FDA approves GroPep-based biopharma product

A biopharmaceutical product that uses GroPep's (ASX:GRO) cell culture products in its manufacturing process has received US Food and Drug Administration (FDA) regulatory approval.

Approval is also expected, in 2006, for an application to market the product in the European Union.

GroPep said it was the seventh time a biopharmaceutical product containing its product had received regulatory approval, but that it could not name the specific product or company.

"Confidentiality agreements that span through the supply chain restrict us," said GroPep CFO Tony Mitchell. "I think it's just the nature of the pharmaceutical industry being very secretive about the processes of manufacture and the raw materials being used in the manufacture of their products."

Mitchell said there were a number of products in mid to late clinical trials that were using GroPep's growth factors. "Some products are already approved and on market but they're also still in clinical trials for other indications," he said.

Mitchell said approved products using GroPep cell culture products included those for indications such as ankylosing spondylitis, juvenile rheumatoid arthritis, adult rheumatoid arthritis, psoriatic arthritis and psoriasis. Two products have also been approved as diagnostic imaging agents for the disease MPS-I and MPS-VI as well as a skin substitute product.

Products currently in clinical trials using GroPep's products are being tested for indications such as colon rectal cancer, lung cancer, renal cancer, Crohn's disease, juvenile ideopathic arthritis, multiple myeloma, osteoporosis and another product for rheumatoid arthritis.