Key Developments: Takeda Pharmaceutical Co Ltd (4502.T)

4502.T on Tokyo Stock Exchange

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25 Nov 2014
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Latest Key Developments (Source: Significant Developments)

Takeda Pharmaceutical Co Ltd responds to verdict in diabetes drug case
Monday, 17 Nov 2014 09:08pm EST 

Takeda Pharmaceutical Co Ltd and Takeda Pharmaceuticals U.S.A., Inc:Announces that in the case of Richard F. Myers, et al. v. Takeda Pharmaceuticals America, et al. the jury found that plaintiffs failed to prove that ACTOS (pioglitazone HCl) was unsafe or that Takeda was negligent.However, the jury found in favor of plaintiffs on their claim for spoliation of evidence and awarded $155,000 in compensatory damages but rejected the claim for punitive damages.Takeda is considering its options, including post-trial motions and an appeal of the spoliation issue.The trial began on Oct. 20, 2014, in Circuit Court of Berkeley County, West Virginia, before Judge Michael Lorensen.Judgments were entered in Takeda's favor in five prior ACTOS trials and Takeda is challenging the outcomes in two other ACTOS trials.  Full Article

Takeda Pharmaceutical files patent infringement lawsuit
Wednesday, 12 Nov 2014 06:45pm EST 

R-Tech Ueno Ltd:Sucampo Pharmaceuticals, R-Tech Ueno, Sucampo AG and Takeda Pharmaceutical (Takeda)filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (Dr. Reddy's).Lawsuit was related to an Abbreviated New Drug Application (ANDA) that Dr. Reddy's filed with the U.S. Food and Drug Administration (FDA) to market, sell and use a generic version of the 8 mcg and 24 mcg AMITIZA (lubiprostone) soft gelatin capsule products.The lawsuit claims infringement of 7 patents that are listed in the FDA's Orange Book, with the latest expiring in 2027.  Full Article

Intra-Cellular Therapies Inc and Takeda announce mutual termination of collaboration
Monday, 3 Nov 2014 07:00am EST 

Intra-Cellular Therapies Inc:Has entered into an agreement to mutually terminate Feb. 2011 license agreement.Says license covering Intra-Cellular Therapies' proprietary compound ITI-214 and related PDE1 inhibitors and to return rights for these compounds to Intra-Cellular Therapies.Under terms of agreement, Intra-Cellular Therapies has regained all worldwide development and commercialization rights for compounds previously licensed to Takeda.Takeda will be responsible for transitioning compounds back to Intra-Cellular Therapies and will not participate in future development or commercialization activities.After transition of program, Intra-Cellular Therapies plans to continue clinical development of PDE1 inhibitors for treatment of central nervous system, cardiovascular and other disorders.  Full Article

Takeda Pharmaceutical Co Ltd reaffirms FY 2015 guidance - Conference Call
Thursday, 30 Oct 2014 02:15am EDT 

Takeda Pharmaceutical Co Ltd:Says it has decided to maintain FY 2015 guidance.FY 2015 revenue of 1,719 billion yen, net income of 104 billion yen and EPS of 120 yen - Thomson Reuters I/B/E/S.  Full Article

Mersana and Takeda enter commercial license agreement for Novel Fleximer Antibody-Drug Conjugate
Monday, 27 Oct 2014 08:00am EDT 

Takeda Pharmaceutical Co Ltd:Exercised an option to license commercial rights for its first novel Fleximer antibody-drug conjugate (ADC) developed under their collaboration announced earlier this year.With the exercise of the commercial license, Mersana will receive a license fee and is eligible for development and regulatory milestone payments and royalties on net sales.  Full Article

Takeda Pharmaceutical Co Ltd and Sucampo Pharmaceuticals enter into global licensing agreement for AMITIZA (lubiprostone)
Tuesday, 21 Oct 2014 06:00pm EDT 

