Ironwood Retreats from the US Gout Market Save

Ironwood Pharmaceuticals discontinued the marketing and sales of both lesinurad (Zurampic) the combination drug of lesinurad and allopurinol (Duzallo) in the United States effective February 1, 2019. In addition the Duzallo and Zurampic Patient Savings Program were also discontinued on December 31, 2018.

The company stated that this was a financial decision unrelated to the efficacy or safety of lesinurad.

Ironwood is a 20-year-old pharmaceutical company, based out of Cambridge, MA, that is mainly known for developing linoclotide and other gastrointestinal intended therapies for irritable bowel syndrome with constipation and chronic constipation. The company started with the name  Microbia and later changed to Ironwood with new investors in 2008.

Ironwood had three FDA approved drugs: linaclotide (Linzess), for irritable bowel syndrome and constipation; and two gout drugs, lesinurad (Zurampic) and Duzallo. They acquired lesinurad from AstraZeneca in 2016.

Lesinurad was FDA approved in December 2015 and soon after by the EMA in February 2016.   But this came with safety concerns as hit had a boxed warning for renal failure, and the FDA required a postmarketing safety study.

AstraZeneca licensed lesinurad to Ironwood in 2016, but the agent as monotherapy (or co-therapy) never met marketing projections. Beyond the concerns over renal effects, several reports suggested the drug may not be effective as monotherapy. Even in combination (Duzallo) and FDA and EMA approval, there was low market uptake.  NICE in the UK denied the use of lesinurad in patients with hyperuricemia and gout.  

Between January and July 2018, Ironwoods research on lesinurads future potential in in select test markets failed to meet revenue expectations and Ironwood terminated its U.S. lesinurad license agreement with AstraZeneca.  This decision was projected to save Ironwood expects $75 to $100 million in 2019.

2018 sales revenues for lesinurad were north of $1.1 million. Ironwood obtained the US rights to AstraZeneca for $265 million - $100 million up front and up to $165 million more in milestones and royalties. AstraZeneca had acquired lesinurad (in development) in 2013 from Ardea Biosciences for $1.26 billion.

In the last quarter of 2018, Ironwood cut back its workforce by approximately 125 (mostly field-based sales) employees.  (Ironwood had previously reduced its workforce in January 2018 by approximately 60 field-based sales representatives.) 

On the company’s website they say, “If you have been taking either DUZALLO or ZURAMPIC to treat your condition, please consult with your healthcare professional before making any decisions to stop treatment. Please work with your healthcare professional for an alternate treatment for your condition.” And for any questions, please contact Ironwood via the Contact Us Webform (https://contactus.irwdpi.com/) or call the Ironwood Contact Center at 1-844-374-4793.