Chugai Pharmaceutical Co.

Gotemba, Japan

Chugai Pharmaceutical Co.

Gotemba, Japan
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Receive press releases from Strathmore Who's Who: By Email David H. Deming, of New York, New York, has recently been recognized as a member of the Strathmore’s Who’s Who Lifetime VIP Club for his outstanding contributions and achievements in field of Financial Management. New York, NY, May 11, 2017 --( David H. Deming is a Managing Partner with TAG Healthcare Advisors, LLC, which he founded in 2013. The company specializes in Advisory Services (Mergers, Acquisitions and Licensing), Capital Raising (Public and Private Placements of Equity/Debt) and investments. Mr. Deming has 30+ years in investment banking, 12 years of which were spent as the leader of JP Morgan’s Healthcare Investment Banking Group. His expertise is in general financial advice for pharmaceutical, biotech, medical device companies and service companies. Prior to his role as founder of TAG Healthcare Advisors, LLC, he was the CEO of a start–up pension management business, SmartNest, LLC. His association with JP Morgan Chase and JP Morgan lasted more than 27 years. There he conducted M&A across industries before joining the healthcare investment banking effort. Mr. Deming served as head of the global healthcare investment banking team for 12 years. Prior to his role with TAG Healthcare Advisors, some of Mr. Deming’s former client assignments were Johnson & Johnson, Baxter International, Gilead Sciences, Scios Pharmaceuticals, CV Therapeutics, Calgene Corporation, and Tenet Healthcare. He has also worked with some Japanese clients including Chugai Pharmaceutical Co., Elsai Co., Fujisawa Pharmaceutical Co., and Mitsubishi Tanabe Pharma. Mr. Deming was the Board Chair of Hobart & William Smith Colleges from 2005-12. In his leisure time, he enjoys sailing and skiing. www.alberleengroup.com About Strathmore’s Who’s Who Strathmore's Who's Who publishes an annual two thousand page hard cover biographical registry, honoring successful individuals in the fields of Business, the Arts and Sciences, Law, Engineering and Government. Based on one's position and lifetime of accomplishments, we honor professional men and women in all academic areas and professions. Inclusion is limited to individuals who have demonstrated leadership and achievement in their occupation, industry or profession. New York, NY, May 11, 2017 --( PR.com )-- About David H. DemingDavid H. Deming is a Managing Partner with TAG Healthcare Advisors, LLC, which he founded in 2013. The company specializes in Advisory Services (Mergers, Acquisitions and Licensing), Capital Raising (Public and Private Placements of Equity/Debt) and investments. Mr. Deming has 30+ years in investment banking, 12 years of which were spent as the leader of JP Morgan’s Healthcare Investment Banking Group. His expertise is in general financial advice for pharmaceutical, biotech, medical device companies and service companies. Prior to his role as founder of TAG Healthcare Advisors, LLC, he was the CEO of a start–up pension management business, SmartNest, LLC. His association with JP Morgan Chase and JP Morgan lasted more than 27 years. There he conducted M&A across industries before joining the healthcare investment banking effort. Mr. Deming served as head of the global healthcare investment banking team for 12 years. Prior to his role with TAG Healthcare Advisors, some of Mr. Deming’s former client assignments were Johnson & Johnson, Baxter International, Gilead Sciences, Scios Pharmaceuticals, CV Therapeutics, Calgene Corporation, and Tenet Healthcare. He has also worked with some Japanese clients including Chugai Pharmaceutical Co., Elsai Co., Fujisawa Pharmaceutical Co., and Mitsubishi Tanabe Pharma. Mr. Deming was the Board Chair of Hobart & William Smith Colleges from 2005-12. In his leisure time, he enjoys sailing and skiing. www.alberleengroup.comAbout Strathmore’s Who’s WhoStrathmore's Who's Who publishes an annual two thousand page hard cover biographical registry, honoring successful individuals in the fields of Business, the Arts and Sciences, Law, Engineering and Government. Based on one's position and lifetime of accomplishments, we honor professional men and women in all academic areas and professions. Inclusion is limited to individuals who have demonstrated leadership and achievement in their occupation, industry or profession. Click here to view the list of recent Press Releases from Strathmore Who's Who


