| Monday, June 12, 2006 |
| Organon Starts Phase III Development Of Unique Combined Oral Contraceptive |
Organon, the human healthcare business unit of Akzo Nobel, announced today that it has started the phase III development program for NOMAC/E2, its novel combined oral contraceptive.
NOMAC/E2 is viewed as the first major innovation in hormone content since the introduction of "The Pill" in the nineteen sixties. NOMAC/E2 is the first natural estrogen containing combined oral contraceptive; it contains exactly the same estrogen - estradiol - that is produced in women's bodies. All currently available combined oral contraceptives contain synthetic ethinyl estradiol (EE). The new combined pill also contains NOMAC , a hormone new in contraception that resembles the progesterone a women's body produces at certain times in her menstrual cycle.
"NOMAC/E2 represents a novel approach for oral contraception and one that has been pursued by many in this field for a considerable time," said Herm Cukier, Executive Vice President, Global Marketing and Global Venture Teams. "NOMAC/E2, when approved, will complement our already innovative contraceptive portfolio. The development of NOMAC/E2 also reflects our continued commitment to using novel technologies in order to address important unmet needs for women seeking an efficacious, safe and convenient method of contraception, be it oral or otherwise. Bringing this new contraceptive into phase III adds value to Organon's strong late stage development pipeline."
The phase III program includes two large, randomized open-label multi-centre 13-cycle comparative trials that will enrol more than 4200 women and generate more than 30,000 cycles of exposure to NOMAC/E2. In total more than 200 centres in 24 countries including the USA are taking part.
Organon was granted development and marketing rights of NOMAC/E2 by Merck KgaA affiliate Laboratoire Theramex in 2005. Theramex successfully completed a phase II program suggesting that NOMAC/E2 will be the first E2-containing pill able to combine good contraceptive efficacy with an expected cyclic bleeding pattern and an acceptable safety profile.
NOMAC is the acronym given to the progestogen, nomegestrol acetate. |
| posted by Jennie Tate @ 5:50 AM |
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