Next generation protein-based therapeutics developer Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) has obtained small and medium sized enterprise (SME) status from the European Commission and the European Medicines Agency (EMEA). The program addresses the particular needs of small and medium size companies developing medicinal products in Europe.
Prolor's patented technology uses naturally occurring amino acid sequence (CTP) to slow the removal of therapeutic proteins from the body without increasing toxicity or altering the overall biological activity. The clinical stage company is developing longer-acting, proprietary versions of already approved therapeutic proteins, which target a $50 billion market. The company's lead product is a growth hormone.
Companies granted SME designation may seek scientific advice, protocol assistance, and other information and training from EMEA 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.
SME designation also provides companies reduced or deferred fees associated with MAAs, scientific advice, and inspections.
Prolor president Shai Novik said, "We anticipate that this designation… 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's share price rose 0.8% at the opening on the American Stock Exchange today to $7.25, giving a market cap of $388 million, after rising 2% on the TASE to NIS 26.60.
Published by Globes [online], Israel business news - www.globes-online.com - on December 20, 2010
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