- ENESTnd data indicate trend for longer overall survival and event-free survival in newly diagnosed Ph+ CML patients on Tasigna versus Glivec
- Data demonstrated higher rates of early and deeper molecular response in newly diagnosed patients, including MR4.5, and a reduced risk of progression
- Separate study, ENESTcmr, confirms treatment with Tasigna led to deeper molecular response in patients who switch after long-term treatment with Glivec
- New data show patients who failed to respond to frontline Glivec achieved higher rates of molecular response with switch to Tasigna versus Glivec dose escalation
Basel, Switzerland, 12-12-2013 — /EuropaWire/ — Findings from three large, randomized Phase III studies demonstrate the superiority of Tasigna® (nilotinib) compared to Glivec® (imatinib)* at achieving deeper molecular responses across various Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) patient populations, including newly diagnosed patients, patients with residual disease who switched to Tasigna after long-term treatment with Glivec, and patients who failed to respond to frontline Glivec (as defined by 2013 European LeukemiaNet [ELN] guidelines),,,.
These results, which were presented in oral sessions at the 55th annual meeting of the American Society of Hematology (ASH) in New Orleans, add to the growing body of evidence confirming the superiority of Tasigna to Glivec at achieving molecular response in Ph+ CML patients,,.
“These new and updated data reaffirm the superiority of Tasigna over Glivec at achieving deeper molecular responses and provide even more evidence supporting Tasigna as an appropriate treatment of choice in newly diagnosed patients and in those who switch to Tasigna after long-term treatment with Glivec,” said Giuseppe Saglio, MD, ENEST studies investigator, Professor of Internal Medicine and Haematology and Director of the Department of Molecular Medicine and Targeted Therapy at San Luigi Hospital, University of Turin, Italy. “Now we are looking at how deeper molecular responses may help guide our approach towards how we treat CML in the future.”
Presented at ASH were the five-year ENESTnd data, which continued to support the use of Tasigna in newly diagnosed Ph+ CML patients and demonstrated higher rates of early and deeper sustained molecular response, including MR4.5, and a reduced risk of progression compared to Glivec. The difference in the rates of both MR4 and MR4.5 continued to be higher for both Tasigna 300 mg and 400 mg twice daily arms compared to Glivec (MR4: 9-14% difference by one year, 21-24% difference by five years; MR4.5: 6-10% difference by one year, 21-23% difference by five years). Data indicated a trend for higher overall survival (OS) and event-free survival (EFS) rates in patients treated with Tasigna compared to patients treated with Glivec. Fifteen patients treated with Glivec had CML-related deaths, compared to six and four patients on the Tasigna 300 mg and 400 mg twice daily arms, respectively. Few new adverse events (AEs) and laboratory abnormalities were observed between four and five years. Rates of patients with AEs leading to discontinuation were 11.1%, 17.7% and 13.2% in the Tasigna 300 mg twice daily, Tasigna 400 mg twice daily and Glivec arms, respectively.
In a separate follow-up analysis, results from the 36-month ENESTcmr data continued to show that Ph+ CML patients with residual disease following long-term treatment with Glivec achieved deeper molecular responses** after switching to Tasigna. Among patients without documented MR4.5 at baseline, cumulative incidence of MR4.5 was higher in patients randomized to Tasigna versus Glivec (46.9% vs. 33.3%; nominal p=0.0453). MR4.5 was achieved faster with median time to response of 24.0 months in the Tasigna arm and was not reached in the Glivec arm (nominal p=0.0011). The safety profiles for Tasigna and Glivec were consistent with prior studies. By 36 months, no patients in either arm progressed to accelerated phase/blast crisis (AP/BC).
Also presented were results from the LASOR study, which demonstrated higher rates of molecular response in patients who failed to achieve a cytogenetic response (CCyR) with frontline Glivec (patients who do not achieve CCyR by six months, have loss of response at any time or have intolerance) who switched to Tasigna, versus those who dose escalated on Glivec (600 mg daily). While the primary endpoint of CCyR at six months after randomization, which was confounded by high rates of crossover to Tasigna from the Glivec arm, did not achieve statistical significance (p=0.3844), the clinical benefit of Tasigna was best evaluated when considering cross-over patients as non-responders. A sensitivity analysis conducted supported the efficacy of Tasigna over Glivec. The safety profile for both drugs was consistent with prior reports of patients who switched therapy after inadequate responses to Glivec.
