Nes-Ziona, Israel – August 10, 2011 – PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that the Israeli Office of the Chief Scientist (OCS) has approved a 2011 grant to PROLOR’s Israeli-based R&D subsidiary for the company’s development program for hGH-CTP, its long-acting version of human growth hormone (hGH).
The OCS approved a grant of $1.7 million to support PROLOR’s hGH-CTP program for 2011.
hGH-CTP is PROLOR’s proprietary biobetter version of human growth hormone. Human growth hormone is used for the long-term treatment of children and adults with growth hormone deficiency due to inadequate secretion of endogenous growth hormone. It is also sometimes used to counter involuntary weight loss and certain physical manifestations of aging. Currently available forms of hGH must be injected daily. Global sales of hGH products are estimated at about $3 billion annually.
PROLOR recently reported positive results from a Phase II study of hGH-CTP in adults with growth hormone deficiency. The study showed that hGH-CTP has the potential to reduce the required hGH dosing frequency from the one injection per day required currently to a single weekly injection. The company is planning to initiate a Phase III trial of hGH-CTP in adults with growth hormone deficiency in 2012.
“This generous $1.7 million grant is an important non-dilutive cash resource for our hGH-CTP development program,” said Abraham Havron, Ph.D., Chief Executive Officer of PROLOR.
Under the terms of the grant, PROLOR is required to repay the OCS the sum of the grant plus accrued interest through a series of payments that would begin only when hGH-CTP or other products that PROLOR develops with its CTP technology begin to generate commercial revenues.
PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its 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, and PROLOR is currently developing long-acting versions of human growth hormone, which is completing Phase II clinical development, as well as Factor VII, Factor IX, interferon beta, erythropoietin, an anti-obesity peptide and agents for atherosclerosis and rheumatoid arthritis, which are all 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.
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