PROLOR Biotech receives EU GMP certification for hGH-CTP biobetter version of human growth hormone

Jun 29 2010

PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received formal Good Manufacturing Practice (GMP) certification for hGH-CTP, the company's proprietary biobetter version of human growth hormone.  GMP certification is required by the European Union (EU) clinical trials legislation as a precondition for conducting clinical trials in EU member countries.

Article 13 of 2001/20/EC of the EU clinical trials legislation was established to ensure, prior to the initiation of a clinical trial study in any EU member country, that the drug product to be used in such clinical trial study has been manufactured in accordance with EU GMP regulations and meets the conditions of the clinical trial authorization and the product specification file.  PROLOR's facilities for working with hGH-CTP, as well as those of the contract manufacturing organizations for the drug substance and drug product, were inspected and audited as part of the assessment process.

"EU GMP certification is a rigorous process that we are delighted to have completed successfully," said Abraham Havron, Ph.D., CEO of PROLOR.  "Preparation for the manufacturing audit process and the audit itself were a top priority for the company and a critical milestone for the first half of 2010.  This certification allows PROLOR to move forward with our hGH-CTP Phase II clinical trial, which we expect to initiate later this summer."