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SAN DIEGO--(BUSINESS WIRE)--Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology company, today highlighted phase 1b data evaluating vadastuximab talirine (SGN-CD33A; 33A) in combination with the frontline standard of care regimen for induction (cytarabine and daunorubicin, also known as 7+3) for younger patients with newly diagnosed acute myeloid leukemia (AML) in an oral presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Diego, California, December 3-6, 2016. The data were also featured in an ASH press program and selected to be included in the 2017 Highlights of ASH post-meeting program. 33A is an investigational antibody-drug conjugate (ADC) targeted to CD33, a protein which is expressed on leukemic cells in nearly all AML patients. “Our clinical trial data reported at ASH demonstrate that adding vadastuximab talirine, also known as 33A, to standard of care treatment results in a rapid, high rate of remissions in frontline, younger AML patients with poor prognosis. Notably, seventy-eight percent of patients who achieved remissions in this trial tested negative for minimal residual disease, which means no cancer could be detected with a sensitive test,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “In this trial, 33A in combination with 7+3 was well-tolerated, with a low early mortality rate. Based on these promising, early data, we plan to initiate a randomized phase 2 clinical trial in 2017 in younger newly diagnosed AML patients to further evaluate the potential benefit of adding 33A to standard of care.” “People with acute myeloid leukemia die of infections or bleeding within weeks or a few months of diagnosis without effective, aggressive chemotherapy. Even with current treatment regimens, fewer than 50% of younger adults are successfully treated. The phase 1 results of 33A in combination with standard of care show a high rate of remissions in younger newly diagnosed AML patients without significantly adding to the toxicity of the treatment. Notably, 94 percent of remissions occur with only one cycle of treatment,” said Harry P. Erba, M.D., Ph.D., University of Alabama-Birmingham and presenter of the phase 1 data at ASH. “Furthermore, the majority of these patients have no evidence of disease following the 33A combination even using a very sensitive test for residual leukemia (minimal residual disease negative). The rate at which patients become minimal residual disease negative following 33A combination treatment offers encouraging preliminary evidence that 33A in combination with 7+3 could reduce relapse rates and improve long-term outcomes for these patients.” The following interim results from the ongoing phase 1 study evaluating 33A in combination with 7+3 in frontline AML will be presented by Dr. Harry P. Erba, University of Alabama-Birmingham, in an oral session on Saturday, December 3, 2016: A Phase 1b Study of Vadastuximab Talirine in Combination with 7+3 Induction Therapy for Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) (Abstract #211, oral presentation on Saturday, December 3, 2016 at 4:00 p.m. PT) Data were reported from 42 newly diagnosed AML patients with a median age of 46 years and intermediate or adverse cytogenetic risk of 50 percent and 36 percent, respectively. Seventeen percent of patients had secondary AML. Key findings include: Seattle Genetics is broadly evaluating 33A across multiple lines of therapy in patients with myeloid malignancies. The ongoing global phase 3 CASCADE study is a randomized, double-blind, multi-center trial designed to evaluate 33A in combination with hypomethylating agents (HMAs) in approximately 500 previously untreated AML patients. Further, phase 1 and 2 clinical trials for relapsed AML and for previously untreated myelodysplastic syndrome (MDS) are currently underway. More information about 33A and ongoing clinical trials can be found at www.ADC-CD33.com. Acute myeloid leukemia, also called acute myelocytic leukemia or AML, is an aggressive cancer of the bone marrow and blood that progresses rapidly without treatment. Cancerous cells called leukemic blasts multiply and crowd out normal cells in the bone marrow and interfere with normal blood cell production leading to anemia, infection, and bleeding. According to the SEER database and Kantar Health Sciences, in 2016 approximately 33,000 new cases of AML (mostly in adults) will be diagnosed in the U.S. and Europe. In the U.S. alone, nearly 10,500 deaths will occur from AML this year. Treatment options for AML have remained virtually unchanged for nearly 40 years and frontline treatment consists primarily of chemotherapy. A subset of patients (typically those over 60 years of age) cannot tolerate such therapy and are typically given lower intensity agents, supportive care, or are recommended for clinical trials. Vadastuximab talirine (SGN-CD33A; 33A) is a novel investigational ADC targeted to CD33 utilizing Seattle Genetics’ proprietary ADC technology. CD33 is expressed on most AML and MDS blast cells. The CD33 engineered cysteine antibody is stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer via site-specific conjugation technology (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the EC-mAb technology allows uniform drug-loading onto an ADC. The ADC is designed to be stable in the bloodstream and to release its potent cell-killing PBD agent upon internalization into CD33-expressing cells. 33A was granted Orphan Drug Designation by both the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of AML. FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. Seattle Genetics is an innovative biotechnology company that develops and commercializes novel antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab vedotin), the company’s lead product, in collaboration with Takeda Pharmaceutical Company Limited, is the first in a new class of ADCs commercially available globally in 65 countries for relapsed classical Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC in a phase 3 trial for acute myeloid leukemia. Headquartered in Bothell, Washington, Seattle Genetics has a robust pipeline of innovative therapies for blood-related cancers and solid tumors designed to address significant unmet medical needs and improve treatment outcomes for patients. The company has collaborations for its proprietary ADC technology with a number of companies including AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of SGN-CD33A, the possibility that 33A may be combined with existing standard of care agents for AML and the planned randomized clinical trial. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to show sufficient activity in subsequent clinical trial(s) and the risk of adverse events as SGN-CD33A advances in clinical trials and regulatory actions. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


