India-based Sun Pharma has signed an exclusive worldwide licensing agreement with US-based Merck for its investigational therapeutic antibody candidate, tildrakizumab (MK-3222).

Tildrakizumab is a humanised and anti-IL-23p19 monoclonal antibody, which binds specifically to IL-23p19 and is designed to selectively block the cytokine IL-23.

Currently, it is being evaluated in Phase III registration trials to treat chronic plaque psoriasis, a skin ailment.

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

The deal has been signed through their respective subsidiaries and allow Sun Pharma to acquire worldwide rights related to tildrakizumab for use in all human indications from Merck.

"Once the product receives approval, Sun Pharma will take care of regulatory activities."

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

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Once the product receives approval, Sun Pharma will take care of regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product.

Merck will also receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties on sales.

Sun Pharma business development senior vice-president Kirti Ganorkar said: "Sun Pharma is very pleased to enter into this collaboration with Merck, a recognised leader in the field of inflammatory/immunology therapies, for this late-stage candidate for chronic plaque psoriasis."

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

Image: Plaques of psoriasis. Photo: courtesy of James Heilman, MD.