Sun Pharmaceutical Industries, a Mumbai, India-based company, and Almirall, a Spanish pharmaceutical company, have formed a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis.

Under the license agreement, Almirall will pay Sun Pharma an initial upfront payment of $50 million. Phase III studies of tildrakizumab have recently been completed. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales, the terms of which are confidential. Almirall will be able to lead European studies and participate in larger global clinical studies for psoriasis indication subject to the terms of the Sun Pharma –Merck & Co. Inc. agreements, as well as certain cost sharing agreements. 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. Additionally, the license agreement has a provision for possible co-promotion agreement at some point in the future, subject to certain conditions.

Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary acquired worldwide rights to tildrakizumab from Merck in 2014. Funded by a Sun Pharma subsidiary, Merck 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 Food and Drug Administration. 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, including subsequent submissions, pharmacovigilance, post-approval studies, manufacturing, and commercialization of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post-approval studies, manufacturing and commercialization of approved products for all non-U.S. markets. Merck is eligible to receive milestone payments and royalties on sales of tildrakizumab. The agreement between Sun Pharma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck.

Source: Almirall