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Takeda and Zinfandel Pharmaceuticals Discontinue TOMMORROW Trial Following Planned Futility Analysis

Osaka, Japan, and Chapel Hill, NC, January 25, 2018 -- Takeda Pharmaceutical Company Limited [TSE: 4502] (“Takeda”) and its partner, Zinfandel Pharmaceuticals, Inc. (“Zinfandel”) today announced that the global Phase III TOMMORROW trial has been terminated. The decision to discontinue the trial was based on a planned interim futility analysis, which showed an inadequate treatment effect with the investigational drug pioglitazone 0.8 mg SR in delaying the onset of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD). This decision was not related to safety of the investigational product or study procedures.

“We thank the commitment of the participants, investigators and clinical research personnel involved in the TOMMORROW trial for their invaluable contributions in the pursuit of advancing research in Alzheimer’s disease,” said Emiliangelo Ratti, head of Takeda’s Neuroscience Therapeutic Area. “Takeda and Zinfandel will further analyze data from the trial, including the performance of the genetic-based biomarker risk assignment algorithm, with the hope that this information may ultimately help in the global fight against AD. Takeda remains committed to the discovery and development of potential treatments for AD.”

“While we are extremely disappointed with the interim futility outcome and the decision to terminate conduct of the TOMMORROW study, we are deeply grateful to the dedicated study participants, project partners, investigators, site personnel, independent committees, and study teams for their unwavering commitment over these past four years”, said Ann Saunders, Chief Executive Officer of Zinfandel Pharmaceuticals. “This was a unique, groundbreaking opportunity, and the volume and quality of clinical data generated by TOMMORROW will provide valuable insights into the earliest stages of the AD process and contribute to easing the burden of AD.”

The TOMMORROW trial was investigating a genetic-based biomarker risk assignment algorithm (BRAA) as well as evaluating the safety and efficacy of investigational drug pioglitazone 0.8 mg SR in delaying the onset of MCI due to AD in cognitively normal individuals projected to be at high risk, as determined by the BRAA. Results from the TOMMORROW trial will be presented at a future scientific meeting and efforts will be made to share the primary data with the scientific community.

Takeda in Neuroscience

Neuropsychiatric disorders are complex conditions that are associated with significant suffering. Takeda harnesses the latest science, technologies and external partnerships to discover and develop innovative medicines for people with neuropsychiatric disorders who lack treatment options. Takeda takes a patient-centric approach to drug discovery and development in Neuroscience, focusing on specific underlying sub-domains in these disorders to identify novel treatment targets in addition to selecting well-defined, patient populations to investigate treatment response.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.

About Zinfandel Pharmaceuticals

Zinfandel Pharmaceuticals, based in Chapel Hill, NC, is a privately held company dedicated to using pharmacogenetics to improve prediction of risk for Alzheimer’s disease and thus facilitate the development of effective therapies.

Source: Takeda Pharmaceutical Company Limited

Posted: January 2018

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