Gotemba, Japan
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TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) hat heute bekannt gegeben, dass die Daten aus der globalen Phase-II-Studie (die XCIMA-Studie) für die geplante Indikation von atopischer Dermatitis (AD) im New England Journal of Medicine online am 2. März 2017 (EST) veröffentlicht worden sind. Die Studie wurde durchgeführt, um die Sicherheit und Wirksamkeit von Nemolizumab bei 264 Patienten mit mittelschwerer bis schwerer AD zu bewerten, und die Sicherheit und Wirksamkeit von Nemolizumab wurde nach 12 Wochen bestätigt. „Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis”, Thomas Ruzicka, M.D., et al http://www.nejm.org/doi/full/10.1056/NEJMoa1606490 Die Wirksamkeit und Sicherheit von Daten aus einer einjährigen Verlängerung der Studie werden am 4. März den topaktuellen Forschungsforen der Jahrestagung 2017 des Meetings der American Academy of Dermatology (AAD) vorgestellt, das vom 3. bis 7. März in Orlando im US-Bundesstaat Florida stattfindet. [Überblick über die Studie] 264 Patienten wurden in eine von vier Nemolizumab-Dosisgruppen randomisiert (0,1, 0,5, 2,0 mg / kg alle 4 Wochen (Q4W) oder 2,0 mg / kg alle 8 Wochen) oder Placebo-Gruppe (Q4W) im Verhältnis von 1:1:1:1:1. Der primäre Endpunkt der Studie zeigte eine signifikante Verbesserung der Änderung des Pruritus VAS nach 12 Wochen im Vergleich zum Placebo mit einem Score von -43,7 % für Nemolizumab 0,1 mg / kg Q4W, -59,8 % für Nemolizumab 0,5 mg / kg Q4W, -63,1 % für Nemolizumab 2,0 mg / kg Q4W und -20,9 % für Placebo Q4W (p<0,01 für alle Vergleiche). Der sekundäre Endpunkt war die Veränderung von EASI nach 12 Wochen von -23,0 %, -42,3 % und -40,9 % für jeweils die Gruppen mit Nemolizumab 0,1, 0,5 und 2,0 mg / kg Q4W im Vergleich zu -26,6 % für Placebo. Ein weiterer sekundärer Endpunkt, der Anteil (%) der Patienten mit ≥2-Punkt-Verbesserung in sIGA betrug 13,8 %, 37,5 % bzw. 25,1 % für die Gruppen mit Nemolizumab 0,1, 0,5 und 2,0 mg / kg Q4W, verglichen mit 10,5 % für Placebo. Die häufigsten unerwünschten Ereignisse (UE) waren die Verschlimmerung von AD, Nasopharyngitis, Infektionen des oberen Respirationstrakts, periphere Ödeme und erhöhte Kreatinphosphokinase. 15 Patienten erlitten UE im Zusammenhang mit Therapieabbrüchen und 10 von 15 beruhten auf UE in Zusammenhang mit AD (wie Verschlimmerung der AD und Dermatitis exfoliativa).


News Article | February 21, 2017
Site: www.eurekalert.org

Osaka University and Otsuka Pharmaceutical Co., Ltd. (Otsuka) signed a comprehensive collaboration agreement for advanced research in immunology between the Osaka University Immunology Frontier Research Center (IFReC) and Otsuka. This agreement allows researchers at IFReC to focus on original basic research areas and, with Otsuka, to develop innovative new treatments therefore contributing back to society with the results of their advanced immunology research. IFReC was selected for the World Premier International Research Center (WPI) Initiative Program initiated by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) in 2007 and launched at Osaka University in October of the same year as a research center in immunology. Led by Director Shizuo Akira, an eminent immunologist, IFReC brings together around 170 of the world's leading investigators in the fields of immunology, live imaging and bioinformatics from Japan and across the world to conduct innovative immunological research. The center provides an international environment coupled with excellent research facilities, making it possible to pursue leading-edge research. IFReC researchers publish in internationally renowned academic journals to high acclaim including the award of several prestigious international prizes. Guided by our corporate philosophy, Otsuka-people creating new products for better health worldwide, Otsuka is committed to improving the health and well-being of patients and consumers through "treating diseases" and "promoting daily health". As a total healthcare company, Otsuka continues to focus on creating creative and innovative products. In order to address unmet needs in medicine, we focus our research on central nervous system disorders and oncology, and also develop treatments in cardiovascular, infectious, ophthalmological, and dermatological disease fields. According to the agreement, Otsuka will have access to information regarding results of independent basic research projects at IFReC. Although Chugai Pharmaceutical Co., Ltd., which signed a prior agreement has the right of first refusal on joint research projects and intellectual property. Otsuka can discuss future joint research with IFReC, and receive disclosure about future patent rights in immunology from Osaka University. As part of this agreement, Otsuka will contribute to the research activity expenses of IFReC for a period of 10 years.


News Article | February 27, 2017
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for the anti-cancer agent, alectinib hydrochloride (brand name: Alecensa®) for the treatment of people with “anaplastic lymphoma kinase (ALK) positive, advanced non-small cell lung cancer (NSCLC) who have progressed on or those intolerant to crizotinib.” “We believe that the approval of Alecensa by the TFDA would bring the great news to Taiwanese patients who are fighting against this disease,” said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. “We are pleased that Alecensa created by Chugai will contribute to the treatment of ALK-positive NSCLC.” Taiwan’s approval was based on two clinical phase I/II studies, as summarised below: - The NP28761 study is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib. (Data cut-off: January 22, 2016) - The NP28673 study is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib. (Data cut-off: February 1, 2016) - People in the phase II studies received 600 mg of Alecensa orally twice daily. In both trials, the primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1), and evaluated by an Independent Review Committee (IRC). Secondary endpoints included duration of response (DOR) and safety. - Alecensa demonstrated a safety profile consistent with that observed in previous studies. - The most common Grade 3 or higher adverse events were an increase in muscle enzymes (increased blood levels of creatine phosphokinase; five percent), increased liver enzymes (alanine aminotransferase; 4.8 percent, and aspartate aminotransferase; 3.6 percent) and shortness of breath (dyspnoea; 3.6 percent). Alecensa is a highly selective oral ALK inhibitor discovered by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases. Alecensa is currently approved in the United States, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, the EU and Taiwan for the treatment of advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib. In Japan, Alecensa is available to patients with “ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai. 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.


