NES-ZIONA, Israel, April 8, 2013 /PRNewswire/ -- PROLOR
Biotech, Inc. (NYSE MKT: PBTH) today announced that it received a
notice of allowance from the U.S. Patent and Trademark Office for a
new patent application covering the company's proprietary
long-acting CTP-enhanced coagulation factors for the treatment of
hemophilia: Factor VIIa-CTP, Factor Vll-CTP and Factor
IX-CTP. The allowed claims cover both product composition and
treatment methods.
"This new patent allowance is important for PROLOR, as we move
forward with plans to initiate a Phase II clinical study of our
long-acting Factor VIIa-CTP in early 2014," said Shai Novik, President of PROLOR. "Our
intellectual property strategy is designed to provide multiple
layers of protection for our product portfolio, and we believe that
this new patent will provide additional reinforcement to our
existing patent estate for our hemophilia drug candidates."
PROLOR previously presented preclinical data on its long-acting
versions of factor Vlla and factor IX. In hemophilic mice,
Factor VIIa-CTP demonstrated superior performance on multiple
parameters and resulted in greater survival of the subjects
compared to commercially available factor VIIa. Factor
VIIa-CTP also demonstrated the potential for subcutaneous
administration in addition to administration using standard IV
dosing. Factor IX-CTP demonstrated significantly longer
duration of clotting activity in hemophilic mice, and bleeding
episodes were significantly shorter and less intense compared with
commercially available factor IX. None of the animals treated
with Factor IX-CTP had any spontaneous re-occurring bleeding
events, as compared with a 50% incidence of re-bleeding events for
the group treated with commercially available factor IX.
The new patent is expected to issue in the next few months.
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.
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PROLOR
CONTACT:
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MEDIA
CONTACT:
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Shai
Novik, President
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Barbara
Lindheim
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PROLOR
Biotech,
Inc.
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BLL
Partners, LLC
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Tel: +1
866 644-7811
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+1
212 584-2276
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Email:
shai@prolor-biotech.com
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blindheim@bllbiopartners.com
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SOURCE PROLOR Biotech, Inc.