Takeda Enters into Strategic Collaboration with NuBiyota for Microbiome Therapeutics

Takeda Pharmaceutical Company Limited (TOKYO:4502) today announced a strategic collaboration with NuBiyota LLC for the development of Microbial Ecosystem Therapeutic products for gastroenterology (GI) indications with a high unmet medical need.

Takeda and NuBiyota will collaborate to advance oral microbial consortia products developed by using NuBiyota’s microbiome platform for GI indications. NuBiyota will receive an upfront payment and is eligible for success-based development, regulatory and commercial milestones and tiered royalties based on net sales. Further details of the agreement were not disclosed.

“We are excited to partner with NuBiyota as this collaboration reinforces Takeda’s long-term commitment to unmet medical need in gastroenterology and adds to our other microbiome-related partnerships,” said Asit Parikh, M.D., Ph.D., head of Takeda’s gastroenterology therapeutic area unit. “Through these partnerships, we are exploring both microbial consortia and microbiome derived bioactives to investigate how the microbiome can be harnessed for treatment of GI diseases.”

NuBiyota’s Microbial Ecosystem Therapeutic is a clinic-ready microbial consortia which provides an entry point for clinical evaluation of microbiome based therapeutics which will enhance understanding of the role of microbiota in GI disease.

Takeda’s Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. Beginning in the 1990’s Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors. Since that time, Takeda’s global capabilities have expanded into the specialty care market in gastroenterology and biologics with a focus on ulcerative colitis and Crohn’s disease. Takeda's expertise also remains focused on therapeutic agents that work to reduce the production of acid in the stomach, and options for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation and opioid-induced constipation. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited 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 central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom.

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 NuBiyota nor Takeda undertake 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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Contact information

Media Contacts:
Takeda Pharmaceutical Company Limited
Kazumi Kobayashi – Japan
kazumi.kobayashi@takeda.com
+81-3-3278-2095
or
Julia Ellwanger – USA
julia.ellwanger@takeda.com
+1-224-554-7681