News Article | February 21, 2017
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that F. Hoffmann-La Roche Ltd. obtained conditional marketing authorization from the European Commission (EC) , for the anti-cancer agent, alectinib hydrochloride (brand name: Alecensa®) for the treatment of adult patients with “anaplastic lymphoma kinase (ALK) positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or those intolerant to crizotinib.” “Alecensa was created by Chugai, and in July 2014, Japan became the first country in the world to receive regulatory approval. We believe that the approval of Alecensa by the EC will bring great hope for patients in the EU living with this disease,” said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. “We are extremely pleased that Alecensa can contribute to the treatment of patients with ALK positive NSCLC in each country.” EU approval was based on two clinical phase I/II trials, as summarised below: - The NP28761 study is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 87 people with ALK positive NSCLC whose disease progressed on crizotinib. (Data cut-off: October 24, 2014) - The NP28673 study is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib. (Primary data cut-off including safety: August 18, 2014, updated Independent Review Committee (IRC) data cut-off: January 8, 2015) - People in the phase II studies received 600 mg of Alecensa orally twice daily. In both trials, the primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1), and evaluated by an IRC. Secondary endpoints included duration of response (DOR), progression-free survival (PFS) and safety. - Alecensa demonstrated a safety profile consistent with that observed in previous studies. - The most common Grade 3 or higher adverse events were an increase in muscle enzymes (increased blood levels of creatine phosphokinase; eight percent), increased liver enzymes (alanine aminotransferase; six percent, and aspartate aminotransferase; five percent) and shortness of breath (dyspnoea; three percent). Alecensa is a highly selective oral ALK inhibitor discovered by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases. Chugai has out-licensed the rights of Alecensa to Roche in overseas countries including Europe and the US. Alecensa is currently approved in the United States, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland and India for the treatment of advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib. In Japan, Alecensa is available to patients with “ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai. 1) Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients 2) Soda et al., Nature. 448: 561-566 (2007) 3) Takeuchi et al., Clin Cancer Res. 15: 3143-3149 (2009) 4) Sakamoto et al., Cancer Cell. 19: 679-690 (2011) 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.


News Article | February 21, 2017
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) ha annunciato che F. Hoffmann-La Roche Ltd. ha ottenuto l’autorizzazione all'immissione in commercio condizionata da parte della Commissione europea (CE), di agenti anti-tumorali, alectinib cloridrato (nome del marchio: Alecensa®) per il trattamento di pazienti adulti con “ALK (anaplastic lymphoma kinase, chinasi del linfoma anaplastico) positivo, carcinoma polmonare non a piccole cellule (non-small cell lung cancer, NSCLC) diffuso o per pazienti intolleranti al crizotinib.”


News Article | February 24, 2017
Site: www.businesswire.com

TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) ha comunicado que F. Hoffmann-La Roche Ltd. ha conseguido la aprobación de comercialización condicional de la Comisión Europea (CE) , para el agente anticancerígeno, clorhidrato del alectinib (nombre de marca: Alecensa®) para el tratamiento de los pacientes adultos con “cáncer de pulmón de células no pequeñas metastásico (CPCNP) ALK positivo, en aquellos pacientes que han avanzado en la enfermedad o que son intolerantes a crizotinib.”


Patent
The General Hospital Corporation and Chugai Pharmaceutical Co. | Date: 2013-10-16

The present invention relates to a polypeptide, or pharmaceutically acceptable salt thereof, comprising the formula PTH(1-X)/PTHrP(Y-36). Further, the present invention refers to a polypeptide which binds the PTH receptor and has a high affinity for the R^(0) form of the PTH receptor and to a polypeptide having affinity for PTH RG and a low affinity for PTH R^(0). Moreover, the present invention includes to a pharmaceutical composition comprising such polypeptide. The present invention further relates to a polypeptide or a pharmaceutical composition of the present invention for use in a method for treating a disease or condition. Moreover, the present invention refers to a nucleic acid comprising a sequence encoding a polypeptide of the present invention, a vector comprising said nucleic acid, a cell comprising said vector and a method of making a polypeptide of the present invention. Finally, the present invention further relates to a method for determining whether a candidate compound is a long-acting agonist of a G protein coupled receptor (GPCR).


Patent
Chugai Pharmaceutical Co. and The General Hospital Corporation | Date: 2013-09-25

The present invention provides screening methods for GPCRs based on the discovery that the affinity of a receptor agonist for a GPCR (such as the parathyroid hormone receptor) when not bound to a G-protein is correlated with the length of time over which the agonist is effective, independently of its pharmacokinetic properties. The invention also provides PTH- and PTHrP-derived polypeptides.


TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) ha annunciato oggi che i dati studio globale di Fase II (lo studio XCIMA) per la prevista indicazione per le dermatiti atopiche (DA) sono stati pubblicati sul New England Journal of Medicine Online in data 2 marzo 2017 (fuso orario degli Stati Uniti orientali).

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