Research & Development
Calliditas announces exclusive in-licensing related to autoimmune hepatitis in the US market
13 August 2019 -

Calliditas Therapeutics AB (Calliditas) (STO:CALTX), a specialty pharmaceutical company, announced on Monday the exclusive in-licensing of Budenofalk 3mg oral capsule for the US market from the German pharmaceutical company Dr. Falk Pharma GmbH (Dr. Falk), a leading company in gastroenterology.

This deal has an initial upfront payment of EUR1.5m and foresees additional regulatory related payments, subject to market approval from the US Food and Drug Administration (FDA). The total deal value amounts to EUR40m, including future sales milestones and comes with typical royalties.

This 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.

Calliditas added that it 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 programme could then be initiated in 2020.

Calliditas Therapeutics is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which the company can partially or completely participate in the commercialisation efforts.

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