Linzagolix choline

TORONTO, Oct. 7, 2025 /PRNewswire/ - Searchlight Pharma Inc.("Searchlight"), Apotex Inc's ("Apotex") Branded Medicines Division today announced it has entered into a strategic licensing agreement securing exclusive Canadian rights to linzagolix, a once-daily oral treatment developed by Kissei Pharmaceutical Co., Ltd. Linzagolix belongs to a class of medicines called GnRH antagonists. Under the agreement, Searchlight will lead efforts to pursue marketing authorization for linzagolix in Canada, following regulatory approval. "Securing the Canadian rights to linzagolix is a meaningful step in our strategy to expand access to innovative therapies," said Allan Oberman, President and CEO, Apotex. "By adding this treatment to our portfolio, we continue to build on our commitment to addressing areas of significant need and supporting the well-being of patients." "Our strategic focus is on delivering high-quality, novel therapies that meet the evolving needs of Canadian patients and complement our existing women's health portfolio," said Mark Nawacki, President, Searchlight Pharma. "Linzagolix represents a meaningful advancement in the treatment of uterine fibroids, offering a potential new option for women across the country. We're pleased to introduce this treatment option as part of our Journey of Health growth strategy and our ongoing commitment to improving patient outcomes and expanding access to innovative therapies." Uterine fibroids affect up to 70% of Canadian women by age 50, with an estimated 1.4 to 3.5 million experiencing symptoms that can adversely impact their quality of life.1 The introduction of linzagolix offers a much-needed treatment option for those affected, reinforcing Apotex's commitment to improving access to care in areas of high unmet need. About "Linzagolix" Linzagolix was launched in Europe under the brand name Yselty®. It is indicated for adult women of reproductive age for the treatment of moderate to severe symptoms of uterine fibroids, and for the symptomatic treatment of endometriosis in women with a history of prior medical or surgical treatment. Yselty contains the active substance linzagolix choline. Linzagolix works by lowering estrogen and progesterone levels, which helps reduce the size of uterine fibroids and relieve symptoms. It is indicated for adult women of reproductive age experiencing moderate to severe symptoms of uterine fibroids.2 About Apotex Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at About Kissei Pharmaceutical Co., Ltd. Kissei Pharmaceutical Co., Ltd., founded in 1946 and headquartered in Matsumoto, Japan, is a research-driven pharmaceutical company listed on the Tokyo Stock Exchange. Kissei specializes in the development and commercialization of innovative therapies in key areas including urology, dialysis, women's health, ophthalmology, endocrinology, and metabolism. In addition to pharmaceuticals, the company provides therapeutic and care foods, as well as services such as healthcare information and construction. Kissei maintains a global presence, including an overseas subsidiary in New Jersey, USA. SOURCE Apotex Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NHS patients will soon be able to access Theramex’s once-a-day endometriosis pill Yselty (linzagolix), following final draft guidance from the National Institute for Health and Care Excellence (NICE). The health technology assessment agency has recommended the at-home treatment be used to manage endometriosis symptoms in patients across England, Wales and Northern Ireland with a history of previous medical or surgical treatment for their endometriosis. It will be given with add-back hormone therapy, which involves using low-dose hormone replacement therapy to minimise or eliminate menopause-like symptoms and bone loss. Affecting approximately 1.5 million women in the UK, endometriosis occurs when tissue similar to the lining of the uterus grows elsewhere in the body. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain. Yselty is designed to block the hormones that contribute to endometriosis symptoms. The drug is expected to be available in the coming months and could benefit more than 1,000 patients every year, according to NHS England. NICE’s decision was supported by results from the EDELWEISS 3 study, in which Yselty used alongside add-back therapy demonstrated statistically significant reductions in both co-primary endpoints of non-menstrual pelvic pain and dysmenorrhea compared to placebo. Sue Mann, national clinical director in women’s health for NHS England, said: “This is welcome news for women with endometriosis who haven’t found relief from previous therapies or surgery – it’s another treatment option which will help women take control of their health and better manage the symptoms of this often painful and debilitating condition.” NICE’s final guidance on Yselty is set to be published on 25 June, after which the NHS must make the treatment available within 90 days. The announcement comes less than two months after NICE recommended Gideon Richter’s Ryeqo (relugolix, estradiol and norethisterone) as the first long-term daily pill for endometriosis. Commenting on the agency’s latest decision, Emma Cox, chief executive at Endometriosis UK said: “Historic lack of research into women’s health means those with endometriosis have far too few options for managing their sometimes debilitating pain and other symptoms of endometriosis. “It’s good to see companies investing in research, and NICE approving a new drug for endometriosis, offering more choice for those considering medical menopause to manage symptoms.”