- Takeda to Solely Conduct promotional activities for Two Products from April 2023 (Scheduled)
- Shionogi to Transfer Intuniv® Tablets 1mg/3mg and Vyvanse® Capsules 20mg/30mg Regulatory Approvals to Takeda
OSAKA, Japan, October 31, 2022 - Takeda Pharmaceutical Company Limited (Head Office: Osaka, Japan; President & CEO: Christophe Weber; hereafter "Takeda") and Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that Takeda has exercised the option right, originally granted to Shire (integrated with Takeda in 2019), to re-acquire full rights to the attention-deficit/hyperactivity disorder therapeutic agents Intuniv® Tablets 1mg/3mg (hereafter "Intuniv®") and Vyvanse® Capsules 20mg/30mg (hereafter "Vyvanse®"), as specified in the license agreement for co-development and co-commercialization in Japan between Shire (merged with Takeda in 2019) and Shionogi, concluded in November 2011.
This option exercise by Takeda will terminate the license agreement for co-development and co-commercialization of Intuniv® and Vyvanse®. Takeda and Shionogi have concluded a basic agreement for transfer of assets, etc., based on the option exercise.
Shionogi will receive a one-time payment in fiscal 2023 to which it is entitled pursuant to the basic agreement. The license agreement for co-development and co-commercialization of Intuniv® and Vyvanse® will terminate at the end of March 2023. From April 2023, Takeda is scheduled to solely promote both products. For a period to be determined, Shionogi will continue to hold regulatory approvals for both products, and the timing of the transfer of distribution operations and the succession of regulatory approvals will be mutually agreed.
Takeda and Shionogi have been co-promoting Intuniv® and Vyvanse® for patients with attention deficit/hyperactivity disorder. The two companies will continue to work closely together for a smooth transition of the two products. In addition, both companies will continue to work to ensure stable supply of the products, provision and collection of product information, and proper use during the period until the activities are fully transferred to Takeda.
Attention-deficit/hyperactivity disorder is a neurodevelopmental disorder and is also called ADHD. Symptoms include inattentiveness, hyperactivity, and impulsiveness.
Takeda （TSE：4502/NYSE:TAK） is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.
In its Group Vision, SHIONOGI indicates the direction in which it aims to transform itself from a drug discovery based pharmaceutical company into a HaaS* company that provides a wider array of healthcare solutions. By pursuing this mission intensively, we seek to address the healthcare needs of individuals and society on a increasingly comprehensive basis.
For more information, please visit https://www.shionogi.com/jp/en/.
* Providing various healthcare services that meet customer needs in addition to providing pharmaceuticals
This media release is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development.
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); the extent to which our internal energy conservation measures and future advancements in renewable energy or low carbon energy technology will enable us to reduce our greenhouse gas emissions; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this report or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this report may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.