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Agreements

Date: 2017-07-24

Type of information: Development agreement

Compound: NKTR-358

Company: Eli Lilly (USA - IN) Nektar Therapeutics (USA - CA)

Therapeutic area: Autoimmune diseases – Inflammatory diseases

Type agreement: development - commercialisation

Action mechanism:

  • immunotherapy product. NKTR-358 works by optimally targeting the interleukin-2 receptor complex in order to stimulate proliferation and activation of regulatory T cells. By increasing the number of regulatory T cells, the pathogenic auto-reactive T cells can be controlled and the proper balance of effector and regulatory T cells can be achieved to restore the body's self-tolerance mechanisms.
  • In preclinical studies, NKTR-358 has demonstrated that it could suppress antigen-driven inflammation in a model of cutaneous hypersensitivity. NKTR-358 has also shown that it reduces markers of progression in a mouse model of systemic lupus erythematosus.
  • NKTR-358 is being developed as a once or twice-monthly self-administered injection for a number of auto-immune diseases.
 

Disease:

Details:

  • • On July 24, 2017, Eli Lilly and Nektar Therapeutics have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar. NKTR-358 targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells.
  • By activating these cells, NKTR-358 may act to bring the immune system back into balance. The product has achieved first human dose in Phase 1 clinical development in March of 2017, has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

Financial terms:

  • Under the terms of the agreement, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis.
  • Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.

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