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PROLOR Biotech (PBTH) to Present New Data on its Long-Acting Human Growth Hormone and Long-Acting Oxyntomodulin at ENDO 2013


6/13/2013 6:22:00 AM

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SAN FRANCISCO and NES-ZIONA, Israel, June 13, 2013 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH), today announced that the company will present new data on its long-acting human growth hormone (hGH-CTP) in Phase III development for the treatment of growth hormone deficiency and its long acting oxyntomodulin (MOD-6030) in preclinical development for the treatment of obesity and type 2 diabetes at ENDO 2013, the 95th Annual Meeting of the Endocrine Society.

PROLOR's scientists will present additional pre-clinical and clinical safety data on hGH-CTP and will discuss its manufacturing process. Data previously reported by the company confirmed that hGH-CTP appears to be safe and well tolerated and that it has the potential to be administered once-weekly to adults with growth hormone deficiency. The new data provides further information on the excellent safety and tolerability profile of hGH-CTP in a variety of pre-clinical and clinical studies. PROLOR recently announced that it has initiated a pivotal Phase III study of hGH-CTP in growth hormone deficient adults.

In addition, PROLOR scientists will make an oral presentation discussing MOD-6030, also known as LA-Oxyntomodulin, the company's long-acting GLP-1 and Glucagon dual agonist with potential for the treatment of type 2 diabetes and obesity. New pre-clinical data will be presented on MOD-6030's effects on weight reduction and glucose tolerance in animal models.

The PROLOR presentations include the following:

FP02-3: The Long-Acting Dual GLP-1/Glucagon Agonist, Mod-6030, Improves Glycemic Control and Induces a Prolonged Weight Loss in Diet-Induced Obesity Mice Following a Once-Weekly Administration. See abstract for more information.

SAT-120: Metabolic and Safety Parameters of Once-Weekly, CTP-Modified Human Growth Hormone (MOD-4023): Results of a Phase 2 Dose and Frequency Finding Study. See abstract for more information.

SAT-644: Pre-clinical Characterization of MOD-4023, a Long-Acting Growth Hormone. See abstract for more information.

SAT-647: Highly Producing Fed-Batch Manufacturing Process of Long-Acting Human Growth Hormone (MOD-4023) in CHO Cells. See abstract for more information.

SUN-637: Development of a Population Pharmacokinetic and Pharmacodynamic Model Following a Phase II Study of MOD-4023 in Growth Hormone Deficient Adults. See abstract for more information.

ENDO 2013 abstracts are available online at: https://endo.confex.com/endo/2013endo/webprogram/COP.html.

ENDO 2013, the 95th Annual Meeting & Expo of the Endocrine Society, is being held June 15-18, 2013, in San Francisco. For more information, visit: https://www.endocrine.org/meetings/endo-annual-meeting/endo-2013#/nav/.

About PROLOR PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including patented CTP technology and its long-acting reversible-pegylation 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 developing a long-acting version of human growth hormone, which is in a Phase IIl 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 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.



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