“Today, we know from clinical studies that patients who achieve and maintain deep levels of response, known as MR4.5, do not progress to the advanced stages of CML,” said Hervé Hoppenot, President, Novartis Oncology. “These large studies continue to establish the benefits of Tasigna at achieving deeper molecular responses and we are committed to exploring the impact this may have on how we treat CML in the future.”
Novartis Commitment to CML
Over the past several decades, Novartis research in Ph+ CML has helped transform the disease from a fatal leukemia to a chronic condition and today, the company continues its long-standing commitment to the global CML community. The Novartis treatment-free remission (TFR) clinical trial program includes eight studies that are now underway and actively enrolling Ph+ CML patients in more than 100 study centers across 40 countries. In total, it is planned that more than 2,500 patients will be enrolled in these studies.
Stopping treatment is not a clinical recommendation and should only be attempted in the context of a well-controlled clinical study. A very important part of these TFR studies is the inclusion of regular molecular monitoring with International Scale Real-Time Quantitative Polymerase Chain Reaction (IS RT-Q-PCR) testing. Once treatment is stopped, molecular monitoring is used to identify if a patient’s level of disease remains in deep molecular response or if the reintroduction of treatment is needed.
ENESTnd study details
ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Newly Diagnosed Patients) is a Phase III, randomized, open-label, multicenter trial comparing the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase. It is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients.
The study is being conducted at 217 global sites with 846 patients enrolled. Patients were randomized to receive Tasigna 300 mg twice daily (n=282), Tasigna 400 mg twice daily (n=281) or Glivec 400 mg once daily (n=283). The primary endpoint was major molecular response (MMR) at 12 months; the key secondary endpoint was durable MMR at 24 months (patients having MMR when evaluated at both 12 and 24 months). MMR was defined in this study as 0.1% or less of BCR-ABL, as measured by IS RT-Q-PCR. Patients on the Glivec treatment arm who had suboptimal response or treatment failure were allowed to escalate dose and/or switch to Tasigna in a separate extension study. These data, presented at ASH, were the five-year (defined as 60 cycles of 28 days) follow-up.
The five-year ENESTnd update found that higher rates of MMR, MR4 and MR4.5by five years were achieved in Tasigna versus Glivec-treated patients. The difference in the rates of both MR4 and MR4.5continued to be higher for both Tasigna 300 mg and 400 mg twice daily arms compared to Glivec (MR4: 9-14% difference by one year, 21-24% difference by five years; MR4.5: 6-10% difference by one year, 21-23% difference by five years). Fewer patients progressed to AP/BC on Tasigna versus Glivec. The estimated rates of patients whose disease did not progress to AP/BC at 60 months in the Glivec, Tasigna 300 mg and Tasigna 400 mg twice daily arms were 95.2%, 99.3% and 98.7%, respectively. The estimated rates of patients without on-treatment event (no death, progression to AP/BC, loss of partial cytogenetic response [PCyR], loss of CCyR or loss of complete hematologic response [CHR]) at 60 months in the Glivec, Tasigna 300 mg and Tasigna 400 mg twice daily arms were 92.6%, 95.0% and 97.4%, respectively. The estimated rates of patients who are alive (OS) at 60 months in the Glivec, Tasigna 300 mg and Tasigna 400 mg twice daily arms were 91.6%, 93.6% and 96.0%, respectively. The estimated rates of patients who didn’t die from a CML-related cause at 60 months in the Glivec, Tasigna 300 mg and Tasigna 400 mg twice daily arms were 93.7%, 97.7% and 98.5%, respectively. The safety profiles for both drugs were consistent with previous ENESTnd reports.
