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Takeda and enGene Establish Strategic Alliance to Develop Novel Therapeutics for Gastrointestinal Diseases

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Takeda Pharmaceutical Company Ltd. (TOKYO:4502) and enGene, Inc. today announced a strategic alliance to discover, develop and commercialize novel therapies for specialty gastrointestinal (GI) diseases using enGene’s “Gene Pill” gene delivery platform. The strategic alliance will leverage enGene’s expertise and intellectual property position in delivering therapeutic genes to cells of the gut lining by using its proprietary non-viral vector platform.

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Under the terms of the agreement, enGene will develop up to two undisclosed targets selected by Takeda through pre-clinical proof of concept and IND enabling studies. At that point, Takeda will have an option to exclusively license the global rights for the product candidates.

Following option exercise, Takeda will be responsible for all clinical development and commercialization of those products. enGene will receive an upfront payment and reimbursement of all R&D costs incurred during the development of the selected targets. In addition, enGene is eligible to earn milestone payments for the product candidates based on accomplishment of specific research, clinical, regulatory and commercial milestones. enGene also will receive tiered royalties on future net sales of the collaboration products. Further details of the agreement were not disclosed.

Takeda will also collaborate with enGene in developing Gene Pill into a platform for oral delivery of antibodies. Takeda has the exclusive option to obtain a right of first negotiation for up to three antibody targets.

“We aim to have a positive impact on patients’ lives by translating unique innovations in science into life-changing medicines to treat GI disorders,” said Gareth Hicks, who leads gastroenterology discovery research at Takeda. “Therefore, we are pleased to partner with enGene to further investigate the potential of their ‘Gene Pill’ delivery platform.”

“We are very excited to be collaborating with the team at Takeda to investigate new medicines for the specialty GI market using enGene’s innovative gene delivery platform for the gut,” said Dr. Anthony T. Cheung, chief executive officer and a co-founder of enGene. “In addition to gaining non-dilutive funding to support the development of our own products, this alliance provides our company an excellent opportunity to grow our drug development capabilities through working with a leading pharmaceutical company in the gastroenterology space.”

About enGene, Inc.
enGene Inc. is a privately held biotechnology company developing a versatile, proprietary non-viral vector platform for gene delivery to mucosal cells lining the gut. The vector system can be administered to the intestine via the oral or enema route. enGene is developing its unique gene delivery formulation into an orally available “Gene Pill”, which has the potential to be a platform for oral delivery of a wide range protein drugs. Its primary focus is targeting its technology to enable localize delivery of immune-modulating proteins to the gut for treating various immune disorders.

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 enGene 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.

Contact information

For Takeda:
Tsuyoshi Tada – Japan
Corporate Communications Dept.
tsuyoshi.tada@takeda.com
+81-3-3278-2417
or
Julia Ellwanger – USA
R&D Communications
julia.ellwanger@takeda.com
+1-224-554-7681
or
enGene
Dr. Anthony Cheung, Chief Executive Officer
+1-514-332-4888, ext. 204
acheung@engeneinc.com

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