TAP Files NDA For Prevacid Follow-On To Treat GERD-Related Illnesses
This article was originally published in The Pink Sheet Daily
Executive Summary
Secret of novel delivery system, trial data for TAK-390MR will be revealed at Digestive Disease Week conference in May, TAP VP-Gastrointestinal Marketing Rudolphi tells “The Pink Sheet” DAILY.”
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TAP Pharmaceuticals filed an NDA for its investigational TAK-390MR compound Dec. 28, seeking an indication for acid-related diseases and the treatment and maintenance of patients suffering from gastro esophageal reflux disease. The NDA, filed in a fully electronic format, will proceed under a 10-month review, and TAP anticipates a fourth-quarter 2008 launch for the drug, the company said. The compound, a follow-on to Prevacid (lansoprazole), should position TAP to retain its gastrointestinal market position for years to come, Tim Rudolphi, TAP's VP of gastrointestinal marketing, told "The Pink Sheet" DAILY." The sales force for the drug already is in place, he added. "We're already structured for this marketplace; we're very confident where we stand," Rudolphi said. "We've got the strong relationships not only with the thought leaders in the GI space, all the way to the primary care physicians who treat the majority of the [gastroesophageal reflux]/acid-related disorders." Although the company, a U.S. joint venture of Abbott Park, Ill.-based Abbott Laboratories and Takeda Pharmaceutical, in Osaka, Japan, announced the filing Jan. 3, it will not be revealing any data from pivotal Phase III trials or details about what it calls a novel delivery system for the proton pump inhibitor until the Digestive Disease Week conference, May 17-22 in San Diego. "We're absolutely excited about that unique delivery system," Rudolphi said. "We think it's absolutely critical in this marketplace and really brings a tremendous amount of advantage to the compound." Rudolphi predicted the delivery system for the once-daily capsule will bring significant benefit to patients. The compound was designed to stay "in the body longer and controls the acid suppression for a longer period of time, thus helping more patients," he explained. "What happens in patients with GERD, or erosive esophagitis as a result of GERD, is that their stomachs are producing too much acid. [Proton pump inhibitors] are designed to stop production of that acid." The only Phase III trial data TAP released notes the compound was tested globally, in more than 20 countries and on more than 6,000 patients with erosive and non-erosive GERD. TAP began the Phase III trials in 2005, anticipating a 2008 NDA filing (1 (Also see "Prevacid Follow-On NDA To Be Submitted In 2008" - Pink Sheet, 30 Aug, 2005.)). -Joseph Haas ([email protected]) |