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Sun Pharma and Merck sign exclusive worldwide licensing agreement for Tildrakizumab

Merck and Sun Pharmaceutical Industries have entered into an exclusive worldwide licensing agreement for the former's investigational therapeutic antibody candidate, tildrakizumab (MK-3222).

Tildrakizumab is a humanized, anti-IL-23p19 monoclonal antibody that binds specifically to IL-23p19 and is designed to selectively block the cytokine IL-23. It is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment.

Signed through their respective subsidiaries, the agreement will allow Sun Pharma to acquire worldwide rights to tildrakizumab for use in all human indications from Merck.

Merck in exchange will receive an upfront payment of $80m and will continue all clinical development and regulatory activities, which will be funded by Sun Pharma.

Following the receipt of approval for the product, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.

Under the agreement, Merck will be eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties on sales.

Merck Research Laboratories Business Development and Licensing senior vice-president Dr Iain D. Dukes said: "Consistent with our previously announced global initiative to sharpen our commercial and R&D focus, including prioritizing our late stage pipeline candidates, we are pleased to enter into this agreement with Sun Pharma to help realize the potential of tildrakizumab for patients with chronic plaque psoriasis."

Sun Pharma Business Development senior vice-president Kirti Ganorkar said: "This collaboration is a part of our strategy towards building our pipeline of innovative dermatology products in a market with strong growth potential."

The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.