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Eisai Co Ltd (4523.T)

4523.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Biogen And Eisai Reports Data From Long-Term Extension Phase 1b Study
Tuesday, 28 Aug 2018 07:30am EDT 

Aug 28 (Reuters) - Biogen Inc ::BIOGEN AND EISAI REPORT DATA FROM LONG-TERM EXTENSION PHASE 1B STUDY OF INVESTIGATIONAL ALZHEIMER’S DISEASE TREATMENT ADUCANUMAB.BIOGEN INC - THERE ARE SMALL PATIENT NUMBERS IN NEW ANALYSES.BIOGEN INC - RESULTS IN STUDY ARE "GENERALLY CONSISTENT" WITH PREVIOUS INTERIM ANALYSES.BIOGEN INC - THERE WERE NO CHANGES TO RISK-BENEFIT PROFILE OF ADUCANUMAB IN STUDY.BIOGEN - OF 185 PATIENTS DOSED WITH ADUCANUMAB IN PHASE 1B STUDY, 46 PATIENTS EXPERIENCED AMYLOID IMAGING ABNORMALITIES (ARIA)-E (EDEMA).BIOGEN INC - EIGHT PATIENTS EXPERIENCED MORE THAN ONE EPISODE OF ARIA-E IN STUDY.BIOGEN - MAJORITY OF ARIA EVENTS IN STUDY WERE TYPICALLY MILD RADIOGRAPHICALLY, CLINICALLY ASYMPTOMATIC AND RESOLVED OR STABILIZED WITHIN 4-12 WEEKS.  Full Article

Eisai And Merck Announce FDA Grants Breakthrough Therapy Designation
Tuesday, 31 Jul 2018 06:30am EDT 

July 31 (Reuters) - Merck & Co Inc ::EISAI AND MERCK ANNOUNCE FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION FOR LENVIMA® (LENVATINIB) IN COMBINATION WITH KEYTRUDA® (PEMBROLIZUMAB) AS THERAPY FOR PREVIOUSLY TREATED PATIENTS WITH ADVANCED AND/OR METASTATIC NON-MSI-H/PMMR ENDOMETRIAL CARCINOMA.  Full Article

Eisai Receives FDA Priority Review Designation For Fycompa
Wednesday, 30 May 2018 09:59am EDT 

May 30 (Reuters) - Eisai Inc::EISAI RECEIVES FDA PRIORITY REVIEW DESIGNATION FOR FYCOMPA® (PERAMPANEL) CIII PEDIATRIC INDICATIONS SUPPLEMENTAL NEW DRUG APPLICATION (SNDA).  Full Article

Morphotek Announces Agreement To License Its Eribulin-Linker Payload To Bliss Biopharmaceutical Of China
Monday, 9 Apr 2018 10:00am EDT 

April 9 (Reuters) - Morphotek::LICENSED ITS ERIBULIN-LINKER PAYLOAD TO BLISS BIOPHARMACEUTICAL CO OF CHINA.LICENSING AGREEMENT WITH BLISSBIO INCLUDES UPFRONT PAYMENT, MILESTONES, SALES ROYALTY PAYMENTS, WHICH ARE UNDISCLOSED.BLISSBIO HAS EXCLUSIVITY OPTION TO EXPAND TERRITORY BEYOND CHINA & TO DEVELOP THERAPEUTIC ADCS TO 2 ADDITIONAL ONCOLOGY TARGETS.AGREEMENT GRANTS BLISSBIO EXCLUSIVE RIGHT TO USE ERIBULIN-LINKER PAYLOAD TO DEVELOP THERAPEUTIC ADC AGAINST ONCOLOGY TARGET FOR CHINA MARKET .  Full Article

Eisai Submits sNDA To FDA For Fycompa Pediatric Indications
Friday, 30 Mar 2018 02:53pm EDT 

March 30 (Reuters) - Eisai Inc : :EISAI SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) TO FDA FOR FYCOMPA® (PERAMPANEL) PEDIATRIC INDICATIONS.EISAI INC - SUBMISSION ALSO PROPOSES PEDIATRIC INDICATION FOR MONOTHERAPY, ADJUNCTIVE USE FOR PGTC SEIZURES IN CHILDREN WITH EPILEPSY.EISAI INC SAYS SNDA IS FOR BOTH FYCOMPA TABLET AND ORAL SUSPENSION FORMULATIONS.  Full Article

Nichi-Iko Pharmaceutical says business and capital alliance with Eisai
Wednesday, 28 Mar 2018 02:41am EDT 

