AstraZeneca (AZ) has signed a deal worth up to $150m with Ironwood Pharmaceuticals to develop and commercialise its irritable bowel syndrome (IBS) drug linaclotide in China.
The drug was approved as the first product of its kind in the US in August this year, where it is marketed by Ironwood and Forest Laboratories under the brand name Linzess for both IBS and chronic idiopathic constipation (CIC), and this latest deal marks an attempt to break into the emerging Chinese healthcare market.
“China is one of the fastest growing prescription medicines markets in the world and linaclotide represents a valuable opportunity to meet the needs of local patients by providing an innovative new treatment option,” said Mark Mallon, regional VP for Asia Pacific and president, AstraZeneca China.
The deal comprises an upfront payment of $25m from AZ to the drug's original developers Ironwood, as well as an additional $125m available in milestone payments.
Any profit or loss related to linaclotide's sales in China will be split 55-45 in favour of AZ until a certain milestone is reached, after which, the split will be 50-50.
AZ will also benefit from the use of Ironwood's US sales force to promote its drug Nexium (esomeprazole magnesium) for use in of gastroesophageal reflux disease (GERD) as part of the agreement.
Ironwood has 160 clinical sales specialists who will add to AZ's efforts to promote the drug to physicians throughout the US, with the companies looking to capitalise on the relationship between bowel conditions and GERD - a chronic condition in which stomach acid backs up into the oesophagus, leading to such symptoms as heartburn, nausea and pain with swallowing.
“A large percentage of adult patients who have IBS-C or who have CIC, may also suffer from GERD,” said Thomas McCourt, chief commercial officer, senior VP, marketing and sales, Ironwood Pharmaceuticals.
“This agreement provides our experienced clinical sales specialists with the opportunity to bring two different and effective therapies to physicians for managing their patients who have these prevalent and troublesome gastrointestinal disorders.”
Ironwood has a separate agreement in place with Almirall to market linaclotide in Europe under the brand name Constella, which the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended for approval last month as a treatment for adult IBS patients with constipation.