients-with-relapsed-refractory-indolent-lymphoma-at-ash-2018/en

Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 MEDALIST Trial Evaluating Luspatercept in Patients with Myelodysplastic Syndromes at the ASH 2018 Plenary Session

Pivotal phase 3 data demonstrated treatment with investigational luspatercept resulted in statistically significant increased red blood cell transfusion independence compared to placebo

Regulatory submissions planned in the United States and Europe in the first half of 2019

SUMMIT, N.J. & CAMBRIDGE, Mass.-Monday 3 December 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced results from the pivotal, phase 3 MEDALIST trial evaluating the efficacy and safety of investigational luspatercept to treat patients with ring sideroblast (RS+) myelodysplastic syndromes (MDS)-associated anemia who require red blood cell transfusions and who had failed, were intolerant to, or ineligible for erythropoietin therapy. Results were presented by Alan F. List, M.D. during the Plenary Scientific Session at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, C.A. (Abstract #1).

“Severe anemia resulting in red blood cell transfusion dependence is a significant challenge for patients with low- and intermediate-risk MDS. Those who become resistant or refractory to currently available treatments have limited alternatives,” said Dr. List, President and CEO of Moffitt Cancer Center. “The findings from MEDALIST are very exciting as they support the hypothesis that targeting red blood cell precursor maturation could help to address patients’ anemia and allow them to achieve transfusion independence.”

MEDALIST met the primary endpoint of red blood cell transfusion independence (RBC-TI) for 8 or more weeks during the first 24 weeks of the study. Treatment with luspatercept resulted in a statistically significantly greater proportion of patients achieving RBC-TI ≥ 8 weeks compared to placebo. The study also found in secondary endpoints that treatment with luspatercept resulted in a statistically significant higher percentage of patients achieving RBC-TI of 12 or more weeks in the first 24 or 48 weeks of the study, as well as hematologic improvement-erythroid (HI-E) of 8 or more weeks.

                             
Endpoints         Luspatercept         Placebo         P-Value
RBC-TI ≥8 weeks (weeks 1-24)         37.9    % (58/153)         13.2    % (10/76)         < 0.0001
RBC-TI ≥12 weeks (weeks 1-24)         28.1    % (43/153)         7.9    % (6/76)         0.0002
RBC-TI ≥12 weeks (weeks 1-48)         33.3    % (51/153)         11.8    % (9/76)         0.0003
HI-E ≥ 8 weeks (IWG 2006, weeks 1-24)         52.9    % (81/153)         11.8    % (9/76)         < 0.0001
                             
MEDALIST Safety Summary

Treatment-emergent adverse events (TEAEs) of Grade 3 or 4 were reported in 42.5% (65/153) of patients receiving luspatercept and 44.7% (34/76) of patients receiving placebo. Progression to acute myeloid leukemia (AML) occurred in four patients, three patients (2.0%) receiving luspatercept and one patient (1.3%) receiving placebo. Five patients receiving luspatercept (3.3%) and four patients receiving placebo (5.3%) experienced one or more TEAE that resulted in death.

Most common TEAEs of any Grade in Greater than 10% of Patients in Either Arm

         
Luspatercept

N=153

    
Placebo

N=76

Fatigue         26.8    %         13.2    %
Diarrhea         22.2    %         9.2    %
Asthenia         20.3    %         11.8    %
Nausea         20.3    %         7.9    %
Dizziness         19.6    %         5.3    %
Back pain         19.0    %         6.6    %
                   
“The MEDALIST results demonstrate the potential clinical benefit of luspatercept in achieving red blood cell transfusion independence in patients with low-to-intermediate risk RS+ MDS, an area in need of new treatments,” said Alise Reicin, MD, President, Global Clinical Development for Celgene. “Based on these results, we are encouraged that this first-in-class erythroid maturation agent may help these patients address the underlying cause of their disease-related chronic anemia.”

“It’s truly an honor to showcase the results from the MEDALIST trial as the first presentation of the ASH Plenary Session,” said Habib Dable, President and Chief Executive Officer of Acceleron. “The results from the MEDALIST trial increase our confidence in the potential of luspatercept to provide a meaningful treatment option for patients suffering from lower-risk RS+ MDS worldwide. We’re excited to continue our clinical development program in MDS, beta-thalassemia, and myelofibrosis, while also exploring additional applications for luspatercept in a range of diseases associated with anemia.”

