PROLOR Biotech's Longer-Acting Human Growth Hormone Receives Orphan Drug Designation in the U.S.

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

NES-ZIONA, Israel, Oct. 5 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone for the treatment of growth hormone deficiency.  hGH-CTP is currently in a Phase II clinical trial.

"By reducing the frequency of injections from as many as seven per week to just one injection every one to two weeks, 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 are therefore very pleased to receive this orphan drug designation, which has been broadly defined for the treatment of growth hormone deficiency in both adults and children."

PROLOR is developing hGH-CTP to provide growth hormone-deficient adults and children with therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current growth hormone regimens.  Results from a successful Phase I trial showed that hGH-CTP met all safety and tolerability endpoints and could potentially be effective when injected just twice per month.  

The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone.  PROLOR expects to complete the Phase II trial in 2011.

FDA's Orphan Drug Act of 1983 was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect 200,000 persons or less in the U.S.  The orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, certain tax credits and additional regulatory support for R&D initiatives.

ABOUT PROLOR BIOTECH

PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, 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, and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides.  For more information on PROLOR, 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" 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.

GendeLLindheim BioCom Partners

Tel: +1 866 644-7811

+1 212 918-4650

Email: [email protected]





SOURCE PROLOR Biotech, Inc.

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