Femta Pharmaceuticals, Lonza Group collaborate in cGMP production of FM101 antibody

Dec 15 2009

Femta Pharmaceuticals and Lonza Group Ltd jointly announce the execution of a manufacturing services agreement to facilitate the development and cGMP manufacturing of FM101. FM101 is a high affinity monoclonal antibody in late pre-clinical development for the treatment of Rheumatoid Arthritis. The agreement allows Femta access to Lonza’s GS Gene Expression System™ (GS: glutamine synthetase) along with cell line, purification and process development to support a robust cGMP process for Femta’s clinical development program.

“We have chosen to work with Lonza for the cGMP production of FM101 our lead high affinity humanized anti IL (interleukin) 6 monoclonal development candidate as they are considered the leader in the expression and manufacture of monoclonal antibodies. FM101 is a femto molar binding antibody that we are developing for subcutaneous delivery in patients with autoimmune and inflammatory diseases. To facilitate our clinical program, we have begun our manufacturing development. We plan to submit an IND (investigational new drug application) and initiate a Phase I clinical trial in 2010. By leveraging Lonza’s considerable expertise in gene expression and antibody manufacturing, FM101 will have the additional benefit of speed, and yield optimization to further enhance the economies of scale for our antibody,” said Stephen Keane, President and COO, Femta Pharmaceuticals.

“We are pleased to be working with Femta Pharmaceuticals and to be supporting the development of this promising new compound for the clinical program,” added Stephan Kutzer, COO Lonza Custom Manufacturing. “Having Femta Pharmaceuticals selecting the GS Gene Expression System™ underlines the leading position of the system which is characterized by its speed and ease of use.”