SAN DIEGO--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, today highlighted three oral data presentations on vadastuximab talirine (SGN-CD33A; 33A) in patients with acute myeloid leukemia (AML) at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Diego, California, December 3-6, 2016. The data included updated results from an ongoing phase 1 clinical trial evaluating 33A in combination with hypomethylating agents (HMAs; azacitidine, decitabine) in frontline older AML patients. Further oral presentations focused on results from phase 1 clinical trials evaluating 33A in three distinct settings, including 1) as monotherapy in newly diagnosed older AML patients, 2) in combination with high-dose cytarabine for younger AML patients in first remission and 3) as monotherapy maintenance for younger AML patients who have completed frontline therapy or after allogeneic stem cell transplant. 33A is an investigational antibody-drug conjugate (ADC) targeted to CD33, a protein which is expressed on leukemic cells in nearly all AML patients. Seattle Genetics is broadly evaluating 33A across multiple lines of therapy in patients with myeloid malignancies. In addition to the clinical trials presented at ASH this year, 33A is currently being evaluated in combination with HMAs in the ongoing global phase 3 CASCADE study. This trial is randomized, double-blind, and being conducted at multiple centers globally to evaluate if 33A in combination with azacitidine or decitabine can extend overall survival compared to azacitidine or decitabine alone in approximately 500 older patients with newly diagnosed AML. Additional phase 1 and 2 clinical trials for frontline younger AML and frontline myelodysplastic syndrome (MDS) are also underway. More information about 33A and ongoing clinical trials can be found at www.ADC-CD33.com. “We are pleased with the growing body of data demonstrating that vadastuximab talirine, also known as 33A, has a promising overall tolerability and activity profile in clinical trials for patients with AML,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “We are committed to improving the therapeutic options for AML patients through innovative, targeted approaches. Our most advanced 33A clinical study, CASCADE, is a randomized phase 3 trial designed to test 33A in combination with hypomethylating agents, or HMAs, in approximately 500 older patients with newly diagnosed AML. Based on the encouraging data presented at ASH, we believe 33A has the potential for clinical development in multiple AML settings, with the goal of providing new treatment options for patients struggling with this aggressive and life-threatening disease.” “AML therapy has not meaningfully changed over the past 40 years, and there is a dire need for improved treatment options. Older AML patients have a particularly poor prognosis with the standard of care, hypomethylating agents or HMAs,” said Amir Fathi, M.D., Massachusetts General Hospital Cancer Center. “I am pleased with the balance of activity and tolerability we have observed in phase 1 clinical trials evaluating 33A both as monotherapy and combination therapy in AML patients. For older patients with newly diagnosed AML, the 73 percent remission rate of 33A in combination with HMAs, with 50 percent of those patients negative for minimal residual disease, signals promise in improving long-term outcomes.” The following data from the ongoing phase 1 studies evaluating 33A combination therapy or monotherapy in AML patients were presented: Vadastuximab Talirine Plus Hypomethylating Agents: A Well-Tolerated Regimen with High Remission Rate in Frontline Older Patients With Acute Myeloid Leukemia (Abstract #591, oral presentation on Monday, December 5, 2016 at 7:30 a.m. PT) Outcomes for AML patients who are older or ineligible to receive standard chemotherapy remain poor. HMAs are frequently used in this setting, but efficacy is limited. Updated results from an ongoing phase 1 study evaluating 33A in combination with HMAs (either azacitidine or decitabine) in newly diagnosed older AML patients were presented by Dr. Amir Fathi, Massachusetts General Hospital Cancer Center. Data were reported from 53 frontline AML patients with a median age of 75 years and predominantly intermediate or adverse cytogenetic risk who had declined intensive therapy. Regarding additional poor-prognosis indicators, 42 percent of patients had evidence of underlying myelodysplasia, 11 percent had FLT3-mutated disease and 43 percent had secondary AML, which is AML that arises from prior chemotherapy, a pre-existing MDS or myeloproliferative disease. Key findings include: Vadastuximab Talirine Monotherapy in Older Patients with Treatment Naive CD33-Positive Acute Myeloid Leukemia (Abstract #590, oral presentation on Monday, December 5, 2016 at 7:15 a.m. PT) Interim results from 93 patients in the ongoing phase 1 study evaluating 33A monotherapy in AML patients were previously presented at the 2015 ASH Annual Meeting. New results describing the safety and activity of the recommended 33A monotherapy dose of 40 micrograms per kilogram (mcg/kg) in an expansion cohort of treatment-naïve older AML patients were presented by Dr. Anjali Advani, Cleveland Clinic. Data were reported from 27 treatment-naïve older AML patients with a median age of 74 years and intermediate or adverse cytogenetic risk of 70 percent and 26 percent, respectively. Regarding additional poor-prognosis indicators, 48 percent of patients had evidence of underlying myelodysplasia and 22 percent had FLT3 mutated disease. Key findings include: A Phase 1b Study of Vadastuximab Talirine as Maintenance and in Combination with Standard Consolidation for Patients with Acute Myeloid Leukemia (Abstract #340, oral presentation on Sunday, December 4, 2016 at 10:15 a.m. PT) Interim results from an ongoing phase 1b study evaluating 33A in the AML post-remission setting, as a single agent for maintenance therapy or in combination with consolidation therapy (high-dose cytarabine; HiDAC), were presented by Dr. Jay Yang, Karmanos Cancer Institute. Acute myeloid leukemia, also called acute myelocytic leukemia or AML, is an aggressive cancer of the bone marrow and blood that progresses rapidly without treatment. Cancerous cells called leukemic blasts multiply and crowd out normal cells in the bone marrow and interfere with normal blood cell production leading to anemia, infection, and bleeding. According to the SEER database and Kantar Health Sciences, in 2016 approximately 33,000 new cases of AML (mostly in adults) will be diagnosed in the U.S. and Europe. In the U.S. alone, nearly 10,500 deaths will occur from AML this year. Treatment options for AML have remained virtually unchanged for nearly 40 years and frontline treatment consists primarily of chemotherapy. A subset of patients (typically those over 60 years of age) cannot tolerate such therapy and are typically given lower intensity therapies agents, supportive care, or are recommended for clinical trials. Vadastuximab talirine (SGN-CD33A; 33A) is a novel investigational ADC targeted to CD33 utilizing Seattle Genetics’ proprietary ADC technology. CD33 is expressed on most AML and MDS blast cells. The CD33 engineered cysteine antibody is stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer via site-specific conjugation technology (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the EC-mAb technology allows uniform drug-loading onto an ADC. The ADC is designed to be stable in the bloodstream and to release its potent cell-killing PBD agent upon internalization into CD33-expressing cells. 33A was granted Orphan Drug Designation by both the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of AML. FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. Seattle Genetics is an innovative biotechnology company that develops and commercializes novel antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab vedotin), the company’s lead product, in collaboration with Takeda Pharmaceutical Company Limited, is the first in a new class of ADCs commercially available globally in 65 countries for relapsed classical Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC in a phase 3 trial for acute myeloid leukemia. Headquartered in Bothell, Washington, Seattle Genetics has a robust pipeline of innovative therapies for blood-related cancers and solid tumors designed to address significant unmet medical needs and improve treatment outcomes for patients. The company has collaborations for its proprietary ADC technology with a number of companies including AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com. Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of SGN-CD33A and the possibility that 33A may be combined with existing standard of care agents or used by itself for treatment of AML. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to show sufficient activity in subsequent clinical trial(s) and the risk of adverse events as SGN-CD33A advances in clinical trials and regulatory actions. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | October 31, 2016
Site: globenewswire.com

