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perty rights – A business opportunity Patents • Trademarks • Design • Domain Names Legal Services • Post-grant / Enforcement Strategic Counselling • Annuities & Renewals Since 1894 BUSINE S S ENTERS LICENSE AGREEMENTS Together with Everest Medicines the company will develop and commercialize Nefecon in Greater China and Singapore and it has also in-licensed Budenofalk for the US market from Dr. Falk Pharma. NDER THE TERMS of the agreement with Everest, Calliditas will receive an initial upfront payment of MUSD 15 on signing of the agreement, as well as future payments linked to pre-defined development, regulatory and commercialization milestones up to an additional MUSD 106, including an option worth up to MUSD 20 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. The agreement gives Everest exclusive rights to develop and commercialize Nefecon in China, Hong Kong, Macau, Taiwan and Singapore and may, depending on the outcome of consultation with the relevant regulatory authorities, lead to the inclusion of Chinese study centers in the ongoing study, NefIgArd, with the result of achieving registration approval for the Chinese market on an accelerated basis. Following potential registration approvals, Everest will be responsible for the commercialization of Nefecon in the relevant territories. HE AGREEMENT WITH Dr. Falk 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 with a view to accelerate approval and market access. The deal has an initial upfront payment of M€1.5 and foresees additional regulatory related payments, subject to market approval from the FDA. The total deal value amounts to M€40, including future sales milestones and comes with typical royalties. 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. www.valea.eu ANETTE ROMARE M.Sc. Chem. Eng. & Biotechnology European Patent Attorney Anette has a chemical background with particular expertise in absorbent products. She has vast experience of EPO opposition and appeal proceedings as well as patent evaluations and opinions.