Wednesday, May 31, 2017

Takeda Showcases Broadened Oncology Portfolio Through Data Presentations at Upcoming Medical Meetings

 − Takeda to Share Data at the American Society of Clinical Oncology (ASCO) Annual Meeting, the Congress of the European Hematology Association (EHA) and the International Conference on Malignant Lymphoma (ICML) –

 − Data Underline Takeda’s Mission to Address the Unmet Needs of Patients Across a Wide Range of Cancers –




CAMBRIDGE, Mass. & OSAKA, Japan-Wednesday, May 31st 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the company will feature new clinical analyses and outcomes research during three upcoming medical meetings: the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), June 2-6 in Chicago, the 22nd Congress of the European Hematology Association (EHA), June 22-25 in Madrid, and the International Conference on Malignant Lymphoma 2017 (ICML), June 14-17 in Lugano, Switzerland. Presentations at this year’s meetings will highlight Takeda’s ongoing commitment to patients with hematologic cancers, while demonstrating a broadened portfolio with the recent addition of new targeted therapies and pipeline assets in solid tumors.

“Takeda Oncology’s presence at these upcoming medical meetings demonstrates our relentless pursuit to deliver innovations for patients with cancer,” said Christophe Bianchi, M.D., President, Takeda Oncology. “The data we are presenting highlight the depth and breadth of our recently expanded portfolio, now including both hematological malignancies and solid tumors with the recent approval of ALUNBRIG™ (brigatinib) for metastatic non-small cell lung cancer, and brings us one step closer to our aspiration to cure cancer.”

At ASCO, Takeda will present patient-reported outcomes and quality of life findings from the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial of ALUNBRIG™, which recently received Accelerated Approval from the U.S. Food and Drug Administration for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Approximately two to eight percent of patients with metastatic NSCLC have a rearrangement in the ALK gene. Results from an analysis of the drug’s activity in crizotinib-resistant ALK+ NSCLC patients according to ALK plasma mutation status will also be featured.

Both ASCO and EHA will feature findings from studies of Takeda medicines for the treatment of a variety of blood cancers, including lymphoma, multiple myeloma and chronic myeloid leukemia. Data from the Phase 3 ALCANZA study of ADCETRIS (brentuximab vedotin) in CD30-positive cutaneous T-cell lymphoma will be presented at both ASCO and EHA. Several Phase 1 and 2 studies investigating NINLARO (ixazomib) in patients with newly diagnosed multiple myeloma will be presented at EHA, including two oral presentations which evaluated ixazomib plus lenalidomide and dexamethasone followed by maintenance with single-agent ixazomib. In addition, ASCO and EHA will highlight five-year data from the Phase 2 PACE trial of ICLUSIG® (ponatinib) in heavily pretreated chronic phase chronic myeloid leukemia.

Among the nine Takeda-sponsored abstracts accepted for presentation during ASCO 2017 and 15 abstracts at EHA 2017, selected highlights include:

ASCO Annual Meeting 2017                           

ADCETRIS (brentuximab vedotin):

    Outcomes by CD30 Expression in Patients with CTCL Receiving Brentuximab Vedotin (BV) vs Physician's Choice (PC) in the Phase 3 ALCANZA Study. Abstract 7517. Monday, June 5, 8:00-11:30 a.m., Hall A (discussion session 1:15 p.m.-2:30 p.m. in E354b).

ALUNBRIG (brigatinib):

    Activity of Brigatinib (BRG) in Crizotinib (CRZ)-Resistant ALK+ NSCLC Patients (Pts) According to ALK Plasma Mutation Status. Abstract 9065. Saturday, June 3, 8:00-11:30 a.m., Hall A.
    Patient-reported Outcomes and Quality of Life in ALTA, the Randomized Phase 2 Study of Brigatinib (BRG) in Advanced ALK+ Non–small Cell Lung Cancer (NSCLC). Abstract 9066. Saturday, June 3, 8:00-11:30 a.m., Hall A.

ICLUSIG (ponatinib):

    Five-year Results of the Ponatinib Phase 2 PACE Trial in Heavily Pretreated CP-CML Patients (Pts). Abstract 7012. Monday, June 5, 8:00-11:30 a.m., Hall A (discussion session 11:30 a.m.-12:45 p.m. in E354b).

EHA 22nd Congress

ADCETRIS (brentuximab vedotin):

    Phase 3 ALCANZA Study of Brentuximab Vedotin (BV) or Physician's Choice (PC) of Methotrexate (MTX) or Bexarotene (BEX) in CD30-positive Cutaneous T-cell Lymphoma (CTCL): Number Needed to Treat Analysis. Abstract P637. Saturday, June 24, 5:30 – 7:00 p.m., Hall 7.

NINLARO (ixazomib):

    Deep and Durable Responses with Weekly Ixazomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma: Long-term Follow-up of Patients Who Did Not Undergo SCT. Abstract S408. Oral presentation. Saturday, June 24, 11:45 a.m. – 12:00 p.m., Hall A.
    Twice-weekly Ixazomib Plus Lenalidomide-dexamethasone in Patients with Newly Diagnosed Multiple Myeloma: Long-term Follow-up Data for Patients Who Did Not Undergo Stem Cell Transplantation (SCT). Abstract S780. Oral presentation. Sunday, June 25, 8:15 – 8:30 a.m., Hall D.

ICLUSIG (ponatinib):

    5-Yr Results from the Pivotal Phase 2 Ponatinib PACE Trial: Efficacy, Safety and Landmark Analysis in Heavily Pretreated Patients (Pts) with Chronic-Phase Chronic Myeloid Leukemia (CP-CML). Abstract P603. Saturday, June 24, 5:30-7:00 p.m., Hall 7.

For more information, please see ASCO (https://am.asco.org/program) and EHA (http://www.eha-2017.org/) online programs. Abstracts for ICML will be released on June 7.

About ADCETRIS® (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials, including three Phase 3 studies, the ongoing ECHELON-1 trial in frontline classical Hodgkin lymphoma and the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, as well as the completed ALCANZA trial in cutaneous T-cell lymphoma for which a supplemental BLA is planned in mid-2017.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

ADCETRIS has received marketing authorization by regulatory authorities in 66 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) Global Important Safety Information

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin is contraindicated as it causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens.

Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. ADCETRIS dosing should be held for any suspected case of PML and should be permanently discontinued if a diagnosis of PML is confirmed.

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. ADCETRIS should be held for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. New or worsening pulmonary symptoms should be promptly evaluated and treated appropriately.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have occurred with ADCETRIS. Patients should be carefully monitored during and after an infusion. If anaphylaxis occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered. If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. These patients should be monitored closely and managed according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically cumulative and reversible in most cases. Patients should be monitored for symptoms of PN, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported. Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops.

Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. If SJS or TEN occurs, treatment with ADCETRIS should be discontinued and appropriate medical therapy should be administered.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorragh, have been reported. New or worsening GI symptoms should be promptly evaluated and treated appropriately.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Liver function should be tested prior to treatment initiation and routinely monitored in patients receiving ADCETRIS. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. However, any patient who experiences an event of hyperglycemia should have their serum glucose closely monitored. Anti-diabetic treatment should be administered as appropriate.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations. The recommended starting dose in patients with hepatic impairment or severe renal impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Patients with renal or hepatic impairment should be closely monitored for adverse events.

Sodium content in excipients: This medicinal product contains a maximum of 2.1 mmol (or 47 mg) of sodium per dose. To be taken into consideration for patients on a controlled sodium diet.

INTERACTIONS
Patients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia and should be closely monitored. Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.

PREGNANCY: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus. If a pregnant woman needs to be treated, she should be clearly advised on the potential risk to the fetus.

LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.

FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose.

ADVERSE REACTIONS
Serious adverse drug reactions were: pneumonia, acute respiratory distress syndrome, headache, neutropenia, thrombocytopenia, constipation, diarrhea, vomiting, nausea, pyrexia, peripheral motor neuropathy, peripheral sensory neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome.

In the clinical studies of ADCETRIS, adverse reactions defined as very common (≥1/10) were: infection, upper respiratory tract infection, neutropenia, PN (sensory and motor), cough, dyspneoa, diarrhea, nausea, vomiting, constipation, abdominal pain, alopecia, pruritus, myalgia, arthralgia, fatigue, chills, pyrexia, infusion-related reactions and weight decreased. Adverse reactions defined as common (≥1/100 to <1/10) were: Sepsis/septic shock, herpes zoster, pneumonia, herpes simplex, anemia, thrombocytopenia, hyperglycemia, dizziness, demyelinating polyneuropathy, ALT/AST increased, rash, and back pain.

About NINLAROTM (ixazomib) capsules

NINLAROTM (ixazomib) is an oral proteasome inhibitor which is also being studied across the continuum of multiple myeloma treatment settings as well as systemic light-chain (AL) amyloidosis. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval. NINLARO was approved by the U.S. Food and Drug Administration (FDA) in November 2015 following a priority review. In the U.S., NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Ixazomib was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis in 2014.

The comprehensive ixazomib clinical development program, TOURMALINE, further reinforces Takeda's ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. TOURMALINE includes a total of five ongoing pivotal trials – four, which together are investigating every major multiple myeloma patient population, and one in light-chain amyloidosis:

    TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
    TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
    TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
    TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT; this study is currently enrolling
    TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis; this study is currently enrolling

In addition to the TOURMALINE program, ixazomib is being evaluated in multiple therapeutic combinations for various patient populations in investigator initiated studies globally.

NINLAROTM (ixazomib): Global Important Safety Information

SPECIAL WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO (28% vs. 14% in the NINLARO and placebo regimens, respectively) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. It did not result in an increase in hemorrhagic events or platelet transfusions. Monitor platelet counts at least monthly during treatment with NINLARO and consider more frequent monitoring during the first three cycles. Manage with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal toxicities have been reported in the NINLARO and placebo regimens respectively, such as diarrhea (42% vs. 36%), constipation (34% vs. 25%), nausea (26% vs. 21%), and vomiting (22% vs. 11%), occasionally requiring use of antiemetic and anti-diarrheal medications, and supportive care.

Peripheral neuropathy was reported with NINLARO (28% vs. 21% in the NINLARO and placebo regimens, respectively). The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

Peripheral edema was reported with NINLARO (25% vs. 18% in the NINLARO and placebo regimens, respectively). Evaluate patients for underlying causes and provide supportive care, as necessary. Adjust the dose of dexamethasone per its prescribing information or the dose of NINLARO for severe symptoms.

Cutaneous reactions occurred in 19% of patients in the NINLARO regimen compared to 11% of patients in the placebo regimen. The most common type of rash reported in both regimens was maculo-papular and macular rash. Manage rash with supportive care, dose modification or discontinuation.

Hepatotoxicity, drug-induced liver injury, hepatocellular injury, hepatic steatosis, and hepatitis cholestatic have been uncommonly reported with NINLARO. Monitor hepatic enzymes regularly and adjust dose for Grade 3 or 4 symptoms.

Pregnancy- NINLARO can cause fetal harm. Advise male and females patients of reproductive potential to use contraceptive measures during treatment and for an additional 90 days after the final dose of NINLARO. Women of childbearing potential should avoid becoming pregnant while taking NINLARO due to potential hazard to the fetus. Women using hormonal contraceptives should use an additional barrier method of contraception.

Lactation- It is not known whether NINLARO or its metabolites are excreted in human milk. There could be potential adverse events in nursing infants and therefore breastfeeding should be discontinued.

SPECIAL PATIENT POPULATIONS
Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.
Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis. NINLARO is not dialyzable and, therefore, can be administered without regard to the timing of dialysis.

DRUG INTERACTIONS
Co-administration of strong CYP3A inducers with NINLARO is not recommended.

ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen, and greater than in the placebo regimen, were diarrhea (42% vs. 36%), constipation (34% vs. 25%), thrombocytopenia (28% vs. 14%), peripheral neuropathy (28% vs. 21%), nausea (26% vs. 21%), peripheral edema (25% vs. 18%), vomiting (22% vs. 11%), and back pain (21% vs. 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.

For European Union Summary of Product Characteristics: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003844/WC500217620.pdf
For US Prescribing Information: https://www.ninlarohcp.com/pdf/prescribing-information.pdf
For Canada Product Monograph: http://www.takedacanada.com/ninlaropm

About ALUNBRIG™ (brigatinib)

ALUNBRIG is a targeted cancer medicine discovered by ARIAD Pharmaceuticals, Inc., which was acquired by Takeda in February 2017. ALUNBRIG received Accelerated Approval on April 28th 2017, from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under Accelerated Approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ALUNBRIG has also received Breakthrough Therapy Designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted Orphan Drug Designation by the FDA for the treatment of ALK+ NSCLC, ROS1+ and EGFR+ NSCLC. A Marketing Authorization Application (MAA) for ALUNBRIG was submitted to the European Medicines Agency (EMA) in February 2017.

The ALTA clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with ALK+ NSCLC worldwide and the healthcare professionals who treat them. In addition to the ongoing Phase 1/2 and Phase 2 ALTA trial, brigatinib is also being studied in the Phase 3 ALTA 1L trial to assess its efficacy and safety in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor.

To learn more about ALUNBRIG, please visit www.ALUNBRIG.com or call ALUNBRIG 1POINT at 1-844-A1POINT (1-844-217-6468).

For additional information on the brigatinib clinical trials, please visit www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION (US)

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG. In Trial ALTA (ALTA), ILD/pneumonitis occurred in 3.7% of patients in the 90 mg group (90 mg once daily) and 9.1% of patients in the 90→180 mg group (180 mg once daily with 7-day lead-in at 90 mg once daily). Adverse reactions consistent with possible ILD/pneumonitis occurred early (within 9 days of initiation of ALUNBRIG; median onset was 2 days) in 6.4% of patients, with Grade 3 to 4 reactions occurring in 2.7%. Monitor for new or worsening respiratory symptoms (e.g., dyspnea, cough, etc.), particularly during the first week of initiating ALUNBRIG. Withhold ALUNBRIG in any patient with new or worsening respiratory symptoms, and promptly evaluate for ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary embolism, tumor progression, and infectious pneumonia). For Grade 1 or 2 ILD/pneumonitis, either resume ALUNBRIG with dose reduction after recovery to baseline or permanently discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3 or 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.

Hypertension: In ALTA, hypertension was reported in 11% of patients in the 90 mg group who received ALUNBRIG and 21% of patients in the 90→180 mg group. Grade 3 hypertension occurred in 5.9% of patients overall. Control blood pressure prior to treatment with ALUNBRIG. Monitor blood pressure after 2 weeks and at least monthly thereafter during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 hypertension despite optimal antihypertensive therapy. Upon resolution or improvement to Grade 1 severity, resume ALUNBRIG at a reduced dose. Consider permanent discontinuation of treatment with ALUNBRIG for Grade 4 hypertension or recurrence of Grade 3 hypertension. Use caution when administering ALUNBRIG in combination with antihypertensive agents that cause bradycardia.

Bradycardia: Bradycardia can occur with ALUNBRIG. In ALTA, heart rates less than 50 beats per minute (bpm) occurred in 5.7% of patients in the 90 mg group and 7.6% of patients in the 90→180 mg group. Grade 2 bradycardia occurred in 1 (0.9%) patient in the 90 mg group. Monitor heart rate and blood pressure during treatment with ALUNBRIG. Monitor patients more frequently if concomitant use of drug known to cause bradycardia cannot be avoided. For symptomatic bradycardia, withhold ALUNBRIG and review concomitant medications for those known to cause bradycardia. If a concomitant medication known to cause bradycardia is identified and discontinued or dose adjusted, resume ALUNBRIG at the same dose following resolution of symptomatic bradycardia; otherwise, reduce the dose of ALUNBRIG following resolution of symptomatic bradycardia. Discontinue ALUNBRIG for life-threatening bradycardia if no contributing concomitant medication is identified.

Visual Disturbance: In ALTA, adverse reactions leading to visual disturbance including blurred vision, diplopia, and reduced visual acuity, were reported in 7.3% of patients treated with ALUNBRIG in the 90 mg group and 10% of patients in the 90→180 mg group. Grade 3 macular edema and cataract occurred in one patient each in the 90→180 mg group. Advise patients to report any visual symptoms. Withhold ALUNBRIG and obtain an ophthalmologic evaluation in patients with new or worsening visual symptoms of Grade 2 or greater severity. Upon recovery of Grade 2 or Grade 3 visual disturbances to Grade 1 severity or baseline, resume ALUNBRIG at a reduced dose. Permanently discontinue treatment with ALUNBRIG for Grade 4 visual disturbances.

