Lilly Enters into Exclusive Licensing Agreement with Rigel Pharmaceuticals Accessing Promising RIPK1 Inhibitor

Lilly Enters into Exclusive Licensing Agreement with Rigel Pharmaceuticals Accessing Promising RIPK1 Inhibitor TrialsiteN

Eli Lilly and Co inked a deal to gain worldwide, exclusive licensing rights to the autoimmune and inflammatory disease treatment candidate of Rigel Pharmaceuticals Inc. in a deal worth up to $960 million. Rigel will receive an upfront payment of $125 million with an upside of up to $835 million in milestone-based payments. The deal centers on Rigel’s main investigational product, R552, which has completed early-stage clinical trials and starting this year commences mid-stage trials.

TrialSite provides a brief breakdown of this news for Investor Watch under licensing deals.

What is the intellectual property Lilly seeks access to?

R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. Lilly will also now lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

What is the promise of RIPK1?

RIPK1 is implicated in a broad range of key inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production. In necroptosis, cells rupture leading to the dispersion of cell contents, which can trigger an immune response and enhance inflammation. In preclinical studies, R552 evidenced prevention of joint and skin inflammation in a RIPK1-mediated murine model of inflammation and tissue damage reports Rigel on its website.

Inhibiting RIPK1 may be a new approach to treating various autoimmune, inflammatory, and neurodegenerative disorders. In preclinical studies, Rigel’s R552 demonstrated prevention of joint and skin inflammation in a RIPK1-mediated murine model of inflammation and tissue damage.

In a recent investor presentation, Rigel Pharmaceuticals shared it had completed a Phase 1 study involving R552 and that the biotech company ought to “broaden exploration of RIPK1 program.” With a “broad potential in numerous large indications,” the San Francisco Bay Area biotech shared it intended to find a collaboration partner—which it has done so in Lilly.

What are the commercial terms of this deal?

As mentioned, Lilly pays Rigel $125 million upfront and has established a series of payments based on development, regulatory and commercial milestones, which could total up to $835 million. Royalties involved range from the mid-single digit to high-teens, depending on Rigel’s clincial development investment.

What specific activities commence moving forward?

Both Lilly and Rigel will co-develop R552 at specified contribution levels. Both Lilly and Rigel will co-develop R552 at specified contribution levels. Lilly is responsible for all costs of global commercialization associated with R552, while Rigel has the rights to co-commercialize R552 in the U.S. Lilly will take on sole responsibility for clinical development and commercialization of brain penetrating RIPK1 inhibitors in CNS indications.

What are the synergies here between the two sponsors?

Lilly’s vice president of immunology like the potential of RIPK1 inhibitors recently sharing that they represent considerable potential and “exciting addition” to the Indianapolis-based pharmaceutical company. Lilly is excited about adding this product to their pipeline. And the deal aligns with the large company’s immunology strategy, focusing on “novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions,” reports Ajay Nirula, MD, PhD.

Meanwhile, Rigel’s CEO Raul Rodriguez is upbeat about “Lilly’s extensive knowledge in immune and CNS diseases,” sharing they are an “ideal partner to ensure the clinical and commercial success of our RIPK1 inhibitor program.”

Is the deal done?

No. The closure of this deal is subject to customary closing conditions, including Hart-Scott Rodino (HSR) Antitrust Improvements Act of 1976.