ENESTcmr study details
ENESTcmr (Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Complete Molecular Response) is an open-label, randomized, prospective, multi-center, Phase III study of Tasigna 400 mg twice daily versus Glivec (400 mg or 600 mg once daily) comparing kinetics of molecular response for patients with Ph+ CML in chronic phase who had achieved CCyR but were still BCR-ABL positive (i.e., had evidence of residual leukemia) after at least two years of treatment with Glivec. The study enrolled 207 patients. The patients were randomized into one of two treatment arms: Tasigna 400 mg twice daily versus continuing Glivec 400 mg or 600 mg once daily (same dose as at study entry).
The primary endpoint was the rate of best confirmed complete molecular response by 12 months of study therapy with Tasigna or Glivec. Secondary objectives included the kinetics of molecular response, duration of molecular response, progression-free survival (PFS) and OS in both arms and were previously presented. After 24 months on study, Glivec patients who did not achieve undetectable BCR-ABL transcript levels had the option to cross over to the Tasigna arm. Overall, 45 Glivec patients (44.6%) crossed over to Tasigna in the 36-month follow up. These data, presented at ASH, were the 36-month follow-up.
More patients treated with Tasigna continued to achieve deeper molecular responses versus Glivec. Among patients without documented MR4.5 at baseline, cumulative incidence of MR4.5 was higher in patients randomized to Tasigna versus Glivec (46.9% vs. 33.3%; nominal p=0.0453). Seven out of the 32 responders in the Glivec arm achieved MR4.5 after crossing over to Tasigna. Patients randomized to Tasigna achieved MR4.5 faster than those who remained on Glivec. Estimated median time to achieve MR4.5 was 24.0 months in the Tasigna arm. In this 36-month follow-up, the estimated median time has not been reached in the Glivec arm (nominal p=0.0011). The safety profiles for Tasigna and Glivec were consistent with prior studies. By 36 months, no patients in either arm progressed to AP/BC.
LASOR study details
LASOR (Imatinib Dose Optimization versus Nilotinib in CML Patients with Suboptimal Response to Imatinib) is a global, randomized, Phase III study comparing the efficacy of Tasigna 400 mg twice daily to Glivec 600 mg once daily in 191 patients with Ph+ CML in the chronic phase who have a failed cytogenetic response to Glivec (400 mg once daily). Patients were randomized to receive Tasigna 400 mg twice daily (n=96) or to dose escalate to Glivec 600 mg once daily (n=95). At the initiation of the study, these patients were considered to be suboptimal cytogenetic responders by ELN guidelines, however are now classified as treatment failures by updated recommendations.
The primary endpoint of the study was CCyR at six months, with a secondary endpoint of MMR at 12 months. Crossover to alternate treatment was allowed before and after the primary endpoint in patients who failed to achieve CCyR by six months or had loss of response or had intolerance to Glivec dose escalation at any time, consistent with standard of care.
Complete cytogenetic response at six months was observed in 47 (49%) and 40 (42.9%) patients in the Tasigna and Glivec arms, respectively (p=0.3844). The primary endpoint did not achieve statistical significance likely because of the confounding effects of crossover occurring before primary endpoint analysis. The most frequent reasons for crossover from Glivec to Tasigna were lack of efficacy (no CCyR after six months) in 28 (30%) patients, intolerance to Glivec dose escalation in 17 (18%) patients, loss of response in 10 (11%) patients, and other in one (1%) patient. While none of the patients who crossed over from Tasigna to Glivec achieved CCyR at six months, six Glivec patients who crossed over to Tasigna did achieve this primary endpoint. The key secondary endpoint of MMR at 12 months was achieved in 35 (36.5%) and 24 (25.3%) patients in the Tasigna and Glivec arms, respectively. Up until the data cut-off, 56 patients crossed over from Glivec to Tasigna and 13 patients crossed over from Tasigna to Glivec. Counting cross-over patients as non-responders, a greater number of patients on Tasigna achieved MMR at 12 months versus Glivec (34 [35.4%; 95% confidence interval (CI) 32-52%] versus 15 [15.8%; 95% CI 12-28%], respectively). The safety profiles for both drugs were consistent with prior reports of patients who switched therapy after inadequate responses to Glivec.