Creatine Phosphokinase (CPK) Elevation: In ALTA, creatine phosphokinase (CPK) elevation occurred in 27% of patients receiving ALUNBRIG in the 90 mg group and 48% of patients in the 90 mg→180 mg group. The incidence of Grade 3-4 CPK elevation was 2.8% in the 90 mg group and 12% in the 90→180 mg group. Dose reduction for CPK elevation occurred in 1.8% of patients in the 90 mg group and 4.5% in the 90→180 mg group. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK levels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK elevation. Upon resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Pancreatic Enzyme Elevation: In ALTA, amylase elevation occurred in 27% of patients in the 90 mg group and 39% of patients in the 90→180 mg group. Lipase elevations occurred in 21% of patients in the 90 mg group and 45% of patients in the 90→180 mg group. Grade 3 or 4 amylase elevation occurred in 3.7% of patients in the 90 mg group and 2.7% of patients in the 90→180 mg group. Grade 3 or 4 lipase elevation occurred in 4.6% of patients in the 90 mg group and 5.5% of patients in the 90→180 mg group. Monitor lipase and amylase during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Hyperglycemia: In ALTA, 43% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 3.7% of patients. Two of 20 (10%) patients with diabetes or glucose intolerance at baseline required initiation of insulin while receiving ALUNBRIG. Assess fasting serum glucose prior to initiation of ALUNBRIG and monitor periodically thereafter. Initiate or optimize anti-hyperglycemic medications as needed. If adequate hyperglycemic control cannot be achieved with optimal medical management, withhold ALUNBRIG until adequate hyperglycemic control is achieved and consider reducing the dose of ALUNBRIG or permanently discontinuing ALUNBRIG.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to pregnant women. There are no clinical data on the use of ALUNBRIG in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of ALUNBRIG.

ADVERSE REACTIONS
Serious adverse reactions occurred in 38% of patients in the 90 mg group and 40% of patients in the 90→180 mg group. The most common serious adverse reactions were pneumonia (5.5% overall, 3.7% in the 90 mg group, and 7.3% in the 90→180 mg group) and ILD/pneumonitis (4.6% overall, 1.8% in the 90 mg group and 7.3% in the 90→180 mg group). Fatal adverse reactions occurred in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (1 patient each).

The most common adverse reactions (≥25%) in the 90 mg group were nausea (33%), fatigue (29%), headache (28%), and dyspnea (27%) and in the 90→180 mg group were nausea (40%), diarrhea (38%), fatigue (36%), cough (34%), and headache (27%).

DRUG INTERACTIONS
CYP3A Inhibitors: Avoid concomitant use of ALUNBRIG with strong CYP3A inhibitors. Avoid grapefruit or grapefruit juice as it may also increase plasma concentrations of brigatinib. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG.
CYP3A Inducers: Avoid concomitant use of ALUNBRIG with strong CYP3A inducers.
CYP3A Substrates: Coadministration of ALUNBRIG with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of CYP3A substrates.

USE IN SPECIFIC POPULATIONS
Pregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.

Lactation: Advise lactating women not to breastfeed during treatment with ALUNBRIG and for 1 week following the final dose.

Females and Males of Reproductive Potential:
Contraception: Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALUNBRIG and for at least 3 months after the final dose.

Infertility: ALUNBRIG may cause reduced fertility in males.

Pediatric Use: The safety and efficacy of ALUNBRIG in pediatric patients have not been established.

Geriatric Use: Clinical studies of ALUNBRIG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Of the 222 patients in ALTA, 19.4% were 65-74 years and 4.1% were 75 years or older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 and younger patients.

Hepatic or Renal Impairment: No dose adjustment is recommended for patients with mild hepatic impairment or mild or moderate renal impairment. The safety of ALUNBRIG in patients with moderate or severe hepatic impairment or severe renal impairment has not been studied.

For US Prescribing Information: https://www.alunbrig.com/assets/pi.pdf

About ICLUSIG® (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD's computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

    Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
    Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

Limitations of use:

Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.

IMPORTANT SAFETY INFORMATION

Based on the Phase 2 48-month follow-up analysis (N=449), except where noted

WARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning.

    Arterial occlusion has occurred in at least 35% of Iclusig® (ponatinib)-treated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Interrupt or stop Iclusig immediately for arterial occlusion. A benefit-risk consideration should guide a decision to restart Iclusig.
    Venous Thromboembolism has occurred in 6% of Iclusig-treated patients. Monitor for evidence of thromboembolism. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.
    Heart Failure, including fatalities occurred in 9% of Iclusig treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
    Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Warnings and Precautions

Arterial Occlusions: Arterial occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease have occurred in at least 35% of Iclusig-treated patients from the phase 1 and phase 2 trials. In the phase 2 trial, 33% (150/449) of Iclusig-treated patients experienced a cardiac vascular (21%), peripheral vascular (12%), or cerebrovascular (9%) arterial occlusive event; some patients experienced more than 1 type of event. Fatal and life-threatening events have occurred within 2 weeks of starting treatment, with doses as low as 15 mg per day. Iclusig can also cause recurrent or multi-site vascular occlusion. Patients have required revascularization procedures. The median time to onset of the first cardiac vascular, cerebrovascular, and peripheral vascular arterial occlusive events was 193, 526, and 478 days, respectively. Patients with and without cardiovascular risk factors, some age 50 years or younger, experienced these events. The most common risk factors observed with these events were hypertension, hyperlipidemia, and history of cardiac disease. Arterial occlusive events were more frequent with increasing age and in patients with a history of ischemia, hypertension, diabetes, or hyperlipidemia. In patients suspected of developing arterial occlusive events, interrupt or stop Iclusig.

Venous Thromboembolism: Venous thromboembolic events occurred in 6% (25/449) of Iclusig-treated patients with an incidence rate of 5% (13/270 CP-CML), 4% (3/85 AP-CML), 10% (6/62 BP-CML) and 9% (3/32 Ph+ ALL). Events included: deep venous thrombosis, pulmonary embolism, superficial thrombophlebitis, and retinal vein thrombosis with vision loss. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.

Heart Failure: Fatal or serious heart failure or left ventricular dysfunction occurred in 6% of Iclusig-treated patients (29/449). Nine percent of patients (39/449) experienced any grade of heart failure or left ventricular dysfunction. The most frequently reported heart failure events were congestive cardiac failure and decreased ejection fraction (14 patients each; 3%). Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation if serious heart failure develops.

Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in a patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with BP-CML or Ph+ ALL. Severe hepatotoxicity occurred in all disease cohorts, with 11% (50/449) experiencing grade 3 or 4 hepatotoxicity. The most common forms of hepatotoxicity were elevations of AST or ALT (54% all grades, 8% grade 3 or 4, 5% not reversed at last follow-up), bilirubin, and alkaline phosphatase. Hepatotoxic events were observed in 29% of patients. The median time to onset of hepatotoxicity event was 3 months. Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, reduce or discontinue Iclusig as clinically indicated.

Hypertension: Treatment-emergent elevation of systolic or diastolic blood pressure (BP) occurred in 68% (306/449) of Iclusig-treated patients. Fifty-three patients (12%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In patients with baseline systolic BP<140 mm Hg and baseline diastolic BP<90 mm Hg, 80% (229/285) experienced treatment-emergent hypertension; 44% (124/285) developed Stage 1 hypertension, 37% developed Stage 2 hypertension. In 132 patients with Stage 1 hypertension at baseline, 67% (88/132) developed Stage 2 hypertension. Monitor and manage blood pressure elevations during Iclusig use and treat hypertension to normalize blood pressure. Interrupt, dose reduce, or stop Iclusig if hypertension is not medically controlled. In the event of significant worsening, labile or treatment-resistant hypertension, interrupt treatment and consider evaluating for renal artery stenosis.

Pancreatitis: Pancreatitis occurred in 7% (31/449, 6% serious or grade 3/4) of Iclusig-treated patients. The incidence of treatment-emergent lipase elevation was 42% (16% grade 3 or greater). Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (26/449). The median time to onset of pancreatitis was 14 days. Twenty-three of the 31 cases of pancreatitis resolved within 2 weeks with dose interruption or reduction. Check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Consider additional serum lipase monitoring in patients with a history of pancreatitis or alcohol abuse. Dose interruption or reduction may be required. In cases where lipase elevations are accompanied by abdominal symptoms, interrupt treatment with Iclusig and evaluate patients for pancreatitis. Do not consider restarting Iclusig until patients have complete resolution of symptoms and lipase levels are less than 1.5 x ULN.

Increased Toxicity in Newly Diagnosed Chronic Phase CML: In a prospective randomized clinical trial in the first-line treatment of newly diagnosed patients with chronic phase (CP) CML, single agent Iclusig 45 mg once-daily increased the risk of serious adverse reactions 2-fold compared to single agent imatinib 400 mg once-daily. The median exposure to treatment was less than 6 months. The trial was halted for safety in October 2013. Arterial and venous thrombosis and occlusions occurred at least twice as frequently in the Iclusig arm compared to the imatinib arm. Compared to imatinib-treated patients, Iclusig-treated patients exhibited a greater incidence of myelosuppression, pancreatitis, hepatotoxicity, cardiac failure, hypertension, and skin and subcutaneous tissue disorders. Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 20% (90/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). The most common peripheral neuropathies reported were paresthesia (5%, 23/449), neuropathy peripheral (4%, 19/449), hypoesthesia (3%, 15/449), dysgeusia (2%, 10/449), muscular weakness (2%, 10/449) and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 2% (10/449) of Iclusig-treated patients (<1%, 3/449 - grade 3/4). Of the patients who developed neuropathy, 26% (23/90) developed neuropathy during the first month of treatment. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Consider interrupting Iclusig and evaluate if neuropathy is suspected.

Ocular Toxicity: Serious ocular toxicities leading to blindness or blurred vision have occurred in Iclusig-treated patients. Retinal toxicities including macular edema, retinal vein occlusion, and retinal hemorrhage occurred in 2% of Iclusig-treated patients. Conjunctival irritation, corneal erosion or abrasion, dry eye, conjunctivitis, conjunctival hemorrhage, hyperaemia and edema or eye pain occurred in 14% of patients. Visual blurring occurred in 6% of patients. Other ocular toxicities include cataracts, periorbital edema, blepharitis, glaucoma, eyelid edema, ocular hyperaemia, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.

Hemorrhage: Serious hemorrhage events including fatalities, occurred in 6% (28/449) of patients treated with Iclusig. Hemorrhage occurred in 28% (124/449) of patients. The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML, and Ph+ ALL. Gastrointestinal hemorrhage and subdural hematoma were the most commonly reported serious bleeding events occurring in 1% (4/449) each. Most hemorrhagic events, but not all, occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and evaluate.

Fluid Retention: Fluid retention events judged as serious occurred in 4% (18/449) of patients treated with Iclusig. One instance of brain edema was fatal. For fluid retention events occurring in >2% of the patients (treatment-emergent), serious cases included: pleural effusion (7/449, 2%), pericardial effusion (4/449, 1%), and edema peripheral (2/449, <1%).

In total, fluid retention occurred in 31% of the patients. The most common fluid retention events were peripheral edema (17%), pleural effusion (8%), pericardial effusion (4%) and peripheral swelling (3%).

Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated.

Cardiac Arrhythmias: Arrhythmias occurred in 19% (86/449) of Iclusig-treated patients, of which 7% (33/449) were grade 3 or greater. Arrhythmia of ventricular origin was reported in 3% (3/86) of all arrhythmias, with one case being grade 3 or greater. Symptomatic bradyarrhythmias that led to pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients.

Atrial fibrillation was the most common arrhythmia and occurred in 7% (31/449) of patients, approximately half of which were grade 3 or 4. Other grade 3 or 4 arrhythmia events included syncope (9 patients; 2.0%), tachycardia and bradycardia (2 patients each 0.4%), and electrocardiogram QT prolonged, atrial flutter, supraventricular tachycardia, ventricular tachycardia, atrial tachycardia, atrioventricular block complete, cardio-respiratory arrest, loss of consciousness, and sinus node dysfunction (1 patient each 0.2%). For 27 patients, the event led to hospitalization.

In patients with signs and symptoms suggestive of slow heart rate (fainting, dizziness) or rapid heart rate (chest pain, palpitations or dizziness), interrupt Iclusig and evaluate.

Myelosuppression: Myelosuppression was reported as an adverse reaction in 59% (266/449) of Iclusig-treated patients and grade 3/4 myelosuppression occurred in 50% (226/449) of patients. The incidence of these events was greater in patients with AP-CML, BP-CML, and Ph+ ALL than in patients with CP-CML. Severe myelosuppression (Grade 3 or 4) was observed early in treatment, with a median onset time of 1 month (range <1-40 months). Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically indicated, and adjust the dose as recommended.

Tumor Lysis Syndrome: Two patients (<1%, one with AP-CML and one with BP-CML) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (31/449) of patients. Due to the potential for tumor lysis syndrome in patients with advanced disease, ensure adequate hydration and treat high uric acid levels prior to initiating therapy with Iclusig.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Postmarketing cases of reversible posterior leukoencephalopathy syndrome (RPLS—also known as Posterior Reversible Encephalopathy Syndrome (PRES)) have been reported in Iclusig-treated patients. RPLS is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances. Hypertension is often present and diagnosis is made with supportive findings on magnetic resonance imaging (MRI) of the brain. If RPLS is diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of RPLS.

Compromised Wound Healing and Gastrointestinal Perforation: Since Iclusig may compromise wound healing, interrupt Iclusig for at least 1 week prior to major surgery. Serious gastrointestinal perforation (fistula) occurred in one patient 38 days post-cholecystectomy.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings from animal studies, Iclusig can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at exposures lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Iclusig and for 3 weeks after the last dose.

Adverse Reactions
Most Common Adverse Reactions: Overall, the most common non-hematologic adverse reactions (≥20%) were abdominal pain, rash, constipation, headache, dry skin, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.

Drug Interactions
Strong CYP3A Inhibitors: Avoid concurrent use or reduce ICLUSIG dose if co-administration cannot be avoided.

Strong CYP3A Inducers: Avoid concurrent use.

Use in Specific Populations
Females and Males of Reproductive Potential: ICLUSIG can cause fetal harm when administered to pregnant women. Advise females to use effective contraception during treatment with ICLUSIG and for 3 weeks after the last dose. Ponatinib may impair fertility in females and it is not known if these effects are reversible. Verify pregnancy status of females of reproductive potential prior to initiating ICLUSIG.

Lactation: Advise women not to breastfeed during treatment with ICLUSIG and for six days after last dose.

For US Prescribing Information: http://www.iclusig.com/pi

About Takeda

Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.

Contacts

Takeda Pharmaceutical Company Limited
Japanese Media
Tsuyoshi Tada, +81 (0) 3-3278-2417
tsuyoshi.tada@takeda.com
or
European Media
Kate Burd, +44 7974 151510
kate.burd@takeda.com



or
Media outside Japan/EU
Amy Atwood, +1-617-551-3683
amy.atwood@takeda.com
or
Liza Heapes, +1-617-621-2315
liza.heapes@ariad.com
or
Sara Noonan, +1-617-551-3683
sara.noonan@takeda.com


Permalink : http://me-newswire.net/news/4000/en

KLAS report: InterSystems TrakCare Tops Global EMR Deployments

Influential report finds that hospitals outside the US choose InterSystems more than any other Electronic Medical Record software vendor, to meet shifting demands of today’s healthcare environment.


CAMBRIDGE, Mass. -Sunday, May 28th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- The electronic medical record (EMR) technology from InterSystems has been deployed by more hospitals than any other vendor’s software during the past four years, according to a research report published today by the internationally recognized research organization KLAS. InterSystems TrakCare®, a unified healthcare information system, has ‘pulled ahead’ of its competitors as a preferred solution, winning significantly more new hospitals globally (non US) than any other supplier in 2016, the report found.

The influential report examines new hospital EMR contracts worldwide, outside of the United States, and found a significant increase in EMR purchasing decisions across the globe in 2016, with TrakCare being a market leader in new hospital wins. Detailing 56 total hospital wins for InterSystems in 2016, the report acknowledged a lower all-in-cost and high proportion of multi-facility contracts for InterSystems customers.

“Broad functionality and a light IT footprint have led to InterSystems being deployed by more hospitals over the past four years than any other solution,” the report said. “InterSystems’ strong 2016 across Europe, Asia, and the Middle East – which included new contracts with several multihospital organizations in the UK and China – was driven by an all-in cost lower than Cerner’s and Epic’s.”

“InterSystems is working with some of the world’s most digitally progressive healthcare providers, who are using TrakCare to improve care and empower clinicians with clinically advanced IT solutions,” said Christine Chapman, vice president for TrakCare at InterSystems. “The success speaks to our commitment to patients and providers alike, our proven ability to deliver value for customers in diverse countries, and a growing need for solutions that respond to the needs of different care settings.”

Highlights from the report included:

    Hospitals wanting a “good mix of functionality with a lower all-in price” during the past three to four years “deployed or chose to deploy InterSystems more than any other vendor.”
    InterSystems contracts represented the highest total number of inpatient facilities, thanks to decisions by multi-site customers such as a public health board in Scotland, a private maternity group in China, and a private hospital group in England.
    InterSystems was reported to be “winning in the UK,” where healthcare providers were said to prefer InterSystems to UK-specific alternatives, and that despite financing challenges faced in the country, providers finalized several EMR contracts. InterSystems “far and away had the most new hospitals associated to these contracts,” the report said, highlighting signings with a health board in Scotland, a large private hospital group and a consortium of NHS trusts.
    InterSystems is the only vendor featured in the report to have clients in China and Thailand on their “go-forward solution” with the corporation expanding presence in both countries in 2016 – including a group of maternity hospitals in China and a well-known private hospital in Thailand.

