Duchesnay, a specialty pharma company with a long-standing commitment to women's health, has acquired exclusive U.S. and Canadian rights to market and distribute Osphena® (ospemifene) from Shionogi Inc. Osphena® is the only oral, non-hormonal prescription medication indicated for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The acquisition is effective immediately.
The exclusive rights granted to Duchesnay enable the company to develop, manufacture and commercialize ospemifene-based products in the United States and Canada. Duchesnay intends to immediately begin detailing Osphena® in the United States through its existing sales force which has well-established relationships with healthcare providers focused on women's health issues. The company will also pursue regulatory approvals in Canada. Shionogi Inc. will continue to book sales for Osphena® in the United States through March 31, 2021, and is expected to continue to supply Osphena® to Duchesnay for 8 years from the effective date of the transaction.
"We are very pleased to be continuing the excellent work done by Shionogi with Osphena® in the U.S and look forward to introducing this new product in Canada as soon as possible to help the thousands of women suffering from dyspareunia" said Éric Gervais, Executive Vice-President of Duchesnay.
It is estimated that 50% of postmenopausal women experience VVA symptoms and that 40% of these women also suffer from dyspareunia (Parish, Sharon, Int J Womens Health 2013: 5: 437-447). A survey of women with VVA undergoing therapy found that approximately 35% had concerns about hormone exposure (Krychman et al, April 2014, Revive Survey). With the acquisition of Osphena®, Duchesnay can now offer these women a non-hormonal oral treatment option. The addition of Osphena® to the Duchesnay product portfolio is also expected to enhance the company's robust relationship with the leading healthcare professionals by providing them with an additional resource to address their postmenopausal patients' health needs.
"Shionogi feels that Duchesnay is the ideal partner to maximize the value of Osphena® because of its track record of success, sole focus on women's health and commitment to improving the health of women. We are also very happy to embark in this new endeavor with Duchesnay to bring Osphena® to patients in Canada," said Dr. Isao Teshirogi, President and CEO of Shionogi & Co., Ltd.
The U.S. Food and Drug Administration approved Osphena® for the treatment of moderate to severe dyspareunia, a symptom of VVA, due to menopause in February 2013. That same year, the Cleveland Clinic recognized Osphena® as one of the top 100 women's health highlights of the year. Osphena® is included in guidelines issued by both the American College of Obstetricians and Gynecologists (ACOG) and the North American Menopause Society (NAMS).
Under the terms of the transaction, Shionogi Inc. will receive certain minimum payments quarterly over a period of 8 years. Under certain conditions dependent upon annual Osphena® performance, Shionogi Inc. may also be eligible to receive additional payments.
Shionogi Inc. will continue to retain its rights to ospemifene in all other countries of the world.
This acquisition enhances Duchesnay's commitment to being a leader in the field of women's health, serving as a compliment to the company's flagship product, Diclegis® (Diclectin® in Canada) and its multivitamin/multimineral supplement tablets, Mteryti® and Mteryti® Folic 5 (Pregvit® and Pregvit Folic 5® in Canada). As a company, Duchesnay is dedicated to women's health at every stage of life.