Women’s health research of Solvay Pharmaceuticals is conducted in close collaboration with the academic world. We also make research agreements with partners to expand our women’s health R&D portfolio. We signed an agreement with Zentaris (Germany) on cetrorelix (a hormone based approach to the treatment of endometriosis and uterine fibroids). Cetrorelix is now in full Phase III development for the treatment of endometriosis.
Cetrorelix is a gonadotrophin releasing hormone antagonist (GnRH antagonist). GnRH analogues (agonists and antagonists) control hormonal stimulation of the endometrial tissue. They predictably stop ovulation and menstruation. Agonists take more days of treatment than antagonists do to shut down the ovaries. Phase II clinical studies in endometriosis have demonstrated promising benefits and a good safety and tolerability profile. Full development is expected to allow registration submissions to be made in 2008, with first launches from 2009.
In the women’s health therapeutic area, Solvay Pharmaceuticals also signed a research collaboration and license agreement with Hormos Medical Corporation (Finland). It comprises a collaborative discovery program, combining the special skills and insights Hormos has on molecules that can influence hormones, with the proven abilities of Solvay to develop and market women’s health products successfully.
Endometriosis is a condition in which endometrial cells, normally found only inside the uterus as its lining cells, ‘escape’ to other places. They can embed and survive outside the uterus, typically within the cavity lining the abdomen. They usually bed in the abdomen on the ovaries, fallopian tubes, and ligaments that support the uterus; the area between the vagina and rectum; the outer surface of the uterus; and the lining of the pelvic cavity. Other sites for these endometrial growths may include the bladder, bowel, vagina, cervix, vulva, and in abdominal surgical scars. Less commonly they are found in the lung, arm, thigh, and other locations.
This misplaced tissue develops into growths or lesions which respond to the menstrual cycle in the same way that the tissue of the uterine lining does: each month the tissue builds up, breaks down, and sheds. Menstrual blood flows from the uterus and out of the body through the vagina, but the blood and tissue shed from endometrial growths has no way of leaving the body. This results in internal bleeding, breakdown of the blood and tissue from the lesions, and inflammation — and can cause pain, infertility, scar tissue formation, adhesions, and bowel problems. There is a high unmet clinical need, as current treatments have unfavorable profiles and are not suitable for long term use or have relatively low efficacy. It is expected that around 8% of women will be affected by endometriosis at some time in their life.