– Partnership leverages Theramex’s leading women’s health capabilities and commercial infrastructure to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia –
– Linzagolix is an oral GnRH antagonist in development for the management of moderate to severe symptoms of uterine fibroids and endometriosis-associated pain –
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
GENEVA, Switzerland – February 10, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced a strategic licensing agreement with Theramex, a leading global pharmaceutical company specializing in women’s health, to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia.
Linzagolix has the potential to be a best-in-class GnRH receptor antagonist for the treatment of uterine fibroids due to its efficacy and favorable tolerability profile.1,2,3 Regulatory filings for approval of linzagolix in the treatment of uterine fibroids have now been made in both Europe and the U.S.. Linzagolix recently received United States Food and Drug Administration (FDA) acceptance for review of the uterine fibroids New Drug Application (PDUFA target action date of September 13, 2022). Linzagolix is also in development as a potential treatment for endometriosis-associated pain, and ObsEva recently announced positive topline results for its first Phase 3 trial (EDELWEISS 3) in this indication.
“Theramex is a proven global leader in women’s health and the ideal partner to maximize the opportunity for linzagolix in key international markets,” said Brian O’Callaghan, CEO of ObsEva. “By leveraging Theramex’s extensive global commercial infrastructure, we hope to bring more individualized treatment options to women suffering from uterine fibroids and endometriosis, both of which represent large, underserved markets. This Theramex partnership in Europe, together with our relationship with Syneos Health for the commercialization of linzagolix in the U.S., provides ObsEva with a strong foundation to realize the full value of the linzagolix program.”
Robert Stewart, Chief Executive Officer of Theramex, commented: “Linzagolix is an important innovation in women’s health and we are thrilled to work with ObsEva to bring this potential new treatment option to the global markets we serve. As a company whose mission it is to improve the quality of life of women, we are proud to partner with ObsEva in commercializing novel treatments addressing the unmet medical needs of women suffering from uterine fibroids and endometriosis. This agreement strengthens our portfolio and we look forward to deploying our extensive global commercial infrastructure to unlock linzagolix’s potential.”
Under the terms of the agreement, ObsEva is entitled to receive royalties of a mid-thirties percentage on commercial sales, which includes the cost of goods sold to Theramex. Furthermore, the agreement contains up to EUR72.75 million in upfront and milestone payments, including EUR5 million to be paid at signing, up to EUR13.75 million in development and commercial milestones and up to EUR54 million in sales-based milestones.
Theramex’s extensive women’s health commercial infrastructure includes a dedicated sales force of more than 180 experienced reps across Europe, Brazil, and Australia, alongside third party distributors across approximately 60 countries in Europe, the Middle East and Africa, Asia-Pacific, and Latin America.
About Linzagolix
Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile 1,2,3. Linzagolix has completed clinical trial development for the treatment of uterine fibroids and is currently in late-stage clinical development for the treatment of pain associated with endometriosis. Obseva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, 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 www.ObsEva.com
About Theramex
Theramex is a leading global speciality pharmaceutical company dedicated to women and their health. We support women at every stage of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Our commitment is to listen to and understand our patients, serve their needs and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through every stage of life.
About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.” As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases.
