Merck's FSH-CTP Approved In Europe Jan 2010

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 daily, for seven days, with FSH, at around ovulation time. The FSH market is significant, with more than $1.0 billion in 2007.

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 pharmaceutlcals company (NSYE: MRK) has used the CTP technology to extend the life of FSH. The long-acting FSH is named corifollitropin alfa (FSH-CTP). 

Merck and PROLOR, have the exclusive license from Washington University to utilize the CTP technology. PROLOR's License Agreement is exclusive for human therapeutics, with the right to sub-license, for all therapeutic proteins and peptides, of natural or non-natural sequence, other than four endocrine proteins - LH, FSH, TSH and hCG, previously licensed to Merck & Co.The phase III human clinical trials conducted by Merck with FSH-CTP have shown no adverse effects of toxicity or immunogenicity. Merck's FSH-CTP requires only one injection, compared to the seven injections required for the regular FSH. 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.