With Calliditas Therapeutics' drug formulation, designed to unlock a new use case for the common corticosteroid budesonide, under review in the E.U. and U.S., Stada has struck a deal to bring it to market in certain regions.
Budesonide, the corticosteroid found in products including Pulmicort, is already administered in a wide range of dosage forms including oral capsules to treat conditions such as asthma and Crohn’s disease. Calliditas spied an opportunity to use its drug delivery technology to develop a formulation for use in the chronic autoimmune kidney disease IgA nephropathy patients.
Stada's deal covers the E.U. and certain neighboring countries including Switzerland and the U.K. The company is paying €20 million ($24 million) upfront and committing up to €77.5 million in milestones tied to regulatory and commercial events. Calliditas is also in line to receive tiered royalties on net sales “expressed as a percentage between the low twenties and the low thirties.”
In return, Stada has secured rights to the oral formulation designed to get a high concentration of budesonide to target cells while limiting systemic exposure. The capsules are designed to stay intact until they encounter the pH found in the ileum, the part of the small intestine where most of Peyer’s patches are found. Calliditas is targeting the patches because of links between mucosal inflammation and the kidneys that suggest getting budesonide to the lower small intestine may treat IgA nephropathy.
Calliditas' oral formulation uses a two-step technology to delay absorption of the active ingredient until the lower small intestine. The company linked the formulation to improvements in the urine protein-creatinine ratio compared to placebo in a phase 3 clinical trial, giving it the data to file for approval. If the drug is approved in the E.U. in the first half of next year, Stada will apply its marketing and sales capabilities to the product.
As the capsule dissolves, it releases beads of budesonide that have three layers of coating for sustained release. Releasing the budesonide beads in the ileum is designed to both increase the amount of drug that reaches the target cells and limit the amount that enters systemic circulation to minimize side effects.