Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) has obtained formal Good Manufacturing Practice (GMP) certification for its hGH-CTP human growth hormone. GMP certification is required by EU clinical trials legislation as a precondition for conducting clinical trials in EU member countries.
Prolor's share price jumped 7% on the TASE by mid-afternoon, before ending the day up 5.6% to NIS 28.38, in heavy trading, bucking the market. The share rose 1.5% at the opening on the American Stock Exchange today to $7.27, giving a market cap of $330 million.
hGH-CTP is a proprietary biobetter therapeutic protein for the long-term treatment of children and adults with growth hormone deficiency due to inadequate secretion of endogenous growth hormone. The drug can be injected weekly or monthly, compared with the daily injections needed for current products. The company estimates global sales of growth hormone products at $3 billion a year.
Prolor CEO Dr. Abraham Havron said, "EU GMP certification is a rigorous process that we are delighted to have completed successfully. 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."
Published by Globes [online], Israel business news - www.globes-online.com - on June 29, 2010
© Copyright of Globes Publisher Itonut (1983) Ltd. 2010