Calliditas Receives Approval Orphan Drug Exclusivity of 7 Years for Nefecon

Calliditas Receives Approval Orphan Drug Exclusivity of 7 Years for Nefecon

By, Admin 14 March 2024

Everest Medicines’ partner Calliditas receives US FDA orphan drug exclusivity period of seven years for Nefecon

Observation

Everest Medicines, a biopharmaceutical company, announced that its licensing partner Calliditas Therapeutics AB (Calliditas) received US FDA orphan drug exclusivity period of seven years for Nefecon, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.

Exclusivity Period Indications

  • Following full approval in December 2023, Nefecon is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression”. 
  • The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN.

Words from CEO: Everest Medicines

“We congratulate our partner for receiving seven more years of market exclusivity for Nefecon in the US, which is a further testament of FDA’s recognition of the drug’s capability to preserve kidney function and significantly delay disease progression for all adult patients,” said Rogers Yongqing Luo, chief executive officer of Everest Medicines. “Nefecon represents a revolutionary first-in-disease therapeutic option for Chinese patients who have more rapid disease progression in IgAN with no effective treatment options. Following its NDA approval in mainland China in November and successful commercialization in Macau in December, we now look forward to Nefecon’s imminent commercial launch in mainland China to make the drug available to 5 million IgAN patients as soon as possible.”

South Korea’s Ministry of Food and Drug Safety granted Orphan Drug Designation status for Nefecon in November 2022.

About Nefecon

  • Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. 
  • The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. 
  • Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
  • About agreement
  • In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. 
  • The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets.

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