    The report described InterSystems’ expansion in Asia and market presence in Europe and the Middle East, with commentary highlighting new InterSystems contracts in countries including Italy and France and with a hospital group in the United Arab Emirates.

For more information on the KLAS report visit KLAS online at www.klasresearch.com.

About KLAS

KLAS is a research firm on a global mission to improve healthcare delivery by enabling providers to be heard and counted. Working with thousands of healthcare executives and clinicians, KLAS gathers data on software, services, medical equipment and infrastructure systems to deliver timely reports, trends and statistical overviews. The research directly represents the provider voice and acts as a catalyst for improving supplier performance. KLAS was founded in 1996, and their staff and advisory board average 25 years of healthcare information technology experience. Follow KLAS on Twitter at www.twitter.com/KLASresearch.

About InterSystems

InterSystems is the engine behind the world’s most important applications. In healthcare, finance, government, and other sectors where lives and livelihoods are at stake, InterSystems is the power behind what mattersTM. Founded in 1978, InterSystems is a privately held company headquartered in Cambridge, Massachusetts (USA), with offices worldwide, and its software products are used daily by millions of people in more than 80 countries. For more information, visit InterSystems.com.

ICVR, LLC Established to Create Standard for VR Headset Connectivity

 Industry Standard Based on DisplayPort over USB-C Will Accelerate Growth of VR Ecosystem

SANTA CLARA, Calif. -Wednesday, May 31st 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- ICVR, LLC has been founded by LG Electronics, Analogix Semiconductor, Tencent, and Dell to develop the Interface for Connected VR (ICVR™) standard, which defines how virtual reality source (VRS) devices, such as smartphones, PCs and other consumer electronics, connect and interoperate with head-mounted displays (HMD).

An open industry standard for virtual reality (VR), augmented reality (AR), and mixed reality (MR) headset connectivity based on DisplayPort™ over USB-C™, ICVR carries high quality multi-channel audio, high-definition video, and the head tracking measurement data required to render the virtual environment between the VRS and the HMD. Industry standard content protection technology is also available.

Separating the VR source device from the head-mounted display means that the VR HMD has no heavy battery, no warm CPU, and no transmitting radio next to the user’s head. This allows manufacturers to optimize the headset for high-performance, comfortable and immersive VR experience. The ICVR standard also simplifies mobile device architectures by removing the burden of more expensive screens and sensors required for phone-based VR applications.

“The ICVR connectivity standard allows interoperability between devices from different manufacturers of VR solutions and will give consumers confidence that their VR headsets will work with any ICVR compliant smartphones or PCs. That is, a VR source device from one manufacturer will work with a VR or AR headset from another manufacturer,” said Ramchan Woo, vice president, new product development at LG Electronics. “This will drive an increased level of investment in VR products by hardware manufacturers, developers, and content creators, bringing more applications and an improved VR user experience to consumers.”

The universality of USB Type-C eliminates proprietary protocols and connectors, which is beneficial for the entire VR ecosystem.

“VR solutions available in the market today are all proprietary so they don’t interoperate with each other. DisplayPort over USB-C carries the power, data, and high-definition video/audio needed to drive a high-quality VR headset in a single, thin and light, standard cable,” said Dr. Ning Zhu, Chief Technology Officer for Analogix. “We are going to see a whole new category of innovative high-performance, lightweight, and affordable HMDs come to market powered by a connected VR smartphone or PC. The ICVR connectivity standard allows VR HMD makers to tap into the existing USB Type-C ecosystem, benefiting from mobile devices that already support DisplayPort over USB-C and accessories such as extended cables and adapters to older interfaces.”

“Part of our leadership role is to help the industry define and drive open standards for technologies that can lead to better VR/AR/MR experiences. Connecting and powering a VR headset environment today involves multiple cables; our goal is to leverage a single cable connectivity solution that can simplify set-up and maintain the necessary performance and quality,” said Liam Quinn, CTO at Dell.

The ICVR specification will be available for adopters who join ICVR, LLC in Q3 2017. Organizations interested in learning more about ICVR and how to become an adopter should send an email to: adopter@icvrllc.org.

About ICVR, LLC

ICVR, LLC oversees and manages the development, adoption, and promotion of the ICVR Specification. The ICVR Specification was developed by LG Electronics, Analogix Semiconductor, Tencent, and Dell as an open standard for virtual reality headset connectivity. ICVR, LLC is a wholly owned subsidiary of Analogix Semiconductor, Inc.

For more information visit www.icvrllc.org, follow us on Twitter @ICVRLLC, or connect with us on LinkedIn.

ICVR™ is a trademark or registered trademark of ICVR, LLC. All other trademarks and trade names are the property of their respective owners.



Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=51565570&lang=en

Contacts

ICVR, LLC Media Contact
Gratia Stefan, 408-988-8848
pr@icvrllc.org

Permalink : http://me-newswire.net/news/3996/en

A.M. Best Briefing: VAT Implementation Poses Significant Challenges for GCC Insurers



LONDON -Wednesday, May 31st 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- Uncertainty persists as to when precisely Value Added Tax (VAT) will be introduced in the member states of the Gulf Cooperation Council (GCC), and the process surrounding a roll-out. However, given the fiscal pressures in the region, the introduction of taxation seems inevitable and could cause short-term cash-flow issues for insurers.

The GCC member states of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates (the UAE) are in the process of establishing separate national legislation to simultaneously adopt taxation on 1 January, 2018. Laws for the implementation of VAT under the unified Gulf Cooperation Council (GCC) Value Added Tax (VAT) Framework Agreement are still to be passed in most GCC member states, but should the deadline remain, this could mean that companies and markets may have to rush towards implementation.

In a new briefing, “VAT Implementation Poses Significant Challenges for GCC Insurers,” A.M. Best states that as implementation laws have yet to be passed, this has resulted in a debate as to whether the target date is achievable. Whilst there may be some delay, in A.M. Best’s opinion, VAT likely is to be introduced as quickly as possible. Public financing across the GCC has become more restrained in recent years, reflecting the decrease in revenue from the sharp fall in the oil price. As a result, the introduction of VAT at a standard rate of 5% appears inevitable as governments seek to bolster their inward receipts.

Aneela Mather-Khan, associate financial analyst, said: "A.M. Best notes that the implementation of the VAT rules will increase the cost of doing business for insurers in the GCC as VAT will be applied to almost all goods and services in the value chain, including outsourced services."

The briefing also notes that few insurers appear to be prepared for the change in legislation, with some assuming that any impact would be limited. Salman Siddiqui, associate director, added: "A.M. Best believes that insurers should consider the implementation of VAT as part of their risk management framework, paying particular attention to the correct classification of all business transactions."

With regards to the credit quality of insurers, A.M. Best believes that there likely is to be an adjustment period, where insurers will have to take a hit to move in-line with the requirements. This could affect operating performance and capitalisation, although this would likely be a short-term effect, while companies adjust pricing as policies renew.

To access a complimentary copy of this special briefing, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=262168.

A.M. Best is the world’s oldest and most authoritative insurance rating and information source. For more information, visit www.ambest.com.

Copyright © 2017 by A.M. Best Rating Services, Inc. and/or its subsidiaries.

ALL RIGHTS RESERVED.

Contacts

A.M. Best
Salman Siddiqui, +44 20 7397 0331
Associate Director
salman.siddiqui@ambest.com
or
Aneela Mather-Khan, +44 20 7397 0319
Financial Analyst
aneela.mather-khan@ambest.com
or
Edem Kuenyehia, +44 20 7397 0280
Director, Market Development & Communications
edem.kuenyehia@ambest.com
or
Jim Peavy, +1-908-439-2200, ext. 5159
Director, Public Relations
james.peavy@ambest.com
or
Yvette Essen, +44 20 7397 0322
Director, Research & Communications - Europe & Emerging Markets
yvette.essen@ambest.com

Permalink : http://www.me-newswire.net/news/3994/en

World Bedwetting Day Steering Committee: New global guidelines call for more effective treatment for bedwetting, a common condition which affects 1 in 15 children1

SAINT-PREX, Switzerland-Tuesday, May 30th 2017 [ ME NewsWire ]

    Bedwetting affects 1 in 15 seven year olds1
    Boys are twice as likely to suffer as girls and the risk is 44% if one parent wet the bed and 77% if both did, suggesting a genetic link2
    Bedwetting has a serious impact on self-esteem, emotional well-being, functioning and school/work performance3,4,5
    Treatment is available, yet in most cases there may be a significant delay before a child is seen by a healthcare professional about their bedwetting problem

(BUSINESS WIRE)-- The World Bedwetting Day Steering Committee (WBD-SC) has launched simplified practical guidelines to help healthcare professionals understand how best to treat bedwetting.

