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Linzagolix, an oral GnRH antagonist, is pending regulatory approval in the U.S. and Europe for the treatment of uterine fibroids.
October 13, 2021
By: Kristin Brooks
Managing Editor, Contract Pharma
ObsEva SA, a biopharmaceutical company dedicated to women’s reproductive health, entered a strategic relationship with Syneos Health, an integrated CRO for biopharmaceutical services, to commercialize linzagolix. 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. If approved, it would be the only GnRH antagonist for uterine fibroids with flexible dosing options, as well as the first to offer a low dose option to address the needs of women who cannot or do not want to take hormones. Linzagolix is also being evaluated in an ongoing Phase 3 (EDELWEISS 3) study as a potential treatment for endometriosis-associated pain. Brian O’Callaghan, CEO of ObsEva, said, “We are thrilled to work with Syneos Health on the commercialization of linzagolix. With a leading women’s health sales force, Syneos Health is uniquely suited to support our goal of offering relief to women suffering from uterine fibroids. While traditional partnering arrangements with large pharma companies were considered, we believe that Syneos Health offers ObsEva the best option to maximize and maintain control, value and optionality for this important product. This Syneos Health relationship, together with the newly announced financing facility and revised Kissei license terms, provides ObsEva with a strong foundation to execute on its commercialization plans.”
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