Calliditas Therapeutics Appoints Frank Bringstrup as VP Regulatory Affairs

STOCKHOLM, Jan. 14, 2019 /PRNewswire/ --

Calliditas Therapeutics AB (publ) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced the appointment of Dr. Frank Bringstrup as Vice President Regulatory Affairs effective February 1, 2019. As a member of the Management Team, Frank will have a leading role in the regulatory discussions and approval process of the company's pivotal clinical phase 3 study NEFIGARD in patients with IgA nephropathy (IgAN).

"I am delighted to welcome Frank to the team at this exciting stage in the company's development. The combination of his strong experience in regulatory affairs, not only with the FDA but on a broad international basis with a proven track record and experience from orphan drug development and bringing products to market will play a key role as we progress development of Nefecon through phase 3 clinical trials," said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

Dr. Bringstrup brings over 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 their 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 1 through phase 3 with five parallel MAAs and NDAs and five major approvals gained in a 15-month period.

Dr. Bringstrup has a wealth of experience of Regulatory Affairs in the US, EU, Japanese and international markets, and was, among other things, responsible for overseeing the lifecycle development for new indications for the orphan drug NovoSeven, a recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade.

"I am excited to take on this role at Calliditas. With the phase 3 trial of Nefecon well underway, this is a pivotal time for the company. Currently, there are no approved treatments for IgA Nephropathy, and Nefecon has the potential to be a disease-modifying treatment for patients suffering from this chronic autoimmune disease. I am delighted to be working with this dynamic team to progress the development of Nefecon through to market," said Frank Bringstrup.