News Article | May 25, 2017
Site: www.eurekalert.org

Under the terms of the agreement, PharmaMar will receive an upfront payment as well as development milestones related to the health approval procedure of Aplidin® in this country. PharmaMar will retain exclusive production rights and will supply the finished product to Eczasibasi for commercial use. Aplidin® is PharmaMar´s second most advanced anticancer drug currently under development for the treatment of multiple myeloma and angioimmunoblastic T-cell lymphoma. The Company announced in March 2016 that plitidepsin has shown positive results in a pivotal Phase III clinical trial (ADMYRE) for multiple myeloma and in September 2016, PharmaMar presented to the European Medicines Agency (EMA) the submission of the Marketing Authorization Application (MAA) for this drug in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM) . "The partnership with Eczasibasi will help in the commercialization in Turkey of plitidepsin, developed to tackle hematologic cancer. We are looking forward to working with one of the leading Health Care companies in this country", said Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit. "We are firmly committed to advancing in the development of innovative oncology therapies", he added. Atalay, CEO and President of the Eczasibasi Group, stated that "the agreement between PharmaMar and Eczac?ba?? Pharmaceuticals Marketing (EIP) offered a major advance for healthcare in Turkey, as Aplidin® represented the latest innovation in cancer treatment". Elif Çelik, Executive Vice President of the Eczasibasi Healthcare Division, noted that "the agreement ensured that multiple myeloma patients in Turkey would have access to the most innovative treatment at the same time as patients in other EU countries". She added that "the two parties hoped to extend the partnership to innovative products in other treatment areas as well". Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. A Phase III trial in multiple myeloma relapsed or refractory has been completed. Plitidepsin has received orphan drug designation in the European Union and the United States of America. Founded in 1942, Eczasibasi is a prominent Turkish industrial group, over 12,750 employees and a combined net turnover of TL 9.6 billion in 2016. Eczasibasi's core sectors are healthcare, consumer products and building products. Additionally, the Group is active in finance, welding technology and mining. The pioneer of Turkey's pharmaceutical industry, the Eczasibasi Healthcare Division is unique in the breadth of its activities, which range from preventive care to early diagnosis and from innovative treatment to close patient follow-up and home care. Through this holistic approach, the Division contributes to wellbeing at every phase of human life. EIP is a wholly-owned Eczasibasi Group company with an expertise in the marketing, sales and distribution of imported and locally manufactured pharmaceutical and health-based personal care products. EIP's diverse portfolio has a special focus on specialty care and rare diseases, and the company is now preparing to launch biosimilar products for cancer treatments not currently available in Turkey. EIP has four strategic business units, with a sizeable sales force covering 25,000 physicians and 5,000 pharmacies all around Turkey. One of the fastest growing pharmaceutical companies in Turkey, EIP has numerous licensing agreements with multinational partners, among them Galderma, Procter&Gamble Health, Chugai Pharmaceutical, Cadila Healthcare, Astellas, and Tillots Pharma. Aplidin® is expected to be marketed in Turkey no later than 2020. Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www. .


Patent
Hoffmann-La Roche and Chugai Pharmaceutical Inc. | Date: 2017-03-09

This application discloses compounds according to generic Formula (I): wherein all variables are defined as described herein, which inhibit Btk. The compounds disclosed herein are useful to modulate the activity of Btk and treat diseases associated with excessive Btk activity. The compounds are useful for the treatment of oncological, auto-immune, and inflammatory diseases caused by aberrant B-cell activation. Also disclosed are compositions containing compounds of Formula (I) and at least one carrier, diluent or excipient.


