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-
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.
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.