NEW YORK, Oct. 31, 2016 (GLOBE NEWSWIRE) -- Patients with chronic diseases in Europe experience losses in quality of life that vary significantly by country, according to new findings from Kantar Health's National Health and Wellness Survey (NHWS). The research will be presented today at the ISPOR (International Society for Pharmacoeconomics and Outcomes Research) 19th Annual European Congress in Vienna. "European countries vary considerably in both lifestyle and healthcare delivery systems," said Jeffrey Vietri, Ph.D., Director of Health Outcomes Research at Kantar Health. "While we expect patients with chronic conditions to have lower quality of life than people without those conditions, we were surprised by how much the country in which a patient lives affects the degree of impact a condition has on patients' quality of life." Measuring health-related quality of life with the visual analog scale from the EQ-5D-5L validated scale in the NHWS, Kantar Health looked at the impact of having a chronic condition on patients in the 5EU countries. Conditions were selected from those listed as having a high burden according to the U.S. Centers for Disease Control and Prevention: cardiovascular disease, cancer, obesity, osteoarthritis and diabetes. The results from NHWS showed that patients with heart disease in Germany lost significantly more quality of life than heart disease patients in France, Italy and Spain. Meanwhile, cancer was associated with significantly less change in the quality of life of adults in the UK than adults in France, Germany and Italy. Obesity has much less of an effect on quality of life for patients in Italy and Spain than it does on patients in France, Germany and the UK. "There's a tendency for the pharma industry and policymakers to use one European country as an analogue for patients in other countries in the region," Dr. Vietri said. "However, the results of our survey suggest that manufacturers and policymakers who want to optimize the allocation of healthcare resources should rely on country-level rather than pan-European studies to determine disease burden and ultimately improve patients' quality of life." About the National Health and Wellness Survey (NHWS) The study's results were drawn from the 2016 NHWS, a nationally representative, self-administered survey conducted annually. Respondents were provided with a list of conditions and asked which they had experienced and been diagnosed with. Topics covered include the health status, attitudes, behaviors and outcomes among adults 18 or older. Kantar Health conducts the NHWS in the U.S., Europe, Asia and Latin America. The survey is the largest self-reported dataset in the healthcare industry. About Kantar Health Kantar Health is a leading global healthcare consulting firm and trusted advisor to many pharmaceutical, biotech, and medical device and diagnostic companies worldwide. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and brand and marketing expertise to help clients evaluate opportunities, launch products and maintain brand and market leadership. Kantar Health deeply understands the influence of patients, payers and physicians, especially as they relate to the performance and payment of medicines and the delivery of healthcare services. Its 600+ healthcare industry specialists work across the product lifecycle, from preclinical development to launch, acting as catalysts to successful decision-making in life sciences and helping clients prioritize their product development and portfolio activities, differentiate their brands and drive product success post-launch. Kantar Health is part of Kantar, the data investment management division of WPP. For more information, please visit www.kantarhealth.com.