"Living with diabetes can be challenging and complicated which is why we are excited to launch the new Accu-Chek Guide System combining simple advancements and state-of-the-art technology to provide a better testing experience," said Brad Moore, Head of Roche Diabetes Care, North America. "Additionally, as a company that operates and manufactures its test strips in the US, we recognize that in addressing the needs of the millions of people in this country living with diabetes, it is equally important to provide a solution that ensures all patients receive better quality of care without cost being a barrier." The Accu-Chek Guide System, which is now available at most pharmacies, also automatically tracks results to the Accu-Chek® Connect diabetes management app and online portal eliminating the need for a logbook as well as a test strip ejector button, allowing fast, easy, and hygienic strip disposal. To utilize the savings program patients can hand the SimplePay card to their pharmacist along with the Accu-Chek Guide meter and strip prescription to start saving. For more information and to download the free SimplePay Savings card visit accu-chek.com/guide. Survey Methodology The Roche Diabetes Care Survey was conducted by Wakefield Research (www.wakefieldresearch.com) among 500 U.S. adults with diabetes, between April 11th and April 19th, 2017, using an email invitation and an online survey. Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. For the interviews conducted in this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 4.4 percentage points from the result that would be obtained if interviews had been conducted with all persons in the universe represented by the sample. About Accu-Chek® Guide The Accu-Chek® Guide system is Roche Diabetes Care's new generation of wireless blood glucose monitoring (BGM) systems, designed to respond to previously unmet needs of people with diabetes and their healthcare professionals. As such, it offers new features such as the exclusive, SmartPack TM spill-resistant strip vial and new test strip chemistry and design. Moreover, the system provides Bluetooth® low energy connectivity to the Accu-Chek® Connect diabetes management app and online portal and offers reliable test results that exceed the new global ISO 15197:2013/EN ISO 15197:2015 accuracy standards2,3. About Roche Diabetes Care Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 40 years, the Accu-Chek® brand has been dedicated to enabling people with diabetes to live life as normally and actively as possible as well as to empowering healthcare professionals to manage their patients' condition in an optimal way. Today, the Accu-Chek® portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management, spanning from blood glucose monitoring through information management to insulin delivery. The Accu-Chek® brand encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – contributing to an improved medical outcome. For more information please visit www.accu-chek.com About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. For more information please contact: Anne Gill Head of Communications, Diabetes Care North America Indianapolis, IN Phone: 317.521.0500 anne.gill@roche.com 1 95% of the measured glucose results shall fall within ±10 mg/dL of lab reference value for blood glucose concentrations <100 mg/dL and within 10% for blood glucose concentrations ≥100 mg/dL. Data on file 2 Brazg RL, Klaff LJ, Sussmann, AM, Parkin: Accu-Chek Guide Blood Glucose Monitoring System Exceeds International Accuracy Standards, Journal of Diabetes Science and Technology 1–2, DOI: 10.1177/1932296816652902 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/roche-diabetes-care-introduces-blood-glucose-meter-and-savings-program-designed-to-help-the-over-29-million-people-living-with-diabetes-300462947.html


TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKIO:4519) ha anunciado que los resultados del estudio japonés de fase III (J-ALEX) de Alecensa®, en pacientes con cáncer de pulmón de células no pequeñas positivos a los genes de fusión ALK (NSCLC), se han publicado en la versión electrónica de “The Lancet” el 10 de mayo de 2017.http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext El comunicado en el idioma original, es la versión oficial y autorizada del m


TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) heeft vandaag bekendgemaakt dat de resultaten van het Japanse fase II-onderzoek (J-ALEX) naar Alecensa® voor patiënten met ALK-fusiegenpositieve niet-kleincellige longkanker, is op 10 mei gepubliceerd in de elektronische versie van The Lancet. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext De eerste resultaten van J-ALEX zijn eerder gepresenteerd in een sessie van de bijeenkomst van de American Society of Clinical Oncology (ASCO) in Chicago, op 6 juni 2016. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.


TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) ha annunciato oggi che i risultati dello studio giapponese di fase III (J-ALEX) di Alecensa®, sono stati pubblicati sulla versione digitale di “The Lancet” il 10 maggio 2017. Lo studio ha coinvolto pazienti affetti da carcinoma polmonare non a piccole cellule (Non-Small Cell Lung Cancer, NSCLC) positivo al gene di fusione ALK. Il testo originale del presente annuncio, redatto nella lingua di partenza, è la versione ufficiale c


TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO : 4519) a annoncé aujourd'hui que les résultats de l'étude japonaise de phase III (J-ALEX) portant sur l'Alecensa®, réalisée auprès de patients atteints d'un cancer bronchique non à petites cellules (CBNPC) à gène de fusion ALK-positif, avaient été publiés dans la version électronique de « The Lancet » le 10 mai 2017. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext « La publication des résultats de l'étude J-ALEX dans 'The Lancet' assure la solide position de l'Alecensa comme traitement de première ligne pour les patients atteints de CBNPC à gène de fusion ALK-positif », a déclaré le Dr Yasushi Ito, vice-président principal et directeur de l'Unité de gestion des projets et du cycle de vie. « Nous sommes convaincus que l'Alecensa va également contribuer à améliorer les résultats thérapeutiques des patients suivant un traitement de première ligne, ainsi qu'un traitement de deuxième ligne à l'avenir. » Le risque relatif de SSP du bras Alecensa par rapport au bras crizotinib a été de 0,34 (CI à 99,7 % : 0,17-0,71, test logarithmique par rangs stratifié p<0,0001), et l’Alecensa a démontré une SSP significativement prolongée. La SSP médiane n'a pas été atteinte (CI à 95 % : 20,3-Non estimé) dans le bras Alecensa alors qu'elle a été de 10,2 mois (CI à 95 % : 8,2-12,0) dans le bras crizotinib. Dans le bras Alecensa, la constipation (35 %) a constitué un événement indésirable (EI) avec une fréquence supérieure à 30 %, tandis que dans le bras crizotinib, les nausées (74 %), les diarrhées (73 %), les vomissements (58 %), les troubles visuels (55 %), la dysgueusie (52 %), la constipation (44 %), une élévation de l'ALT (32 %) et une élévation de l'AST (31 %) ont été constatés chacun chez plus de 30 % des patients. Des EI de grade 3-4 sont survenus chez 26 % des patients du bras Alecensa et chez 52 % des patients du bras crizotinib, et aucun décès lié au traitement n'a été constaté dans l'un ou l'autre bras. Chugai Pharmaceutical, l’une des principales sociétés pharmaceutiques axées sur la recherche au Japon, est experte dans les produits biotechnologiques. Basée à Tokyo, Chugai est spécialisée dans les médicaments sur ordonnance et est cotée à la première section de la Bourse de Tokyo. En tant que membre important du groupe Roche, la société Chugai est activement impliquée dans des activités de R&D au Japon et à l’étranger. Chugai se consacre tout particulièrement à la mise au point de produits novateurs pouvant répondre à des besoins médicaux non satisfaits, en se concentrant principalement sur le domaine de l’oncologie. Au Japon, les installations de recherche de Chugai basées à Gotemba et à Kamakura se sont associées afin de développer de nouveaux produits pharmaceutiques, et les laboratoires d’Ukima effectuent actuellement des recherches dans le domaine du développement technologique à des fins de production industrielle. À l’étranger, la société Chugai Pharmabody Research, basée à Singapour, est engagée dans la recherche axée sur la génération de nouveaux médicaments anticorps utilisant les technologies d’ingénierie des anticorps innovants et brevetés de Chugai. Chugai Pharma USA et Chugai Pharma Europe sont engagées dans des activités de développement clinique aux États-Unis et en Europe. En 2016, le montant total du revenu consolidé de Chugai a atteint 491,8 milliards de yens, pour un bénéfice d’exploitation de 80,6 milliards de yens (selon la base fondamentale IFRS). Des informations supplémentaires sont disponibles sur Internet, à l’adresse http://www.chugai-pharm.co.jp/english.


TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) hat heute bekannt gegeben, dass die Ergebnisse der japanischen Phase-III-Studie (J-ALEX) zu Alecensa® bei Patienten mit ALK-Fusionsgen-positivem nicht kleinzelligem Lungenkarzinom (Non-Small-Cell Lung Cancer, NSCLC) in der elektronischen Version von „The Lancet“ vom 10. Mai 2017 veröffentlicht wurden. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext Die ersten Ergebnisse der J-ALEX-Studie wurden am 6. Juni 2016 bei einem Meeting der American Society of Clinical Oncology (ASCO) in Chicago vorgestellt. „Die Veröffentlichung der Ergebnisse der J-ALEX-Studie in ‚The Lancet‘ untermauert die wichtige Rolle von Alecensa in der Primärtherapie (First-Line-Therapie) von Patienten mit ALK-Fusionsgen-positivem NSCLC“, erklärte Dr. Yasushi Ito, Senior Vice President, Leiter des Projekts und der Lifecycle Management Unit. „Wir sind davon überzeugt, dass Alecensa zukünftig in der Primärtherapie und in der Sekundärtherapie (Second-Line-Therapie) zu verbesserten Ergebnissen bei den Patienten beitragen wird.“ Chugai Pharmaceutical ist eines von Japans marktführenden forschungsorientierten Pharmaunternehmen mit Schwerpunkt auf biotechnologischen Produkten. Chugai mit Sitz in Tokio ist auf verschreibungspflichtige Arzneimittel spezialisiert und im ersten Abschnitt der Tokioter Börse notiert. Als wichtiges Mitglied des Roche-Konzerns ist Chugai aktiv an Forschungs- und Entwicklungsaktivitäten in Japan und im Ausland beteiligt. Chugai arbeitet insbesondere an der Entwicklung innovativer Produkte, mit denen eventuell ein nicht gedeckter medizinischer Bedarf gedeckt werden kann, und konzentriert sich dabei vor allem auf den Bereich der Onkologie. In Japan arbeiten die Forschungseinrichtungen von Chugai in Gotemba und Kamakura an der Entwicklung neuer Arzneimittel, und in Laboren in Ukima werden Studien zur Entwicklung von Technologien für die industrielle Produktion durchgeführt. Außerhalb Japans ist Chugai Pharmabody Research in Singapur mit Forschungsarbeiten mit Schwerpunkt auf der Herstellung neuartiger Antikörpermedikamente mittels der unternehmenseigenen innovativen Antikörpertechnologien von Chugai beschäftigt. Chugai Pharma USA und Chugai Pharma Europe beschäftigen sich mit der klinischen Entwicklung in den USA und Europa. Der Konzernumsatz von Chugai im Jahr 2016 betrug 491,8 Milliarden Yen bei einem Betriebsgewinn von 80,6 Milliarden Yen (IFRS-Core-Basis). Weitere Informationen finden sich im Internet unter https://www.chugai-pharm.co.jp/english.


News Article | May 11, 2017
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the Japanese phase III study (J-ALEX) of Alecensa®, in patients with ALK fusion gene positive non-small cell lung cancer (NSCLC), were published in the electronic version of “The Lancet” on May 10, 2017. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext The initial results of the J-ALEX study were presented at a session of the American Society of Clinical Oncology (ASCO) meeting held in Chicago, on June 6, 2016. “The publication of the J-ALEX study results in 'The Lancet' assures the firm position of Alecensa in the first line therapy of patient with ALK fusion gene positive NSCLC,” said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. “We believe that Alecensa will also contribute to improving the outcomes for patients in first line therapy, as well as second line therapy in the future.” The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by an independent review board. The secondary endpoints included overall survival, objective response rate, safety, and other endpoints. The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 (99.7% CI: 0.17-0.71, stratified log-rank p<0.0001) and Alecensa demonstrated significantly prolonged PFS. Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (35%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (58%), visual disturbance (55%), dysgeusia (52%), constipation (44%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 26% of the Alecensa arm and in 52% of the crizotinib arm, there were no treatment-related deaths in either arm. In February 2016, Chugai carried out a prospectively-defined interim analysis and had an independent data monitoring committee examine the results. Since the results showed that the Alecensa arm significantly prolonged the PFS, the committee decided to recommend an early discontinuation of the J-ALEX study. Based on the results of the J-ALEX study, Alecensa was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in September 2016 for first line therapy of patients with ALK-positive non-small cell lung cancer. Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area. In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated revenue in 2016 of Chugai totalled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis). Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.

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