Notice on the release by ObsEva, the licensee of "Linzagolix", GnRH antagonist

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan, Chairman and CEO: Mutsuo Kanzawa) notifies that ObsEva (ObsEva SA, Head Office: Geneva, Switzerland, CEO: Brian O'Callaghan) which has exclusive development and commercialization rights worldwide, except certain Asian countries including Japan, to GnRH antagonist linzagolix originally discovered by Kissei, has announced that they have decided to commence composition proceedings.

This decision is based on the fact that the U.S. Food and Drug Administration (FDA) has notified ObsEva of review issues of the New Drug Application (NDA) for linzagolix for uterine fibroids. ObsEva believes that resolution of this issue may not be feasible by the September 13, 2022 target action date under the Prescription Drug User Fee Act (PDUFA) and has come to this conclusion.

ObsEva has obtained marketing authorization from the European Commission for linzagolix in June this year. ObsEva has also contracted a sublicense agreement with Theramex to commercialize linzagolix in all countries except for North America and Asia. Under the terms of the license agreement of Kissei and ObsEva, Kissei terminates this agreement and obtains the assignment of sublicense agreement of Theramex and ObsEva.
Kissei will now lead the way to target the launch in Europe in the first quarter of 2023, and continue to move forward the global expansion of linzagolix.

The projected financial results for this fiscal year is currently being examined. If there are any matters that should be made public, we will do so promptly.

For ObsEva's release, please refer to their website.
　URL　https://www.obseva.com/press-releases/

《 Reference 》

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 has obtained marketing authorization from European Commission and MHRA in the United Kingdom for uterine fibroids.In the United States, the New Drug Application for Linzagolix for uterine fibroids is under review by the Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) target action date of September 13, 2022. 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.

About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health and pregnancy. ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is traded under the ticker symbol "OBSN".
For more information, please visit https://www.obseva.com/