About Tasigna (nilotinib)
Tasigna® (nilotinib) is approved in more than 110 countries for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Glivec® (imatinib), and in more than 85 countries for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase.
Tasigna Important Safety Information
Use with caution in patients with uncontrolled or significant cardiac disease and in patients who have or may develop prolongation of QTc. Low levels of potassium or magnesium must be corrected prior to Tasigna administration. Monitor closely for an effect on the QTc interval. Baseline ECG is recommended prior to initiating therapy and as clinically indicated. Uncommon cases (0.1 to 1%) of sudden death have been reported in clinical studies in patients with significant risk factors.
Use with caution in patients with liver impairment, with a history of pancreatitis and with total gastrectomy. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not use Tasigna. Tasigna may cause fetal harm in pregnant women. Women taking Tasigna should not breastfeed.
The most frequent Grade 3 or 4 adverse events are hematological (neutropenia and thrombocytopenia) which are generally reversible and usually managed by withholding Tasigna temporarily or dose reduction. Monitor blood counts regularly. Pancreatitis has been reported. The most frequent non-hematologic adverse events were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, constipation and diarrhea. Most of these adverse events were mild to moderate in severity.
Please see full Prescribing Information available at www.tasigna.com.
About Glivec (imatinib)
Glivec® (imatinib) is approved in more than 110 countries for the treatment of all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST), which cannot be surgically removed and/or have metastasized and for the treatment of adult patients following complete surgical removal of KIT+ GIST.
Glivec Important Safety Information
Glivec can cause fetal harm in pregnant woman Glivec has been associated with severe edema (swelling) and serious fluid retention. Cytopenias (anemia, neutropenia, thrombocytopenia) are common, generally reversible and usually managed by withholding Glivec or dose reduction. Monitor blood counts regularly. Severe congestive heart failure and left ventricle dysfunction, severe liver problems including cases of fatal liver failure and severe liver injury requiring liver transplants have been reported. Caution in patients with cardiac dysfunction and hepatic dysfunction. Monitor carefully.
Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. Skin reactions, hypothyroidism in patients taking levothyroxine replacement , GI perforation, in some cases fatal, tumor lysis syndrome which can be life threatening have also been reported,with Glivec. Correct dehydration and high uric acid levels prior to treatment. Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use. In patients with hypereosinophilic syndrome and heart involvement, cases of heart disease have been associated with the initiation of Glivec therapy. Growth retardation has been reported in children taking Glivec. The long-term effects of extended treatment with Glivec on growth in children are unknown.
The most common side effects include fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash. Glivec should be taken with food and a large glass of water.
Please see full Prescribing Information.
The foregoing release contains forward-looking statements that can be identified by words such as “trend,” “committed,” “continues,” “commitment,” “underway,” “planned,” “will,” or similar terms, or by express or implied discussions regarding potential new indications or labeling for Tasigna or Glivec, or regarding potential future revenues from Tasigna and Glivec. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Tasigna or Glivec will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Tasigna and Glivec will be commercially successful in the future. In particular, management’s expectations regarding Tasigna and Glivec could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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*Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and Israel.
**In ENESTcmr, molecular response (reduction of BCR-ABL transcripts in the blood of patients) is measured at four levels, based on an international standard:
- MMR (<= 0.1% BCR-ABL)
- MR4 (<= 0.01% BCR-ABL)
- MR4.5 (<= 0.0032% BCR-ABL)
- Undetectable BCR-ABL (no detectable BCR-ABL transcript level with sample sensitivity of at least 4.5 log)
 Saglio G, et al. ENESTnd Update: Nilotinib (NIL) Vs Imatinib (IM) In Patients (pts) With Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP) and The Impact Of Early Molecular Response (EMR) and Sokal Risk At Diagnosis On Long-Term Outcomes. Abstract #92. 2013 American Society of Hematology Annual Meeting, New Orleans, LA.
