Merck & Co. has licensed exclusive worldwide rights for its Phase III chronic plaque psoriasis candidate tildrakizumab (MK-3222) to Sun Pharmaceutical Industries. The deal could net Merck more than $80 million, the companies said today.
Under their licensing deal, Merck will continue all clinical development and regulatory activities, to be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.
Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody that showed promise in earlier clinical studies in treating inflammatory conditions by selectively blocking the cytokine IL-23—specifically by binding to IL-23p19.
Other potential indications, which may be evaluated in future, include psoriatic arthritis and Crohn’s Disease, Merck and Sun Pharma said.
Sun Pharma agreed to pay Merck an $80 million upfront payment, plus undisclosed payments tied to regulatory milestones—including product approval—and sales milestones. Merck is also eligible for tiered royalties ranging from mid-single digit through teen percentage rates on sales, the companies added.
The licensing deal is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.
Iain D. Dukes, Ph.D., svp, business development and licensing, Merck Research Laboratories, said the deal was “consistent with our previously announced global initiative to sharpen our commercial and R&D focus, including prioritizing our late stage pipeline candidates.”
Merck articulated those priorities last October when it launched a restructuring of R&D and commercial operations that will involve elimination of 8,500 jobs through 2015, on top of an earlier-announced reduction of 8,500 jobs. At the time, Merck said it intended to strengthen its pipeline through new licensing and business development activities with external partners.