Proteologix US, Inc.

The potential acquisition comes as J&J seeks to bolster its portfolio. Credit: Skorzewiak/Shutterstock. Johnson & Johnson (J&J) has announced it will acquire Intra-Cellular Therapies, a company specialising in central nervous system disorder treatments. The news was first reported by Bloomberg late on Sunday (12 January) and confirmed by Johnson and Johnson through an official announcement on 13 January. Intra-Cellular’s market value has soared to $10bn after a 40% increase in share price in the 12 months to January. The company is known for its approaches to mental health and neurological disorders, with a major depressive disorder drug currently in late-stage trials. Its shares rose following a recent settlement with Sandoz over Caplyta, a bipolar depression medication. Meanwhile, J&J’s market capitalisation reportedly stands at $342bn, following a 12% decline over the same one-year period. J&J announced this news as major thought leaders started the first day at the JP Morgan Healthcare conference, taking place in San Francisco from 13-16 January. This deal will be one of the biggest biotech transactions in more than a year, highlighting a resurgence in healthcare deals after a slump. The potential acquisition comes as J&J seeks to bolster its portfolio following the spin-off of its consumer health division and the $13.1bn acquisition of Shockwave Medical, a heart device manufacturer. The move is part of J&J’s strategy to sustain growth amid challenges such as the impending loss of exclusivity for its psoriasis treatment, Stelara. In May 2024, J&J expanded its biotech footprint with the $850m acquisition of Proteologix, which focuses on immune-mediated diseases, with additional milestone payments possible. Update: This news story was updated on 13 January after Johnson and Johnson officially announced plans to acquire Intracellular Therapeutics. Paragraphs 1, 2, 3 and 4 have been updated with the latest news.

Johnson & Johnson (J&J) will be gaining exclusive rights to Kaken Pharmaceutical’s STAT6 programme for autoimmune and allergic diseases, including atopic dermatitis (AD). The agreement gives J&J a global licence to develop, manufacture and commercialise the programme. This includes Kanken’s lead oral candidate KP-723, which is expected to enter phase 1 clinical development for AD this year. Kaken will retain the commercialisation rights to the programme in Japan, where J&J will have an option to enter into a co-promotion agreement. Though J&J did not disclose financial details of the deal, the company said that Kaken will be eligible to receive an equity investment separately from its venture capital organisation, J&J Innovation. Also referred to as eczema, AD is a chronic inflammatory skin disorder affecting more than 9.6 million children and 16.5 million adults in the US. The disease is characterised by an overactive immune system that causes damage to the skin barrier, leaving it dry, itchy and prone to rashes, and leading to an increased risk of skin infections. STAT6 is a key nodal transcription factor that selectively mediates downstream signalling of interleukin-4 and interleukin-13, which have been shown to play a central role in type 2 inflammatory diseases. “STAT6 represents a promising area of research, as it offers a potential for an effective and safe oral option for people struggling to manage AD and other autoimmune diseases,” explained David Lee, global immunology therapeutic area head, J&J Innovative Medicine “To address the significant unmet need for people living with the highly heterogeneous diseases of AD and asthma, we must have multiple treatment candidates in our pipeline that target key pathways driving disease progression,” Lee said. The agreement comes six months after J&J completed its $850m acquisition of Proteologix, giving it access to two investigational bi-specific antibodies in development for moderate-to-severe AD and asthma. The company also completed its $1.25bn acquisition of Yellow Jersey, a demerged subsidiary of Numab Therapeutics, in July to secure the global rights for another investigational bi-specific antibody for AD.

