Calliditas Therapeutics has signed a licensing deal with Everest Medicines to develop its phase 3 drug candidate Nefecon in Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN).
The Swedish biotech launched its initial public offering (IPO) on the Stockholm Nasdaq last year, and has now secured a valuable partner which could unlock access to China’s huge market.
Nefecon is a novel oral formulation of the corticosteroid budesonide which targets the active ingredient to B cells in the lower small intestine and control the output of IgA antibodies.
The company believes Nefecon can improve the organ function by stopping the accumulation of the antibodies in the kidneys of patients with IgA nephropathy, while avoiding the severe side-effects seen in traditional high dose steroid treatment.
While IgAN is an orphan disease in the US and Europe, its prevalence is much higher in China. There, IgAN is the most common primary glomerulonephritis, and accounts for about 40% of primary glomerular diseases. China is the world’s largest market in terms of the number of IgAN patients. which takes a significant economic and social toll.
The deal sees Calliditas receive an initial upfront payment of $15m, as well as future payments linked to pre-defined development, regulatory and commercialisation milestones up to an additional $106m, including an option worth up to $20m for the development of Nefecon in other potential indications. Everest will also pay typical royalties on net sales.
The agreement gives Everest exclusive rights to develop and commercialise Nefecon in China, Hong Kong, Macau, Taiwan and Singapore. It says study centres in the region could be added to the pivotal phase 3 study, if regulators give permission, with the result of achieving registration approval for China’s market on an accelerated basis.
Once approved, Everest would be responsible for the commercialisation of Nefecon in the region.
Renée Aguiar-Lucander
“We are excited to be entering into this partnership with Everest Medicines to expand Nefecon’s market reach to China, where there is a significant unmet medical need for this large patient population,” said Renée Aguiar-Lucander, chief executive of Calliditas.
“We look forward to working in close collaboration with Everest Medicines to bring the innovative approach of Nefecon, which has shown great promise in our large Phase 2b study, to IgAN patients as rapidly as possible. Everest Medicines offers a unique combination of strong expertise in the clinical development and regulatory arena, with an innovative biopharma approach for this market,” she added.
“We look forward to partnering with Calliditas to develop and commercialise Nefecon as a potential novel therapy for the treatment of IgAN,” said Ian Woo, president and chief financial officer of Everest Medicines.
The first 200 randomised patients in the ongoing pivotal NefIgArd study will form the basis for topline data readout expected to occur during the second half of 2020, following which Calliditas will submit applications for accelerated/conditional regulatory approval to the FDA and the EMA respectively.
Calliditas has one competitor in the field, Omeros,which is developing its OMS721 for IgA nephropathy. However doubts have swirled around its phase 3 trial of the candidate, despite it having an FDA Breakthrough status for the condition, with a meeting with the US regulator in January addressing concerns about the trial design.