 Leber B, et al. Achievement and Maintenance Of Deeper Molecular Response By Switching To Nilotinib In Patients (pts) With Chronic Myeloid Leukemia In Chronic Phase (CML-CP) With Residual Disease On Long-Term Imatinib: ENESTcmr 36-Month Follow-Up. Abstract #94. 2013 American Society of Hematology Annual Meeting, New Orleans, LA.
 Cortes J, et al. Switching To Nilotinib In Patients (pts) With Chronic Myeloid Leukemia In Chronic Phase (CML-CP) With Suboptimal Cytogenetic Response (CyR) On Imatinib: First Results Of The LASOR Trial. Abstract #95. 2013 American Society of Hematology Annual Meeting, New Orleans, LA.
 Baccarani M, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. Pre-published online June 26, 2013.
 Novartis data on file.
 National Comprehensive Cancer Network (NCCN): Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia, V4.2013. Available at: http://www.nccn.org/professionals/physician_gls/pdf/cml.pdf.
 Kim, D. Recent advances in the path toward the cure for chronic myeloid leukemia. The Korean Journal of Hematology. 2011; 46(3), 169-174.
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- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
- Donna Thomas Joins Visual Data Media Services as Senior Vice President of Sales, Americas
- Discover how business proposals almost write themselves with the use of Artificial Intelligence in a new update from Offorte.com
- Haizol, Where Buyers Meet Suppliers
- Digi Communications N.V. announces the publishing of the Financial Calendar for 2021
- Digi Communications NV announces: Final dismissal by the US Court of the claim brought by certain US citizens against all the initial defendants, including i-TV Digitális Távközlési Zrt
- Firebolt Group Joins Top 1% of Companies Recognized for Sustainability Efforts
- Electriq Global and GVG Oil Trade B.V. to partner in fuelling Passenger Canal Boats with Electriq Fuel
- Haizol Deliver Fast Lead Times & Quality Parts at speed in the lead up to Chinese New Year
- Digi Communications N.V. announces the conclusion a MVNO agreement between the Company’s Italian subsidiary (Digi Italy) and Vodafone regarding the access to Vodafone’s radio spectrum and mobile communication network and infrastructure
- Experts demand for more transparency for medical treatment of politicians
- Electriq Global will launch its Zero Emissions, Hydrogen-Rich Fuel in the Netherlands by powering passenger canal boats with an Electriq PowerPack in compliance with the Amsterdam municipality requirement that all passenger vessels will be emission-free from 2025
- Spanish team wins the Farming by Satellite Prize 2020
- Digi Communications N.V. announces the senior facility agreement concluded between Digi Group and a syndicate of banks
- Corma.de launches Social Links OSINT Academy
- Can Chinese save the world economy?
- Pleme social network has been building throughout the Pandemic
- Visual Data Media Services to Partner with Endeavour Capital for Next Phase of Growth
- Digi Communications NV announces the release of the Q3 2020 Financial Results
- Haizol Expand its Capabilities into Motorcycle Manufacturing & Custom Made Bike Parts
- Digi Communications NV announces Investors Call on the Financial Results for Q3 2020
- Dutch Police selects bodycams from Zepcam to support police officers on the street
- Palette Life Sciences expands availability of online education and resources for paediatric urologists across Europe
- Sumitomo Corporation Europe Limited and NORCE Norwegian Research Centre AS sign Memorandum of Understanding
- Syniti & SAP Expand Partnership to Increase Client Options for Moving Harmoniously to SAP S/4HANA
- China’s manufacturing industry continues to expand according to the latest Purchasing Managers’ Index figures, with Haizol at the forefront of the growth
- AutoSock sono conformi alla regolamentazione Svizzera riguardante le catene da neve
- Introverts, nerds and geeks make the best salespeople
- Digi Communications NV announces the extension of the agreement entered into between the Company’s subsidiary from Spain (Digi Spain) and Telefonica Moviles España, S.A. regarding the access to TME’s radio spectrum and mobile communication network and infrastructure
- Tiqets’ US Awakens Week Highlights Exclusive New Experiences From Newly Reopened Museums and Attractions
- Haizol Boosts Companies Operational Agility
- Eveliqure announces the initiation of a Phase 1 clinical study of its combined Shigella and ETEC vaccine candidate
- eFax führt das EMEA-Kanalprogramm ein
- eFax lance un programme de distribution dans la région EMEA
