Linzagolix choline

The UK's National Institute for Health and Care Excellence (NICE) recommended Theramex’s Yselty (linzagolix) as a treatment option for moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. Subsequent to the decision, the oral gonadotropin-releasing hormone (GnRH) receptor antagonist can now be routinely prescribed to eligible patients through the NHS in England and Wales.Backed by the two Phase III PRIMROSE trials, Yselty was approved in the EU and UK in 2022, making it the first GnRH antagonist offering a non-hormonal option for women with uterine fibroids. “Linzagolix offers greater flexibility as it can be taken either with or without hormone therapy and means clinicians can provide more personalised care,” said Jonathan Benger, NICE chief medical officer. Longer-term use onlyNICE noted that the drug is only recommended for longer-term use of over 6 months and is unsuitable for those requiring short-term treatment, such as before uterine fibroid surgery. Yselty carries an annual list price of £1097.20 ($1410) and £1040.00 ($1336) with and without hormonal add-back therapy, respectively.According to NICE, around a third of women are likely to develop symptomatic uterine fibroids during their lifetime and up to 30,000 women in England and Wales could benefit from the new treatment option. “We are continuing to work with NICE and the NHS in the hope that we can provide as many women as possible the opportunity to access this treatment, wherever they live,” remarked Tina Backhouse, UK general manager at Theramex.Originally an asset of Kissei Pharmaceutical, the GnRH antagonist was licensed to ObsEva in 2015 for commercialisation outside Asia. In 2022, ObsEva struck a deal with Theramex to support the drug’s commercialisation in markets excluding the US, Canada and Asia. However, ObsEva soon ran into trouble with the FDA regarding the drug’s US filing, resulting in a strategic restructuring and Theramex being assigned as Kissei’s ex-Asia licensing partner.

NEW YORK, April 28, 2023 /PRNewswire/ -- Gameto, a female-led biotech company developing therapies to improve the female reproductive journey, today announced the expansion of its executive team with the appointment of Teri Loxam as its first Chief Financial Officer. In this new role, Teri will oversee Gameto's financial function, as well as play a key role in overall company strategy. "Teri is a proven CFO and an impressive female leader, whose decades of experience will immediately add value to our company," said Dina Radenkovic, co-founder and CEO of Gameto. "Her depth of knowledge in capital markets and financing in the biotechnology and pharmaceutical industries comes at an exciting time for the company as we work on clinical development and go-to-market strategy for our lead program, Fertilo, to make the IVF process shorter, safer and more effective for women. Teri's personal passion for women's health is extremely important to us as we continue to grow." Teri joins Gameto with over 20 years of diverse experience in strategy, investor relations and finance across the pharmaceutical, biotech, and TMT industries. Prior to joining Gameto, Teri was Chief Operating Officer & Chief Financial Officer at Kira Pharmaceuticals, a clinical-stage biotech company developing transformative therapies for people with complement-mediated diseases. There, she built financial and operational functions across the U.S. and China locations to get the company public-ready. Prior to Kira, Teri served as CFO of SQZ Biotechnologies, a novel cell therapy company developing treatments for cancer, infectious disease and other serious conditions, where she raised over $200M, including taking the company public in October 2020. Prior to joining SQZ, Teri held various positions at Merck, IMAX Corporation, and Bristol-Myers Squibb. Teri is also a member of the board of directors and audit chair of Vaxcyte, Inc. and Cardiol Therapeutics, Inc. She has a B.S. in Biology from the University of Victoria, B.C. Canada and an MBA from the University of California, Irvine. "Gameto's highly innovative platform and dedication to improve and support women's health is impressive," said Teri Loxam, Chief Financial Officer of Gameto. "I am eager to work with a talented team of professionals who are passionate about transforming the traditional IVF processes and advancing developments for women." Teri's appointment is one of many new senior hires this year. Gameto recently appointed Jean-Pierre Gotteland as Head of Development to the management team. Prior to joining Gameto, Jean-Pierre was Chief Scientific Officer and Head of R&D at ObsEva SA, a clinical-stage biotech company developing innovative women's reproductive health therapeutics. There, he led the development and approval of linzagolix, for uterine fibroids, and brought to clinical trials nolasiban, for increasing live birth rate following IVF. Jean-Pierre also served as Chief Development Officer at PregLem SA where he led the development and EU approval of ulipristal acetate for uterine fibroids and infertility. Prior to joining PregLem, Jean-Pierre held various R&D positions at Serono, a world-leading pharmaceutical company before its acquisition by Merck KgA. Jean-Pierre will facilitate clinical development of Gameto's lead program, Fertilo. These new senior hires expand the multidisciplinary team of stem cell engineers, computational biologists, embryologists and physicians Gameto has brought together. About Gameto Based in New York and Madrid, Gameto is a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system. Gameto brings together an experienced scientific management team with vision and passion to develop a product offering that will support women throughout their reproductive journey. Gameto is currently working on its first program, Fertilo, a product for IVF and egg freezing, aiming to make the process shorter, safer and more effective. The preclinical studies for Fertilo found that it can increase egg yield per cycle and maturation for both conventional and reduced stimulation cycle. Gameto is currently conducting preclinical studies with partners Inception Fertility, Spring Fertility, Extend Fertility, RMA, Pozitivf, Ovation Fertility, ReproART, Clinica Tambre, and Hospital Ruber Internacional, Eugin Group. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and leader in the fertility space Martin Varsavsky as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen.