Risks of License Termination and Commercialization Arising from Rehabilitation Proceedings of an Overseas Licensee
First written in FY2023-Q1. 5 of 9 entries say "Mitigated", first in FY2024-Q1. Latest entry: 2026-05-11.
Kissei Pharmaceutical moved to the "Worse" side of this theme in 2022, 1 year before the typical company in this theme (2023).
The whole theme swung hardest in 2020: 8 of 42 companies on the "Worse" side.
8 other companies' latest entry also says "Mitigated".
- 2026-05-11MitigatedFinancial results briefing materials
「Overseas, Ceramex Pharmaceuticals (UK) continued launching products or preparing for launches in European countries and elsewhere, while Simcere BioPharma (Taiwan) newly launched the product in Taiwan in March 2026 for the indication of uterine fibroids. Commercialisation by licensing partners progressed, and export sales increased.」
Ceramex Pharmaceuticals continued launches and launch preparations in European countries, advancing the overseas commercialisation of linzagolix. - FY2025MitigatedAnnual report
「Linzagolix (generic name), created by the Company and licensed to Theramex (UK), was launched by Theramex in Germany in September 2024 under the brand name "Yselty (イセルティ)" for the indication of uterine fibroids. Launches and preparations for launch have since progressed in other European countries and elsewhere.」
Regarding overseas commercialisation risks after ObsEva's restructuring proceedings, a European launch through Theramex was achieved, advancing from the preparation stage to the market launch stage. - FY2025-H1MitigatedAnnual report
「In the overseas development of linzagolix, Theramex (UK), the technology licensee, launched the product in Europe in September 2024 under the brand name "YSELTY (イセルティ)" for the indication of uterine fibroids.」
In response to the overseas commercialisation risks associated with ObsEva's restructuring proceedings, the product was launched in Europe through Theramex, advancing from the commercialisation preparation stage to the launch stage. - FY2024MitigatedAnnual report
「Overseas, セラメックス社 (United Kingdom), the licensee for linzagolix, is preparing for the market launch in Europe during the first half of fiscal 2024 for the treatment of uterine fibroids.」
Regarding overseas commercialisation risks after ObsEva's restructuring proceedings, preparations for a European launch under the framework with Theramex were formalised as a plan for the first half of FY2024. - FY2024-Q2WorsenedAnnual report
「Overseas, the launch schedule for linzagolix, a treatment for uterine fibroids and endometriosis (generic name), has been revised. セラメックス社 (United Kingdom), the licensee, is preparing for the market launch in Europe during fiscal 2024 for the treatment of uterine fibroids.」
While the framework for overseas commercialisation with Theramex was established after ObsEva's restructuring proceedings, the European launch schedule was revised, with preparations for launch planned during FY2024. - FY2024-Q1MitigatedAnnual report
「Our company United Kingdom セラメックス社 Exclusive development and commercialization rights for linzagolix, a treatment for uterine fibroids and endometriosis, in all countries excluding North America and parts of Asia including Japan Upfront payment API supply Royalties at a specified rate From April 2023 until the latest of the patent expiry date, the end of the regulatory market exclusivity period, and the 15th anniversary of product launch」
Regarding the uncertainty in the licensing arrangements arising from ObsEva's restructuring proceedings, the Company disclosed that it had entered into a new exclusive development and sales rights agreement with Theramex. The process advanced from discussions in the previous quarter to signing an agreement. - FY2023-Q3MaterialisedAnnual report
「The licensing agreement between the Company and ObsEva (Switzerland), under which ObsEva was granted exclusive development and sales rights for linzagolix worldwide, excluding Japan and certain other parts of Asia, ended at the end of November last year. Under the agreement, part of the sublicense agreement that ObsEva had entered into with Theramex (UK) for commercialisation of the product in North America and regions other than Asia automatically transferred to the Company at the same time. The Company is currently discussing the terms of a new licensing agreement with Theramex for a launch of the product in Europe during FY2023.」
The licensing agreement with ObsEva ended, and part of the sublicense agreement with Theramex was automatically transferred to the Company. Discussions on the terms of a new agreement for a European launch are continuing. - FY2023-Q2MaterialisedAnnual report
「Overseas, ObsEva (Switzerland), which was granted exclusive development and sales rights for linzagolix worldwide, excluding Japan and certain other parts of Asia, decided to commence company rehabilitation proceedings and take other related actions. In response, the Company is proceeding with the return of all rights and interests relating to the product from ObsEva. ObsEva had entered into a sublicense agreement with Theramex (UK) for commercialisation of the product in North America and regions other than Asia. After terminating its licensing agreement with ObsEva, the Company will acquire the sublicense agreement between ObsEva and Theramex in accordance with that agreement. The Company is continuing discussions with Theramex regarding the product's launch in Europe. In August of the same year, ObsEva withdrew from the US Food and Drug Administration (FDA) its new drug application (NDA) for the product for the indication of uterine fibroids.」
The return of rights and interests and termination of the licensing agreement associated with ObsEva's restructuring proceedings progressed, while discussions continued with Theramex on assuming the sublicense agreement and on a European launch. The withdrawal of the US NDA also occurred, and overseas commercialisation risks became more concrete. - FY2023-Q1MaterialisedAnnual report
「As ObsEva SA (Switzerland, hereinafter "ObsEva"), with which the Company has entered into a licensing agreement for linzagolix, a drug created by the Company to treat uterine fibroids and endometriosis, decided on 27 July 2022 to commence company rehabilitation proceedings and take other related actions, the Company will terminate the agreement in accordance with its terms.」
ObsEva, the overseas licensee for linzagolix, decided to commence restructuring proceedings and take other related actions, resulting in termination of the licensing agreement. The Company stated that it had acquired the rights required for a European launch and would proceed with commercialisation under its leadership.