Phase III clinical trials of tildrakizumab were completed in May, with positive results
Sun Pharma, a speciality Indian generics manufacturer has agreed a licensing deal with Almirall to develop and commercialise tildrakizumab for psoriasis in Europe.
Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated to treat moderate-to-severe plaque psoriasis.
It blocks the cytokine IL-23 and with this precise targeting has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis while having a limited impact on the rest of the immune system.
Phase III studies of tildrakizumab were completed in May, with positive results, the firm said.
Under terms of the agreement, Almirall will pay Sun Pharma US$50 million.
Sun Pharma will be eligible to receive development and regulatory milestone payments plus sales milestones and royalties on net sales, the terms of which are confidential.
Almirall will lead European studies, and participate in larger global clinical studies for psoriasis indication subject to the terms of the Sun Pharma/Merck agreements signed in 2014, as well as certain cost sharing agreements.
Under terms of the agreement, Almirall will pay Sun Pharma US$50 million
As part of the agreement with Merck, the German firm is responsible for the completion of Phase III trials in patients with mild-to-moderate plaque psoriasis and, as appropriate, submission of a Biologics License Application to the US FDA.
Merck is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch.
Post-approval in the US, Sun Pharma will be responsible for all other regulatory activities, plus manufacturing and commercialisation. The company will also be responsible for these activities in countries outside the US.
Merck is eligible to receive milestone payments and royalties on sales.
The new agreement between Sun Pharma and Almirall remains subject to this exclusive licensing agreement between Sun Pharma and Merck.
Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe.
'Sun Pharma is committed to growing our dermatology franchise, with tildrakizumab as our lead investigational compound,' said Dilip Shanghvi, Managing Director, Sun Pharma.
'We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are proud to be partnering with a regional leader in dermatology, like Almirall, to bring tildrakizumab to the European market.'
Jorge Gallardo, President of Almirall, added: 'This agreement allows us to add a novel biologic for treatment of psoriasis to our extensive dermatology portfolio.'