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China approves Ironwood Pharma’s IBS treatment

Coincides with AZ's Mark Mallon taking over as CEO

Ironwood Pharmaceuticals’ irritable bowel syndrome treatment Linzess has gained approval in China, opening up a market of up to 14m adults with the condition.

The good news coincides with big changes at the US specialist pharma company, with a new CEO, AstraZeneca's Mark Mallon, and a splitting out into two separate companies.

The company to be named Ironwood will retain its three marketed gastrointestinal therapies (including Linzess), while the other company will be called Cyclerion (R&D Co) and will be led by Peter Hecht, the founder and current CEO of Ironwood. Cyclerion will focus on five promising candidates in the soluble guanylate cyclase (sGC) class, targeting serious and orphan diseases.

Linzess is central to the future of Ironwood. The drug first reached the US market in 2012, where it is forecast to reach 2018 full year sales of around $750m, and is also approved in more than 30 other countries.

Approval by China’s NMPA for adults with irritable bowel syndrome with constipation (IBS-C) opens up the country's huge market to the treatment.

The product has been jointly developed by AstraZeneca and Ironwood, and is expected to be launched in China in the second half of 2019, with AstraZeneca 'primarily responsible' on commercialisation across the vast country.

Tom McCourt, Ironwood's new president said: “Regulatory approval in China represents another important step in bringing linaclotide to millions of adult patients suffering from IBS-C in many countries around the world.

“This approval is incredibly important as it brings a new option to treat some of the bothersome recurring abdominal and constipation symptoms associated with IBS-C.”

Linzess

Mark Mallon is a good fit as Ironwood's new CEO, having worked extensively with Ironwood in his role as global marketing leader at AstraZeneca, and before that having led the big pharma company's expansion in China.

Mark Mallon

Mark Mallon, CEO, Ironwood Pharmaceuticals and Cyclerion

Ironwood and Allergan (its US marketing partner) have also just secured a vital Linzess patent settlement with generic challenger Mylan. This grants US market exclusivity for the firms until 2030, when Mylan will launch its cut-price version of the drug.

Article by
Gemma Jones

16th January 2019

From: Regulatory

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