“For decades, people thought children would outgrow wetting the bed, but we know now that it is a medical condition which can be treated relatively easily,” says Professor Serdar Tekgül at the Department of Urology at Hacettepe University. “Bedwetting affects more boys than girls and has a big impact on social wellbeing, so I would urge everyone affected to see a doctor and see what help is available.”

Bedwetting is a common medical condition that has a serious impact on a child’s self-esteem, emotional well-being and day time functioning, including school and social performance2,3,5. Bedwetting has been linked to brain function/psychological problems and improvements in their working memory and other daily activities have been seen after treatment6.

The impact of bedwetting is often underestimated and training for healthcare professionals rarely includes specific guidance on bedwetting. Using the worldwide input of the steering committee members, the simplified guidelines act as a clear, reliable source of information to healthcare professionals across the globe, to improve treatment and thereby limit the child’s burden caused by bedwetting.

Professor Serdar Tekgül at the Department of Urology at Hacettepe University said, “Half of parents whose children wet the bed don’t seek medical help, preferring to try lifestyle solutions, which means there may be a significant delay before a patient has visited a healthcare professional about their bedwetting problem. So it really is important that when they see a doctor, they get the right support and guidance needed.”

About Bedwetting

Bedwetting, also known as nocturnal enuresis, is an uncontrollable leakage of urine while asleep7. In most cases it is caused by over-production of urine at night or reduced capacity of the bladder3. An inability to wake up can be another cause3. Bedwetting does not have a psychological cause3. Bedwetting is a common childhood medical condition, with approximately 5–10% of 7 year-olds regularly wetting their beds and the problem may persist into teenage and adulthood1.

About World Bedwetting Day

World Bedwetting Day was initiated to raise awareness among the public and healthcare professionals that bedwetting is a common medical condition that can and should be treated.

World Bedwetting Day 2017 will take place on Tuesday 30th May and occurs on the last Tuesday of May each year. The theme is: ‘Time to Take Action’, in recognition that much more can be done to diagnose and treat children who suffer from bedwetting.

For more information please visit www.worldbedwettingday.com.

About the World Bedwetting Day Steering Committee

The World Bedwetting Day Steering Committee brings together experts from across the globe to support this initiative and consists of the International Children’s Continence Society (ICCS), the European Society of Paediatric Urology (ESPU), the Asia Pacific Association of Paediatric Urology (APAPU), the International Paediatric Nephrology Association (IPNA), the European Society of Paediatric Nephrology (ESPN), the Sociedad Iberoamericana de Urologia Paediatrica (SIUP), and the North American Paediatric Urology Societies. The initiative is supported by Ferring Pharmaceuticals.

References

1 Nevéus T. Nocturnal enuresis—theoretic background and practical guidelines. Pediatr Nephrol. 2011; 26:1207–1214

2 Iannelli V. Bedwetting. Available at https://www.verywell.com/bedwetting-bedwetting-statistics-2633257. Last accessed January 2017.

3 Vande Walle J et al, Practical consensus guidelines for the management of enuresis. Eur J Pediatr 2012;171:971-98

4 Theunis M et al. Self-Image and Performance in Children with Nocturnal Enuresis. European Urology. 2002; 41:660-667

5 Joinson C et al. A United Kingdom population-based study of intellectual capacities in children with and without soiling, daytime wetting, and bed-wetting Pediatrics. 2007;120(2):e308-16

6 Van Herzeele C, Dhondt K, Roels S P et al. Desmopressin (melt) therapy in children with monosymptomatic nocturnal enuresis and nocturnal polyuria results in improved neuropsychological functioning and sleep. Pediatr Nephrol. 2016; DOI 10.1007/s00467-016-23351-3

7 Austin P et al. The Standardization of Terminology of Lower Urinary Tract Function in Children and Adolescents: Update Report from the Standardization Committee of the International Children’s Continence Society, The Journal of Urology. 2014;191:1863-1865

Contacts

Burson-Marsteller, on behalf of World Bedwetting Day Steering Committee
Jack Dixey
Jack.dixey@bm.com
02073006221



















Permalink : http://www.me-newswire.net/news/3991/en

SOBHA Declared Top Brand for the 3rd Consecutive Year

 Track2Realty Brand X Report 2016-17




BANGALORE, India-Tuesday, May 30th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- SOBHA Limited, India’s most admired and trusted real estate brand, has been declared the top brand of the Indian real estate sector for the 3rd consecutive year by the Brand X Report 2016-17, an annual study conducted by Track2Realty. This has been a rare accomplishment – the first HATTRICK of brand leadership by any real estate player in India so far.

This in-depth Brand Perception Audit Report recognizes SOBHA for the third time in a row as the Top National Realty Brand across Asset class in India and the Top National Realty Brand in Consumer Confidence Index. In addition, the report has carried out a global survey which rates SOBHA as the Number 1 Real Estate Company in top of the mind recall of the NRIs spread over a number of countries. The NRIs from the US, UK, Middle East, South Africa, Canada, Australia, New Zealand, Malaysia, Singapore and Mauritius participated in the survey.

SOBHA is also on top of the chart for carrying out its sterling Corporate Social Responsibility (CSR) activities in the country.

Mr. Ravi Menon, Chairman, SOBHA Ltd., was delighted and he said, “This recognition has been extremely humbling for the entire SOBHA family. We have been very conscious of our international quality products built to perfection and delivered on time. SOBHA’s brand strength depends on our delivery excellence which is an outcome of our unique integrated business model. We will continue to leverage our strengths and capacities and lead the way, breaking new grounds to take SOBHA to newer heights of excellence. This recognition by Track2Realty reiterates our commitment and endorses that we have been able to improve on brand reputation in a challenging market environment and consolidate our positioning and competitive edge.”

About SOBHA Limited

Founded in 1995, SOBHA Limited is one of the fastest growing and foremost backward integrated real estate players in India. It means that the company has all the key competencies and in-house resources to deliver a project from its conceptualization to completion. SOBHA is primarily focused on residential and contractual projects. For more information on SOBHA Limited, please visit: www.sobha.com

Contacts

SOBHA Limited
Abhinav Kanchan
Head, Corporate Communications
Off: +91 80 49320000 Ext. 6029
abhinav.kanchan@sobha.com


Permalink : http://me-newswire.net/news/3992/en

Tuesday, May 30, 2017

Friends Provident International invests in Munich Re’s ALLFINANZ digital new business solution to streamline policy application and improve customer service

DUBLIN-Tuesday, May 30th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- Munich Re Automation Solutions Ltd., the leading provider of new business underwriting solutions to the life insurance industry, today announced that Friends Provident International (FPI) has become the latest international life insurance provider to implement the ALLFINANZ Interview Server solution. The automated underwriting platform will enable FPI to streamline the policy application process, accelerate customer acquisition and improve customer service.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170530005007/en/

FPI, a part of the Aviva Group, has over 35 years’ experience providing savings, investment and protection products to customers in Asia and the UAE. The company has more than 500 staff located in offices in Dubai, Hong Kong, Singapore and the Isle of Man.

“Our focus is on delivering a world class proposition to meet the complex needs of our mainly expatriate customer base” said Marcus Gent, Managing Director, Middle East and Africa at FPI. “We constantly seek to improve the customer journey and improve customer service response times, which in turn motivate sales offices, advisers and partners. We selected Munich Re's innovative ALLFINANZ Interview Server because of its international reputation for ease of use and flexibility.”

FPI expects the implementation of ALLFINANZ will lead to improved operational efficiency and faster turnaround times in underwriting. At the same time, it will provide advisors and expatriate customers with faster and more consistent underwriting decisions.

"We are delighted to have been selected by FPI as their technology partner for this important initiative” said Paul Donnelly, Executive Vice President EMEA at Munich Re Automation Solutions Ltd. “By taking this step, FPI will further improve the response times of its award-winning customer service, while providing a foundation for a high-performance operation that can easily grow to process increasing volumes of new business.”

About Munich Re Automation Solutions Ltd.

Munich Re Automation Solutions Ltd., a Munich Re subsidiary, is the world leading software provider of digital new business and underwriting solutions to the life insurance industry. For the past 30 years, the company has transformed how consumers are buying life insurance with creative technology that gives insurance companies the power to grow their business profitably.





