Takeda to Acquire Late-Stage, Potential Best-in-Class, Oral Allosteric TYK2 Inhibitor NDI-034858 From Nimbus Therapeutics

Takeda announced that it will acquire NDI-034858 from Nimbus Therapeutics. NDI-034858 is an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis. When the transaction is complete, NDI-034858 will be known as TAK-279.

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“Adding this TYK2 inhibitor to our late-stage pipeline gives Takeda an exciting program that has the potential to significantly expand our portfolio and patient impact, while enhancing our growth strategy beyond ENTYVIO” said Christophe Weber, president and chief executive officer of Takeda. “We are confident we can execute a broad development program and deliver a best-in-class therapy for these patients, given Takeda’s strong background in immune-mediated diseases, including inflammatory bowel disease (IBD).”

Nimbus recently disclosed positive topline results from a Phase 2b study evaluating NDI-034858 in patients with moderate-to-severe plaque psoriasis. Takeda intends to present results from this Phase 2b study early in 2023. NDI-034858 is anticipated to enter Phase 3 in psoriasis in 2023. It is in an ongoing Phase 2b study in active psoriatic arthritis, and Takeda plans to investigate it for the treatment of IBD and other autoimmune diseases.

“This program further expands Takeda’s GI clinical programs and therapeutic focus. After having seen the NDI-034858 Phase 2b data, particularly the PASI scores, we are excited by the differentiation of this molecule within the TYK2 class, and we believe in its broad potential for people with autoimmune diseases,” said Andy Plump, M.D., Ph.D., president of Research & Development at Takeda. “By virtue of its unique allosteric mechanism of action, NDI-034858 is both a potent and highly selective TYK2 inhibitor with exceptional clinical activity, a strong tolerability profile and wide therapeutic margins. NDI-034858 is a potentially best-in-class TYK2 inhibitor across a wide range of immune mediated conditions.”

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“Since the acquisition of Shire in 2019, we have made excellent progress in reducing our debt ratio towards ‘low-twos’ net debt to adjusted EBITDA and we are on course to achieve this target one year ahead of plan. This acquisition is an opportunity to invest in the company’s mid-to-long term growth. Even after closing the deal, we expect to end this fiscal year with a debt ratio in the ‘low-to-mid-twos,’ and with a weighted average interest fixed rate of approximately 2%,” said Costa Saroukos, chief financial officer of Takeda. “Takeda’s solid financial profile and robust cash flow outlook positions the company well to invest in growth drivers and focus on shareholder returns, while maintaining solid investment grade credit ratings.”

Under the terms of the agreement, Takeda will pay Nimbus $4B upfront, and two milestone payments of $1B each upon achieving annual net sales of $4B and $5B. The upfront payment will be primarily funded by cash on hand. The transaction is expected to be finalized before the end of FY2022. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.

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