On the heels of positive Phase IIb data in plaque psoriasis, Takeda is acquiring both the therapy and Nimbus Lakshmi, a wholly owned subsidiary, in a potentially $6 billion deal.
Courtesy Tomohiro Ohsumi/Getty Images
Two weeks after Nimbus Therapeutics reported positive Phase IIb data for NDI-034858, Takeda is acquiring both the therapy and Nimbus Lakshmi, a wholly owned subsidiary, in a potentially $6 billion deal.
The therapy is an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor being developed to treat autoimmune diseases. The Phase IIb readout in late November was for moderate-to-severe plaque psoriasis.
In the Phase IIb study of 259 patients, NDI-034858 met the primary efficacy endpoint, demonstrating a statistically significant higher number of patients hitting a 75% improvement in skin lesions. The measurement was via the Psoriasis Area and Severity Index (PASI-75) compared to placebo at 12 weeks.
Under the terms of the deal, Takeda will pay Nimbus $4 billion upfront. There are two additional sales milestones of $1 billion each when or if annual net sales of the drug reach $4 and $5 billion.
Jeb Keiper, CEO of Nimbus, told BioSpace Nimbus’ goal is to design breakthrough medicines and take them through clinical development and then to “collaborate with multinational pharma companies that can accelerate [the medicines] forward through commercialization.”
This isn’t the first large deal for Nimbus. In 2016, the company’s lead clinical program, firsocostat in NASH, which was acquired by Gilead Sciences.
The FDA approved Bristol Myers Squibb’s Sotyktu (deucravacitinib), a first-in-class, oral TYK2 inhibitor for moderate-to-severe plaque psoriasis in September.
Nimbus and Takeda believe NDI-034858 has the potential to compete effectively against Sotyktu in the marketplace, despite being significantly behind in getting to market. Earlier projections have estimated Sotyktu could hit $4 billion in annual sales.
A Takeda spokesperson told BioSpace that adding the TYK2 inhibitor to its pipeline gives Takeda the opportunity to expand its portfolio, as well as its GI clinical programs and therapeutic focus.
A private company, Nimbus raised $125 million in mid-September, with new investors Bain Capital Life Sciences and SV Health Investors joining an existing stable of prominent investors.
Those funds supported the Phase IIb trial of NDI-034858 as well as the launch of the psoriasis Phase II trial and additional Phase IIb trials of the drug in inflammatory bowel disease and lupus.
Now, with an additional $4 billion, the company has plenty of funds to advance the ongoing Phase I/II trials of NDI-101150, its hematopoietic progenitor kinase 1 (HPK1) inhibitor in solid tumors. It also has preclinical programs targeting Casitas B-lineage lymphoma b (Cbl-b) and Werner syndrome helicate (WRN).
