Calliditas Therapeutics and Everest Medicines have entered into a license agreement. The agreement has been made to develop and commercialise Swedish Calliditas’ leading drug candidate Nefecon in Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN).
The agreement gives Everest Medicines exclusive rights to develop and commercialise Nefecon in China, Hong Kong, Macau, Taiwan and Singapore.
Under the terms of the agreement, Calliditas will receive an initial upfront payment of US$15 million at the signing of the agreement. There are then future payments linked to pre-defined development, regulatory and commercialisation milestones. These additional payments consist of 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.
Calliditas is currently running a global Phase 3 clinical trial with Nefecon for the treatment of patients with IgAN. Depending on the outcome of consultation with the relevant regulatory authorities, this may also lead to the inclusion of Chinese study centres in this trial. This would aim to put Nefecon on an accelerated track to Chinese market approval.
Following potential registration approvals in China, Everest will then be responsible for the commercialisation of Nefecon in the relevant territories.
Need in China
Renée Aguiar-Lucander, CEO of Calliditas, explained that there is significant unmet need for this medicine in the Chinese population.
“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,” said Aguiar-Lucander.
While IgAN is an orphan disease in the US and Europe, the prevalence is much higher in China, where IgAN is the most common primary glomerulonephritis and accounts for about 40% of primary glomerular diseases. Unsurprisingly, therefore, China is the world's largest market in terms of the number of IgAN patients which extracts a significant economic and social impact.
Ian Woo, President and CFO of Everest Medicines, said: “Calliditas’ strong foundation of clinical development of Nefecon, coupled with Everest’s local clinical and regulatory expertise lays the groundwork for expediting the development of this promising therapeutic candidate as a potential treatment option for patients in Greater China and Singapore suffering from IgAN.”
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 positive results of a study in 2020, Calliditas will submit the applications for accelerated/conditional regulatory approval to the US Food and Drug Administration and the European Medicines Agency respectively.
Torreya, the global investment bank serving life science companies, acted as exclusive financial advisor to Calliditas on the transaction.
