In 2021, Johnson & Johnson’s (NYSE:JNJ) pharmaceutical segment Janssen reported revenue of more than $50 billion in fiscal 2021 and operational growth of 13.1%.
Janssen exec Tom Cavanaugh’s next big goal for Janssen is ensure Janssen is a $60 billion pharmaceutical company by 2025.
Heavy reliance on R&D will get them there, said Cavanaugh — Janssen’s company group chairman, global commercial strategy organization — in an interview.
The company spent $11.9 billion on R&D in 2021, a 24% increase over the previous year, Cavanaugh said.
The company spends more on R&D than sales and marketing. To choose where to invest the funding, the company looks for the greatest unmet medical needs across six core therapeutic areas.
The drugs helping fuel current growth
When asked which drugs stand out in its current portfolio, Cavanaugh first singled out Darzalex (daratumumab), which first won FDA approval in 2015 for patients with previously treated multiple myeloma. Licensed from Genmab, Darzalex binds to a protein known as CD38 on red blood cells.
The drug now has eight FDA-approved regimens and a year-over-year growth rate of 40%.
Another growth driver is its IL-23 inhibitor Tremfya (guselkumab). First scoring FDA approval in 2017 for plaque psoriasis, the drug won an indication for psoriatic arthritis in 2020. “Tremfya provides patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis (PsA) with an opportunity for complete skin clearance,” Cavanaugh said.
Janssen now has substantial data regarding the efficacy, long-term safety, and durability of Tremfya. “We have up to five years of safety follow-up in PsO and up to two years in psoriatic arthritis,” Cavanaugh said.
In the first quarter of 2022, Tremfya had net sales growth exceeding 46% over the same quarter in 2021.
A pipeline in a pathway
Tremfya also provides an example of Janssen’s pathway-based approach to drug development. The company has ongoing clinical trials involving the drug in PsA, Crohn’s disease, ulcerative colitis, lupus nephritis and giant cell arteritis.
Cavanaugh described the company’s pathway approach as “systematic and evidence-driven.”
“It starts with deep insights into unmet medical needs [and] aligns these market insights with our deep understanding of immune pathway science to focus on the highest impact assets and programs,” he said.
The roots of the pathway approach trace back to the TNF-alpha inhibitor Remicade (infliximab), which the FDA approved in 1998 for Crohn’s disease. The drug would later win a slew of indications, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and plaque psoriasis.
Another example of the pathway approach can be found in Simponi (golimumab), which received FDA approval in 2009 as the first once-monthly, anti-TNF for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. In 2013, it won an indication for ulcerative colitis.
The pathway-based approach also played a role in Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020. One of the promising compounds in the acquisition is nipocalimab, which Janssen views as providing a potential “pipeline in a pathway.”
The company aims to redefine immunology treatment paradigms with four significant pivots of its pathway-based approach.
The first pivot is from immunosuppression to immune homeostasis, Cavanaugh said. The second pivot is to move from about six anatomy-based diseases to more than 20 addressable diseases.
“What’s really exciting is this third pivot from a single treatment paradigm, namely the injectable monotherapies,” Cavanaugh said. The aim is to use “the full range of modalities, including novel tissue-directed and systemic orals and industry-first combination therapies.”
The fourth pivot is to address the significant unmet need in immune-mediated diseases.
“Nearly 90% of the patients [with immune-mediated diseases] need something better,” Cavanaugh said. “We’re going from a goal of signs and symptoms response to a goal of disease remission for all patients.”
Filed Under: Biologics, clinical trials, Drug Discovery, Drug Discovery and Development