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May 20, 2014
08:14 EDTRLYPRelypsa announces commercial manufacturing agreement with DSM Fine Chemicals
Relypsa 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 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. In addition to DSM Fine Chemicals, the company also has an agreement with Lanxess Corporation 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.
News For RLYP From The Last 14 Days
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January 26, 2016
08:31 EDTRLYPRelypsa Veltassa black box warning could be lifted, says Oppenheimer
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January 25, 2016
19:28 EDTRLYPOn The Fly: After Hours Movers
UP AFTER EARNINGS: Swift Transportation (SWFT), up 5.4%... Sanmina (SANM), up 4.6%... Rambus (RMBS), up 6.6%. ALSO HIGHER: Aratana Therapeutics (PETX), up 12.9% after filing a New Animal Drug Application with the FDA... Relypsa (RLYP), up 16.5% after announcing results from Veltassa drug-drug interaction studies. LOWER: Centene (CNC), down 1.9% after announcing an internal search for six hard drives that are unaccounted for.
16:11 EDTRLYPRelypsa announces results from Veltassa drug-drug interaction studies
Relypsa announced results from 12 Phase 1 studies in healthy volunteers evaluating potential drug-drug interactions between Veltassa for oral suspension and 12 drugs that had previously demonstrated binding in in vitro tests. When Veltassa was administered at the same time as the drugs being tested, there was no clinically meaningful reduction in absorption for nine of the 12 drugs. Three drugs showed reduced absorption when they were co-administered with Veltassa, however, when dosing of Veltassa and these drugs was separated by three hours, no reduction in absorption was observed. Relypsa reports results from Phase 1 in vivo studies in healthy volunteers evaluating potential drug-drug interactions between Veltassa and 12 drugs administered either at the same time or three hours apart. The 12 drugs were selected based on results of previously announced in vitro tests, in which Veltassa had demonstrated binding with 14 of 28 drugs tested; 12 of these 14 were considered relevant for further testing to assess whether the in vitro results translated into an effect in people. Results of the Phase 1 studies showed nine of the 12 drugs tested showed no clinically meaningful reduction in absorption when administered at the same time as Veltassa. No reduction in absorption was observed for any of the 12 drugs tested with a three-hour dosing separation from Veltassa.

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