PROLOR Biotech Reports Merck Receives Positive Regulatory Opinion

Published November 25th, 2009 - 09:42 GMT

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®, 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."


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