View source version on businesswire.com: http://www.businesswire.com/news/home/20170530005007/en/

Contacts

Munich Re Automation Solutions Ltd.
David Bordas, Marketing Manager
Tel: +353 1 293 2888
E: dbordas@munichre.com
Web: www.munichre.com/automation-solutions

Permalink : http://www.me-newswire.net/news/3990/en

BenQ Unveils The First DLP 4K UHD LED Home Cinema Projector, Taking Home Entertainment To The Next Level

 X12000 Combines Philips ColorSpark™ HLD LED Technology and Exclusive CinematicColor™ Technology to provide unmatched Digital Cinema Quality at home.




Dubai, United Arab Emirates -Monday, May 29th 2017 [ ME NewsWire ]

World’s leading DLP projector brand BenQ introduced yet another impressive 4K UHD digital home cinema projector – X12000. With razor-sharp true 8.3-million-pixel detail, X12000 perfectly combines the high brightness from Philips ColorSpark™ HLD LED technology and cinema-accurate colours from BenQ-exclusive CinematicColor™ Technology.  The X12000 delivers an ultra-wide DCI-P3 colour gamut that works wonders for its colour precision and high brightness, bringing flawless, quality cinema to homes.

X12000 has definitely raised the bar higher for home cinema projectors with its state of the art offerings. The launch of BenQ X12000 took place at Vox Cinema Gold Class in Deira City Centre, Dubai. It brought together some of UAE’s well known AV Partners, Home Automation Integrators, Home Cinema Integrators, Commercial Cinema Integrators, Audio Visual Specialists, Integrators and even Consultants who wanted to get an actual feel of the Home Cinema experience. The fact that this projector can be integrated into any upscale cinema seamlessly does attract a lot of attention from other brands operating in the space of Home Cinema.

The Perfect Theatre Experience Delivered in Comfort of Homes

For all those who have a home theatre system or a cinema lounge setting at home, X12000 is the perfect projector to give them the cinematic experience they’ve always wanted. This projector is a great fit for villas and bungalows that have dedicated rooms with upscale theatre gadgets. Built with technology to give you a complete theatre like picture quality in the comfort of homes; X12000 is a must have projector for those who wish to enjoy a flawless cinema viewing.

High Brightness, Colour Accuracy and Spectacular 4K UHD Picture Quality

make for an amazing viewing experience

X12000 perfectly combines the high brightness from Philips ColorSpark™ HLD LED technology and cinema-accurate colours from BenQ-exclusive CinematicColor™ Technology. and utilizes the advanced DLP 4K UHD DMD with XPR technology for 3840 x 2160 distinct pixels and true 8.3-million pixel 4K UHD resolution. The revolutionary Philips ColorSpark HLD LED technology provides up to three times screen brightness and BenQ’s exclusive CinematicColor Technology harnesses this higher brightness to produce the expansive DCI-P3 colour gamut, matching commercial digital cinema standards. equalling the high standards of commercial digital cinema. X12000’s suave 4K optical system delivers dazzling visual quality that replicates an authentic digital cinema experience with 14 high-resolution elements, a true zoom system, and special low-dispersion lens coatings.

Home Cinema Projector Range Designed to deliver Finest Cinematic Color

With the launch of X12000 and other home cinema projectors like W11000 & W8000 BenQ has brought a world of change to home cinema. Add to that BenQ’s wide range of all-in-one Home Entertainment Projectors W1600UST, W2000, W1210ST, W1110 & W1090 ensures that there is a unique model to suit every consumer’s application & installation needs and tastes whether it be sports matches or movies or even big screen immersive gaming.

BenQ is constantly innovating new ways for families to immerse in big-screen entertainment. Their home cinema products bring the thrill of watching sports games in bars and movies in theatres to the comfort of people’s homes. Packed with features like up-close ultra-short throw projection means children can play freely in the room without casting distracting shadows while parents watch a movie. BenQ has always been inclined towards the home cinema segment and over the years has come a long way to deliver instant big-screen entertainment in tight urban settings in ways that were never before imaginable.

“BenQ has been making pioneering efforts in bringing theatre-like and even better quality to home cinema. We bring a range of most intelligent and impressive home cinema projectors with high quality that are not just easy to install, but can also be easily integrated into any upscale home cinema viewing. Especially in X12000, the colour standards used have been derived from the same technology that is being used in all IMAX auditoriums around the globe.” said Manish Bakshi - Managing Director, BenQ Middle East & Turkey.

BenQ’s X12000 4K UHD LED home cinema projector is priced at AED 30,000 and will be launched on 24th May 2017 at VOX Cinemas Gold Class, Deira City Centre, Dubai.  To know more about BenQ’s range of home cinema projectors, please visit www.benq.co.ae.

About BenQ Corporation

Founded on the corporate vision of “Bringing Enjoyment ‘N’ Quality to Life”, BenQ Corporation is a world-leading human technology and solutions provider aiming to elevate and enrich every aspect of consumers’ lives. To realize this vision, the company focuses on the aspects that matter most to people today – lifestyle, business, healthcare and education – with the hope of providing people with the means to live better, increase efficiency, feel healthier and enhance learning. Such means include a delightful broad portfolio of people-driven products and embedded technologies spanning digital projectors, monitors, interactive large-format displays, audio products, cloud consumer products, mobile communications and lifestyle lighting. Because it matters. 



About BenQ Group

The BenQ Group is a $22+ billion powerhouse comprised of nearly 20 independent companies operating in over 30 countries across numerous industries with a combined workforce of over 100,000 employees.  Each Group member is a recognized leader in its own field, contributing to the BenQ Group’s vast resources, broad R&D, and distinct strategic strengths.  By leveraging each company’s vertical specialization to create true scale across horizontal markets, the BenQ Group controls a highly efficient value chain with the unrivaled ability to deliver critical components and world-class solutions in the following industries: TFT-LCD, green energy, fine chemicals and advanced materials, lighting, IC design, precision components, system integration, branded business, and service.  The Group is committed to profitable and sustainable businesses that share its long-standing vision of Bringing Enjoyment ‘N’ Quality to Life.

The BenQ Group companies are:  BenQ Corporation, AU Optronics Corporation (world’s top manufacturer of large-size TFT-LCD panels), Qisda Corporation, Darfon Electronics Corporation, BenQ ESCO Corp., BenQ Materials Corp., BenQ Guru Corp., BenQ Medical Center, BenQ Medical Technology Corp., BenQ AB DentCare Corp., Daxin Materials Corp., Dazzo Technology Corp., Darwin Precisions Corp., Lextar Electronics Corp., LILY Medical Corp. and Raydium Semiconductor Corp.



Contacts

Sonal Salvi

Absolute Public Relations      

+971 55 902 9360

SonalS@AbsoluteCG.net


Permalink : http://me-newswire.net/news/3970/en

Monday, May 29, 2017

Phenomenal Changes to make Permanent Residency of Canada Faster and Easier

Dubai, United Arab Emirates -Monday, May 29th 2017 [ ME NewsWire ]

For all those looking to settle and get permanent residency of Canada, there cannot be better times. The Canadian government seems to be committed in achieving the 3 lakh immigrants target for the country. Major changes in the immigration rules have been made in recent times to make Canadian migration a possibility for more skilled workers and professionals.

The fast track Express Entry system started in 2015 and the first draw that took place in January 2015, issued Invitation to Apply (ITA) to 779 applicants with a cut off of 886 points. Looking at the recent draw held on May 4, the number of ITAs has increased fivefold to 3,796 with a cut off of 423 points. This has been the lowest point requirement in the history of Express Entry. It also means that more people are eligible to apply under the Express Entry category than ever before.

Some of the phenomenal changes in Canadian immigration are as below:

    Ontario’s Express Entry Human Capital Priorities Stream to Invite Candidates Weekly
    3,796 Invitations to Apply for Canadian Permanent Residence Issued in May 4 Express Entry Draw
    Maximum Age of Dependent Children to be Raised to 21 and under with effect from October 24, 2017
    Removal of Conditional Permanent Residence Provision
    New occupations announced for Nova Scotia under Express Entry Stream
    Proposal to reduce amount of time permanent residents have to live in Canada in order to become eligible to apply for citizenship, from four out of six years to three out five years



Express Entry Program and Provincial Nominee Programs are the key programs to getting permanent residency of Canada in 6-12 months. All occupations are in demand and the qualifying criteria are also relaxed. This is the best time to apply and reach the maple country as the right talent pool is just what the country requires.



No complications, high visa success rate, fast track processing are just some of the many benefits enjoyed by applicants taking help of WWICS. The golden opportunity to apply is now as there are many occupations in demand offering lucrative salaries to the deserving applicants. Apply now and give wings to your dreams of making a living in Canada.

