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Two Phase III clinical trials on corifollitropin alfa (Org 36286),reach randomization target

OSS, the Netherlands, June 27, 2007-Organon, the human healthcare business unit of Akzo Nobel, announced today that two out of three Phase III clinical trials with corifollitropin alfa (Org 36286), a new long-acting fertility hormone, have reached their randomization target.

Corifollitropin alfa is a new recombinant fertility hormone. It is the first of a new class of gonadotropins (a sustained follicular stimulant or SFS) of which, due to its long half-life, one single injection may replace the first 7 injections with conventional gonadotropins during a fertility treatment cycle.

The objective of the ENGAGE trial, the largest double-blind fertility trial ever performed, is to demonstrate clinical efficacy and safety of corifollitropin alfa 150 µg in a double-blind comparison with Organon’s Puregon®, one of the most commonly used preparations to treat infertile patients. The recruitment goal of the ENGAGE trial was to include a total of 1400 patients from 34 fertility clinics in Europe, USA and Canada and was started in July, 2006. The study reached its randomization target on June 10, 2007.

A second trial, the ENSURE trial, is an efficacy and safety trial with corifollitropin alfa 100 µg designed specifically for women who weigh less than 60 kg (133 lbs). This double-blind study comparing corifollitropin alfa with Puregon® was started in January 2007 in 19 clinical trial centers in Europe and Asia with a recruitment goal of 330 patients by June 30, 2007. All 330 subjects have now been randomized.

David Nicholson, executive vice-president Research and Development at Organon commented: “The enthusiasm and dedication of investigators and staff involved in these trials was decisive in reaching our recruitment targets.”

A third Phase III trial in the LIFE program (the TRUST trial) focuses on safety of repeated treatments with corifollit
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