Research & Development
Theramex gains commercial license for Intrarosa in Europe, Australia, Russia and the Ukraine
19 July 2018 -

Theramex has entered into a definitive commercial agreement with Endoceutics for Intrarosa (Prasterone), the private pharmaceutical company disclosed on Thursday.

The agreement grants Theramex the license to commercialise Intrarosa in countries across Europe, Australia, Russia, as well as select countries within the Commonwealth of Independent States (CIS).

Intrarosa is a unique non-oestrogen prescription therapy that has been approved for the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women experiencing moderate to severe symptoms. VVA affects up to 50% of postmenopausal women, causing dryness, irritation, soreness, and dyspareunia (or pain during sexual activity).

Clinical trials showed that Intrarosa improved the structure of the vaginal tissues and reduced pain during sexual intercourse. Intrarosa was well-tolerated in the trials. It was approved by the US Food and Drug Administration (FDA) in November 2016 as a treatment of dyspareunia, while the European Medicines Agency (EMA) approved it in January 2018 for the treatment of VVA.

Terms of the deal were not disclosed but the countries included in the license agreement are: Australia, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Romania, Serbia, Slovakia, Slovenia, United Kingdom, the Russian Federation, Kazakhstan, and the Ukraine.

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