tak*****

Pexidartinib (PLX3397)

FDA Grants Breakthrough Therapy Designation for Daiichi Sankyo and Plexxikon's Investigational CSF-1R Inhibitor Pexidartinib (PLX3397) in Tenosynovial Giant Cell Tumor
-- A rare, potentially destructive tumor of the joint or tendon sheath, tenosynovial giant cell tumor (TGCT) can lead to significant pain, joint destruction, frequent surgery and loss of mobility
-- No FDA-approved systemic therapy currently exists for the treatment of TGCT
-- First Breakthrough Therapy Designation for Daiichi Sankyo's innovative portfolio of oncology compounds

http://www.prnewswire.com/news-releases/fda-grants-breakthrough-therapy-designation-for-daiichi-sankyo-and-plexxikons-investigational-csf-1r-inhibitor-pexidartinib-plx3397-in-tenosynovial-giant-cell-tumor-300169556.html

SAVAYSA® (edoxaban)

PARSIPPANY, N.J., Nov. 2, 2015 /PRNewswire/ -- Daiichi Sankyo, Inc. today announced that data from four new subgroup analyses from the phase 3 ENGAGE AF-TIMI 48 study will be presented at the American Heart Association (AHA) Scientific Sessions 2015, taking place from November 7-11, 2015, in Orlando, Florida. Results will provide further insights about the safety and efficacy profile of once-daily SAVAYSA® (edoxaban) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients.

http://www.prnewswire.com/news-releases/daiichi-sankyo-announces-new-subgroup-analyses-of-once-daily-savaysalixiana-in-patients-with-non-valvular-atrial-fibrillation-will-be-presented-at-aha-scientific-sessions-2015-300170128.html

Genentech announced:
South San Francisco, CA -- November 10, 2015 --

FDA Approves Genentech’s Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma

• FDA approval underscores the important role of targeted medicines to help people with BRAF V600 mutation-positive advanced melanoma
• Pivotal coBRIM study showed the combination improved progression-free and overall survival compared to Zelboraf alone

http://www.gene.com/media/press-releases/14611/2015-11-10/fda-approves-genentechs-cotellic-cobimet

Pieris Pharmaceuticals Collaborator Daiichi Sankyo Doses First Subject in a Phase 1 Clinical Study for Lead Partnered Anticalin Program

BOSTON, MA -- (Marketwired) -- 11/19/15 -- Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel bio therapeutics through its proprietary Anticalin® technology platform, announced today that collaborator Daiichi Sankyo Company, Limited ("Daiichi Sankyo"), headquartered in Chuo Ward, Tokyo, dosed the first subject in a Phase I clinical study for the parties' lead partnered Anticalin program, also triggering an undisclosed milestone payment. The clinical trial is being conducted in the United States under an Investigational New Drug Application accepted by The U.S. Food and Drug Administration.

http://ir.pieris.com/press-releases/detail/520

Anticalin®
http://www.pieris.com/anticalin-technology/overview

Roche receives EU approval of Cotellic for use in combination with Zelboraf (PLX4032; Plexxikon) in advanced melanoma
Basel, 25 November 2015

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved CotellicTM (cobimetinib) for use in combination with Zelboraf® (vemurafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The EU approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening.

http://www.roche.com/media/store/releases/med-cor-2015-11-25.htm

Affibody receives clinical milestone from Daiichi Sankyo

Solna, Sweden, December 1, 2015.
Affibody AB announced today that it will receive a clinical milestone in connection with Daiichi Sankyo Company Limited’s (hereinafter Daiichi Sankyo; headquartered in Chuo Ward, Tokyo, TSE 4568) initiation of a Phase I study.

http://www.affibody.com/en/News/News/Affibody-receives-clinical-milestone-from-Daiichi-Sankyo/

Sorry, BAD REPORT:
Anti-platelet therapy (Prasugrel, Effient®) does not significantly reduce pain crises in sickle cell disease
Dana-Farber Cancer Institute

BOSTON, MA, and OAKLAND, CA (Dec. 8, 2015) - Treatment with the antiplatelet agent prasugrel does not significantly reduce the rate of pain crises or severe lung complications in children with sickle cell disease, according to a report published in the New England Journal of Medicine describing one of the largest and most geographically diverse international clinical trials on sickle cell disease to date.

http://www.eurekalert.org/pub_releases/2015-12/dci-atd120315.php

>>現状の適用範囲内で副作用等ネガティブ情報が入ってきた場合の方がよっぽど怖い！

クロピドグレル、全世界で長期間使用されているP2Y12受容体阻害薬。
その初期活性代謝物、プラスグレルに、
現在の適応症使用に何の懸念があると思っているのですか。

予期せぬ副作用とかでは、医薬品OBとしての答えにはなりませんよ。

ArQule and Daiichi Sankyo Announce Completion of Accrual in METIV-HCC Phase 3 Trial of Tivantinib for Second-Line Hepatocellular Carcinoma

Planned interim analysis expected to occur early in the second quarter of 2016

BURLINGTON, MA and PARSIPPANY, NJ, USA I December 10, 2015 I ArQule, Inc. (Nasdaq:ARQL) and Daiichi Sankyo, Inc. today announced that the phase 3 METIV-HCC trial for tivantinib in second-line hepatocellular carcinoma (HCC) has completed accrual. In addition, the planned interim analysis, which is triggered when 60 percent of events occur, is expected to take place early in the second quarter of 2016.

http://files.shareholder.com/downloads/ARQL/1155639440x0x865961/0D8A6C98-9982-4F61-B589-681EB1A3E15E/METIV-HCC_Complete_Recruitment_-_US_-_FINAL.pdf