Founded in 1993, WWICS has emerged as a pioneer in providing Global Resettlement Solutions, which is vouched by more than 1,00,000 successful clients who have happily settled in some of the most favored countries like Canada, Australia, USA, UK, New Zealand and Europe.



Contacts

WWICS Immigration services LLC.

Parvinder Sandhu ,Sr.Director and ICCRC member,

+9714-396-9102

 +971-561616130  

dub.info@wwicsgroup.com




Permalink : http://me-newswire.net/news/3989/en

IBC2017 Conference Programme Presents Keynote Sessions That Embrace the Diversifying Media Ecosystem

 - Keynote speakers include senior executives from Facebook, Liberty Global, HTC, Modern Times Group and Fox Networks -


LONDON -Friday, May 26th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- IBC announces today details of keynote sessions for its forthcoming IBC2017 Conference, which runs from 14-18 September at the RAI in Amsterdam, starting a day ahead of the exhibition. Under this year’s theme of ‘Truth, Trust and Transformation’, keynote sessions will foster debate and seek clarity on the myriad of challenges and opportunities facing all content creators and aggregators, both from the traditional media industry and in adjacent markets.

The opening keynote on day one of the conference will explore how the rise of fan and friend power in the media ecosystem is driving new approaches to broadcasting, as well as paving the way for new partnerships and funding models. This must-attend keynote session entitled Fans, Friends and the Future of Broadcasting includes Dan Danker, Product Director at Facebook and Jørgen Madsen Lindemann, President & CEO at Modern Times Group. They will ask: as the lines blur between traditional broadcasting and online video, what are the new audiences teaching us and how are some of the biggest players responding?

Brian Sullivan, President & COO, Digital Consumer Group, Fox Networks Group at 21st Century Fox, will take to the stage to deliver insight into the American market and developments of Fox Network’s leading TV Everywhere services, with his talk: View from the USA: What Consumer Power Means for Fox Products and Services.

Balan Nair, Executive Vice President and Chief Technology Officer, Liberty Global will join other key industry leaders for the CTO Roadmap Keynote. With many CTOs certainly facing the same challenges as most executives in the broadcast and media industry, this panel will explore what they see as the biggest challenges and most importantly how they intend to address them.

Delivering the Technology Forward Keynote: What's Happening in VR, AR and Mixed Reality is Rikard Steiber, President, Viveport and SVP Virtual Reality, HTC.

Additional keynotes will be announced in the coming weeks.

Notes to Editors:

About IBC
IBC is the world’s leading media, entertainment and technology show. It attracts 55,000+ attendees from more than 170 countries and combines a highly respected and peer-reviewed conference with an exhibition that showcases more than 1,700 leading suppliers of state of the art electronic media and entertainment technology.

IBC2017 Dates
   
Conference:                       14 – 18 September 2017    
Exhibition:                       15 – 19 September 2017    

For more information about IBC2017 visit: https://show.ibc.org/

Contacts

Bubble Communications
Louise Wells
E: louisew@bubbleagency.com
T: +44 7718 985 252

GAC MOTOR launches its flagship vehicles GS8 and GA8 in Qatar

The all-new GS8 and GA8 lead the way for GAC MOTOR in Qatar

~With unmatched driving pleasure, the GA8 (sedan) and GS8 (SUV) are equipped with GAC MOTOR’s newest second generation 320T engine~


Doha, Qatar-Sunday, May 28th 2017 [ ME NewsWire ]

GAC MOTOR, one of China's leading automobile producers has unveiled the GS8and GA8, two flagship vehicles at a launch ceremony at The St. Regis Doha on May 21, 2017. The event was attended by distinguished guests including Ambassador of The People's Republic of China in The State of Qatar, H.E. Li Chen, Economic and Commercial Counsellor Mr. Yang Song, DOMASCO Managing Director Mr. Faisal Sharif , Deputy General Manager of GAC MOTOR Mr. Wang Shunsheng and Director of International Business Decision of GAC MOTOR Mr. Liu Haoyuan.

Extending his warm welcome to the media and attendees at the press conference, Mr. Wang Shunsheng said, “GAC MOTOR is dedicated to bringing the best vehicles to global consumers as we expand our brand in the overseas market. We would like to thank our partner DOMASCO, who supported our endeavor to bring the models of GA8, GS8this time and previously the models of GS4, GA6, GA3S and GS5to Qatar. We believe that as the trade between Qatar and China grows, we will continue to build on our foundation of mutual economic trade and business cooperation. We are committed to introducing even stronger products to the Qatar market.”

The GS8 and GA8 are two flagship models with GAC MOTOR’s newest second generation 320T engine being launched in Qatar. Since the sales of GS8 were kicked off in 2017 in China, GS8 was the top grosseramongst sales in full size 7-seater SUV category which includes brands likeFord Edge, Toyota Highlander and claimed the champion position by April 2017. GA8 incorporates GAC MOTOR’s highest quality resources for engine, gear box and chassis.  The interior configuration and exterior design reflect GAC MOTOR’s excellence in defining the new meaning of luxury. The GA8 is set to exceed Qatar’s expectations with its quality of luxury.

Today, GAC MOTOR has established sales and service networks in 14 countries globally, while continuing expansion into international markets. With the launch of GA8 and GS8 in Qatar, GAC MOTOR strives to drive the sales and build a solid foundation for the business development of GAC MOTOR and its partners in Qatar.

About GAC MOTOR GA8:

An innovative use of European aesthetic thinking to restructure Chinese elements and mm-level carving make the five pioneering "Flying Dynamics" front faces become the model of modeling aesthetics. The all-new GA8 carries the newest second generation 320T engine. It generates peak torque of 300Nm between 1600 and 4500 RPM. The engine performance fully out-performs a 3.0L natural aspirated engine. The power is transmitted by an advanced 6 speed automatic transmission gear box from the international leading supplier – Aisin. It offers an extremely smooth transmission experience. The high strength car body and 8 airbags protection is the guardian to ensure the power is unleashed with full safety. As of the human touches, GA8’s outstanding interior design offers the driver and passengers a luxury experience. The 1910 mm ultra wide comfortable space, 360 degree sound insulation solution, the full grain luxury genuine leather and ice-blue atmosphere lighting system are mind refreshing for anyone onboard. 

About GAC MOTOR GS8:

GS8 has powerful horizontal lines and chromium-plating grills, a perfect combination of strength and beauty. In addition to domineering appearance, the brand-new hard-boiled flying dynamics will be the totem of the conqueror. The new edge of all luxury LED headlamps, matrix design with the auto adjusted beaming system highlights the charm of luxury technology. Double U-shape LED complex tail lights adopts the tunnel structure. It creates a three-dimensional sense and an interpretation of wild freedom. In the interior design, GS8 offers full scale of luxury configuration including second generation PEPS keyless entry and one button start system, Harman Hi-Fi system, ultra wide panoramic sunroof, multi-function seats, etc. With 7 full size seats and a large trunk in the rear, it provides spacious freedom to all passengers to bring what’s needed for a long journey. For GS8, the fearless power and driving control is out of question. GAC’s newest 320T engine and the 6-mode drive is born to conquer all conditions.

About GAC MOTOR:

A subsidiary of GAC Group, GAC MOTOR develops and manufactures premium quality vehicles, engines, components and auto accessories, achieving more than 80% sales growth for 5 consecutive years. GAC MOTOR ranked 5th, among all brands in J.D. Power Asia Pacific's 2016 China Initial Quality Study, the highest of all Chinese brands for  four consecutive years.In 2016, GAC MOTOR was ranked No.5 across the board, surpassing most auto brands from Japan, South Korea, Europe and America. In 2015 Dubai International Motor Show, authoritative media such as Reuters and the Associated Press commented highly on GAC MOTOR as the "The Best Chinese Car Brand".

With strategic partnership and cooperation with the world’s top ten component suppliers, GAC MOTOR has developed "GAC Production System" by incorporating the essence of Toyota's "Lean Production Mode", Honda's production management model and the company’s own experience. Throughout the development over the years, GAC MOTOR has effectively developed the sedan and SUV line-up including models of GS8, GA8, GA6, GS4, GA3S andGS5. In addition, GAC MOTOR plans to bringnew energy vehicles to the emerging markets.

Contacts

Malaika Fernandes, 00971 52 954 9333

malaika.fernandes@mediaagency-me.com



Doha Marketing Services Company(DOMASCO)

Address: Salwa Road, near Qatar Decoration R/A, opposite HSBC Bank

Tel: +974-44248989 

Facebook: @GACQatar

Twitter: @GACQatar

Website: www.gacmotor.qa


Permalink : http://me-newswire.net/news/3986/en