Relypsa selects DSM to manufacture API for hyperkalemia treatment
This is one of the first contracts DSM has won since merging with Patheon in deal worth $2.65bn. Analysts said that deal created the world’s second largest CMO as Catalent remains the largest.
“They’ve been around the industry for many years and they’re one of the key players,” Wilhelm Stahl, SVP of pharmaceutical operations at Relypsa, told Outsourcing-Pharma.com. “We’ve been working with DSM for a number of years so it’s a logical step to secure commercial supplies.”
In addition to DSM, Relypsa also has an agreement with Lanxess to supply API for patiromer. Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during the company's clinical development program.
Relypsa said that it expects Lanxess will be the initial sole manufacturer named in its planned New Drug Application, or NDA.
Stahl told us that they’re bringing in DSM to ensure the security of their supply.
The company plans to submit a NDA supplement seeking approval for DSM as an additional manufacturer upon potential US approval of patiromer.
“The general timeline is that we want to file an NDA by Q3 of this year, which means we might be able to launch as early as the end of 2015,” Stahl told us.
Patiromer is a high capacity non-absorbed, non-metal oral potassium binder being developed for the treatment of hyperkalemia. The compound has been evaluated in CKD patients with hyperkalemia, including a two part Phase 3 trial, a 12-month Phase 2 trial and a 48-hour short-term Phase 1 onset-of-action trial. In all of those trials, patiromer met its efficacy endpoints and the treatment was well tolerated.