SMi Group Reports: With Brexit and the new EU Falsified Medicine Directive, what does the future hold for parallel trade? Over 90 senior leaders in parallel trade will meet in London in February 2017 to discuss upcoming trends and share best practices. London, United Kingdom, December 02, 2016 --( Falsified medicines (the term "falsified" is used to distinguish the issue from IP violations, so-called "counterfeits") are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level. (Source: European Commission)* Dr. Rick Greville, Director Wales and Director Distribution & Supply, The Association of the British Pharmaceutical Industry, will be speaking on “The European Commission’s Falsified Medicines Directive (FMD) – Recent Update” at SMi Group’s Parallel Trade 2017 conference, taking place in London on the 6th and 7th of February. Dr. Greville will discuss what progress has been made since February 2016, what the market participants need to know about "product information templates," what are the regulatory requirements for nationally authorised products and much more. Further information on this presentation and the conference programme is available at http://www.parallel-trade.com/PRcom Parallel Trade for Pharma conference, organised by the SMi Group, will be returning to London in February 2017, for its 11th year. This meeting will bring 90+ selected senior leaders in parallel trade to discuss upcoming trends and share best practices, short term and long term concerns of pharma manufacturers, regulators and parallel traders. Other key topics to be discussed during the 2-day conference are: Pharmaceutical anti-counterfeiting – Combating the danger from fake drugs, Regional focus – From Germany to Eurasia, Legal view – Intellectual property, competition and regulatory challenges, The future of parallel trade, New trends and their impact on parallel trade and so much more. The event programme also features three panel debates on: Shortages; Challenges and opportunities for parallel traders; Technology & new trends; and two exclusive post conference workshops on “Understanding IP and competition law issues in parallel trade” (Hosted by Kathy Osgerby, Associate and Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP) and “Parallel Trade – Management Strategies” (Hosted by Janice Haigh, Practice Leader, Market Access, Quintiles). For further information please refer to http://www.parallel-trade.com/PRcom Expert Speakers Line up for 2017 includes: The Association of the British Pharmaceutical Industry (Dr Rick Greville, Director Distribution & Supply), Shire International GmbH (Eric Noehrenberg, Director, Regional Market Access Lead, Latin America), Delfarma (Tomasz Dzitko, President), European Association for Euro-Pharmaceutical Companies (Heinz Kobelt, Director European Affairs), ISPOR (Vladimir Zah, Health Economics Consultant), Abacus Medicine (Flemming Wagner, CEO), IMS Health (Alexey Savin, Principal Russia and CIS), Arnold & Porter (UK) LLP (Kathy Osgerby, Associate, and Karoline Zwierzynska, Associate), Europe Economics (Dermot Glynn, Senior Advisor), European Alliance for Access to Save Medicines (Mike Isles, Executive Director), Research Health (Dr Andrew Stainthorpe, Director Market Access and Managed Entry) and many more. The complete 2-day event programme is available for complimentary download at http://www.parallel-trade.com/PRcom Latest confirmed attendees include senior representatives from MHRA, AbbVie Deutschland GmbH & Co. KG, Astellas Pharma, AstraZeneca, Teva UK, Vifor Pharma, Janssen Pharmaceutica NV, Napp Laboratories, Ratiopharm GmbH, Kantar Health, Ferring Pharmaceuticals, LEO Pharma, AstraZeneca Czech Republic, Swedish Orphan Biovitrum AB, Amgen, Novartis Pharmaceuticals, Novartis Turkey, LEO Pharma, Johnson & Johnson, Novo Nordisk Pharma, Daiichi Sankyo Europe GmbH, Sunovion Pharmaceuticals Europe Ltd and many more. Feedback from past attendees of SMi Group’s Parallel Trade: “Interesting conference, generating a good debate from all sides,” “Great conference! Audience very enthusiastic and actively participating in discussions,” “Very good discussing about pricing issues and competition,” “Overall, a very positive experience!” “The best Parallel Trade conference of the last 5 years!” *Source: European Commission http://ec.europa.eu/health/human-use/falsified_medicines/index_en.htm 11th annual Parallel Trade 6-7 February 2017, Holiday Inn Kensington Forum, London, UK http://www.parallel-trade.com/PRcom Sponsorship, Exhibition contact: Alia Malick, +44 (0) 207 827 6168, amalick@smi-online.co.uk Delegates/Group contact: Fateja Begum, +44 (0) 207 827 6184, fbegum@smi-online.co.uk Media Contact: jrotar@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, December 02, 2016 --( PR.com )-- The Falsified Medicines Directive introduces tough directives to improve the protection of public health with new pan-European measures to ensure that medicines are safe and that the trade in medicines is strictly controlled.Falsified medicines (the term "falsified" is used to distinguish the issue from IP violations, so-called "counterfeits") are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level. (Source: European Commission)*Dr. Rick Greville, Director Wales and Director Distribution & Supply, The Association of the British Pharmaceutical Industry, will be speaking on “The European Commission’s Falsified Medicines Directive (FMD) – Recent Update” at SMi Group’s Parallel Trade 2017 conference, taking place in London on the 6th and 7th of February.Dr. Greville will discuss what progress has been made since February 2016, what the market participants need to know about "product information templates," what are the regulatory requirements for nationally authorised products and much more.Further information on this presentation and the conference programme is available at http://www.parallel-trade.com/PRcomParallel Trade for Pharma conference, organised by the SMi Group, will be returning to London in February 2017, for its 11th year. This meeting will bring 90+ selected senior leaders in parallel trade to discuss upcoming trends and share best practices, short term and long term concerns of pharma manufacturers, regulators and parallel traders.Other key topics to be discussed during the 2-day conference are: Pharmaceutical anti-counterfeiting – Combating the danger from fake drugs, Regional focus – From Germany to Eurasia, Legal view – Intellectual property, competition and regulatory challenges, The future of parallel trade, New trends and their impact on parallel trade and so much more.The event programme also features three panel debates on: Shortages; Challenges and opportunities for parallel traders; Technology & new trends; and two exclusive post conference workshops on “Understanding IP and competition law issues in parallel trade” (Hosted by Kathy Osgerby, Associate and Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP) and “Parallel Trade – Management Strategies” (Hosted by Janice Haigh, Practice Leader, Market Access, Quintiles).For further information please refer to http://www.parallel-trade.com/PRcomExpert Speakers Line up for 2017 includes: The Association of the British Pharmaceutical Industry (Dr Rick Greville, Director Distribution & Supply), Shire International GmbH (Eric Noehrenberg, Director, Regional Market Access Lead, Latin America), Delfarma (Tomasz Dzitko, President), European Association for Euro-Pharmaceutical Companies (Heinz Kobelt, Director European Affairs), ISPOR (Vladimir Zah, Health Economics Consultant), Abacus Medicine (Flemming Wagner, CEO), IMS Health (Alexey Savin, Principal Russia and CIS), Arnold & Porter (UK) LLP (Kathy Osgerby, Associate, and Karoline Zwierzynska, Associate), Europe Economics (Dermot Glynn, Senior Advisor), European Alliance for Access to Save Medicines (Mike Isles, Executive Director), Research Health (Dr Andrew Stainthorpe, Director Market Access and Managed Entry) and many more.The complete 2-day event programme is available for complimentary download at http://www.parallel-trade.com/PRcomLatest confirmed attendees include senior representatives from MHRA, AbbVie Deutschland GmbH & Co. KG, Astellas Pharma, AstraZeneca, Teva UK, Vifor Pharma, Janssen Pharmaceutica NV, Napp Laboratories, Ratiopharm GmbH, Kantar Health, Ferring Pharmaceuticals, LEO Pharma, AstraZeneca Czech Republic, Swedish Orphan Biovitrum AB, Amgen, Novartis Pharmaceuticals, Novartis Turkey, LEO Pharma, Johnson & Johnson, Novo Nordisk Pharma, Daiichi Sankyo Europe GmbH, Sunovion Pharmaceuticals Europe Ltd and many more.Feedback from past attendees of SMi Group’s Parallel Trade: “Interesting conference, generating a good debate from all sides,” “Great conference! Audience very enthusiastic and actively participating in discussions,” “Very good discussing about pricing issues and competition,” “Overall, a very positive experience!” “The best Parallel Trade conference of the last 5 years!”*Source: European Commission http://ec.europa.eu/health/human-use/falsified_medicines/index_en.htm11th annual Parallel Trade6-7 February 2017, Holiday Inn Kensington Forum, London, UKhttp://www.parallel-trade.com/PRcomSponsorship, Exhibition contact: Alia Malick, +44 (0) 207 827 6168, amalick@smi-online.co.ukDelegates/Group contact: Fateja Begum, +44 (0) 207 827 6184, fbegum@smi-online.co.ukMedia Contact: jrotar@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


