Alfasigma acquisition of Zelnorm : Alfasigma USA, a subsidiary of Italian pharmaceutical company Alfasigma, has acquired IBS-C drug Zelnorm (tegaserod), a prescription treatment for irritable bowel syndrome with constipation (IBS-C), from Sloan Pharma, a subsidiary of US WorldMeds, for an undisclosed price.
Alfasigma intends to relaunch Zelnorm in the US. The IBS-C drug, which was approved originally in 2002, was withdrawn voluntarily from the market in 2007 because of concerns about possible cardiovascular risk. However, Zelnorm has remained available in the US via an expanded access program authorized by the FDA.
Earlier this year, Zelnorm was approved by the US regulator for reintroduction for use in adult women, aged over 65 years with IBS-C. The approval to relaunch Zelnorm was granted following a safety review by the regulator and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC).
The evaluation of the IBS-C drug was made up of a review of the clinical data gathered from 29 placebo-controlled clinical trials and post-marketing treatment outcomes data.
Commenting on Alfasigma acquisition of Zelnorm, and the relaunch of the IBS-C drug, Bryan Downey – President and CEO at Alfasigma USA, said: “We are excited by the opportunity to make Zelnorm once again available to healthcare providers to treat adult women in the US suffering from IBS-C.
“There is a substantial unmet need for IBS-C therapies with reliable efficacy, comparable safety, and that help address the debilitating pain and bloating associated with the disease. We look forward to making this effective IBS-C treatment available to the patients who may benefit the most.”
Zelnorm is a selective serotonin-4 (5-HT4) receptor agonist. The IBS-C drug works by targeting the 5-HT4 receptor at various neurons (sensory, motor, secretory motor) and smooth muscle cells in the gastrointestinal tract to trigger contraction and relaxation, and reduce pain signaling.
Hans van Zoonen – Manager of the Switzerland Branch of Sloan Pharma, commenting on Alfasigma acquisition of Zelnorm, said: “We believed in the value of Zelnorm and invested a tremendous amount of time and effort to receive FDA approval for reintroduction and support for the revised indication in March, 2019. The commercial capabilities of Alfasigma USA make it the right organization to reintroduce Zelnorm to the US market.”
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