- Mono Solutions partners with Lokale Internetwerbung to launch in leadhub platform
- Syniti Launches Podcast Series to Address Growing Focus on Mergers, Acquisitions and Divestitures, featuring Leading CEOs
- Mono Solutions and Ecwid partner for the seamless delivery of websites with e-commerce for small businesses
- Galata Chemicals to produce Tin Stabilizers and Intermediates at Dahej, India
- Sintecs selected as Mentor’s value-added reseller of its HyperLynx® products in Europe focused on serving Altium Designer® users
- INFOCUS CORPORATION AND CELEXON EUROPE SIGN EXCLUSIVE EUROPEAN MASTER DISTRIBUTION AGREEMENT
- L’Awakening Week de Tiqets en France met en avant les nouvelles expériences exclusives de plus de 15 musées et attractions qui ont récemment rouvert
- Tiqets UK Awakens Celebrates Reopened Museums & Attractions and Sponsors Visits for NHS Staff
- Tiqets Awakening Weeks Brings Together 100+ Museums and Attractions to Celebrate Their Reopenings
- A Jewish-Bedouin Partnership is bringing the Negev cuisine to Europe
- Digi Communications NV announces the release of the H1 2020 Financial Results
- New Chief Financial Officers appointed at Mono Solutions & Bauer Media Group SME Services
- Digi Communications NV announces Investors Call on the Financial Results for H1 2020
- Palette Life Sciences AB and Gedeon Richter Plc. Receive National Marketing Authorization in the United Kingdom for Novel Pain Relief Product, LIDBREE™
- Palette Life Sciences launches Deflux.com/UK, an online resource for paediatric urologists, parents and caregivers in the United Kingdom
- Digi Communications N.V. announces the publishing of Independent Limited Assurance Report issued by the external auditor of the Company on 30 July 2020 regarding the information included in the current reports issued by the Company under Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- The Pavilions Hotels & Resorts Excited To Announce First Luxury Resort Brand In El Nido, Palawan Island Philippines
- New Customer Data Platform Options Emerge During Pandemic Slowdown: CDP Institute Report
- Digi Communications N.V. announces The Competition Council authorized the economic concentration accomplished by the Company’s Romanian subsidiary („RCS&RDS”) by gaining control over some of the assets held by Akta Telecom S.A., Digital Cable Systems S.A. and ATTP Telecommunications S.R.L.
- TABS Score™ Expands its European Footprint; Begins Partnership Discussions Amongst Key Players in EU Venture Ecosystem
- Mono and Brandify partner to bring appointment booking to local businesses
- Digi Communications N.V. announces ANCOM approval for RCS & RDS S.A. to continue to apply a surcharge for certain roaming services provided in the EEA for a renewed maximum period of 12 months
- DerbySoft Expands Metasearch Coverage for Hotels Around the World
- Palette Life Sciences Announces European Distribution Expansion for Deflux® and Solesta® for More Than Twenty Countries Through Five Leading Distributors and Direct Sales Effort
- Pierre Koukjian and Cedric Koukjian, Designer Duo in Collaboration with Bulgari
- Pierre Koukjian et Cédric Koukjian, Duo de designers en collaboration avec Bulgari
- Former Duff & Phelps EMEA Leader Yann Magnan joins 73 Strings as Co-founder and CEO
- Concern for the oceans drives consumers to 'vote with their forks' for sustainable seafood
- Digi Communications N.V.: Exercise of stock option by Marius Catalin Vărzaru, a Non-Executive Director and VP of the Board of Directors of the Company
- SecurLine Certified to Protect Classified Communications
- Digi Communications N.V. announces that a stock option programme was approved for employees and managers of the Romanian Subsidiary of the Company
- Digi Communications NV announces the exercise of stock options by the Executive Directors of the Company
- Matvil Corp. продолжает бороться с противозаконными действиями юридической системы Молдовы
- Digi Communications NV announces the release of the Q1 2020 Financial Results
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the general shareholders’ meeting approval from 30 April 2020
- MEDIS medical imaging systems acquires Advanced Medical Imaging Development S.r.l. (AMID) and secures further investment from Van Herk Ventures
- Digi Communications NV announces Investors Call on the Financial Results for Q1 2020
- Digi Communications N.V. announces the availability of the instructions on the 2019 share dividend payment
- Mono Solutions hires Chief Product Officer
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 30 Apr 2020
