AstraZeneca (AZ) and Ironwood Pharmaceuticals say they are on course to submit irritable bowel syndrome treatment linaclotide for approval in China in early 2016.
A phase III trial of linaclotide in IBS with constipation (IBS-C) – conducted in China – showed that the drug improved symptoms such as abdominal pain and discomfort, bloating and straining whilst also improving the frequency of bowel movements compared to placebo.
Linaclotide is a guanylate cyclase‐C agonist that is already sold in the US as Linzess for IBS-C and chronic idiopathic constipation (CIC) by Ironwood and Allergan and is growing quickly with prescription growth said to be up 65% last year on the back of a direct-to-consumer (DTC) advertising campaign. In the first quarter of the year sales approached $100m.
AZ licensed rights to the drug in China in 2012 in a $150m deal that ties in with the company’s bid to expand its business in emerging markets, one of six growth platforms intended to drive annual sales to $45bn by 2023.
If approved by the China Food and Drug Administration (CFDA) linaclotide would be the first prescription drug specifically approved for IBS-C in the country, said Leon Wang, president of AZ’s China and Hong Kong operations. There are around thirteen million people in China with IBS-C, he added.
Any profit or loss related to linaclotide’s sales in China will be split 55-45 in favour of AZ until certain commercial milestones are reached, after which the split will be 50-50.
Ironwood notes linaclotide is also being developed in a new lower, once-daily dose due for filing in the US later this year and as a colonic-release formulation, as well as in mid-stage trials for opioid-related constipation. The drug is also partnered with Astellas in Japan, where it is in phase III trials in IBS-C and phase II in CIC.
AZ offloads Entocort
While AZ is expanding its GI portfolio in Asia, it has also slimmed down in other areas, selling off its inflammatory bowel disease (IBD) product Entocort (budesonide) to Tillots Pharma – part of the Japanese Zeria group, for $215m. The deal only includes rights to the drug outside the US.
Entocort is sold in capsule and enema formulations and is marketed for ulcerative colitis and Crohn’s disease in more than 40 countries worldwide, with ex-US sales of $53m last year. The brand will be sold alongside Tillot’s IBD drug Asacol (mesalamine).