March 28 (Reuters) - Nichi-Iko Pharmaceutical Co Ltd <4541.T>:Says it forms business and capital alliance with Eisai Co Ltd <<<4523.T>>>.Says two entities will mainly cooperate on generic drug business model reform, ecosystem construction and API application .Says it will acquire 100 percent stake in ELMED EISAI Co Ltd from Eisai Co Ltd, for 17.12 billion yen in total.Says it plans to complete stake acquisition on April 1, 2019 .  Full Article

Morphotek Announces FDA Acceptance Of IND For Cancer Treatment
Wednesday, 10 Jan 2018 09:00am EST 

Jan 10 (Reuters) - Eisai Co Ltd <4523.T>::MORPHOTEK ANNOUNCES FDA ACCEPTANCE OF INVESTIGATIONAL NEW DRUG APPLICATION FOR NEXT-GENERATION FARLETUZUMAB ANTIBODY-DRUG CONJUGATE MORAB-202.MORPHOTEK - U.S. FDA ACCEPTED INVESTIGATIONAL NEW DRUG APPLICATION FOR MORAB-202.  Full Article

Eisai, Merck Receive Breakthrough Therapy Designation From FDA For Lenvima, Keytruda
Tuesday, 9 Jan 2018 06:45am EST 

Jan 9 (Reuters) - Eisai Co Ltd <4523.T>::EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.  Full Article

Albireo Announces Agreement With Healthcare Royalty Partners
Wednesday, 3 Jan 2018 08:00am EST 

Jan 3 (Reuters) - Albireo Pharma Inc ::ALBIREO ANNOUNCES ROYALTY MONETIZATION AGREEMENT WITH HEALTHCARE ROYALTY PARTNERS FOR ELOBIXIBAT IN JAPAN.ALBIREO PHARMA INC - ‍ALBIREO SUBSIDIARY ELIGIBLE TO RECEIVE UP TO $60 MILLION UNDER AGREEMENT​.ALBIREO PHARMA INC - ‍DECISION ON JAPANESE NEW DRUG APPLICATION FOR ELOBIXIBAT EXPECTED IN FIRST HALF OF 2018​.ALBIREO PHARMA -HCR OBTAINS RIGHT TO RECEIVE ROYALTIES, SALES MILESTONES FOR ELOBIXIBAT IN JAPAN THAT MAY BE PAYABLE BY EA PHARMA, UP TO A THRESHOLD​.ALBIREO PHARMA INC - ‍ELOBIX HAS RETAINED ITS RIGHT TO RECEIVE A MILESTONE PAYMENT FROM EA PHARMA IF ELOBIXIBAT IS APPROVED BY MHLW​.ALBIREO PHARMA INC - ‍ IF SPECIFIED THRESHOLD IS REACHED, ELOBIX WILL AGAIN BECOME ELIGIBLE TO RECEIVE ROYALTIES AND SALES MILESTONES FOR ELOBIXIBAT.  Full Article

Biogen and Eisai expand existing collaboration agreement to develop and commercialize investigational Alzheimer's disease treatments including phase 3 aducanumab
Monday, 23 Oct 2017 07:15am EDT 

Oct 23 (Reuters) - Biogen Inc :Biogen and Eisai expand existing collaboration agreement to develop and commercialize investigational Alzheimer's disease treatments including phase 3 aducanumab.Biogen Inc - ‍Eisai has exercised its option to jointly develop and commercialize aducanumab, with Biogen continuing as development lead​.Biogen Inc - Co, Eisai to co-promote co's multiple sclerosis treatments, avonex , tysabri, tecfidera in Japan to accounts that co does not call upon​.Biogen Inc - ‍Neither party is making any upfront payments associated with exercise of aducanumab option​.Biogen Inc - ‍Under terms of agreement co will receive 55 percent of potential profits in United States and 68.5 percent of potential profits in Europe​.Biogen Inc - ‍Eisai's, Biogen's respective milestone payments under original agreement for aducanumab and BAN2401, have been eliminated​.Biogen Inc - ‍ Companies will continue to jointly develop elenbecestat (e2609), a beta amyloid cleaving enzyme (bace) inhibitor, and BAN2401​.Biogen Inc - ‍Financial terms for elenbecestat and ban2401 remain unchanged, other than eliminated BAN2401 milestone payments​.Biogen - Co to continue to lead phase 3 development of aducanumab, remain solely responsible for development costs for aducanumab until April 2018​.Biogen Inc - ‍ Under terms of agreement Eisai will receive 80 percent of potential profits in Japan and Asia excluding China and South Korea​.  Full Article

Nikkei rises to 2-week high on weak yen, pharmaceuticals

* Paper sector pushed up by brokerage's target price hike on co