NES-ZIONA, Israel, Nov. 24 /PRNewswire/ -- PROLOR Biotech, Inc., today noted the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for marketing approval in Europe for ELONVA((R)), a long-acting CTP-modified version of the fertility hormone FSH from Merck & Co. 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 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 is currently in clinical trials.
PROLOR is using the exact same CTP peptide to extend the duration of action of other protein therapeutics, including human growth hormone (hGH-CTP) and interferon beta, with the aim of reducing the number of injections required for these chronic indications. Human growth hormone, which is used to treat growth hormone deficiency in children and adults, must currently be injected between three and seven times per week, while interferon beta, which is prescribed for the treatment of multiple sclerosis, must currently be injected between one and three times per week. These are both major drugs, with existing estimated market sizes of $2.7 billion for human growth hormone and $4.8 billion for inteferon beta, yet neither is commercially available in a long-acting version.
hGH-CTP is currently in a Phase I clinical trial assessing its efficacy and safety profile. The trial is expected to be completed in early 2010.
ABOUT PROLOR BIOTECH
PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and PROLOR is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on PROLOR, visit www.prolor-biotech.com.
PROLOR Biotech, Inc.