Luspatercept is not approved in any region for any indication. The companies are planning regulatory application submissions of luspatercept in the United States and Europe in the first half of 2019.

About MEDALIST

MEDALIST is a phase 3, randomized, double blind, placebo-controlled, multi-center study evaluating the safety and efficacy of luspatercept in patients with very low-, low-, or intermediate-risk non-del(5q) myelodysplastic syndromes (MDS). All patients were RBC transfusion dependent and were either refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) therapy, or were ESA naïve with endogenous serum erythropoietin ≥ 200 U/L, and had no prior treatment with disease modifying agents. The median age of the patients enrolled in the trial was 71 years in the luspatercept treatment group and 72 years in the placebo group. Median transfusion burden in both treatment arms was 5 RBC units/8 weeks. 229 patients were randomized to receive either luspatercept 1.0 mg/kg (153 patients) or placebo (76 patients) via subcutaneous injection once every 21 days. The study was conducted at 65 sites in 11 countries.

About Luspatercept

Luspatercept is a first-in-class erythroid maturation agent (EMA) that is believed to regulate late-stage red blood cell maturation. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Phase 3 clinical trials continue to evaluate the safety and efficacy of luspatercept in patients with MDS (the MEDALIST trial) and in patients with beta-thalassemia (the BELIEVE trial). The COMMANDS phase 3 trial in first-line, lower-risk, MDS patients, the BEYOND phase 2 trial in non-transfusion-dependent beta-thalassemia, and a phase 2 trial in myelofibrosis are ongoing. For more information, please visit www.clinicaltrials.gov.

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 www.celgene.com.

Follow Celgene on Social Media: Twitter, Pinterest, LinkedIn, Facebook and YouTube.

About Acceleron

Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchise with two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.

For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

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 potential benefits of, and plans relating to the collaboration between Acceleron and Celgene; the potential of luspatercept as a therapeutic drug; and the benefit of each company’s strategic plans and focus. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “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, that the results of any clinical study will be predictive for other clinical studies of the same product candidate, or that development of any of 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 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, except as may be required by law.

Hyperlinks are provided as a convenience and for informational purposes only. Neither Celgene nor Acceleron bears responsibility for the security or content of external websites or websites outside of their respective control.





View source version on businesswire.com: https://www.businesswire.com/news/home/20181202005062/en/

Contacts
Celgene Corporation
Investors:
+1-908-673-9628
ir@celgene.com

Media:
+1-908-673-2275
media@celgene.com

Acceleron Pharma Inc.
Todd James, IRC, (617) 649-9393
Vice President, Investor Relations and Corporate Communications

Candice Ellis, (617) 649-9226
Manager, Investor Relations and Corporate Communications

Media:
Matt Fearer, (617) 301-9557
Director, Corporate Communications


https://www.aetoswire.com/news/celgene-corporation-and-acceleron-pharma-announce-results-of-the-phase-3-medalist-trial-evaluating-luspatercept-in-patients-with-myelodysplastic-syndromes-at-the-ash-2018-plenary-session/en

Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 BELIEVE Trial Evaluating Luspatercept in Adult Patients with Beta-Thalassemia at ASH 2018

Pivotal phase 3 data demonstrated treatment with investigational luspatercept resulted in significant reduction of transfusion burden compared to placebo

Regulatory submissions planned in the United States and Europe in the first half of 2019

SUMMIT, N.J. & CAMBRIDGE, Mass. -Sunday 2 December 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced results from a pivotal, phase 3 trial (BELIEVE) evaluating the safety and efficacy of luspatercept for the treatment of adults with beta-thalassemia-associated anemia who require regular red blood cell (RBC) transfusions. The data were presented by Maria Domenica Cappellini, M.D. in an oral session of the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA (Abstract #163).

“Currently, the standard of care to help patients with beta-thalassemia manage their anemia is regular, lifelong red blood cell transfusions, which over time can result in iron overload and life-threatening co-morbidities,” said Professor Cappellini, M.D., Professor of Medicine, University of Milan - Fondazione IRCCS. “These findings from the BELIEVE study are exciting because they suggest that luspatercept may help patients reduce their dependence on red blood cell transfusions.”