News Article | November 18, 2016
Site: www.PR.com

SMi Group Reports: (2016.11.16, London, UK): Over 90 senior leaders in parallel trade will meet in London in February 2017 to discuss upcoming trends and share best practices. London, United Kingdom, November 18, 2016 --( Parallel Trade 2017 official website is www.parallel-trade.com/PRcom Dr Rick Greville, Director Wales and Director Distribution & Supply for The Association of the British Pharmaceutical Industry will be speaking on “The European Commission's Falsified Medicines Directive - recent updates.” Dr. Gr0eville will discuss what progress has been made since February 2016 and what the market participants need to know about "product information templates," and much more. Other key topics to be discussed during the 2-day conference are: What will Brexit mean for parallel trade to and from the UK? Parallel Trade 101 - Which factors determine the flow of pharmaceutical products in Europe? Beyond pharmaceutical products – parallel imports of medical devices. The Patient’s perspective. The event programme also features three panel debates on: Shortages; Challenges and opportunities for parallel traders; Technology & new trends; and two exclusive post conference workshops on “Understanding IP and competition law issues in parallel trade” (Hosted by Kathy Osgerby, Associate and Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP) and “Parallel Trade – Management Strategies” (Hosted by Janice Haigh, Practice Leader, Market Access, Quintiles). For further information please refer to www.parallel-trade.com/PRcom Expert Speakers Line up for 2017 includes: The Association of the British Pharmaceutical Industry (Dr Rick Greville, Director Distribution & Supply), Shire International GmbH (Eric Noehrenberg, Director, Regional Market Access Lead, Latin America), Delfarma (Tomasz Dzitko, President), European Association for Euro-Pharmaceutical Companies (Heinz Kobelt, Director European Affairs), ISPOR (Vladimir Zah, Health Economics Consultant), Abacus Medicine (Flemming Wagner, CEO), IMS Health (Alexey Savin, Principal Russia and CIS), Arnold & Porter (UK) LLP (Kathy Osgerby, Associate, and Karoline Zwierzynska, Associate), Europe Economics (Dermot Glynn, Senior Advisor), European Alliance for Access to Save Medicines (Mike Isles, Executive Director), Research Health (Dr Andrew Stainthorpe, Director Market Access and Managed Entry) and many more. The complete 2-day event programme is available for complimentary download at www.parallel-trade.com/PRcom Latest confirmed attendees include senior representatives from Astellas Pharma, AstraZeneca, Teva UK, Vifor Pharma, Janssen Pharmaceutica NV, Napp Laboratories, Kantar Health, Ferring Pharmaceuticals, LEO Pharma, AstraZeneca Czech Republic, Swedish Orphan Biovitrum AB, Amgen, Novartis Pharmaceuticals, Novartis Turkey, LEO Pharma, Johnson & Johnson, Novo Nordisk Pharma, Daiichi Sankyo Europe GmbH, Sunovion Pharmaceuticals Europe Ltd and many more. Feedback from past attendees of SMi Group’s Parallel Trade: “Interesting conference, generating a good debate from all sides”, “Great conference! Audience very enthusiastic and actively participating in discussions,” “Very good discussing about pricing issues and competition”, “Overall, a very positive experience!,” “The best Parallel Trade conference of the last 5 years!” 11th annual Parallel Trade 6-7 February 2017, Holiday Inn Kensington Forum, London, UK www.parallel-trade.com/PRcom Sponsorship, Exhibition contact: Alia Malick, +44 (0) 207 827 6168, amalick@smi-online.co.uk Delegates/Group contact: Fateja Begum, +44 (0) 207 827 6184, fbegum@smi-online.co.uk Media Contact: jrotar@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, November 18, 2016 --( PR.com )-- With Brexit and the new EU Falsified Medicine Directive, what does the future hold for parallel trade? SMi’s Parallel Trade conference will be returning to London next February 6th-7th, for its 11th year, to discuss short term and long term concerns of pharma manufacturers, regulators and parallel traders. They will engage in an interactive debate and discuss how to keep abreast of the current trends and how to overcome all challenges.Parallel Trade 2017 official website is www.parallel-trade.com/PRcomDr Rick Greville, Director Wales and Director Distribution & Supply for The Association of the British Pharmaceutical Industry will be speaking on “The European Commission's Falsified Medicines Directive - recent updates.” Dr. Gr0eville will discuss what progress has been made since February 2016 and what the market participants need to know about "product information templates," and much more.Other key topics to be discussed during the 2-day conference are: What will Brexit mean for parallel trade to and from the UK? Parallel Trade 101 - Which factors determine the flow of pharmaceutical products in Europe? Beyond pharmaceutical products – parallel imports of medical devices. The Patient’s perspective.The event programme also features three panel debates on: Shortages; Challenges and opportunities for parallel traders; Technology & new trends; and two exclusive post conference workshops on “Understanding IP and competition law issues in parallel trade” (Hosted by Kathy Osgerby, Associate and Karoline Zwierzynska, Associate, Arnold & Porter (UK) LLP) and “Parallel Trade – Management Strategies” (Hosted by Janice Haigh, Practice Leader, Market Access, Quintiles).For further information please refer to www.parallel-trade.com/PRcomExpert Speakers Line up for 2017 includes: The Association of the British Pharmaceutical Industry (Dr Rick Greville, Director Distribution & Supply), Shire International GmbH (Eric Noehrenberg, Director, Regional Market Access Lead, Latin America), Delfarma (Tomasz Dzitko, President), European Association for Euro-Pharmaceutical Companies (Heinz Kobelt, Director European Affairs), ISPOR (Vladimir Zah, Health Economics Consultant), Abacus Medicine (Flemming Wagner, CEO), IMS Health (Alexey Savin, Principal Russia and CIS), Arnold & Porter (UK) LLP (Kathy Osgerby, Associate, and Karoline Zwierzynska, Associate), Europe Economics (Dermot Glynn, Senior Advisor), European Alliance for Access to Save Medicines (Mike Isles, Executive Director), Research Health (Dr Andrew Stainthorpe, Director Market Access and Managed Entry) and many more.The complete 2-day event programme is available for complimentary download at www.parallel-trade.com/PRcomLatest confirmed attendees include senior representatives from Astellas Pharma, AstraZeneca, Teva UK, Vifor Pharma, Janssen Pharmaceutica NV, Napp Laboratories, Kantar Health, Ferring Pharmaceuticals, LEO Pharma, AstraZeneca Czech Republic, Swedish Orphan Biovitrum AB, Amgen, Novartis Pharmaceuticals, Novartis Turkey, LEO Pharma, Johnson & Johnson, Novo Nordisk Pharma, Daiichi Sankyo Europe GmbH, Sunovion Pharmaceuticals Europe Ltd and many more.Feedback from past attendees of SMi Group’s Parallel Trade: “Interesting conference, generating a good debate from all sides”, “Great conference! Audience very enthusiastic and actively participating in discussions,” “Very good discussing about pricing issues and competition”, “Overall, a very positive experience!,” “The best Parallel Trade conference of the last 5 years!”11th annual Parallel Trade6-7 February 2017, Holiday Inn Kensington Forum, London, UKwww.parallel-trade.com/PRcomSponsorship, Exhibition contact: Alia Malick, +44 (0) 207 827 6168, amalick@smi-online.co.ukDelegates/Group contact: Fateja Begum, +44 (0) 207 827 6184, fbegum@smi-online.co.ukMedia Contact: jrotar@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


