Relypsa Announces Commercial Manufacturing Agreement With DSM Fine Chemicals
News May 23, 2014
Relypsa, Inc. has announced that it has entered into a multi-year commercial manufacturing and supply agreement with DSM Fine Chemicals Austria NFG GMBH & Co. KG for the active pharmaceutical ingredient ("API") for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. DSM Fine Chemicals is a business unit of the newly formed DPx Holding B.V. which also owns Patheon Pharma Services and Banner Life Sciences.
"We are very pleased to add DSM Fine Chemicals, a well-established contract manufacturer with significant experience in efficiently manufacturing polymers for therapeutic use, as a supplier of API for patiromer," said Wilhelm Stahl, Ph.D., senior vice president pharmaceutical operations at Relypsa. "Engaging another supplier is an important milestone towards preparing to cover our projected commercial demand and improving our security of supplies."
In addition to DSM Fine Chemicals, the company also has an agreement with Lanxess Corporation, also a well-respected contract manufacturer, for the supply of API. Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during the company's clinical development program.
Relypsa expects Lanxess will be the initial sole manufacturer named in its planned New Drug Application, or NDA. The company plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional manufacturer upon potential U.S. approval of patiromer.
PhoreMost and Plexxikon Collaborate to Identify Novel Drug TargetsNews
PhoreMost, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, today announced it has signed a collaborative agreement with Plexxikon Inc., the small molecule structure-guided R&D centre of Daiichi Sankyo.READ MORE
Lonza Opens World’s Largest Dedicated Cell-and-Gene-Therapy Manufacturing Facility in TexasNews
First-of-its-kind, state-of-the-art manufacturing facility with capacity to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases.READ MORE
IONTAS and IGEM Therapeutics Collaborate to Identify Novel IgE AntibodiesNews
The project will add to IGEM’s pipeline of drugs and expand upon IGEM-F, an IgE targeting ovarian and other cancers, currently in a Phase 1/2a study.READ MORE