– The partnership leverages Theramex’s commercial capabilities and infrastructure in women’s health to support the commercialization and market introduction of linzagolix in global markets outside of the United States, Canada and the United States. Asia –
– Linzagolix is an oral GnRH antagonist in development for the management of moderate to severe symptoms of uterine fibroids and pain associated with endometriosis –
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
GENEVA, Switzerland, 10 Feb. 2022 (GLOBE NEWSWIRE) — 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 introduction to market linzagolix in world markets outside of the United States and Canada and Asia.
Linzagolix has the potential to be the best GnRH receptor antagonist for the treatment of uterine fibroids due to its efficacy and favorable safety profile.1,2,3 Regulatory filings for approval of linzagolix for the treatment of uterine fibroids have now been made in Europe and the United States. Linzagolix recently received U.S. Food and Drug Administration (FDA) New Drug Application (NDA) review approval for uterine fibroids (PDUFA target action date of September 13, 2022). Linzagolix is also in development as a potential treatment for pain associated with endometriosis, and ObsEva recently announced positive top results from its first phase 3 trial (EDELWEISS 3) in this indication.
“Theramex is a recognized global leader in women’s health and the ideal partner to maximize opportunities for linzagolix in key international markets,” said Brian O’Callaghan, CEO of ObsEva. “By leveraging Theramex’s extensive global business infrastructure, we hope to provide more individualized treatment options for women with uterine fibroids and endometriosis, two important and underserved markets. This Theramex partnership in Europe, along with our relationship with Syneos Health for the commercialization of linzagolix in the United States, provides ObsEva with a solid foundation to realize the full value of the linzagolix program.
Robert Stewart, Chief Executive Officer of Theramex, said, “Linzagolix is an important innovation in women’s health and we are excited to work with ObsEva to bring this potential new treatment option to the global markets we serve. As a company with a mission to improve women’s quality of life, we are proud to partner with ObsEva to bring to market new treatments that address the unmet medical needs of women with uterine fibroids and endometriosis. This agreement strengthens our portfolio and we look forward to deploying our extensive global business infrastructure to unlock the potential of Linzagolix.
Under the terms of the agreement, ObsEva is entitled to collect royalties of approximately 30 percent on commercial sales, which includes the cost of goods sold to Theramex. In addition, the agreement contains up to €72.75 million in upfront and milestone payments, including €5 million to be paid upon signing, up to €13.75 million in milestones development and commercial milestones and up to €54 million in sales-based milestones.
Theramex’s extensive sales infrastructure for women’s health includes a dedicated sales force of more than 180 experienced representatives across Europe, Brazil and Australia, as well as third-party distributors in approximately 60 countries in Europe, the Middle East and Africa, Asia-Pacific and Latin America.
Linzagolix is a novel once-daily orally administered 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 advanced clinical development for the treatment of pain associated with endometriosis. Obseva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, outside of Asia, for the product. Linzagolix is not currently approved anywhere in the world.
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on novel therapies for the treatment of uterine fibroids, endometriosis and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and trades under the symbol “OBSV” and on the SIX Swiss Exchange where it trades under the symbol “OBSN”. For more information, visit www.ObsEva.com
Theramex is a world leader in the specialty pharmaceutical industry dedicated to women and their health. We support women at every stage of their life by offering a large portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Our commitment is to listen and understand our patients, respond to their needs, and provide healthcare solutions to help improve their lives. Our vision is to be a lifelong partner to women and the healthcare professionals who treat them by providing effective, patient-focused solutions that care for and support women at every stage of life.
About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy of “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees”. As a strongly R&D-oriented company, it is focused on providing innovative pharmaceutical products to patients worldwide in the priority areas of urology, nephrology/dialysis, gynecology and rare/refractory diseases.
Caution Regarding Forward-Looking Statements
Any statements in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as “believe ‘, ‘expect’, ‘may’, ‘plan’, ‘potential’, ‘will’ and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the commercialization of linzagolix in global markets, the FDA’s target action date for linzagolix, the clinical development of ObsEva’s product candidates, including timing, progress and benefits potential therapeutics of such product candidates, the potential for such product candidates to be commercially competitive, expectations regarding regulatory and development milestones, and ObsEva’s ability to obtain and maintain regulatory approvals for its product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in these statements. The risks and uncertainties that could cause actual results to differ materially include the uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of prior clinical trials may not be predictive of the results of subsequent clinical trials, related interactions with regulators, ObsEva’s dependence on third parties over which it does not always have full control, and the capabilities of such third parties, the impact of the novel coronavirus outbreak ongoing and other risks and uncertainties which are described in the Risk Factors section of ObsEva’s annual report. Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission (SEC) on March 5, 2021 and in Report on Form 6-K filed with the SEC on November 4, 2021 and others ObsEva filings made with the SEC. These documents are available on the Investors page of the ObsEva website at the address www.ObsEva.com. All forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this press release, and ObsEva assumes no obligation and does not intend to updates forward-looking statements. , whether as a result of new information, future events or otherwise.
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1. Stewart E, ASRM 2020; Last minute abstract P-930
2. Al-Hendy A, NEJM 2021; 384:630-42
3. Schlaff W, NEJM 2020; 382:328-40