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Strategic in-licensing related to autoimmune hepatitis in the US market

Calliditas Therapeutics AB (publ) (“Calliditas”) today announced that it has exclusively in-licensed Budenofalk 3mg oral capsule for the US market from the German pharmaceutical company Dr. Falk Pharma GmbH (“Dr. Falk”). The agreement covers all indications for the US market, excluding orphan indications outside of liver targets. Initially, Calliditas will leverage Dr. Falk’s clinical trial data and expertise in liver indications, such as autoimmune hepatitis (AIH) with a view to accelerate approval and market access.

The deal has an initial upfront payment of €1.5m and foresees additional regulatory related payments, subject to market approval from the US Food and Drug Administration (FDA). The total deal value amounts to €40m, including future sales milestones and comes with typical royalties.

AIH is an orphan liver disease which Calliditas estimates affects about 60 – 80,000 people in the US and for which there today is no approved treatment. Calliditas initially aims to leverage positive clinical trial data from Dr. Falk to support discussions with the FDA, focused on receiving guidance on the clinical program necessary to obtain an approval to market the product in the US.

This is an excellent opportunity for us to accelerate our development program in AIH and hopefully reduce both cost and time to market, while forging a relationship with a pre-eminent European player in the pharmaceutical space.  In addition, potentially having two separate products in our core market gives us more flexibility regarding positioning and pricing across different orphan indications,” commented Renée Aguiar-Lucander, CEO of Calliditas Therapeutics. 

Calliditas will now focus on preparing for a meeting with the FDA, which preliminarily is planned for Q1 of 2020.  Based on positive feedback regarding the regulatory path for the product from the FDA, a late stage clinical program could then be initiated in 2020.  

Dr. Roland Greinwald, Managing Director of Dr. Falk Pharma GmbH, commented: “Dr. Falk is delighted to partner with Calliditas and to support Calliditas in making Budenofalk oral capsules available as a new treatment option for AIH in the US market.”.

The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 14:40 CET on August 12, 2019.

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Last Updated: 14-Aug-2019