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Agreements

Date: 2016-07-27

Type of information: Licensing agreement

Compound: tildrakizumab

Company: Sun Pharmaceutical Industries (India) Almirall (Spain)

Therapeutic area: Autoimmune diseases - Dermatological diseases - Inflammatory diseases

Type agreement: licensing - development - commercialisation

Action mechanism:

  • monoclonal antibody. Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. 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.
  • The drug has been initially developed by Merck&Co. In September 204, Merck & Co and Sun Pharmaceutical Industries have concluded a licensing agreement for tildrakizumab, (MK-3222).

Disease: psoriasis

Details:

  • • On July 27, 2016, Sun Pharmaceutical Industries and Almirall announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Phase-3 studies of tildrakizumab have recently been completed. 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&Co 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. Additionally, the license agreement has a provision for possible co-promotion agreement at some point in the future, subject to certain conditions.

Financial terms:

  • Under terms of the license agreement, Almirall will pay Sun Pharma an initial upfront payment of $50 million. 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.

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