Daiichi Sankyo Layoffs Begin in Texas as Company Implements Restructuring Plan

December 28, 2015
By Alex Keown, BioSpace.com Breaking News Staff

PARSIPPANY, N.J., -- Pink slips have begun to arrive for Daiichi Sankyo, Inc., employees as the company undergoes a restructuring of its sales force in the United States. This week 18 Texas-based sales team members received layoff notifications, the Dallas Business Journal reported this morning.

http://www.bizjournals.com/dallas/news/2015/12/22/japanese-pharmaceutical-company-to-lay-off-16.html

Daiichi Sankyo Korea Signs Agreement with Daewoong Pharmaceutical for the Co-promotion of LIXIANA® in South Korea

Tokyo, Japan (December 28, 2015) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that its wholly owned subsidiary, Daiichi Sankyo Korea Co., Ltd. (hereafter “DSKR;” headquarters: Jongno-gu, Seoul, South Korea), and Daewoong Pharmaceutical Co., Ltd. (hereafter “Daewoong Pharmaceutical;” headquarter: Gangnam-gu, Seoul, South Korea) have signed an agreement for the co-promotion of the oral, once-daily anti-coagulant, LIXIANA® (generic name: edoxaban).

http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006390.html

ArQule Presents Clinical Biomarker Data From Phase 2 Study and Ongoing Phase 3 METIV-HCC Study of Tivantinib in Second-Line Hepatocellular Carcinoma at the 2016 Gastrointestinal Cancers Symposium

Preliminary analysis of baseline MET incidence in METIV-HCC trial confirms results observed in phase 2 trial

BURLINGTON, Mass., Jan. 25, 2016 (GLOBE NEWSWIRE) -- ArQule, Inc. (NASDAQ:ARQL) today announced that an analysis of preliminary baseline tumor MET status of patients screened in the phase 3 METIV-HCC trial for tivantinib in second-line hepatocellular carcinoma (HCC) confirms previously presented data from the company's phase 2 trial in the same patient population. In both trials MET status, as determined by immunohistochemistry, was more frequently high after first-line therapy and was a predictive and prognostic biomarker in the phase 2 trial. The data was presented in an oral presentation and poster at the 2016 Gastrointestinal Cancers Symposium (ASCO GI) on January 22, 2016.

http://investors.arqule.com/releasedetail.cfm?ReleaseID=951459

ArQule Provides Proprietary Pipeline Update for AKT Inhibitors

#First cohort dosed in phase 1 trial with ARQ 092 in Proteus syndrome
#ArQule receives Investigational New Drug approval for ARQ 751

BURLINGTON, Mass., Jan. 28, 2016 (GLOBE NEWSWIRE) -- ArQule, Inc. (NASDAQ:ARQL) today announced a pipeline update for its AKT inhibitors, including ARQ 092 and ARQ 751, both orally available, selective pan-AKT inhibitors.

http://investors.arqule.com/releasedetail.cfm?ReleaseID=952158

BioInvent receives €2 million milestone payment from Daiichi Sankyo for licensed n-CoDeR® antibody progressing into Phase I clinical trial

Lund, Sweden – 29 February 2016 – BioInvent International (BINV) today announced that it will receive a €2 million milestone payment under the collaboration with Daiichi Sankyo pertaining to the progression of an anti-FGFR4 antibody into a Phase I clinical trial in the EU.

http://www.bioinvent.se/media-centre/press-releases/release/?ReleaseID=0343D46385679286

Daiichi Sankyo and ArQule Announce Continuation of METIV-HCC Phase 3 Study of Tivantinib (ARQ 197) in Second-Line Hepatocellular Carcinoma

BURLINGTON, Mass. and PARSIPPANY, N.J., March 22, 2016 (GLOBE NEWSWIRE) -- ArQule, Inc. (Nasdaq:ARQL) and Daiichi Sankyo today announced that the independent data monitoring committee (DMC) of the METIV-HCC study conducted the planned interim assessment and it was determined the trial will continue to its final analysis.

http://files.shareholder.com/downloads/ARQL/1155639440x0x882287/84DDD033-9DCA-46B6-9556-D4E90448754B/METIV-HCC_Interim_Analysis_Press_Release__cs.pdf

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)の
Press releases (May 31 at 8:30 a.m. ET) がありました。

http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=973265

大日本住友製薬：ニュースリリース　2016.06.07

ボストン・バイオメディカルのウェブサイトに、米国臨床腫瘍学会（ASCO）で発表したnapabucasin（BBI608）およびamcasertib（BBI503）に関するポスター資料を掲載しました

http://www.bostonbiomedical.com/research-and-development/publications/

Charleston Laboratories And Daiichi Sankyo Announce FDA Acceptance Of New Drug Application (NDA) For CL-108
6/13/2016

http://charlestonlabs.com/wp-content/uploads/2016/06/CL-108-NDA-Acceptance-Release-FINAL-6-12-161.pdf

ArQule Presents Preliminary Clinical Data for ARQ 087 Demonstrating Evidence of Anticancer Activity in Intrahepatic Cholangiocarcinoma at the ESMO 18th World Congress on Gastrointestinal Cancer
Jun 30, 2016

75% disease control rate, including a 25% objective response rate, was observed in 12 evaluable patients harboring FGFR2 genetic alterations

http://investors.arqule.com/releasedetail.cfm?ReleaseID=977747

今回成立した特許（出願日：2012. 08. 13）は、
2014. 02. 27に公開されていますが（JP2014037358）、
PCT（特許協力条約）に基づいた国際出願ではありません。
出願時に国外にも日本と同様に直接出願している可能性はありますが、
国外での特許権利化を放棄し、
日本国内のみの成立で良しと判断したのではないでしょうか。