EMA grants SME designation to PROLOR Biotech

Dec 20 2010

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."