Apogee Therapeutics, an I&I biologics maker that quickly went public in 2023, said Monday it’s headed toward a Dupixent face-off next year as it looks to become the next “generational” biotech. The San Francisco company expects its lead drug APG777, an IL-13 targeting monoclonal antibody, can eventually generate more than $10 billion in sales, CEO Michael Henderson told Endpoints News in a preview of Apogee’s R&D day on Monday. The plan is to launch the medicine by the end of this decade, Henderson said. “Historically, people have thought about us as a YTE antibody, a longer-acting version of another antibody,” Henderson said, “and we’ve been making investments to become so much more than that, which is what we’re really excited to show at our R&D day.” Part of those grand ambitions are pinned on a combination future in inflammation and immunology. The I&I field has become one of the industry’s fastest-growing areas of R&D as drugmakers sling deals left and right for a market that Henderson said is only second in breadth to obesity. Apogee’s first big combination test will come next year as it pairs APG777 with its OX40L-targeting mAb called APG990. By way of a co-formulation, those experimental medicines will go up against Dupixent in 50 to 75 patients with moderate-to-severe atopic dermatitis in a Phase 1b, Apogee said. The readout is slated for the second half of 2026. “Everyone says, ‘Oh, we’re going to be better. It should be better,’” Henderson said. “No one ever actually runs that head-to-head study.” Dupixent has become a cornerstone of Sanofi and Regeneron’s I&I pipelines, with the medicine projected to break the $14 billion sales milestone this year. It also became the first biologic to get FDA approval for chronic obstructive pulmonary disease, or COPD, this fall. Apogee isn’t daunted. Its half-life technology, born out of its parent company Paragon Therapeutics, could allow for dosing every three or six months versus every two to four weeks for many other I&I therapies like Dupixent and Eli Lilly’s Ebglyss. Eventually, as part of lifecycle management, Henderson envisions a once-yearly dosing schedule. In 12-month Phase 1 data on Monday, Apogee said APG777 had a half-life of 77 days and “near complete” inhibition of pSTAT6 for up to 12 months with just one administration of the drug. “If we look at psoriasis, you have Skyrizi dosed every three months, and that started with an every two-week paradigm with Humira and then the IL-17s came out every four weeks,” Henderson said. “It’s too early to comment on price, of course, but in those cases, you see the price staying the same or even being higher with fewer injections because the better disease control and improved patient experience.” Enrollment is going so much faster than anticipated in Apogee’s Phase 2 trial of APG777 in atopic dermatitis that the company now plans to unveil 16-week Part A data from the study in mid-2025. That’s “months” earlier than the previously guided second half of next year, Henderson said. As a monotherapy, APG777 will also enter a Phase 1b in asthma by next summer, a Phase 2b in asthma in the second half of next year and a Phase 2 in eosinophilic esophagitis in 2026. The company’s combination plans also include pairing up APG777 with APG333, a mAb that goes after TSLP, which is targeted by Amgen’s Tezspire and candidates from a cohort of other biotechs . While Apogee plans to evaluate APG333 alone in a Phase 1b in asthma, its future relies on combinations with APG777 in asthma and COPD. “TSLP as a mono we are not excited about. People are doing that. It’s OK. But it’s crowded. It really is a combination that we get excited” about, Henderson said. Sanofi has an IL-13 and TSLP-targeting bispecific called lunsekimig, and Johnson & Johnson paid $850 million upfront for Proteologix and its bispecific in the arena. Apogee also said its Phase 1 healthy volunteer trial showed its drug APG808 had a half-life of about 55 days, which could translate to every two or three-month maintenance doses. The investigational IL-4Rα drug is also in a Phase 1b in asthma, with a readout planned for the first half of 2025. Apogee raised more than $400 million in a public offering in March on the back of interim Phase 1 healthy volunteer data. Will the company do it again after its R&D day? “We think that we’re incredibly undervalued right now, especially after the recent pullback in the market,” Henderson said. If the Phase 2 data are what Apogee is hoping for, then the company “should be able to access a much lower cost of capital than we’re at today,” he added. Apogee’s share price $APGE is down about 17% over the past month, but up 61% year-to-date. Henderson thinks the biotech is headed toward becoming a “generational” drugmaker like Vertex or Gilead. “They refuse to stop at good enough. They pursue combinations. They look to cannibalize their own markets,” Henderson said.