Merck's FSH-CTP European Marketing Approval
Follicle Stimulating Hormone ("FSH") is a hormone that naturally exists in females. Women who have fertility problems may get supplemental FSH to increase the likelihood of pregnancy. Women have to be injected with FSH, around the time of ovulation, for seven days. The FSH market is significant, with more than $1.0 billion spent in 2009.
There is no available long-lasting FSH on the market - one that would enable women to inject the FSH less frequently than on a daily basis. Many attempts by biotech companies have been made in an effort to create a long-lasting FSH - all of these attempts have failed. However, Merck & Co., a leading pharmaceuticals company (NSYE: MRK) has used the CTP technology to extend the life of FSH. The long-acting FSH is named corifollitropin alfa (FSH-CTP).
On July 8, 2008 Schering-Plough, a division of Merck & Co, announced successful top-line data from its Phase III ENGAGE trial demonstrating that women receiving a single injection of FSH-CTP achieved the same pregnancy rates as women receiving seven consecutive daily injections of FSH, a primary endpoint of the study. This 1,509 patient trial was the largest double-blind fertility trial ever conducted.
On December 31, 2008 Schering-Plough announced European submission of FSH-CTP. On January 28, 2010 the European Commission (EC) gave Merck & Co. marketing approval with unified labeling valid in all European Union Member States for FSH-CTP, now branded as ELONVA®.
We believe that Merck & Co.'s success to date, in conjunction with our research and development efforts, indicates that the addition of CTP to existing therapeutic proteins is commercially viable.