RARE Daily

Ironwood Expands Pipeline with Option Agreement to Acquire Cour Pharma’s Rare Liver Disease Therapeutic

November 5, 2021

After a troubled past couple of years, stopping development of some programs and trimming R&D, Ironwood Pharmaceuticals is moving forward and expanding its pipeline by entering into a collaboration and license option agreement with Cour Pharmaceutical Development, a company developing novel immune-modifying nanoparticles to treat autoimmune diseases.

Photo: Tom McCourt, president and CEO of Ironwood

Ironwood already has a market presence in the gastrointestinal market with its approved therapy Linzess for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. With this new agreement, it is moving into rare diseases by gaining an option to acquire an exclusive license to develop and commercialize, in the Unites States, Cour’s investigational therapy CNP-104, for the treatment of primary biliary cholangitis (PBC), a rare autoimmune disease targeting the liver that affects an estimated 133,000 people in the U.S. Currently there is no cure, and medical care is focused on disease management. PBC can lead to irreversible damage and scarring of the liver tissue, ultimately requiring liver transplant.

CNP-104 is being developed utilizing Cour’s nanoparticle platform (CNP), a novel, proprietary system, which combines disease-specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying cells from the body. Cour’s platform has shown proof of technology in clinical and preclinical settings.

“Collaborating with Cour fits squarely within our business development framework and guiding principles; moving our strategy forward through expansion of our pipeline, leveraging our deep relationships with gastroenterologists and advancing innovation via highly differentiated opportunities like CNP-104,” said Tom McCourt, president and CEO of Ironwood. “COUR’s expertise in immune reprogramming and Ironwood’s development and commercial strength and reach in the GI disease area, will help introduce a potentially new therapy to patients in significant need of new options. This option agreement highlights our focus on prudently allocating capital to value enhancing opportunities while maintaining the flexibility to simultaneously execute on our other strategic priorities.”

Cour’s IND for CNP-104 was recently approved by U.S. regulators and the company expects to initiate a clinical trial in 2021 to evaluate the safety, tolerability, pharmacodynamics and efficacy of CNP-104 in PBC patients. After reviewing the data from this study, Ironwood has the right to exercise the option.

Under the terms of the agreement, Ironwood will pay Cour approximately $20 million in upfront and near-term payments associated with the initial study. After reviewing the data from the study, if Ironwood exercises its option, Cour will be eligible to receive royalties in the high single digits to low double digits percentage of the aggregated annual net sales in the U.S. of products containing CNP-104, and additional payments of up to $475 million, inclusive of an option exercise payment and commercial milestones over the term of the agreement.

“Ironwood’s success in commercializing and growing Linzess and their deep relationships within the GI community make them an ideal partner for Cour as it relates to PBC,” said John Puisis, CEO of Cour. “This agreement will help expand COUR’s autoimmunity portfolio and further enhance Cour’s reach in immune mediated diseases.

Author: Rare Daily Staff

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