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Takeda and Cour Partner to Develop Novel Therapies for Celiac Disease and Other Gastrointestinal Diseases

Del

Takeda Pharmaceutical Company Limited (TOKYO:4502) and Cour Pharmaceutical Development Company, Inc. today announced a partnership to research and develop novel immune modulating therapies for the potential treatment of celiac disease. The partnership will focus on using nanotechnologies based on Cour’s Tolerizing Immune Modifying nanoParticle (TIMP) platform, which can be extended to certain autoimmune and allergic conditions by inhibiting the abnormal immune responses that cause disease, without affecting the beneficial parts of the immune system.

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The collaboration will explore the potential of TIMP therapy to allow celiac patients to tolerate gluten in their diet. The TIMPs, developed in cooperation with Northwestern University researchers, consist of a proprietary polymer and antigenic proteins, which are fully encapsulated for safety and administered intravenously. The TIMP compounds target the underlying cause of celiac disease by systemically targeting and controlling, gluten-reactive T-cells in patients, as opposed to broad immunosuppression.

Cour will receive upfront and success based milestone payments from Takeda leading to an exclusive option to acquire a global license to the TIMP-GLIA program after the completion of the Phase 2a clinical trial. Cour will also receive royalties on sales of any successful commercialized products resulting from the partnership. Takeda will also have the option to collaborate on up to three additional TIMP compounds each with development, regulatory, and sales milestones and royalties on sales. Further details of the agreement were not disclosed.

“As a global leader in gastroenterology, Takeda is committed to the discovery and development of treatments and products to improve the health of patients with gastrointestinal disorders,” said Dr. Gareth Hicks, head of Takeda’s Gastroenterology Drug Discovery Unit. “In line with our GI drug discovery unit’s focus on building partnerships with groups developing highly novel therapeutic approaches to the treatment of GI diseases, we are excited to initiate this significant collaboration with Cour to create potential new and innovative therapies to meet the substantially unmet needs of these patients.”

“Cour is very pleased to be partnering with Takeda, and our collaboration marks an important breakthrough in the development of therapies for patients suffering from celiac disease,” said John J. Puisis, CEO and co-founder of Cour. “Takeda is the ideal partner based on the company’s strong foundation in gastroenterology and expertise in the discovery and development of therapies meeting unmet needs in patients suffering from gastrointestinal diseases.”

About Cour Pharmaceutical Development Company
Cour is a private development stage company harnessing the power of nano-biotechnology to create novel therapeutics addressing difficult to treat immune diseases. Cour combines world-recognized leadership in immunology, bioengineering, and pharmaceuticals to address significant unmet medical needs in autoimmune, allergy and inflammatory disease. Cour’s Tolerizing Immune Modifying nanoParticle (TIMP) platform creates a unique opportunity to address difficult to treat diseases such as celiac disease and food allergies. The TIMP platform is the result of a partnership between Cour and Northwestern University, where Cour, Dr. Stephen Miller, and Dr. Lonnie Shea combined their respective expertise in immunology and material science to create this pioneering new technology.

Additional information about Cour is available through its corporate website, http://www.courpharma.com

About Takeda
Located in Osaka, Japan, Takeda (TOKYO: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 Cour 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.

Contact information

Media Contacts:
For Cour Pharmaceutical Development Company, Inc.:
Linda Boerema, Corporate Communications
888-551-2687
or
For Takeda Pharmaceutical Company Limited:
Tsuyoshi Tada – Japan
Corporate Communications Dept.
tsuyoshi.tada@takeda.com
+81332782417
or
Julia Ellwanger – USA
R&D Communications
julia.ellwanger@takeda.com
+1-224-554-7681

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