PROLOR Biotech Granted SME Designation by the European Medicines Agency

Dec 20, 2010, 07:30 ET from PROLOR Biotech, Inc.

NES-ZIONA, Israel, Dec. 20, 2010 /PRNewswire/ -- PROLOR Biotech, Inc., (NYSE Amex: PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that the European Commission and the European Medicines Agency (EMA) has granted PROLOR the designation of "Small and Medium Sized Enterprise" (SME).

The SME program is an initiative by the EMA to address the particular needs of small and medium size companies developing medicinal products in Europe. Companies that are granted SME designation are able to seek scientific advice, protocol assistance, and other information and training from dedicated EMA personnel during the drug candidate clinical development process, up through submission of a European marketing authorization application (MAA).  SME-designated companies can discuss such topics as clinical primary endpoints, clinical trial statistics and drug comparators with the EMA early in the clinical development process, with the goal of avoiding clinical delays and increasing the speed and ultimate success of the regulatory approval process.

In addition, SME designation provides companies reduced or deferred fees associated with MAAs, scientific advice and inspections.

"We are very pleased to have received the SME designation for PROLOR," noted Shai Novik, President of PROLOR.  "We anticipate that this designation, which is available only to small and medium-sized companies, will have a number of potential benefits for development of our drug candidates in Europe.  Most importantly, we expect that it will enable us to work closely with European regulators to jointly design our clinical programs as we move forward with our drug candidates. This assistance has the potential to help PROLOR accelerate the regulatory process for gaining marketing approval of our compounds in Europe, saving time and significant clinical development costs while also enhancing our chances for success."


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 in Phase II clinical development, and factor VII, factor IX, interferon beta and erythropoietin, which are in preclinical development, as well as an anti-obesity peptide and agents for atherosclerosis and rheumatoid arthritis.  For more information, visit

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.



Shai Novik, President

Barbara Lindheim

PROLOR Biotech, Inc.

GendeLLindheim BioCom Partners

Tel: +1 866 644-7811

+1 212 918-4650