Calliditas, STADA Ink Budesonide Commercialization Pact In Europe, UK For Immunoglobulin A Nephropathy

  • Calliditas Therapeutics AB CALT and STADA Arzneimittel AG STDAF have announced a license agreement to register and commercialize Nefecon (budesonide), a chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) candidate, in the European Economic Area, Switzerland, and the U.K.
  • Under the terms of the agreement, Calliditas will receive an initial upfront payment of €20 million ($24 million) and up to an additional €77.5 million ($91 million) in milestone payments.
  • STADA will also pay tiered royalties on net sales expressed as percentages between the low twenties and the low thirties.
  • In May, Calliditas submitted a marketing application to the European Medicines Agency for the oral formulation of budesonide.
  • The commercial brand name for this therapy in Europe will be determined and disclosed at a later date.
  • In the U.S., Nefecon is under FDA review.
  • If approved, the product could be available to patients in Europe in the first half of 2022. It would become the first therapy specifically designed and approved for the treatment of IgAN, which can potentially be disease-modifying.
  • Price Action: CALT shares closed at $29.50 on Tuesday.
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