Agreements

Date: 2014-09-17

Type of information: Licensing agreement

Compound: tildrakizumab

Company: Merck&Co (USA - NJ) Sun Pharmaceuticals (India)

Therapeutic area: Autoimmune diseases - Dermatological diseases - Inflammatory diseases

Type agreement: licensing

Action mechanism: monoclonal antibody. Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody that binds specifically to IL-23p19. In clinical studies for the treatment of chronic plaque psoriasis, tildrakizumab demonstrates efficacy in blocking inflammation by blocking IL-23. Other potential indications, which may be evaluated in future, include psoriatic arthritis and Crohn’s disease.

Disease: psoriasis

Details:

• • On September 17, 2014, Merck & Co and Sun Pharmaceutical Industries announced an exclusive worldwide licensing agreement for Merck&Co ’s investigational therapeutic antibody candidate, tildrakizumab, (MK-3222), which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis.
• Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck&Co in exchange for an upfront payment of U.S. $80 million. Merck will continue all clinical development and regulatory activities, which will 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.

Financial terms: Merck&Co  will receive an upfront payment of U.S. $80 million. The company is also eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales.

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