BELIEVE met the primary endpoint of erythroid response, defined as a ≥33% reduction in RBC transfusion burden (with a reduction of ≥ 2 units of RBC) during weeks 13–24 compared to the baseline 12-week interval prior to randomization. The study also included secondary endpoints that evaluated the impact of treatment on RBC transfusion burden. Mean change in transfusion burden from baseline to weeks 13-24 (luspatercept vs. placebo) was -1.35 RBC units.

RBC Transfusion Burden Reduction of ≥ 33% Response Rates1
Response Time Interval                 Luspatercept                    Placebo                     P-value
Weeks 13-24                                 21.4% (48/224)                4.5% (5/112)            < 0.0001
Weeks 37-48                                 19.6% (44/224)                3.6% (4/112)            < 0.0001
Any 12 weeks during                   70.5% (158/224)               29.5% (33/112)        < 0.0001
the entire treatment period
Any 24 weeks during                   41.1% (92/224)                2.7% (3/112)            < 0.0001
 the entire treatment period
                                                     

RBC Transfusion Burden Reduction of ≥ 50% Response Rates1
Response Time Interval                 Luspatercept                   Placebo                        P-value
Weeks 13-24                                  7.6% (17/224)                 1.8% (2/112)                0.0303
Weeks 37-48                                 10.3% (23/224)                0.9% (1/112)                0.0017
Any 12 weeks during                    40.2% (90/224)                6.3% (7/112)            < 0.0001
the entire treatment period
Any 24 weeks during                    16.5% (37/224)                0.9% (1/112)            < 0.0001
the entire treatment period
                                                     

1RBC transfusion burden reduction response rates are calculated versus baseline (i.e., the 12 weeks prior to randomization)

BELIEVE Safety Summary (Safety Population)

Grade 3 or higher treatment-emergent adverse events (TEAEs) were reported in 29.1% (65/223) of patients receiving luspatercept and 15.6% (17/109) of patients receiving placebo. Serious adverse events were reported in 15.2% (34/223) of patients receiving luspatercept and 5.5% (6/109) of patients receiving placebo. A TEAE of acute cholecystitis resulted in death in one placebo-treated patient (0.9%). No luspatercept-treated patients died due to TEAEs.

Grade 3 or 4 TEAEs in at least 1% of patients in either arm
                                                                       Luspatercept           Placebo

                                                                           N= 223                N= 109
               


Anemia                                                              3.1%                    0.0%
Increased liver iron concentration                     2.7%                    0.9%
Hyperuricemia                                                   2.7%                    0.0%
Hypertension                                                     1.8%                    0.0%
Syncope                                                             1.8%                    0.0%
Back pain                                                          1.3%                     0.9%
Bone pain                                                          1.3%                     0.0% 
Blood uric acid increased                                  1.3%                    0.0%
Increased aspartate aminotransferase                1.3%                    0.0%
Increase alanine aminotransferase                     0.9%                    2.8%
Thromboembolic events*                                  0.9%                    0.0%
                                   

*All grades of thromboembolic events, including DVT, PE, portal vein thrombosis, ischemic stroke, thrombophlebitis, and superficial phlebitis were reported in 8 of 223 (3.6%) luspatercept-treated versus 1 of 109 (0.9%) placebo-treated patients

“The BELIEVE results demonstrate the potential of luspatercept to help adults living with beta-thalassemia better manage their anemia and reduce their transfusion burden,” said Alise Reicin, M.D., President, Global Clinical Development for Celgene. “These results further our understanding of the luspatercept clinical profile, which will continue to inform our plans to advance this promising investigational therapy.”

“These outcomes of the BELIEVE trial increase our confidence in the potential of luspatercept to become an important new treatment option for patients suffering from beta-thalassemia,” said Habib Dable, President and Chief Executive Officer of Acceleron. “Our focus now is to work diligently with health authorities to help ensure that this underserved patient population can gain access to luspatercept as quickly as possible.”

Luspatercept is not approved in any region for any indication. The companies are planning regulatory application submissions of luspatercept in the United States and Europe in the first half of 2019.

