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(March 10, 2017)
BLAINVILLE, Quebec and OSAKA, Japan, March 10, 2017 /PRNewswire/ -- 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.
Osphena® is a prescription oral pill that treats moderate to severe painful intercourse, a symptom of changes in and around your vagina, due to menopause.
Important Safety Information for Osphena®
Most Important Information you should know about Osphena®
Osphena® works like estrogen in the lining of the uterus, but can work differently in other parts of the body. Taking estrogen alone or Osphena® may increase your chance for getting cancer of the lining of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause; so tell them right away if this happens while you are using Osphena®.
Osphena® may increase your chance of getting strokes and blood clots.
You and your healthcare provider should talk regularly about whether you still need treatment with Osphena®.
Call your healthcare provider right away if you experience changes in vision or speech, sudden new severe headaches, and severe pains in your chest or legs with or without shortness of breath, weakness and fatigue. Osphena® should not be used if you have unusual vaginal bleeding; have or have had certain types of cancers (including cancer of the breast or uterus); have or had blood clots; had a stroke or heart attack; have severe liver problems; are allergic to Osphena® or any of its ingredients; or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest.
Possible side effects of Osphena®
Serious but less common side effects can include stroke, blood clots, and cancer of the lining of the uterus.
Common side effects can include hot flashes, vaginal discharge, muscle spasms and increased sweating.
Tell your healthcare provider about all of the medicines and supplements you take as some medicines may affect how Osphena® works. Osphena® may also affect how other medicines work.
Please click here for Full Prescribing Information, including Boxed WARNING.
Duchesnay is a specialty pharmaceutical company with a long-standing commitment to women's health. In addition to filling the void in terms of scientific research, education and information and developing pharmacological solutions that are safe for use during pregnancy and breastfeeding, Duchesnay is equally committed to ensuring women's health and improving their quality of life at every stage.
Thus, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives. To learn more about Duchesnay, visit duchesnay.com
Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and well-being of the patients we serve." Shionogi's research and development currently targets two therapeutic areas: infectious diseases and pain/CNS disorders. A 138 year old company, Shionogi has developed and commercialized innovative oral and parenteral anti-infectives for over 50 years. In addition, Shionogi is engaged in new research areas, such as obesity/geriatric metabolic disease and oncology/immunology. Contributing to the health and quality of life of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp/en/. For more information on Shionogi Inc., the US-based subsidiary of Shionogi & Co., Ltd., headquartered in Florham Park, NJ, USA, please visit www.shionogi.com. For more information on Shionogi Ltd., the European-based subsidiary of Shionogi & Co., Ltd., headquartered in London, England, please visit www.shionogi.eu.
Forward Looking Statement
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
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