CHMP positive opinion for marketing ELONVA in Europe

Nov 25 2009

PROLOR Biotech, Inc., (OTC Bulletin Board: PBTH) 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.

ELONVA is the first in the class of sustained follicle stimulants for use in fertility treatments. As a result of the extended longevity provided by the attachment of CTP to the follicle stimulating hormone (FSH), a single injection of ELONVA is intended to replace the seven daily injections of FSH required by fertility patients currently.

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.

PROLOR is conducting a Phase I clinical trial of hGH-CTP and its CTP version of inteferon beta is in late preclinical development. Based on data from studies in relevant animal models, PROLOR researchers project an administration regimen for hHG-CTP ranging from one weekly to two monthly injections, compared with daily injections of commercial hGH required by many patients today, and an administration regimen for its beta interferon of one injection every two to four weeks, compared with the one to three injections per week required for patients currently using commercial interferon beta.

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.

"The positive opinion by the CHMP for marketing approval in Europe of 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 are optimistic that ELONVA's clinical and regulatory successes will be replicated in the ongoing clinical development of our CTP-enhanced human growth hormone and beta interferon."