About BELIEVE

BELIEVE is a phase 3, randomized, double blind, placebo-controlled multicenter study comparing luspatercept + best supportive care (BSC) versus placebo + BSC in adult beta-thalassemia patients who require regular RBC transfusions. The median age of the patients was 30 years in both treatment arms. 336 patients were randomized 2:1 to receive either luspatercept 1.0 mg/kg + BSC (224 patients) or placebo + BSC (112 patients) every 3 weeks for up to 48 weeks. Patients in the luspatercept + BSC arm were able to be titrated up to 1.25 mg/kg of luspatercept every 3 weeks. BSC was defined as RBC transfusions and iron chelation therapy to maintain each patient’s baseline hemoglobin level. Crossover to the luspatercept treatment group was allowed after unblinding and assessment by an independent Data Safety Monitoring committee; patients receiving luspatercept + BSC will be followed for up to 3 years. The study was conducted at 65 sites in 15 countries.

About Luspatercept

Luspatercept is a first-in-class erythroid maturation agent (EMA) that is believed to regulate late-stage red blood cell maturation. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Phase 3 clinical trials continue to evaluate the safety and efficacy of luspatercept in patients with MDS (the MEDALIST trial) and in patients with beta-thalassemia (the BELIEVE trial). A COMMANDS phase 3 trial in first-line, lower-risk, MDS patients, the BEYOND phase 2 trial in non-transfusion-dependent beta-thalassemia, and a phase 2 trial in myelofibrosis are ongoing. For more information, please visit www.clinicaltrials.gov.

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 www.celgene.com.

Follow Celgene on Social Media: Twitter, Pinterest, LinkedIn, Facebook and YouTube.

About Acceleron

Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchise with two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.

For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

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 potential benefits of, and plans relating to the collaboration between Acceleron and Celgene; the potential of luspatercept as a therapeutic drug; and the benefit of each company’s strategic plans and focus. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “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 luspatercept will be successfully developed or complete necessary clinical phases. 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, 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 planned clinical trials; the ability to obtain, maintain and enforce patent and other intellectual property protection for luspatercept; 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, except as may be required by law.

Hyperlinks are provided as a convenience and for informational purposes only. Neither Celgene nor Acceleron bears responsibility for the security or content of external websites or websites outside of their respective control.





View source version on businesswire.com: https://www.businesswire.com/news/home/20181201005028/en/



Contacts

Celgene Corporation
Investors:
+1-908-673-9628
ir@celgene.com
or
Media:
+1-908-673-2275
media@celgene.com

Acceleron Pharma Inc.
Todd James, IRC, (617) 649-9393
Vice President, Investor Relations and Corporate Communications
or
Candice Ellis, (617) 649-9226
Manager, Investor Relations and Corporate Communications
or
Media:
Matt Fearer, (617) 301-9557
Director, Corporate Communications



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Tokyo Gas Switches to Rimini Street Support for SAP Applications

Leading energy provider in Japan maximizes ROI on key SAP system while receiving premium-level support


LAS VEGAS-Saturday 1 December 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced that Tokyo Gas Co., Ltd., Japan’s largest provider of city gas, has switched to Rimini Street support for its SAP BusinessObjects application. By switching to Rimini Street support, Tokyo Gas finds it now receives a vastly improved service model which is more comprehensive and responsive than what they had received before; the company can also maximize its current, stable SAP application without the need to upgrade just to stay fully supported, for a minimum of 15 years from the time the company transitioned to Rimini Street. Additionally, Tokyo Gas has realized significant savings in total maintenance costs when factoring in customized system support needs.

Seeking Better Service, Lower Costs and Increased Efficiency

Tokyo Gas has been using SAP BusinessObjects since 2005 to create reports by extracting data from their existing system. TOKYO GAS i NET CORP., the group that operates IT management for Tokyo Gas, had been searching for new, IT initiatives - including a cost effective maintenance solution. They were facing an expensive upgrade and the renewal of User Interfaces (UI) would require extra training after the updates were completed, adding cost and time to their internal IT team. Therefore, when the upgrade deadline was approaching, Tokyo Gas began exploring their enterprise software support options and ultimately switched to Rimini Street to optimize costs and maintain and maximize the life of their current system.

