Tuesday, October 23, 2012

AstraZeneca collaborates with Ironwood Pharmaceuticals to codevelop and co-commercialize Ironwood's Linaclotide in China

AstraZeneca and Ironwood Pharmaceuticals, Inc. announced today an agreement to co-develop and co-commercialise Ironwood's linaclotide in China. Linaclotide is the first and only guanylate cyclase-C (GC-C) agonist approved by the US Food and Drug Administration, in August, for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

Linaclotide will be launched in the US under the brand name linzess by Ironwood in partnership with Forest labs. Almirall is the European partner for Ironwood and Linaclotide would be sold under the brand name Constella. CHMP has issued a positive recommendation


Terms of the deal 
Under the terms of the collaboration, AstraZeneca will make an upfront payment of $25 million to Ironwood and will share the net profits and losses associated with linaclotide in China, with AstraZeneca carrying 55 percent of each until a certain specified milestone is achieved, moving to a 50/50 split thereafter. Ironwood will also be eligible for $125 million in additional commercial milestone payments contingent on the achievement of certain sales targetsBased on our proprietory analysis of inlicensing deals, it seems that linaclotide could gross upto $300m in peak sales in China

Linaclotide Potential. : A very clean safety profile is a differentiating factor for Linaclotide. It is a peptide analog of an endogenous human hormone known to control fluid secretion in the small intestine. As such, it works through a localized mechanism and is not systemically absorbed, making it extremely safe.  In four Phase 3 trials in chronic constipation and IBS-C, linaclotide provided substantial relief over a three-month period. The agent was very well-tolerated, with no serious adverse events noted. Thus, linaclotide appears well-positioned to take advantage of the substantial unmet need in the GI market.

The current market for chronic constipation (CC) and constipation-predominant irritable bowel syndrome (IBS-C) is large and approximately 8mm individuals in the U.S. alone seek treatment for constipation-related disorders every year. Existing therapies are either only palliative or marginally effective, with substantial side effect risk. We believe this creates a compelling opportunity for firms like Ironwood, since linaclotide is based on a naturally-occurring hormone called uroguanylin and utilizes an evolutionarily-derived mechanism of action.