- Digi Communications N.V.: GSM resolutions from 30 Apr 2020 approving, amongst others, the 2019 Annual Accounts; availability of the adopted Annual Financial Report for the year ended Dec 31, 2019 for the Group
- RCH Embark on Lasting Partnership with Culinary Institute JRE
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Apr 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Apr 2020
- COVID-19: Digi Communications N.V. recommendation regarding participation of shareholders to the AGM convened for 30 April 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Apr 2020
- DIGI COMMUNICATIONS N.V.: Exercise of stock option by a Non-Executive Director of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Mar – 3 Apr 2020
- Chief Commercial Officer joins Mono Solutions
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 23 – 27 Mar 2020
- Digi Communications N.V. reports the admission to trading on the regulated market operated by the Irish Stock Exchange plc (trading as Euronext Dublin) of the senior secured notes issued by RCS & RDS S.A., its Romanian subsidiary
- Delft University of Technology Purchases its Second WebClip2Go Video Production System
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 16 – 20 Mar 2020
- Integrated Services Monitoring Capability Launched by Bridge Technologies
- Digi Communications N.V. announces Convocation of the Company’s general shareholders meeting for 30 April 2020 for the approval of, among others, the 2019 Annual Report and of the 2019 Financial Statements
- Digi Communications N.V. announces The Hungarian Competition Council’s decision to issue a new decision approving the Invitel transaction
- Digi Communications N.V. announces Business continuity in light of the novel coronavirus (“COVID-19”) outbreak
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 9 – 13 Mar 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in February 2020 or in other period but effective in February 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 2 – 6 Mar 2020
European Customer Data Platform Industry Grows Quickly Despite Limited Funding: CDP Institute
- « La levée du pilon sur la plate-forme » peut faire la différence entre le saint et l’ordinaire
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 24 – 28 Feb 2020
- EH GROUP ENGINEERING awarded EU Horizon 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 17 – 21 Feb 2020
- Digi Communications NV announces the release of the Preliminary Financial Results for year ended 31 December 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 10 – 14 Feb 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in January 2020 or in other period but effective in January 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications NV announces Investor Call on the Preliminary Financial Results for the year ended 31 December 2019
- Consolidation Looms for Fast-Growing Customer Data Platform Industry: CDP Institute Report
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 3–7 Feb 2020
- Digi Communications N.V. hereby reports successful closing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 31 Jan 2020
- Digi Communications N.V.: Independent Limited Assurance Report issued by the external auditor on 30 Jan 2020 regarding the information included in the current reports under Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- Digi Communications N.V.: Rectification of the report published on 15 Jan 2020, regarding legal documents concluded by DIGI COMMUNICATIONS N.V. in other periods but effective in Dec 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications N.V. reports the upsize and successful pricing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- RCH To Present New Smart ECR, Robust and Vintage POS Systems at EuroShop 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Jan 2020
- Digi Communications N.V.: (i) launch of an offering by RCS & RDS S.A. of senior secured notes; (ii) issuance of a notice of conditional full redemption of all outstanding €550.0m 5.0% senior secured notes due 2023 issued by the Company and (iii) restatement by the Company of its unaudited interim condensed consolidated financial statements for the 9-month period ended 30 Sep 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Jan 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in December 2019 or in other period but effective in December 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Jan 2020
- Berlin-based SuitePad named Best Places to Work in Hotel Tech 2020 category at HotelTechReport.com’s HotelTechAwards
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Dec 2019 – 3 Jan 2020
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