After moving to Rimini Street, the TOKYO GAS i NET CORP. team began receiving quick and precise responses from Rimini Street for their inquiries, allowing them to move through issues faster. Plus, Tokyo Gas had experienced a new found efficiency, because they could continuously leverage their current, robust system which is a familiar working environment.

“It has been a big concern that we were about to spend too much time and too many resources learning a new UI operation when the upgrade to the new release of SAP BusinessObjects was required,” said a spokesperson for the company who leads the labor group in the HR department of Tokyo Gas. “Since switching to Rimini Street, we will be able to continuously operate efficiently. Also, being able to run our current enterprise software without adjusting its functionality when we introduce Windows 10 next year, will greatly help with our productivity.”

Upgraded Support Model

Tokyo Gas, as with all Rimini Street clients, was assigned a senior level Rimini Street Primary Support Engineer (PSE), who average 15 years’ experience. Tokyo Gas also receives Rimini Street’s industry-leading service level agreement (SLA) guaranteeing a 15-minute response time for Priority 1 critical cases as well as access to a team of local engineers 24/7/365 to address any support issues.

“Rimini Street provides high quality support, including a designated support engineer, which has allowed us to operate swiftly with a smooth transition from the first day of onboarding to today,” said another spokesperson for the company who manages the SAP system in the corporate support group, corporate solution department of TOKYO GAS i NET CORP. “We have approached our Rimini Street team with some issues that we had in the past and received a rapid, accurate response; we were also provided information that had not been communicated to us before regarding certain issues, and having that transparency has been incredibly helpful. Furthermore, with Japan’s recent energy liberalization of gas markets and energy conservation progress, which has increased competition, the transition to digital innovation is required and having our Rimini Street team on board is one of the biggest advantages we have, obtaining their professional knowledge for the long-term as we continue to evolve will be crucial for our success.”

“The energy market is continuing to transform and progress, and staying on the forefront of new, innovative IT solutions is key to maintaining competitive advantage,” said Yorio Wakisaka, general manager Japan, Rimini Street. “Tokyo Gas has succeeded in taking the first step in innovative IT management, and can continue planning for the future. By switching to Rimini Street, Tokyo Gas has been able to unlock significant funds, maintain the value of their current SAP system and focus their internal resources to increase efficiency.”

About Rimini Street, Inc.

Rimini Street, Inc. (Nasdaq: RMNI) is a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products. The Company has redefined enterprise software support services since 2005 with an innovative, award-winning program that enables licensees of IBM, Microsoft, Oracle, Salesforce, SAP and other enterprise software vendors to save up to 90 percent on total maintenance costs. Clients can remain on their current software release without any required upgrades for a minimum of 15 years. Over 1,700 global Fortune 500, midmarket, public sector and other organizations from a broad range of industries currently rely on Rimini Street as their trusted, third-party support provider. To learn more, please visit http://www.riministreet.com follow @riministreet on Twitter and find Rimini Street on Facebook and LinkedIn. (C-RMNI)

Forward-Looking Statements

Certain statements included in this communication are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may,” “should,” “would,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “seem,” “seek,” “continue,” “future,” “will,” “expect,” “outlook” or other similar words, phrases or expressions. These forward-looking statements include, but are not limited to, statements regarding our expectations of future events, future opportunities, global expansion and other growth initiatives and our investments in such initiatives. These statements are based on various assumptions and on the current expectations of management and are not predictions of actual performance, nor are these statements of historical facts. These statements are subject to a number of risks and uncertainties regarding Rimini Street’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, continued inclusion in the Russell 2000 Index in the future; changes in the business environment in which Rimini Street operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Rimini Street operates; adverse developments in pending litigation or in the government inquiry or any new litigation; the final amount and timing of any refunds from Oracle related to our litigation; our need and ability to raise additional equity or debt financing on favorable terms; the terms and impact of our 13.00% Series A Preferred Stock; changes in taxes, laws and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the success of our recently introduced products and services, including Rimini Street Mobility, Rimini Street Analytics, Rimini Street Advanced Database Security, and services for Salesforce Sales Cloud and Service Cloud products; the loss of one or more members of Rimini Street’s management team; uncertainty as to the long-term value of Rimini Street’s equity securities; and those discussed under the heading “Risk Factors” in Rimini Street’s Quarterly Report on 10-Q filed on November 8, 2018, which disclosures amend and restate the disclosures appearing under the heading “Risk Factors” in Rimini Street’s Annual Report on Form 10-K filed on March 15, 2018, and as updated from time to time by Rimini Street’s future Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings by Rimini Street with the Securities and Exchange Commission. In addition, forward-looking statements provide Rimini Street’s expectations, plans or forecasts of future events and views as of the date of this communication. Rimini Street anticipates that subsequent events and developments will cause Rimini Street’s assessments to change. However, while Rimini Street may elect to update these forward-looking statements at some point in the future, Rimini Street specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Rimini Street’s assessments as of any date subsequent to the date of this communication.

