EXCLUSIVE: Ironwood, AstraZeneca PLC IBS-C Drug Will File in China Next Year, CEO Tells BioSpace

EXCLUSIVE: Ironwood, AstraZeneca PLC IBS-C Drug Will File in China Next Year, CEO Tells BioSpace
July 9, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Ironwood and AstraZeneca’s Phase III linaclotide trial, conducted primarily in China, met all primary and secondary endpoints in adults with irritable bowel syndrome with constipation (IBS-C)—news that will push the companies to file in early 2016 for China Food and Drug Administration (CFDA) approval, Ironwood’s CSO told BioSpace Thursday.

BioSpace interviewed Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood Pharmaceuticals, about what the companies’ timeline for the drug looks like in 2015.

1. Can you explain in layman’s terms how linaclotide works?

Linaclotide is a guanylate cyclase-C (GC-C) agonist. In essence, GC-C is a receptor found mainly on the surface of the intestine that is recognized to be a potential therapeutic target in certain gastrointestinal diseases. Linaclotide has been shown in nonclinical studies to bind to and activate GC-C receptors. Activation of GC-C receptors results in increased intestinal fluid secretion and accelerated transit as well as a decrease in the activity of pain-sensing nerves in the intestine.

Linaclotide is the first and only GC-C agonist approved in the U.S., establishing GC-C agonists as a new class of medicines. It is currently marketed by Ironwood and Actavis in the U.S. as LINZESS® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), with nearly 700,000 unique patients in the U.S. having filled more than 2.7 million linaclotide prescriptions since launch, according to IMS Health. Linaclotide is also marketed for adults with IBS-C in several other countries.

2. How did you choose the patients for this study?

The double-blind, randomized, placebo-controlled Phase III clinical trial included 839 adults with IBS-C in China, Australia, Canada, New Zealand and the United States. Patients were selected according to specific inclusion and exclusion criteria.

3. What does this data mean for the standard of care for IBS-C?

If approved by the CFDA, linaclotide would be the first prescription treatment in China specifically for both men and women with IBS-C, which is estimated to affect at least 13 million adults in China.

4. What does this mean for trials going forward? Will you be speeding up late-stage trials?

The regulatory pathway that we are pursuing in China requires only one international multi-center Phase III confirmatory trial that is conducted in at least two countries in addition to China. Since we have now completed this trial, the next step is to file for CFDA approval to market linaclotide in China. We expect to file for approval in early 2016.

5. How about regulatory framework? Will you be asking for a fast track or breakthrough status?

We will be filing for an Import Drug License (IDL) in China. An import drug is one that is approved, manufactured and marketed in a foreign country, for which an application is filed for registration and sale in China.

As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.

The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.

The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.

But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.

That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?

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