Almirall and Sun Pharma announce regulatory filing of tildrakizumab in Europe

Pivotal Phase 3 data demonstrated potential of Tildrakizumab to offer patients treatment for moderate-to-severe plaque psoriasis without burden of frequent injections

Almirall and Sun Pharmaceutical Industries announced the validation of the Regulatory Filing of tildrakizumab with the European Medicines Agency (EMA) by Almirall. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.

The filing includes efficacy and safety data from the pivotal Phase III clinical trials (reSURFACE 1 and 2) that included over 1,800 patients across more than 200 clinical sites.

"The filing of tildrakizumab in Europe is a significant step forward for healthcare providers as many patients are still suffering from the disease. Tildrakizumab adds a novel biologic treatment option to our extensive and innovative portfolio, strengthening our position as a leading Dermatology player," said Eduardo Sanchiz, CEO, Almirall.

According to Jesper Jensen, Executive Vice President – Biologics & Dermatology, Sun Pharma, "Not all people living with psoriasis achieve long-term systemic control with currently available treatments, there are those who continue to struggle every day with the chronic nature of psoriasis. The European filing of tilidrakizumab is the next step in our effort to bring a new treatment option to people suffering from psoriasis."

In July 2016, Almirall entered into a licensing agreement with Sun Pharma for the development and commercialisation of tildrakizumab for psoriasis in Europe. Under the terms of the signed agreement, Sun Pharma will continue to lead other indications, for which Almirall will have the right to primary negotiation. In addition, Almirall will be able to lead European studies, and participate in larger Global clinical studies for psoriasis.