Merlien Institute today announced that submissions are open for the 3rd MRMW Awards. The MRMW Awards are a celebration of innovation and excellence in the Market Research Industry and recognize the hard work of individuals who have achieved significant breakthroughs in mobile market research. The Award entries are open until January 31, 2017. To submit an entry, please visit http://na.mrmw.net/awards/. The winners will be announced at the MRMW conference held on April 25&26 in Chicago. Six categories are available for this year’s MRMW Awards. An independent panel, comprised of the MRMW Advisory Board members and internationally recognized market research experts, will judge all entries. Categories for the 2017 MRMW Awards are: MRMW Researcher of the Year (Client) - By nomination: The “Oscar” for market research. It recognizes individuals that have demonstrated leadership and creativity in harnessing new technologies and techniques for market research. MRMW Research Company of the Year - By nomination: Recognizes companies that have demonstrated excellence in designing and implementing innovative research for clients. This can be an outstanding individual project or based on a portfolio of research projects. Best Mobile Qual Project: Showcases and promotes excellence in mobile qualitative research. The entries are judged on the research design, execution of the project as well as the research outcome for clients’ business objectives. Best New Technology: Recognizes proprietary new technology that has disrupted the traditional market research paradigm. Winners are selected based on how the new technology answers a particular challenge in a market research project. Best Use of Mobile Technology: Recognizes innovative use of mobile technology for market research. This can be an innovative new use of existing technology or the introduction of a new mobile technology for market research. Best Client-Supplier Collaboration: Honors those valued relationships between agency and client. Given to partnerships that demonstrate excellence in client and research supplier collaboration. Both clients and research suppliers can submit entries. The MRMW Awards 2017 are open to individuals and companies across the market research industry and may be entered online. A full list of categories, deadlines and award criteria can be found http://na.mrmw.net/awards-categories/. Entries will close on January 31st, 2017. The shortlisted nominees for each category will be announced in February 2017 on the MRMW website and in writing. Best Use of Mobile Technology: Kantar Health & Lumi Technologies


Touboul C.,Kantar Health
Journal of the European Academy of Dermatology and Venereology | Year: 2015

Background Melanoma accounts for a small proportion of skin cancers but is the most serious. The prognosis is, however, good if it is diagnosed early, before the metastatic stages. For these reasons, population awareness and knowledge with regard to melanoma and the associated risk factors are critical to improving the effectiveness of melanoma primary prevention campaigns. Objectives The EDIFICE Melanoma survey was designed to cover a large number of topics related to sun exposure and melanoma: knowledge and awareness of the risks associated with sun and artificial ultraviolet exposure, knowledge of melanoma and the associated risk factors, behaviour regarding protective measures in adults and children. Methods The survey questionnaire was administered by experienced independent interviewers from the Kantar Health Institute using the Computer-Assisted Telephone Interview technique. It was important to avoid the effects of 'contamination' in answers to questions about sun exposure habits. Questions about exposure habits were therefore asked before those relating to knowledge of best practices for sun protection. A sample of 1502 individuals aged 18 years and over was interviewed. The survey data were weighted to eliminate structural variations between the sample interviewed and the reference population. Quantitative data were described by the means and standard deviations and categorical data by the numbers in each category and corresponding percentages. Three multivariate logistic regression analyses were conducted and expressed in terms of odds ratio and 95% confidence intervals. Results In addition to the classic questions relating to sociodemographic characteristics, the EDIFICE Melanoma study questionnaire was organized around three themes: the opinion, attitude and knowledge of individuals regarding sun exposure and melanoma. The survey questionnaire lasted approximately 20 min. Conclusions This study provided a complete 'snapshot' of opinions, attitudes and knowledge of French people in 2011 with regard to sun exposure. © 2015 European Academy of Dermatology and Venereology.


Vietri J.,Kantar Health | Prajapati G.,AllSource PPS | El Khoury A.C.,Merck And Co.
BMC Gastroenterology | Year: 2013

Background: Few studies have examined the impact of Hepatitis C virus (HCV) infection on patient reported outcomes in Europe. This study was conducted to assess the burden of HCV infection in terms of work productivity loss, activity impairment, health-related quality of life, healthcare resource utilization, and associated costs.Methods: The 2010 European National Health and Wellness Survey (n = 57,805) provided data. Patients reporting HCV infection in France, Germany, the UK, Italy, and Spain were matched to respondents without HCV using propensity scores. Outcome measures included the Work Productivity and Activity Impairment (WPAI) questionnaire and the Medical Outcomes Study Short Form-12 (SF-12v2) questionnaire. Subgroup analyses focused on treatment-naïve patients.Results: HCV Patients (n = 286) had more work impairment (30% vs. 18%, p < .001), more impairment in non-work activities (34% vs. 28%, p < .05), and more annual physician visits per patient (19.8 vs. 13.3, p < .001). Estimated indirect and direct costs were €2,956 (p < .01) and €495 (p < .001) higher than in matched controls, respectively. Health-related quality of life was also lower among HCV patients. Treatment-naïve HCV patients (n = 139) also reported higher work impairment (29% vs. 15%, p < .01), as well as more frequent physician visits (19.5 vs. 12.1, p < .01) than matched controls. Each treatment-naïve HCV infected patient incurred €934 in direct costs vs. €508 (p < .01 in matched controls. Employed treatment-naïve patients reported higher productivity loss per year compared to matched controls (€6,414 vs. €3,642, p < .05).Conclusion: HCV infection in Europe is associated with considerable economic and humanistic burden. This is also true of diagnosed patients who have never been treated for HCV. © 2013 Vietri et al.; licensee BioMed Central Ltd.


News Article | October 26, 2016
Site: globenewswire.com

NEW YORK, Oct. 26, 2016 (GLOBE NEWSWIRE) -- Kantar Health, a leading global healthcare consulting and market research firm, is proud to announce that Mike Kelly, CEO of the Americas, has been honored with the 2016 R.R. Fordyce Award by the Pharmaceutical Marketing Research Group (PMRG). In honor of industry leader Richard "Dick" Fordyce, this award is given each year to a recipient who exemplifies the principles of excellence, innovation and integrity in pharmaceutical market research. "Mike has inspired many colleagues both within Kantar Health and beyond," Kantar Health Global CEO Lynnette Cooke said. "He's always willing to give of his time when mentoring colleagues, and he's well-respected by clients and those at competitor companies, both of which often seek his advice. I'm so proud that his contributions to healthcare market research are being recognized through this prestigious award." Mr. Kelly has had a long career in the pharmaceutical industry, including leadership roles in engineering, marketing, market research and sales. At Kantar Health, his leadership and business acumen have been the driving force behind his success in growing the Americas business organically and via mergers and acquisitions. He is a member of Kantar Health's Global Strategy Board, which is responsible for setting the organization's long-term growth strategy. "Mike has been a leader in our profession, a mentor and a pivotal player in the history of PMRG," said Stephanie Reynders, Executive Director at PMRG. "I'm honored to present him with our organization's most sought-after accolade, the R.R. Fordyce Award." R.R. Fordyce Award recipients have made an outstanding contribution to healthcare market research. In addition, they must demonstrate a pattern of leadership that is observable in the way they serve their clients and internal business partners and the way they conduct themselves among their peers and colleagues. About Kantar Health Kantar Health is a leading global healthcare consulting firm and trusted advisor to many pharmaceutical, biotech, and medical device and diagnostic companies worldwide. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and brand and marketing expertise to help clients evaluate opportunities, launch products and maintain brand and market leadership. Kantar Health deeply understands the influence of patients, payers and physicians, especially as they relate to the performance and payment of medicines and the delivery of healthcare services. Its 600+ healthcare industry specialists work across the product lifecycle, from preclinical development to launch, acting as catalysts to successful decision-making in life sciences and helping clients prioritize their product development and portfolio activities, differentiate their brands and drive product success post-launch. Kantar Health is part of Kantar, the data investment management division of WPP. For more information, please visit www.kantarhealth.com.


News Article | November 14, 2016
Site: globenewswire.com

NEW YORK, Nov. 14, 2016 (GLOBE NEWSWIRE) -- Breast cancer in China is diagnosed in patients who are about 10 years younger than in the United States, and patients in China typically have a higher percentage of triple negative tumors, according to new data from Kantar Health, a leading global healthcare consulting and market research firm. According to data from the newly launched CancerMPact® Patient Metrics China, the average age at breast cancer diagnosis in China is approximately 55 years, compared with 63 in the United States. As a result, a higher percentage of Chinese patients are likely to be premenopausal than in the United States, and premenopausal patients have more limited treatment choices than postmenopausal women. Female breast cancer patients in China have a higher percentage of triple negative cancers, especially in Stage IV. Triple negative breast cancer usually has a poorer prognosis than other types of breast cancer. "The high percentages of premenopausal and triple negative breast cancer patients represent high unmet medical needs because premenopausal patients with breast cancer in China are mainly treated with tamoxifen, while postmenopausal patients can be treated with an aromatase inhibitor," said David Robinson, Vice President at Kantar Health. "Triple negative breast cancer patients currently can only rely on cytotoxic systemic chemotherapy in China." CancerMPact Patient Metrics China combines epidemiologic data and analysis to estimate incidence (annual new cases of cancer) by stage; restaged 10-year prevalence (annual surviving cancer patients from up to 10 years prior to diagnosis that accounts for progression to later stages); active disease (estimate of treatment-eligible patients by stage that does not include early-stage patients in remission); and treated patient populations by modality (surgery, radiation, drug therapy, etc.), and drug regimens. About Kantar Health Kantar Health is a leading global healthcare consulting firm and trusted advisor to many pharmaceutical, biotech, and medical device and diagnostic companies worldwide. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and brand and marketing expertise to help clients evaluate opportunities, launch products and maintain brand and market leadership. Kantar Health deeply understands the influence of patients, payers and physicians, especially as they relate to the performance and payment of medicines and the delivery of healthcare services. Its 600+ healthcare industry specialists work across the product lifecycle, from preclinical development to launch, acting as catalysts to successful decision-making in life sciences and helping clients prioritize their product development and portfolio activities, differentiate their brands and drive product success post-launch. Kantar Health is part of Kantar, the data investment management division of WPP. For more information, please visit www.kantarhealth.com.

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