Notice on withdrawal of New Drug Application in the US of GnRH antagonist "Linzagolix"

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan, Chairman and CEO: Mutsuo Kanzawa) notifies that the New Drug Application (NDA) for the GnRH antagonist linzagolix originally discovered by Kissei for the indication of uterine fibroids, filed by ObsEva (ObsEva SA, Head Office: Geneva, Switzerland, CEO: Brian O'Callaghan) which had exclusive development and commercialization rights worldwide, except certain Asian countries including Japan, has been withdrawn.

ObsEva has made a release on 27th July 2022 that deficiencies were identified by the FDA during the review may not be feasible to be solved by the PDUFA date of 13th September 2022. Therefore, ObsEva has decided to terminate the license agreement with Kissei for linzagolix and has undertaken planned corporate restructuring. Kissei is working collaboratively with ObsEva on the return and transfer of rights, approvals and data.
For the development of linzagolix in the US, Kissei will consider the development strategy after reassessing the submitted data.

In the EU, linzagolix received marketing authorization in June 2022. All ObsEva's rights connected with the marketing of linzagolix in the EU have been transferred to Kissei, including ObsEva's sublicense agreement with Theramex (UK) for territories outside the US and Asia. Kissei and Theramex will continue to cooperate to launch the product in the EU and in other ex-US and Asia territories.
In Japan, Kissei has initiated Phase III clinical trial for uterine fibroids. In China, Bio Genuine (China) which has exclusive development and commercialization rights for China, is under preparation to start clinical trials.
Kissei will continue to strive to expand linzagolix globally.

The impact to the sales revenue and R&D expenditure is currently being analyzed. If there are any matters that should be disclosed, we will do so promptly.

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About Linzagolix
Linzagolix is a novel, orally administered GnRH receptor antagonist. Linzagolix acts by antagonizing the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. In November 2015, Kissei licensed out exclusive rights to develop and market in countries excluding part of Asia such as Japan to ObsEva. ObsEva has conducted clinical development of Linzagolix for uterine fibroids and endometriosis. In June 2022, ObsEva obtained marketing authorization from European Commission and MHRA in the United Kingdom for uterine fibroids. Linzagolix is also in phase III clinical trial for the endometriosis indication. In Asia, Kissei licensed out exclusive rights to develop and market in China to Bio Genuine in September 2021, and is now in preparation to start clinical trials. In Japan, Kissei will initiate Phase III clinical trial for uterine fibroids and has completed Phase II clinical trial for endometriosis.