Ospemifene

BLAINVILLE, Quebec, June 21, 2022 (GLOBE NEWSWIRE) -- Duchesnay Inc., a pharmaceutical company specializing in women’s health and part of Duchesnay Pharmaceutical Group headquartered in Blainville, Quebec, is pleased to announce that it has launched its newest treatment, Vablys® (dequalinium chloride vaginal tablets). Vablys® is the first prescription antiseptic and anti-infective treatment for bacterial vaginosis in women under 55 years of age. With its multiple modes of action and anti-infective properties against a wide range of pathogens, a treatment course of Vablys® consists of one tablet inserted in the vagina at bedtime for six consecutive days. “Vablys® offers Canadian physicians and their patients the first gynecological anti infective and antiseptic prescription treatment option,” said Gino Henry, Senior Manager, Commercial Affairs, at Duchesnay. “We’re convinced that our product provides a new and effective way to treat this condition.” 1 Vablys® is the third new prescription treatment for Canadian women launched by Duchesnay in 2022, achieving an aggressive target set by the company’s new management team. The other two new treatments are the contraceptive Slynd® (drospirenone), a progestin-only pill (POP) which offers a 24-hour safe window for a missed pill, during which no other contraception is needed to prevent pregnancy, and Osphena® (ospemifene tablets), a selective estrogen receptor modulator (SERM) approved by Health Canada as a once-daily prescription treatment for postmenopausal women to treat vaginal dryness and painful intercourse. “Duchesnay is very proud to have achieved its ambitious target of bringing three new innovative prescription treatments to Canadian women in the first six months of 2022, a key element of our growth plans under our new management team,” said Dany Hallé, Vice-President, Commercial Affairs at Duchesnay. “All three new treatments address important needs for women at different stages of their lives and demonstrate concretely the commitment of Duchesnay to providing women’s health solutions. We look forward to continuing to do so.” The Health Canada-approved product monographs for Vablys®, Slynd® and Osphena® are available on the Duchesnay website at . They give contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The product monographs are also available through the Duchesnay Medical Information Department, 1-888-666-0611 or medicalinfo@duchesnay.com. About bacterial vaginosis Bacterial vaginosis (BV) is an imbalance of the naturally-occurring, healthy bacteria found in the vagina or internal genitals. This imbalance can cause symptoms that may include more vaginal discharge than usual, a fish-like smell or irritation in the vaginal area2, though often symptoms are not noticed. According to the Public Health Agency of Canada, bacterial vaginosis is the most common cause of vaginal discharge in people of reproductive age. Bacterial vaginosis is not usually considered sexually transmitted, but it is associated with increased acquisition of human immunodeficiency virus (HIV), human papilloma virus (HPV) and Chlamydia trachomatis (CT).3 About Duchesnay Pharmaceutical Group Duchesnay Pharmaceutical Group, with its affiliated companies, is headquartered in Blainville, Quebec. The group consists of five pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad. The companies are Duchesnay and Duchesnay USA, both dedicated to women's health; Médunik Canada and Medunik USA, which provide treatments for rare diseases; and Analog Pharma, an American generic drugs company, specializing in authorized generics and orphan drugs. From its state-of-the-art manufacturing plant, Duchesnay can export its innovative treatments to more than 50 countries. Duchesnay and Medunik, through their proprietary research and development, and through partnerships, offer innovative treatments for a variety of medical conditions in women's health, urology, oncology as well as for rare diseases. The group of companies recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and giving back to the community through the support of various charitable organizations. For more information, please visit duchesnay.com, medunik.com and analogpharma.com. References Duchesnay Inc., Vablys® Product Monograph, September 2021. British Columbia Centre for Disease Control, Bacterial Vaginosis, Health Canada, STI-associated syndromes guide: Vaginitis, Public Health Importance, September 2021, Media contact: Email: info@duchesnay.com Telephone: (877) 833-7734 A photo accompanying this announcement is available at Vablys Vablys

Yuriko Nakao/Getty Images The trial’s primary endpoint was to assess endometrial health, with additional goals of evaluating the safety and tolerability of the drug. Yuriko Nakao/Getty Images Women experiencing menopause may have some relief on the horizon, according to Phase III clinical data reported Monday by Astellas Pharma . The study investigated the safety and tolerability of fezolinetant, a drug designed to help treat hot flashes and night sweats. If approved by the U.S. Food and Drug Administration , this would be a first-in-class non-hormonal option. Between 60 and 80% of women who go through menopause experience severe vasomotor symptoms (VMS), which include hot flashes and night sweats. Currently, a common form of treatment for vasomotor symptoms is hormone therapy. However, this carries significant risks. The FDA warns that in some women, menopause hormone therapy may increase the risk of blood clots, heart attacks, strokes and breast cancer. Astellas is trying to change that narrative by developing fezolinetant, an oral, nonhormonal selective neurokinin-3 receptor agonist. The drug works by blocking neurokinin B from binding on the kisspeptin/neurokinin/dynorphin neuron, which regulates the brain’s thermoregulatory center. Researchers at Astellas hoped that by blocking this binding, the brain’s hypothalamus could moderate hot flashes more effectively. Fezolinetant was tested in SKYLIGHT 4, a Phase III clinical trial that was randomized, placebo-controlled and double-blind. The trial involved more than 1,800 women who were experiencing VMS symptoms in menopause in a year-long study across more than 180 sites in the U.S., Canada and Europe. The trial’s primary endpoint was to assess endometrial health, with additional goals of evaluating the safety and tolerability of the drug. The results met the primary endpoint and supported the long-term safety and tolerability of fezolinetant. The most common adverse effects were headaches and COVID-19, which were also consistent with the placebo group. “Vasomotor symptoms are often reported as the most bothersome symptoms of menopause, yet there has been very little innovation in this therapeutic area. I am excited by the potential of a new nonhormonal treatment option for women experiencing moderate to severe VMS associated with menopause,” said Genevieve Neal-Perry, M.D., Ph.D., chair at the UNC School of Medicine Department of Obstetrics and Gynecology. But Astellas has competition in the women’s health market. Bayer is also leading a series of Phase III clinical development trials in its OASIS program , which is investigating the drug elinzanetant to treat VMS symptoms during menopause. Like fezolinetant , this drug is also nonhormonal, so it will be a race for regulatory approvals to see which company can market its drug first. Other companies are also investing in menopausal or post-menopausal women’s health. In February 2022, Duchesnay , a pharmaceutical company specializing in women’s health, announced that its drug, Osphena®, was approved by Health Canada as an effective treatment for dyspareunia (painful sexual intercourse) and vaginal dryness in postmenopausal women. Osphena has already been in the U.S. for several years and has been “commercially successful and well-received,” said Dany Hallé, vice president of commercial affairs at Duchesnay. Dyspareunia was also the target of Imvexxy , estradiol vaginal inserts created by TherapeuticsMD . These inserts deliver doses of either 4 mcg or 10 mcg of vaginal estradiol to help treat vaginal pain due to menopause. Switzerland-based ObsEva is another pharmaceutical company developing therapies for menopause symptoms. ObsEva recently announced a partnership with Theramex to commercialize linzagolix, a best-in-class GnRH receptor agonist that helps treat uterine fibroids. These treatments are part of worldwide investment in women’s health, a market expected to hit $27.54 billion USD by 2028.