AstraZeneca, Ironwood announce linaclotide collaboration for China

Friday, October 26, 2012 02:20 PM

AstraZeneca, a global biopharmaceutical company, and Ironwood Pharmaceuticals, a Cambridge, Mass.-based entrepreneurial pharmaceutical company, have signed an agreement to co-develop and co-commercialize Ironwood’s linaclotide in China.

Linaclotide is the first and only guanylate cyclase-C (GC-C) agonist approved by the FDA, in August 2012, for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

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% 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 targets.

AstraZeneca and Ironwood are jointly responsible for strategic oversight of the development and commercialization of linaclotide in China. AstraZeneca will have primary responsibility for the local operational execution.

In addition, the companies also agreed that Ironwood’s sales force of approximately 160 experienced clinical sales specialists will promote AstraZeneca’s Nexium (esomeprazole magnesium) in the U.S. This agreement will provide Ironwood with an opportunity to increase its presence with the key gastrointestinal physicians in the U.S.

“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 vice-president, 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.”

In May 2012, Ironwood filed a clinical trial application with the State FDA in China for a phase III clinical trial to assess the efficacy and safety of linaclotide in adult patients suffering from irritable bowel syndrome with constipation (IBS-C).

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs