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Bayer Schering Pharma AG, Germany, announced that it has signed a global exclusive cooperation agreement with the Canadian company EndoCeutics, Inc.
This agreement is for the development and commercialization of Vaginorm an intra-vaginal application of dehydroepiandrosterone (DHEA). A Phase III clinical program for Vaginorm in the treatment of symptoms of vulvovaginal atrophy and female sexual dysfunction in postmenopausal women has been initiated. Many women experience changes in vaginal tissue after menopause. These vaginal tissue changes are called vaginal atrophy and they may cause vaginal discomfort including vaginal dryness, itching and burning, and painful sex. Epidemiological research has shown that one quarter to one-half of postmenopausal women suffer from vaginal atrophy.(1)
“Vaginorm is an important late stage addition to our Gynecological Therapy R&D pipeline. We are pleased to work with EndoCeutics towards bringing a new treatment alternative for vaginal atrophy and female sexual dysfunction to an area of high unmet medical need,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma. “Gynecological Therapies are a new growth area adding to our contraception business. Our research, in-licensing and innovation efforts are all geared towards this strategic goal.”
EndoCeutics is responsible for conducting the Phase III studies for Vaginorm. Thereafter, Bayer will be responsible for the registration and commercialization of Vaginorm. Under the terms of agreement, EndoCeutics grants Bayer a worldwide, exclusive license to develop, manufacture and commercialize Vaginorm. Further details of the deal have not been disclosed. The transaction is subject to pre-merger notification under the HSR Act.
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