The companies said the transaction gives Duchesnay the rights to develop, manufacture and commercialize ospemifene-based products in the United States and Canada.
Duchesnay said plans to begin detailing Osphena in the U.S. through its current sales force, which has well-established relationships with health care providers focused on women’s health. The company also aims to pursue regulatory approvals in Canada. The Food and Drug Administration approved Osphena for the treatment of moderate to severe dyspareunia, or painful intercourse, due to menopause in February 2013.
“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,” stated Eric Gervais, executive vice president of Duchesnay.
Osphena is the only oral, non-hormonal prescription medication indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) due to menopause. It is estimated that 50% of postmenopausal women experience VVA symptoms and that 40% of these women also suffer from dyspareunia. A survey of women with VVA undergoing therapy found that about 35% had concerns about hormone exposure. With the addition of Osphena, Duchesnay can now offer these women a non-hormonal oral treatment option.
Plans call for Shionogi to continue to book sales for Osphena in the U.S. through March 31, 2021, and the company is expected to continue to supply Osphena to Duchesnay for eight years from the effective date of the transaction. Shionogi will retain its rights to ospemifene outside the U.S. and Canada.
“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,” commented Isao Teshirogi, president and chief executive officer of Shionogi & Co. Ltd.
Duchesnay noted that the acquisition of Osphena complements its women’s health product portfolio, led by its flagship product Diclegis (Diclectin in Canada) and its multivitamin/multimineral supplement tablets Mteryti and Mteryti Folic 5 (Pregvit and Pregvit Folic 5 in Canada).