know about ObsEva Announces Confirmation of Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids
Ad hoc announcement pursuant to art. 53 LR of the SIX Swiss Exchange
Geneva, Switzerland – April 252022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company that develops and markets novel therapies for women’s health, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its previously adopted positive opinion, recommending approval of linzagolix for the treatment of uterine fibroids (UF).
The positive CHMP opinion, which was initially adopted on 16 December 2021, was confirmed at the CHMP meeting in April 2022 following further review of the marketing authorization application for linzagolix. The European Commission (EC) will now review the CHMP recommendation. If approved by the EC, linzagolix will be the only approved oral GnRH antagonist offering flexibility and choice to women with UF, including the first and only approved non-hormonal dosing option to address the needs of millions of women with UF who do not can or do not want to take hormones. The decisions of the European Commission are valid in the Member States of the European Union, as well as in Iceland, Norway and Liechtenstein.
ObsEva has signed a license agreement with Theramex to support the commercialization and market introduction of linzagolix in Europe. Theramex’s extensive women’s health business infrastructure includes a dedicated sales force of more than 180 experienced representatives in Europe, Brazil and Australia, along with third-party distributors in approximately 60 countries in Europe, the Middle East and Africa, Asia-Pacific and Latin America. .
“Launch preparations in Europe are firmly underway as we look towards early approval of linzagolix. Theramex is a proven global leader in women’s health with a track record of successful new product launches, making it ideally positioned to execute the launch of linzagolix in Europe. In parallel, preparations for the commercialization of linzagolix in the United States are advancing through our relationship with Syneos Health as we approach our September PDUFA target action date. Together, these agreements are expected to maximize the market opportunity for linzagolix, which has the potential to be the first and only GnRH receptor antagonist approved for uterine fibroids with a dosing option without AHT,” said Brian O ‘Callaghan, CEO of ObsEva.
In the United States, the New Drug Application for linzagolix is currently under review by the Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of September 13 2022. In October 2021, ObsEva announced a strategic relationship with Syneos Health to commercialize linzagolix within the United States.
Linzagolix is an investigational, novel, once-daily oral GnRH receptor antagonist with a potentially best-in-class profile.1,2,3. Linzagolix was developed to offer flexibility and choice to women with uterine fibroids, with proposed dosing regimens alone and in combination with complementary hormone therapy. For women with uterine fibroids for whom hormone support therapy is appropriate, linzagolix has the potential to offer a best-in-class efficacy rate and tolerability profile. For women with uterine fibroids who are unable or unwilling to take hormones, linzagolix has the potential to be the first and only approved oral GnRH antagonist with a non-hormonal dosing option. 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.
ObsEva is a biopharmaceutical company that develops and markets novel therapies to improve women’s reproductive health and pregnancy. Through strategic licensing and disciplined drug development, ObsEva has established a line of late-stage clinical products 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 ticker symbol “OBSV” and on the SIX Swiss Exchange where it trades under the ticker symbol “OBSN”. For more information please visit www.ObsEva.com
Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at every stage of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Theramex is committed to listening to and understanding its patients, serving their needs and providing healthcare solutions to help improve their lives. Theramex’s vision is to be a lifelong partner to women and the healthcare professionals who treat them, providing effective, patient-centered solutions that care for and support women at every stage of life.
About Syneos Health
Syneos Health® (Nasdaq: SYNH) is the only fully integrated biopharmaceutical solutions organization. The company, which includes a Contract Research Organization (CRO) and a Contract Commercial Organization (CCO), is specifically designed to accelerate client performance to address the realities of the modern marketplace. Syneos Health brings together approximately 27,000 clinical and business minds with the ability to support clients in more than 110 countries. Together they share knowledge, use the latest technologies and apply advanced business practices to accelerate the delivery of important therapies to patients by their clients. For more information on how Syneos Health is Shortening the distance from the laboratory to life®to visit syneoshealth.com either subscribe to his podcast.
About Kissei Pharmaceutical Co., Ltd.
Linzagolix has been discovered by Central Research Laboratories of Kissei Pharmaceutical Co., Ltd. Kissei is a Japanese pharmaceutical company based on the management philosophy of “contributing to society through high-quality and innovative pharmaceutical products” and “serving society through our employees. As a strong R&D-oriented corporation, it is focused on providing innovative pharmaceutical products to patients around the world in the focus fields of urology, nephrology/dialysis, gynecology, and rare/untreatable diseases.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained 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. These statements may be identified by words such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “could”, “ongoing”, “target”, “plan”, “potential”, “predict”, “ should”, “will”, “would”, or the negative of these and other similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the possible approval of linzagolix by regulatory authorities, including the European Commission and the FDA, and the timing of such approval, the timing or results of interactions with regulatory authorities, the development of ObsEva’s product candidates, including the timing, advancement, and potential therapeutic benefits of such product candidates, including linzagolix, the potential for linzagolix and other product candidates to be commercially competitive, the success of the Company’s partnerships with third parties including Theramex and Syneos Health, expectations regarding 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 such statements. Risks and uncertainties that could cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that earlier clinical trial results may not predict the results of later clinical trials, interactions related to regulators, including interactions with the EMA during the marketing authorization application process and with the FDA during the new drug application process for linzagolix, ObsEva’s reliance on third parties over which it may not always have full control, and the capabilities of such third parties, the impact of the ongoing novel coronavirus outbreak and other risks and uncertainties described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission (SEC) on March 10, 2022 , and other filings ObsEva makes with the SEC. These documents are available on the investors page of the ObsEva website at www.ObsEva.com. Any forward-looking statement speaks only as of the date of this press release and is based on information available to ObsEva as of the date of this release, and ObsEva does not undertake any obligation or intend to update any forward-looking statement. , whether as a result of new information, future events or otherwise.
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1. Stewart E., ASRM 2020; Breaking Summary P-930
2. Al-Hendy A, NEJM 2021; 384:630-42
3. Schlaff W, NEJM 2020; 382: 328-40