NES-ZIONA, Israel, Feb. 13, 2013 /PRNewswire/ -- PROLOR
Biotech, Inc. (NYSE MKT: PBTH) today announced that the European
Commission and the European Medicines Agency (EMA) have granted
orphan drug designation to hGH-CTP, PROLOR's longer-acting version
of human growth hormone in development for the treatment of growth
hormone deficiency. PROLOR will receive 10 years of marketing
exclusivity in Europe for hGH-CTP,
beginning at product launch. This is the first time a growth
hormone product has received orphan drug designation in
Europe.
In Phase II studies in growth hormone-deficient adults, hGH-CTP
was safe and well tolerated, and it demonstrated the potential to
be administered once-weekly, replacing seven daily injections of
currently marketed human growth hormone. These results
enabled PROLOR to initiate a Phase II trial in children with growth
hormone deficiency and to proceed with plans for a Phase III trial
in growth hormone-deficient adults, which is scheduled to begin
later this year.
"By reducing the dosing frequency to just one injection every
week, our longer-acting human growth hormone has the potential to
improve the lives of the many individuals with growth hormone
deficiency," said Dr. Abraham Havron, CEO of PROLOR. "We
believe this European orphan drug designation further confirms that
hGH-CTP may provide significant benefits to patients. We also
believe that the designation will prevent any other long-acting
recombinant growth hormone from being marketed in Europe for 10 years after the launch of
hGH-CTP, expanding the breadth of the marketing exclusivity we have
already received from our U.S. orphan drug designation."
PROLOR's hGH-CTP received orphan drug designation in the U.S. in
October, 2010. The U.S. Orphan Drug Act of 1983 provides for
seven years of market exclusivity, reductions in regulatory fees,
certain tax credits and additional regulatory support.
Medicinal products intended for rare diseases in the European
Union can receive an orphan drug designation based on defined
criteria. These include relatively low prevalence, the fact
that the disease is life-threatening or for a serious and chronic
condition, and the lack of a satisfactory method of prevention or
treatment of the condition. If a method currently exists, the
orphan candidate must be of significant benefit to those affected
by the condition.
ABOUT PROLOR
PROLOR Biotech, Inc. is a clinical stage
biopharmaceutical company applying unique technologies, including
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. PROLOR is currently developing a long-acting
version of human growth hormone, which successfully completed a
Phase II clinical trial. It also is developing long-acting
versions of Factor VIIa and Factor IX for hemophilia and a
GLP-1/Glucagon dual receptor agonist peptide for diabetes and
obesity, all of which are in preclinical development. For
more information, visit http://www.prolor-biotech.com.
Safe Harbor Statement: This press release
contains forward-looking statements, which may be identified by
words such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "would", "intends,"
"estimates," "suggests," "has the potential to" and other words of
similar meaning, including statements regarding the results of
current clinical studies and preclinical experiments and the
effectiveness of PROLOR's long-acting protein programs, which are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Investors are
cautioned that forward-looking statements involve risks and
uncertainties that may affect PROLOR's business and prospects,
including the risks that PROLOR may not succeed in generating any
revenues or developing any commercial products, including any
long-acting versions of human growth hormone, erythropoietin,
interferon beta, GLP-1 and other products; that the long-acting
products in development may fail, may not achieve the expected
results or effectiveness and/or may not generate data that would
support the approval or marketing of these products for the
indications being studied or for other indications; that ongoing
studies may not continue to show substantial or any activity; that
the actual dollar amount of any grants from Israel's Office of the Chief Scientist is
uncertain and is subject to policy changes of the Israeli
government, and that such grants may be insufficient to assist with
product development; and other risks and uncertainties that may
cause results to differ materially from those set forth in the
forward-looking statements. The results of clinical trials in
humans may produce results that differ significantly from the
results of clinical and other trials in animals. The results of
early-stage trials may differ significantly from the results of
more developed, later-stage trials. The development of any products
using the CTP platform technology could also be affected by a
number of other factors, including unexpected safety, efficacy or
manufacturing issues, additional time requirements for data
analyses and decision making, the impact of pharmaceutical industry
regulation, the impact of competitive products and pricing and the
impact of patents and other proprietary rights held by competitors
and other third parties. In addition to the risk factors
described above, investors should consider the economic,
competitive, governmental, technological and other factors
discussed in PROLOR's filings with the Securities and Exchange
Commission. The forward-looking statements contained in this
press release speak only as of the date the statements were made,
and we do not undertake any obligation to update forward-looking
statements, except as required under applicable law.
PROLOR
CONTACT:
|
MEDIA
CONTACT:
|
Shai
Novik, President
|
Barbara
Lindheim
|
PROLOR
Biotech, Inc.
|
BLL
Partners, LLC
|
Tel: +1
866 644-7811
|
+1 212
584-2276
|
Email:
shai@prolor-biotech.com
|
blindheim@bllbiopartners.com
|
SOURCE PROLOR Biotech, Inc.