PROLOR Biotech Receives Notice of Allowance for New U.S. Patent for Its Long-Acting Human Growth Hormone
NES-ZIONA, Israel, Oct. 3, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent application covering the company's long-acting CTP-enhanced human growth hormone (hGH-CTP). Upon issuance, the new patent would provide PROLOR with additional intellectual property protection covering methods for the induction of growth in growth hormone deficient patients.
This new patent is the fourth hGH-CTP patent that has been allowed by the USPTO. The expanding hGH-CTP patent estate is expected to provide additional protection for PROLOR's hGH-CTP compound, in addition to a number of CTP platform patents that have already issued.
"Upon issuance, this new hGH-CTP patent will be a significant addition to PROLOR's intellectual property portfolio," said Shai Novik, president of PROLOR. "We have several other CTP-related patent applications that are currently pending, and we believe that this growing patent portfolio will reinforce our existing patent estate for our CTP-enhanced compounds in development, as well as for our CTP platform technology generally."
This new U.S. patent is expected to issue in the next few months.
Previously reported data from the company's Phase II trial of hGH-CTP in growth hormone deficient adults showed that a single weekly injection has the potential to reduce the required dosing frequency of human growth hormone from the current standard of one injection per day to a single weekly injection. In this trial, hGH-CTP demonstrated a good safety and tolerability profile. A Phase II trial in growth hormone deficient children is currently enrolling patients.
About PROLOR's CTP Technology
PROLOR's CTP technology is based on the naturally-occurring human carboxyl terminal peptide (CTP). When attached to a therapeutic protein, CTP significantly extends the length of time the protein remains active in the body. Clinical and preclinical studies have shown that the CTP technology appears to be safe and effective in extending the duration of all proteins tested to date. CTP's safety and efficacy have also been validated by the marketing approval of Merck's long-acting CTP-enhanced fertility drug Elonva® (FSH-CTP). A single Elonva injection replaces a regimen of seven daily FSH injections. Results from a Phase II trial of PROLOR's CTP-modified human growth hormone (hGH-CTP) in growth hormone deficient adults show that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. CTP was identified by researchers at Washington University in St. Louis and is exclusively licensed to PROLOR for all proteins and peptides, except for four endocrine proteins that are licensed to Merck. CTP is manufactured using standard industrial biotech processes.
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.
SOURCE PROLOR Biotech, Inc.