 "Sun Pharma signs licensing pact with Spain’s Almirall for tildrakizumab in Europe")
Sun Pharma has entered into a licensing agreement with Spanish pharma firm Almirall for the development and commercialisation of tildrakizumab for psoriasis, a chronic immune disease that appears on the skin, in Europe. Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis.
Under terms of the license agreement, Almirall will pay Sun Pharma an initial upfront payment of $ 50 million. Phase 3 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 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.
In 2014, Sun Pharma acquired worldwide rights to tildrakizumab from Merck (known as MSD outside the US and Canada). Funded by a Sun Pharma subsidiary, Merck is responsible for the completion of phase 3 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 (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, manufacturing and commercialisation of the approved product. 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.
“Sun Pharma is committed to growing our dermatology franchise, with tildrakizumab as our lead investigational compound. We are proud to be partnering with a regional leader in dermatology, like Almirall, to bring tildrakizumab to the European market. This agreement with Almirall follows the recent announcement that tildrakizumab is the first IL-23p19 inhibitor to demonstrate positive results in phase 3 clinical trials and is another step towards preparing for future regulatory milestones that will potentially enable us to bring a new treatment option to patients with moderate-to-severe plaque psoriasis,” said Dilip Shanghvi, managing director, Sun Pharma.
Jorge Gallardo, president of Almirall, commented, “This agreement with Sun Pharma allows us to add a novel biologic for treatment of psoriasis to our extensive dermatology portfolio. This is an exciting time for the treatment of psoriasis, a disease which can take both a physical and emotional toll on patients’ lives. Emerging new investigational drugs, like tildrakizumab, are increasingly targeted and will potentially offer patients and physicians another alternative.”
It is estimated that psoriasis affects about 125 million and 7.5 million people globally and in the US, respectively. Despite existing treatment options, many people with plaque psoriasis - the most common form of psoriasis - continue to struggle with the ongoing, persistent nature of this chronic disease that often has a debilitating impact not only on their bodies but their everyday lives.
