PROLOR Biotech's Longer-acting Human Growth Hormone Receives Orphan Drug Designation in Europe

   PROLOR Biotech's Longer-acting Human Growth Hormone Receives Orphan Drug
                            Designation in Europe

-PROLOR to Receive 10 Years of Marketing Exclusivity in Europe for
Longer-Acting Human Growth Hormone Products Upon Launch of hGH-CTP-

-Broad Designation for Treatment of Growth Hormone Deficiency Includes Both
Adults and Children-

-First-Ever Growth Hormone Product to Receive Orphan Status in Europe-

PR Newswire

NES-ZIONA, Israel, Feb. 13, 2013

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.

Website: http://www.prolor-biotech.com
 
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