PROLOR Biotech reports the EC approval of Merck's ELONVA

PROLOR Biotech, Inc., (OTC Bulletin Board: PBTH) today noted the European Commission (EC) approval of Merck & Co., Inc.'s ELONVA®, a long-acting CTP-modified version of the fertility drug follicle stimulating hormone (FSH).  With the EC approval, Merck has marketing authorization for ELONVA with unified labeling valid in all European Union Member States.  Merck and PROLOR are both licensees of the CTP technology from Washington University in St. Louis.  CTP prolongs the duration of action of proteins and peptides -- Merck has the exclusive license for use of the CTP technology with FSH and three other fertility hormones while PROLOR has the exclusive license to apply CTP to all other therapeutic proteins and peptides.  PROLOR's CTP-modified version of human growth hormone (hGH-CTP) is currently in clinical trials.

ELONVA is a sustained follicle stimulant for use in fertility treatments.  As a result of the extended longevity provided by the attachment of CTP to FSH, a single injection of the recommended dose of ELONVA is indicated to replace the first seven injections of daily recombinant follicle stimulating hormone currently used for ovarian stimulation in infertility patients.

"The final EC approval in Europe for Merck's CTP version of the fertility drug FSH is a major milestone that serves to validate the utility of our CTP technology platform for the development of superior long-acting protein therapeutics," said Dr. Avri Havron, CEO of PROLOR Biotech."  We believe that ELONVA's clinical and regulatory successes bode well for the ongoing clinical development of our CTP-enhanced versions of human growth hormone and interferon beta, as well as PROLOR's other pipeline products."