On the surface, it seems that Ironwood Pharmaceuticals is doing great, as the net sales generated from its linaclotide on the U.S. market amounted to $112.1 million in the second quarter, marking a 79% increase year-over-year. However, the company’s sales are expected to be struck by Synergy Pharmaceuticals (NASDAQ:SGYP)’s competing drug that continues to do extremely well in its clinical trials. Just recently, Synergy reported positive data for its plecanatide in a Phase III study of 1,346 patients with chronic idiopathic constipation (CIC). The results of the study have shown similar top-line efficacy to the results seen in Ironwood’s linaclotide. Moreover, tolerability data seems to indicate that plecanatide outperforms Ironwood’s product. Synergy Pharmaceuticals is anticipated to announce the results for a second Phase III CIC trial during the third quarter, and intends to file a New Drug Application (NDA) for plecanatide by the end of this year, which means that the product could be brought to the market by the end of next year. Ultimately, it is highly probable that Ironwood’s market share will suffer substantially should Synergy’s plecanatide get FDA approval next year.
Nevertheless, Ironwood’s competitive advantage lies in the fact that its product has started commercializing well ahead of Synergy’s product. Ironwood Pharmaceutical has revealed that more than 510,000 linaclotide prescriptions were filled in the second quarter, up by 56% year-over-year. Even more to that, the company intends to file for China Food and Drug Administration (CFDA) approval to market lenaclotide there at the beginning of 2016, after top-line data has demonstrated that the product met all primary and secondary endpoints in a Phase III clinical trial of adults with irritable bowel syndrome with constipation (IBS-C) conducted in China. Therefore, linaclotide might be the first-of-its-kind prescription in China for adults with IBS-C, which will surely unlock a very prosperous revenue stream for the company.