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Novartis targets underserved fields—and CAR-T—for next phase of immunology growth: exec

Novartis’ star drug Cosentyx recently hit a sales slump thanks to tough competition from newer biologics. But for the company’s next phase of growth in immunology, the Swiss pharma giant is targeting a slew of indications that remain underserved.

Cosentyx has been successful in psoriasis, a common battleground among drugmakers. But Novartis decided it’s “not going to play this game anymore” and is angling the blockbuster IL-17A inhibitor—and the rest of its immunology portfolio—at less cultivated indications, which Chief Commercial Officer Marie-France Tschudin said are still “lost out there.”

“Instead of investing in trials that are replicating the same level of knowledge, we feel that the medical community is asking us for something else,” Tschudin said in an interview with Fierce Pharma.

Common diseases such as psoriasis, atopic dermatitis, rheumatoid arthritis and inflammatory bowel diseases are almost absent in Novartis’ current immunology pipeline. Instead, it’s full of less familiar targets such as hidradenitis suppurativa (HS), Sjögren’s syndrome and chronic spontaneous urticaria.

Cosentyx’s next show

Cosentyx recently gained a thumbs-up from drug reviewers at the European Medicines Agency for the inflammatory skin disease HS, setting the stage for a formal European approval in the coming weeks. An FDA decision is also expected in the second half of this year. If all goes to plan, Cosentyx would become only the second FDA-approved HS treatment after a go-ahead for AbbVie’s Humira eight years ago.

A prevalent but under-diagnosed and under-treated disease, HS affects 1 in 100 people worldwide. Only 5% of patients are treated with biologics today, Tschudin said. That translates into around 200,000 patients each in the U.S. and Europe.  

A sizable market opportunity lies ahead. But can Cosentyx capture it?

One reason for the low diagnosis and treatment rates is a lack of efficacious therapies, Tschudin argued. Specifically, a durable response marked by sustained pain relief remains a huge unmet need for patients.

Novartis recently unveiled 52-week data for Cosentyx in HS. The drug’s response rate—as measured by inflammatory lesion and skin abscesses on a marker called HiSCR—improved to 55% after one year. About half of patients on Cosentyx had a meaningful reduction in HS-related pain.

But a competitor—and an arguably more efficacious one, according to experts interviewed by SVB Leerink analysts—could pose a threat. That drug is UCB’s IL-17A/F inhibitor Bimzelx.

Tschudin argued that “coming in first, being a tried and tested medicine,” Cosentyx could still capture a meaningful portion of the HS market. She said Bimzelx, after a European nod in August 2021 to treat plaque psoriasis, has only gained less than 2% of market share.

To Tschudin, the key to Cosentyx’s success in HS will be to get patients on treatment early in the course of their disease.

“If we can tackle the disease with an efficacious medicine from the get-go, you actually have the longest-lasting impact on that patient.”

But targeting a biologic-naïve population won’t be easy, especially now that cheap Humira biosimilars are available. And, as the experts told SVB, payer coverage often determines a patient’s treatment for HS.

Patient access is also where Cosentyx could compete, Tschudin said, given its legacy in the market.

As for Novartis’ launch strategy, the company plans to initially target physicians who already treat HS and “start giving them experience with the medicine,” Tschudin said. Novartis hopes that once doctors witness the drug’s efficacy and durable response, Cosentyx will garner more interest.

Novartis hopes the HS indication, plus expansions in Europe and China, can lift Cosentyx out of a lull in 2024 to eventually reach the company’s $7 billion peak sales goal for the drug. After a surprise 9% revenue drop in last year’s fourth quarter, Cosentyx’s first-quarter sales were down 4% thanks to a greater proportion of Medicaid patients and inventory changes. Tough competition from the likes of AbbVie’s Skyrizi and Rinvoq also likely didn’t help.

Underserved indications

As for Novartis’ broader immunology pipeline, Tschudin said she’s most excited about rapcabtagene autoleucel, a CD19-targeted CAR-T therapy that Novartis is developing for both diffuse large B-cell lymphoma and lupus nephritis. The company believes that engineered T cells can take down B cells that cause autoimmune reactions.

During Novartis’ first-quarter earning call, CEO Vas Narasimhan named immunology a “top priority” for the company’s CAR program. Novartis has also designed trial protocols to test the therapy across multiple immunology indications once it gets the go-ahead from regulators, he said.

There are challenges. Other companies such as Kyverna Therapeutics and Cabaletta Bio are also working on cell therapies for autoimmune disorders. And, while the high price of a one-time therapy to treat cancer may be acceptable, the autoimmune market hasn’t yet been tested with the approach. Plus, manufacturing complexities could provide another hurdle.

Rapcabtagene autoleucel, also known as YTB323, is based on Novartis’ T-Charge platform, which allows for faster manufacturing turnaround and potentially more energetic T cells by moving most of the cell expansion to within the patient’s body rather than in labs. Tschudin said the company’s work on improving manufacturing efficiency could become an advantage.

As for pricing, she suggested that the health economics calculation in some chronic diseases is actually not that different from cancer.

“I think having a one-time treatment that we can make affordable to the healthcare system, that’s going to be absolutely a winning proposition,” Tschudin said.

While a large proportion of Novartis’ immunology pipeline targets underserved, less explored indications, the company does have BTK inhibitor remibrutinib in late-stage testing for multiple sclerosis (MS). The future of BTK in MS is, however, in question after a series of safety-related setbacks from Sanofi and Merck KGaA plus Biogen’s decision to back out from the field.

Novartis is closely following patients in remibrutinib’s clinical trials, although it hasn’t seen any concerning signals so far, Tschudin said.

Chronic spontaneous urticaria, also known as chronic hives, is remibrutinib’s lead indication. That phase 3 trial is up for a primary analysis in the second half of this year and could have final data and potential FDA submission in 2024.

“The reality is that there are tens of diseases out there where patients don’t have a lot of options,” Tschudin said. Targeting them “has been the Novartis strategy.”