Calliditas Therapeutics AB (publ) (NASDAQ Stockholm: CALTX), a specialty pharmaceutical company based in Stockholm, Sweden, announced yesterday that it has named Dr Frank Bringstrup as its new vice president regulatory affairs, effective 1 February 2019.

As a member of the company's management team, Bringstrup will have a leading role in the regulatory discussions and approval process for the company's pivotal clinical phase three study, NEFIGARD, in patients with IgA nephropathy (IgAN).

Dr Bringstrup has more than 17 years experience in the pharmaceutical industry in regulatory affairs and health authority interactions. He worked in various positions at Novo Nordisk A/S, most recently as its senior global regulatory lead. During his time at Novo Nordisk, he led the strategic regulatory input for the orphan drug NovoEight all the way from phase one to phase three with five parallel MAAs and NDAs and five major approvals gained in a 15-month period. He has a wealth of experience of Regulatory Affairs in the US, EU, Japanese and international markets, and was, among other projects, responsible for overseeing the lifecycle development for new indications for the orphan drug NovoSeven, a recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting haemostasis by activating the extrinsic pathway of the coagulation cascade.