武田薬品工業株式会社
January 27, 2023
Takeda Pharmaceutical Limited (“Takeda”) and Teva Takeda Pharma Limited (“Teva Takeda”) today announced that they have entered into a basic agreement regarding the transfer of assets and manufacturing and marketing approval for “Copaxone® for Subcutaneous Injection 20 mg Syringe” (generic name: glatiramer acetate, hereinafter “Copaxone”) from Takeda to Teva Takeda in Japan for the treatment of multiple sclerosis (MS).
The agreement states that the assets pertaining to Copaxone will be transferred from Takeda to Teva Takeda in April 2023, and thereafter Teva Takeda will be responsible for providing pharmaceutical information and gathering safety information on Copaxone and the Autoject 2 injection aid for Copaxone Subcutaneous Injection 20 mg Syringe, currently sold by Takeda. Takeda will keep the manufacturing and marketing approval for Copaxone for the time being, with the timing of the transfer of the approval to be discussed and finalized later.
Copaxone is a once-daily subcutaneous injection for the prevention of relapses in multiple sclerosis, developed by Teva Pharmaceutical Industries Limited (Head Office: Tel Aviv, Israel; “Teva”). Takeda signed a license agreement with Teva in March 2013 to commercialize Copaxone in Japan, filed an application for manufacturing and marketing approval in December 2014, obtained said approval from the Ministry of Health, Labour and Welfare in September 2015, and launched the product in November of the same year.
The transfer of Copaxone came under consideration as part of the agreement between three companies (Takeda, Teva and Teva Takeda) in September 2020 to expand the business domain of Teva Takeda, a joint venture established by Takeda and Teva, to take on board novel agents as well as products whose patent terms have expired, such as long-listed and generic drugs. Copaxone has contributed to patients in Japan as a treatment option for multiple sclerosis and Teva Takeda, who has Takeda and Teva as parent companies, will take over Copaxone with great care.
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Formulation name |
Copaxone Subcutaneous Injection 20 mg Syringe |
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Active ingredient |
Glatiramer acetate |
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Formulation |
Injection (pre-filled syringe) |
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Indications |
Relapse prevention in multiple sclerosis |
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Dosage and administration |
The standard adult dosage of glatiramer acetate is 20 mg subcutaneously once daily. |
Takeda 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), with expertise in immune and inflammatory diseases. 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.
Teva Pharmaceutical Industries Ltd. has been developing and manufacturing drugs that improve people’s lives for over one hundred years. As a global leader in generics and specialty pharmaceuticals, the company has a portfolio of over 3,500 products spanning virtually every therapeutic area. Approximately 200 million people worldwide take Teva’s drugs regularly, delivered via one of the largest and most complex supply chains in the pharmaceutical industry. In addition to its strong position in the generics field, Teva carries out significant innovative research and manufacturing that supports its growing portfolio of specialty and biopharmaceutical products. For more information, please visit https://www.tevapharm.com/.
Teva Takeda is a joint venture established on April 1, 2016, by Teva Pharmaceutical Industries Ltd. (Head Office: Israel) and Takeda Pharmaceutical Company Limited (Head Office: Chuo-ku, Osaka, Japan). It is comprised of Teva Takeda Pharma Ltd. (Head Office: Nagoya, Japan) and Teva Takeda Yakuhin Ltd. (Head Office: Nagoya, Japan). Teva Takeda meets the diverse needs of patients and healthcare personnel in Japan as well as the growing importance of generics by providing off-patent drugs (OPDs) in the form of generics and long-listed drugs.