Takeda Pharmaceutical Co Ltd and Sucampo Pharmaceuticals:Says on Oct. 17 they entered into a global license, development, commercialization and supply agreement for AMITIZA (lubiprostone).Says through this agreement, Takeda expanded its exclusive rights beyond the United States and Canada to further develop and commercialize AMITIZA in all global markets, except Japan and the People's Republic of China.Under the terms of the agreement, Sucampo will receive an upfront payment of $14 mln from Takeda and will also be eligible for up to $35 mln in additional commercial milestones contingent on the achievement of certain net sales revenue targets.Additionally, Sucampo will be the exclusive supplier of AMITIZA to Takeda at an agreed-upon supply price.Takeda will be responsible for all development activities and costs, with Sucampo assuming responsibility for the first $6 mln in development expenses.In addition, Takeda will become the marketing authorization holder and will be responsible for all commercialization and regulatory activities.  Full Article

Sucampo Pharmaceuticals Inc announces extension of AMITIZA license and collaboration agreement with Takeda
Tuesday, 14 Oct 2014 06:45am EDT 

Sucampo Pharmaceuticals Inc:Says on Oct. 9signs an amendment to existing collaboration and license agreement covering U.S and Canada for AMITIZA with Takeda Pharmaceutical Co Ltd.Amendment includes various modifications to collaboration agreement including extension of current term, minimum commercial investment during current term and various governance changes allowing Takeda additional flexibility in commercializing AMITIZA.During extended term, which will begin on Jan. 1, 2021, Takeda will split with Sucampo gross profits of branded AMITIZA for any dosage strength and form for the existing indications in the U.S. and Canada.In addition, on April 1, 2015 Takeda will no longer reimburse Sucampo for product details made by Sucampo sales representatives to healthcare professionals as well as other ancillary costs of sales force.  Full Article

R-Tech Ueno, Sucampo Pharmaceuticals, Takeda Pharmaceutical settles litigation with Anchen Pharmaceuticals and Par
Thursday, 9 Oct 2014 07:45pm EDT 

R-Tech Ueno Ltd:Sucampo, R-Tech Ueno (RTU), Takeda Pharmaceutical (Takeda) and certain affiliates of Takeda have entered into a settlement and license agreement with Anchen Pharmaceuticals, Par Pharmaceutical, Inc., and Par Pharmaceutical Companies, Inc, (collectively, Par).Agreement resolves patent litigation in U.S. related to Sucampo's AMITIZA 8 mcg and 24 mcg soft gelatin capsules.Sucampo, RTU, Takeda and Par have agreed to dismiss with prejudice the patent litigation filed in the U.S. District Court for the District of Delaware.  Full Article

Seattle Genetics and Takeda announce positive data from phase 3 AETHERA clinical trial of ADCETRIS for consolidation in post-transplant Hodgkin Lymphoma
Monday, 29 Sep 2014 06:45am EDT 

Seattle Genetics Inc and Takeda Pharmaceutical Co Ltd:Says that patients with Hodgkin lymphoma (HL) who received ADCETRIS (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplantation (ASCT) lived significantly longer without disease progression compared to patients who received placebo.Phase 3 clinical trial, known as AETHERA, compared the use of single agent ADCETRIS to placebo in 329 patients with HL who were at risk of relapse.ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL.ADCETRIS has been approved in more than 45 countries for the treatment of relapsed HL and systemic anaplastic large cell lymphoma (sALCL).ADCETRIS is not approved in the AETHERA treatment setting.  Full Article

BioMotiv and Takeda Pharmaceutical enter into strategic partnership
Thursday, 25 Sep 2014 01:15pm EDT 

Takeda Pharmaceutical Co Ltd:Says Takeda has made a strategic investment in BioMotiv and that they have formed a partnership that will leverage the strengths of both organizations to identify and develop pioneering medical innovations.Says Initial investment is $25 mln over five years.Says investment includes exclusive rights relating to programs sourced by BioMotiv specifically in the therapeutic areas of Immunology & Inflammation and Cardio-metabolic Diseases.  Full Article

CORRECTED-Nikkei falls after U.S. and German data sour mood; Fed eyed

(Corrects percentage decline in index and actual level in paragraph 5) * Strong retail sales lifts Seven & i, Aeon * Takeda soars after punitive damages slashed in Actos case * Fujifilm extends gains, but fund manager says its core business uncertain By Ayai Tomisawa TOKYO, Oct 28 - Japanese stocks fell Tuesday morning after Canon Inc tumbled on weak earnings and soft global data offset upbeat domestic retail figures as investors waited cautiously for the outcome o

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