Key Developments: Astellas Pharma Inc (4503.T)

4503.T on Tokyo Stock Exchange

11 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Astellas Pharma Inc and MSD Enter Co-Promotion Agreement in Japan for Ipragliflozin, SGLT2 Inhibitor for Treatment of Type 2 Diabetes
Sunday, 1 Sep 2013 07:30pm EDT 

Astellas Pharma Inc announced that the Company and MSD K.K. have entered into a co-promotion agreement in Japan for ipragliflozin L-proline (generic name; development code: ASP1941), a SGLT2 inhibitor for which Astellas has filed an application for approval in Japan. Astellas will manufacture and sell ipragliflozin. Under the agreement, MSD will co-promote ipragliflozin with Astellas and Kotobuki Pharmaceutical Co., Ltd.  Full Article

Astellas Pharma Inc Receives Approval of Irribow OD Tablets in Japan for Diarrhea-predominant Irritable Bowel Syndrome
Thursday, 15 Aug 2013 03:30am EDT 

Astellas Pharma Inc announced that it has obtained the marketing approval of Irribow Tablets 2.5µg / 5µg (generic name: ramosetron hydrochloride) in Japan. They were approved for an additional formulation of Irribow Tablets with the indication of diarrhea-predominant irritable bowel syndrome in male.  Full Article

Astellas Pharma Inc and FibroGen, Inc. Initiate Phase II Anemia Study in Japan- MarketLine
Sunday, 4 Aug 2013 05:12pm EDT 

MarketLine reported that Astellas Pharma Inc and FibroGen, Inc., a developer of recombinant collagen and gelatin for medical devices, have initiated a Phase II clinical study in Japan with ASP1517/FG-4592 for treatment of anemia associated with chronic kidney disease, or CKD, in patients on dialysis. ASP1517/FG-4592, an orally administered small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PHI), is an advanced candidate in this new class of potential anemia therapeutic agents.  Full Article

Astellas Pharma Inc Establishes Sales Affiliate in Singapore-THE ASAHI SHIMBUN
Thursday, 1 Aug 2013 08:00pm EDT 

THE ASAHI SHIMBUN reported that Astellas Pharma Inc. announced on August 1, 2013 the Company has set up an affiliate in Singapore.  Full Article

R&I Affirms Astellas Pharma Inc's Rating at "AA"; Rating Outlook Stable
Thursday, 1 Aug 2013 02:00am EDT 

Rating and Investment Information, Inc. (R&I) announced that it has reaffirmed the rating on Astellas Pharma Inc at "AA". The rating outlook is stable.  Full Article

Astellas Pharma Inc Announces FDA Approval Of ASTAGRAF XL (tacrolimus extended-release capsules) For Prophylaxis Of Organ Rejection In Adult Kidney Transplant Recipients
Friday, 19 Jul 2013 08:14pm EDT 

Astellas Pharma Inc announced that Astellas Pharma US, Inc. (Astellas), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced that the U.S. Food and Drug Administration (FDA) has approved ASTAGRAF XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. The two primary, randomized, comparative phase 3 clinical studies to support FDA approval enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa.  Full Article

China Probes Pricing At Drugmakers Including Astellas Pharma Inc-Reuters
Thursday, 4 Jul 2013 07:31am EDT 

Reuters reported that China's top economic planning agency is investigating costs and prices charged by drugmakers, including units of GlaxoSmithKline and Merck & Co Inc, as foreign firms come under pressure from Beijing over possible price-fixing. The move follows a separate probe into instant milk powder, which has already led to price cuts. The National Development and Reform Commission (NDRC) is surveying production costs and prices charged at multiple foreign and Chinese drug companies, according to a July 2, 2013 statement from the commission. News of the investigation was reported earlier on Thursday by the official Securities Daily newspaper. The NDRC will examine 27 companies on cost issues and 33 for pricing. The investigation is being done to understand the cost and pricing situation within the companies, and to adjust drug prices in a timely manner, the agency said. In addition to GSK and Merck, other foreign companies being investigated over costs include Astellas Pharma Inc, Novartis AG's generics unit Sandoz, Boehringer Ingelheim, Baxter International Inc and Fresenius SE & Co KGaA. An investigation team from NDRC will visit the companies involved between July and October, the agency said.  Full Article

Astellas Pharma Inc Announces Marketing Approval in Japan for Bisono Tape
Friday, 28 Jun 2013 02:00am EDT 

Astellas Pharma Inc announced that the Company and Toa Eiyo have obtained the marketing approval for Bisono Tape 4mg and Bisono Tape 8mg, a transdermal patch of β1 blocker.  Full Article

Seattle Genetics Inc and Subsidiary of Astellas Pharma Inc Announce Co-Development of an Additional Antibody-Drug Conjugate (ADC) Under Existing Collaboration
Thursday, 27 Jun 2013 08:00pm EDT 

Seattle Genetics, Inc. and Agensys, Inc., a subsidiary Astellas Pharma Inc. announced that Seattle Genetics has exercised an option to co-develop an additional antibody-drug conjugate (ADC) under the companies' existing ADC collaboration agreement. The ADC, called ASG-15ME, targets the tumor antigen SLITRK6, which is known to be expressed on bladder and lung cancer. Agensys has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 1 trial of ASG-15ME.  Full Article

Cytokinetics Inc Enters Into Collaboration And License Agreement With Astellas Pharma Inc.-Form 8-K
Tuesday, 25 Jun 2013 07:09am EDT 

Cytokinetics Inc reported in its Form 8-K that on June 21, 2013, Cytokinetics, Incorporated (Company) entered into a Collaboration and License Agreement with Astellas Pharma Inc. (Astellas). The primary objective of the collaboration to be conducted under the Agreement is to advance therapies for diseases and medical conditions associated with muscle weakness. Under the Agreement, Cytokinetics granted Astellas an exclusive license to co-develop and commercialize CK-2127107, a fast skeletal troponin activator drug candidate, for potential application in non-neuromuscular indications worldwide. CK-2127107, which is currently in Phase I clinical development, will be developed jointly by Cytokinetics and Astellas. Cytokinetics will be primarily responsible for the conduct of Phase I clinical trials and certain Phase II readiness activities for CK-2127107 and Astellas will be primarily responsible for the conduct of subsequent development and commercialization activities for CK-2127107. Cytokinetics will receive an upfront payment of $16 million in connection with the execution of the Agreement, and is eligible to potentially receive over $24 million in reimbursement of sponsored research and development activities during the initial two years of the collaboration.  Full Article


Aveo, Astellas end pact to develop cancer drug tivozanib

- Aveo Oncology and Astellas Pharma Inc said they would end an agreement to develop Aveo's lead experimental drug that has seen a string of failures in multiple cancer indications.

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