Takeda and NsGene Partner to Perform Research in Cell Encapsulation Therapies for Parkinson's Disease

Osaka, Japan, January 8, 2016, and Providence, RI; January 7, 2016 – Takeda Pharmaceutical Company Limited (TSE: 4502) and NsGene, Inc. today announced a research agreement to develop encapsulated cell therapies for the potential treatment of Parkinson's disease. The partnership will focus on the delivery of recombinant Glial Cell Line-Derived Neurotrophic Factor (GDNF) to affected brain regions by way of implanted, encapsulated cell therapy devices.

GDNF has been pursued as a neuro-regenerative growth factor that holds promise in the treatment of Parkinson's disease, but has met problems in delivery of drug to the affected portions of the diseased brain.  This collaboration will explore the potential of surgically implanted recombinant cells housed within a device to directly secrete GDNF on site to promote neuron survival and regeneration. 

NsGene has developed the experimental technology that originated at Brown University into a clinically applicable cell therapy platform. The device contains genetically engineered cells encased in an immune-shielding capsule that can continuously produce therapeutic levels of biotherapeutics for an extended time after implantation.  GDNF is a neurotrophic factor that has been shown in preclinical systems to promote axon growth and protect dopaminergic neurons when delivered directly to the diseased cells for an extended duration.

NsGene will receive funding from Takeda for technology development that enables NsGene to complete critical scientific milestones needed for clinical trials and further constructive partnering.  Further details of the agreement were not disclosed.

Takeda is considering regenerative medicine as a potential new modality to treat diseases and is committed to supporting such research.  The research collaboration with NsGene marks one of Takeda's efforts to explore a novel biologics modality and implantable drug delivery system that could potentially make an impact in the lives of many patients.

About NsGene
NsGene, Inc. is a privately held clinical stage biotechnology company based in Providence, Rhode Island developing the Encapsulated Cell Therapy platform. The company works with industrial and academic partners to develop products with applications in neurological disorders and sensorineural hearing loss. The company has successfully applied its technology in initial clinical studies for the treatment of Alzheimer's disease.

About Takeda
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Takeda's Forward-Looking Statements
This press release contains "forward-looking statements." Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as "anticipate," "expect," "project," "continue," "believe," "plan," "estimate," "pro forma," "intend," "potential," "target," "forecast," "guidance," "outlook," "seek," "assume," "will," "may," "should," and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither NsGene nor Takeda undertakes any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

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