© 2018 Rimini Street, Inc. All rights reserved. “Rimini Street” is a registered trademark of Rimini Street, Inc. in the United States and other countries, and Rimini Street, the Rimini Street logo, and combinations thereof, and other marks marked by TM are trademarks of Rimini Street, Inc. All other trademarks remain the property of their respective owners, and unless otherwise specified, Rimini Street claims no affiliation, endorsement, or association with any such trademark holder or other companies referenced herein.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181129005822/en/

Contacts

Michelle McGlocklin
Rimini Street, Inc.
+1-925 523-8414
mmcglocklin@riministreet.com

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AerSale Acquires Avborne to Expand MRO Capabilities

CORAL GABLES, Fla.-Friday 30 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- AerSale®, a global supplier of mid-life aircraft, engines, used serviceable material, and maintenance, repair, and overhaul (MRO) services, today announced it has acquired aircraft component repair specialist Avborne. Avborne is a certified Federal Aviation Administration (FAA) 145 repair station in Miami, Florida, and a recognized leader in providing highly technical and specialized repair services covering a broad range of commercial and military aircraft systems, including hydraulic, pneumatic, electronic, and landing gear components. Avborne’s formidable in-house engineering development team is continuously introducing innovative cost-saving repair and overhaul regimes as one of the few component MROs operating today under the authority of an FAA Open Class Rating. This licensing allows Avborne to initiate its own FAA repair validation packages for expedited introduction of new repair and overhaul capabilities well in advance of traditional MRO participants. In conjunction with AerSale’s existing MRO facilities, the acquisition of Avborne will enable AerSale to provide complete MRO services across numerous aircraft platforms, from the component level through aircraft heavy maintenance.

 “As a recognized leader in high-tech component repair development and services, Avborne is the ideal partner for expanding our existing portfolio of high-quality aviation products and MRO services,” said Nicolas Finazzo, Chief Executive Officer at AerSale. “We are exhilarated over the added value our customers will enjoy from AerSale’s expanding family of integrated aircraft, engine, and component solutions.”

AerSale is a premier provider of one-stop services offering aircraft and engine leasing, used serviceable material supply solutions, and uncompromising MRO services to the world’s most demanding commercial and governmental operators. The company’s MRO operations include heavy aircraft maintenance and modification, parts manufacturing, and airframe structure and mechanical component services, in addition to aircraft storage, disassembly, and materials distribution. Avborne’s acquisition will include the addition of approximately 100 skilled professionals and technicians to the greater AerSale family, along with a 112,000-square-foot facility located near Miami International Airport. Avborne’s quality assurance ratings include stringent compliance with European Aviation Safety Agency (EASA), Civil Aviation Administration of China (CAAC), AS9110C, and Coordinating Agency for Supplier Evaluation (C.A.S.E.) certifications.

About AerSale

A global aviation leader celebrating its 10-year anniversary, AerSale specializes in the sale, lease, and exchange of used aircraft, engines, and components, in addition to providing a broad range of MRO and engineering services for commercial aircraft and components. AerSale also offers asset management services to owners of end-of-life aircraft and engine portfolios. Headquartered in Coral Gables, Florida, AerSale maintains offices and operations in the United States, Europe, and Asia.

For more information, visit our website at www.aersale.com or contact AerSale Media Relations by calling (305) 764-3200 or via e-mail at media.relations@aersale.com.

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View source version on businesswire.com: https://www.businesswire.com/news/home/20181129005156/en/

Contacts

Lyndelle Nieuwkerk, +1-305-764-3200
media.relations@aersale.com

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