From The Editor | April 15, 2021

Janssen's Innovation Strategy To Target Immune-Mediated Disease

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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Tom Cavanaugh believes there is a tremendous unmet need in the industry for treatments that target patients suffering from immune-mediated diseases. Cavanaugh, the president of immunology for Janssen in the U.S., notes that unmet need is a primary factor that drives the work he and his team perform. However, he believes there is good news for patients as well.

“There is a burgeoning base of new science that I believe will soon bring relief to those patients,” he says. “Despite the unmet need, there have been advances in this therapeutic area. Janssen is investing significantly into R&D to usher in a new era of treatment for those patients and others across all of the disease areas we address across the pharmaceutical companies of Johnson & Johnson.”

Two of the bigger line items for pharmaceutical companies tends to be R&D and sales/marketing. Cavanaugh notes Janssen is investing $9.6 billion into the company’s R&D efforts, according to the company’s most recent transparency report. That is more than double what the company spent on sales and marketing.

“When it comes to R&D, we definitely put our money where our mouth is,” says Cavanaugh. “Those numbers are very important to us and I believe it shows our commitment to driving innovation and collaboration that will help patients better navigate their journey.”

Addressing An Unmet Need

Cavanaugh says there are roughly 60 million patients in western society dealing with immune mediated diseases. Approximately half of those patients are suffering from moderate to severe disease symptoms but are not receiving any advanced therapy.

Tom Cavanaugh, president, immunology U.S., Janssen
“What those numbers do not reflect are the thousands or potentially millions of patients who have not even been diagnosed,” says Cavanaugh. “We believe only about 10 percent of patients are in remission. As you might imagine, sustained remission is the goal in treatment of these patients. That will allow them to have a symptom free life but is also associated with improved longer-term outcomes. When it comes to getting patients the therapies they need, we are just scratching the surface.”

For patients suffering from immune mediated diseases, the symptoms are not trivial. Cavanaugh states the symptoms are chronic, debilitating, and often difficult to manage. The patients with moderate to severe symptoms can experience significant pain due to underlying tissue damage. That disrupts their quality of life, requires greater use of the healthcare system, and adds more costs to the system.

A New R&D Strategy

One of the ways Janssen is addressing the unmet need is with its R&D strategy. Cavanaugh notes the strategy is one of the things that attracted him to the company and is something that he remains excited about.

“First and foremost, our R&D strategy is innovation agnostic. We have multiple external collaborations in place and are active in business development and licensing. We have an active and growing pipeline with 21 first-in-class programs in Phase 2 and Phase 3 trials.”

An example of the innovation agnostic approach is Johnson & Johnson’s innovation centers and hubs, where company personnel work alongside innovators who are external to the company. Those collaborations allow both companies to learn from each other and understand how they can assist each other. Those collaborations will often lead to partnerships.

Janssen is also leveraging its pathway-based strategy to expand the drug pipeline beyond immunosuppression, which is the main therapeutic approach used today to restore the immune balance in patients. Cavanaugh believes this pathway approach is key to unlocking treatments for conditions where patients have limited options.

New Partnerships and Pathways

One example of the pathway approach involves TREMFYA, a marketed product in the Janssen portfolio. TREMFYA is a monoclonal antibody that selectively inhibits interleukin (IL)-23. It is approved for psoriasis and psoriatic arthritis and is the first and only IL-23 approved for both indications.

“We see this as a pipeline in a product,” says Cavanaugh. “We are currently evaluating its potential for patients of ulcerative colitis and Crohn's disease. We are also evaluating novel localized and systemic oral therapies. This is another way in which we aspire to address patient communities who have significant unmet needs.”

Janssen is also investigating how combination therapies may offer new mechanisms of action to improve efficacy over currently available therapies or provide pharmaceutical treatment options in areas where patients currently have no approved therapy. One piece of that R&D strategy in the immunology and infectious disease space is combination therapies. To build on the momentum it has in that space, Johnson & Johnson acquired Momenta Pharmaceuticals in August 2020. The $6.5 billion acquisition is expected to strengthen Janssen’s immune-mediated disease portfolio and grow its interest in autoantibody driven disease therapies.

“That is a great example of our pursuit of new pathway science,” says Cavanaugh. “The acquisition will increase our autoantibody driven disease expertise and give us the opportunity to have a first-in-class mechanism of action with potential to transform care across multiple disease areas.”

A Holistic View of The Patient Journey

Although Janssen has accomplished a lot in advancing the science of immune-mediated diseases, Cavanaugh states the science is just the beginning. The company is now attempting to take a holistic view of innovation and collaboration, which places a focus on the patient journey.

“If you know anyone who suffers from an auto immune disease, such as psoriasis, psoriatic arthritis, or Crohn's disease, you know that patient journey is long and complicated,” he says. “Many of these patients cycle through multiple therapies and insurance plans, and we cannot forget about that. It could take many years for them to be accurately diagnosed.”

To assist with that journey, Janssen is working to improve stakeholder connections through patient support programs and field reimbursement and access specialists. One goal is to ensure patients fully understand the options available to them. Partnering plays a key role.

“We understand that we can’t do this alone,” says Cavanaugh. “Our mission is to relentlessly advance care, and that requires us to partner not only with care providers, but other stakeholders in government, academia, and patient advocacy. Partnering with patient groups allows us to raise awareness of diseases so we can accelerate diagnosis and encourage patients to visit specialists.
We also work with biologic coordinators, who help with the fulfillment process of biologics that can be complex for many patients.”

Looking ahead, Cavanaugh is excited about what the future holds for patients. “What we are seeing right now is really the infancy of the exploration and discovery into the science of immune-mediated diseases,” he adds. “One of the big questions that remains is how do we accelerate development to get products to the marketplace more quickly for patients. The science is accelerating quite rapidly, and we see significant potential in the areas of cardiovascular, immune diseases, infectious disease, neural inflammation, and oncology. The big challenge will continue to be identifying those patients and patient populations, understanding their concerns, and developing better trial protocols in partnership with them.”