Durban – United States-based Aspen Pharma USA Inc. and Aspen Global Incorporated, located in Mauritius, both wholly owned subsidiaries of Aspen Pharmacare Holdings Limited, have announced a license and commercialisation agreement with Avion Pharmaceuticals, LLC, a specialty pharmaceutical company, for the exclusive rights to relaunch Cenestin® in the USA.
This is a New Drug Application (NDA), without any generics, of the plant-derived, synthetic complex conjugated estrogens product for the treatment of hot flushes, night sweats and other moderate-to-severe vasomotor symptoms associated with menopause.
Stephen Saad, Aspen Group Chief Executive said, “Avion’s expertise and success in Women’s Health provides the perfect partnership to relaunch Cenestin®. The nine synthetic conjugated estrogens used in Cenestin® will be manufactured at our active pharmaceutical ingredient (“API”) site in Oss, the Netherlands. The relaunch of Cenestin® provides Aspen with an opportunity to increase our presence in the United States leveraging our niche global intellectual property. Avion is ideally positioned to execute the relaunch of Cenestin® given that they have the necessary technical and commercial resources to drive the sales and marketing of this product in the United States. Cenestin® will provide an effective alternative to millions of women wishing to manage the symptoms of menopause using nine plant-derived synthetic conjugated estrogens. The relaunch of Cenestin® could take place before our financial year end of 30 June 2021, subject to the standard approvals required by the US Food and Drug Administration.”
Art Deas, CEO of Avion Pharmaceuticals said, “Avion Pharmaceuticals has been diligent and focused in supporting our patients and prescribing partners in Women’s Health for over 9 years with our portfolio of prescription nutritional supplements and oral contraceptives. Cenestin® will allow us to expand our commitment to women who are seeking options to manage their menopause journey and allow for effective symptom management. We are honoured to support women throughout their life with their important health-related needs and milestones they encounter.”
Cenestin® is the only plant-derived mixture of nine conjugated estrogens indicated for treatment of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. For the past few decades, the only complex conjugated estrogens product women could choose from was derived from pregnant mares’ urine. Cenestin® tablets will be available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, A.[1]
Vasomotor symptoms are prevalent in approximately 40 to 50 million women in the United States[2], with approximately 1.3 million women becoming menopausal each year[3]. With the relaunch of Cenestin®, millions of menopausal women will have a plant-derived choice in conjugated estrogens products for the treatment of vasomotor symptoms associated with menopause.
Cenestin® showed significant reduction in moderate to severe vasomotor symptoms at weeks 4, 8 and 12 as compared to placebo in a double-blind, placebo-controlled, randomized 12-week clinical trial of 120 postmenopausal women. Cenestin® significantly decreased the mean vaginal pH from baseline as compared to placebo in a 16-week, randomized, placebo-controlled, multicenter clinical study in 72 postmenopausal women. Cenestin® was observed to be well tolerated, safe and effective in both clinical studies.
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf
[2] Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47.
[3] Menopause and Mood Disorders: Overview, Pathophysiology emedicine.medscape.com › article › 295382-overview