Iscalimab

Novartis said Friday that last year was one of its “strongest” financial performances in its history following a multiyear reorg as a pure-play pharma company, bolstered by steady growth of its top three medicines and a skyrocketing cholesterol franchise. CEO Vas Narasimhan said on a media call that the company exceeded its full-year guidance for both sales and operating income. The Swiss drugmaker’s 2024 sales grew 12% to $45.4 billion, according to an earnings release . The update was not a complete surprise, because the company upped its sales guidance through 2028 in November. Novartis’ cholesterol drug Leqvio saw the most growth in 2024, with sales soaring 112% to $754 million. But its top three best sellers were heart failure medicine Entresto ($7.8 billion), psoriasis treatment Cosentyx ($6.1 billion) and multiple sclerosis drug Kesimpta ($3.2 billion). In 2023, the company completed a long-term restructuring process that saw it integrate its pharmaceuticals and oncology business units into a so-called innovative medicines unit, and zero in on four core therapeutic areas: cardiovascular, renal and metabolic (CRM), as well as oncology, immunology and neuroscience. “When you look at [this change] from a value creation standpoint, in January 2018 the market capitalization of Novartis was $196 billion, and you can see today that [it] stands at over $200 billion,” Narasimhan said on the second media call. “The strategy of focusing the company has unlocked value and actually enabled Novartis to be much stronger for the long run.” Last year, the drugmaker slashed the size of its development and commercial functions with an eye to a leaner structure that would allow it to focus on “the biggest opportunities” in its pipeline. It’s targeting 15 new launches or label expansions over the next few years, starting with a potential indication for its immunoglobulin A nephropathy drug Fabhalta. The factor B inhibitor was due for an FDA adcomm meeting next month to discuss its risk-benefit profile in C3 glomerulopathy, but the agency called the meeting off earlier this week. “Our understanding is that the FDA no longer deemed it necessary to hold an advisory committee meeting,” Narasimhan told reporters. “We think it’s based on the overall data package we’ve been able to generate and the additional follow-on data that we’ve provided.” Narasimhan also stressed that Novartis remains a leader in the radiopharmaceutical space, with close to $2 billion in yearly sales from radioligand products, a global manufacturing footprint and more than 15 assets in the clinic using lutetium or actinium isotopes. The company made several investments in the approach last year, including a $1 billion bet on Mariana Oncology. Novartis plans to carry on with this kind of dealmaking , Narasimhan said. “But I think it’s really important to note that right now, lutetium is the isotope that has the most data and is the only approved isotope,” he continued, adding that newer isotopes such as actinium and lead have yet to demonstrate the necessary risk-benefit profile for approval and broad use. Also on the call, the company’s chief medical officer Shreeram Aradhye said it had discontinued development of a Phase 2 candidate for Sjögren’s syndrome. Novartis dropped work on anti-CD40 antibody iscalimab because its risk-benefit profile to date was not competitive, Aradhye said. But the company is still advancing another antibody program for Sjögren’s called ianalumab. In 2022, the drugmaker gave up on advancing iscalimab for liver transplant patients for similar reasons. Editor’s note: This story has been updated to add more comments from the company’s calls.

Sanofi/formerly Provention's Tzield (teplizumab), a CD3 mAb, is the only FDA-approved disease-modifying therapy that delays progression of Stage 2 T1D in patients 8 years and older. However, less than half of U.S. clinicians are impressed with the drug's ability to delay T1D onset, according to findings from REACH Market Research. NEWTON, Mass., July 11, 2023 /PRNewswire/ -- Type 1 Diabetes (T1D) is a life-long autoimmune disease where the immune system destroys the insulin-producing islet cells in the pancreas until they no longer produce insulin. To date, insulin replacement therapy has been the backbone of T1D treatment but has a significant treatment burden on patients. Recently, clinical development appears to be shifting towards therapies that could delay the need for insulin and preserve beta cell function. To access REACH's MarketVue® Report on Type 1 Diabetes, visit or contact us at [email protected]. The launch of Tzield is an important milestone in T1D disease management in that patients in the pre-diabetic stage now have an option to delay T1D onset by ~2 years, thereby delaying insulin use. Further, the approval has increased interest and awareness around screening patients who may be at risk for the disease. While the approval of Tzield has created excitement amongst clinicians, the response to its efficacy and dosing is underwhelming; less than 30% of interviewed doctors reported that they found the dosing impressive, according to REACH Market Research 's MarketVue® assessment. Endocrinologist, U.S.: "What are the potential benefits of a drug like teplizumab in a person who has stage 2 diabetes? It is not a magical bullet, but it's a good start." The current T1D pipeline consists largely of insulin-based treatments with few therapies in development to delay T1D and insulin use in recent-onset patients, including: Sanofi's teplizumab label extension for patients 0-7 yrs and recent-onset T1D NIDDK's anti-thymocyte globulin and granulocyte colony-stimulating factor Diamyd Medical AB's Diamyd, an anti-IL5 mAb Dompe Farmaceutici S.p.A's ladarixin, an anti-IL-8, CXCR1 and CXCR2 inhibitor Novartis' iscalimab, an anti-CD40 mAb Endocrinologists interviewed by REACH are eager for preventative treatments that offer a longer time to T1D progression and more convenient dosing than Tzield. Meghana Pandit, REACH Analyst: "Tzield as a concept is viewed favorably by physicians, however, there are concerns around its dosing, and efficacy profile which is reported as marginal." About MarketVue® MarketVue® reports are a rare disease focused, fresh alternative to traditionally long and outdated market research reports. MarketVue® reports cover rare disease epidemiology and key market dynamics based on research from key opinion leader interviews, physician surveys, and secondary data. About REACH Market Research REACH is an independent pharmaceutical market research company focused on rare and niche diseases. With decades of experience in pharmaceutical market research and life sciences consulting, REACH fills an important gap in the market – accessible market research solutions for rare and niche diseases. SOURCE REACH Market Research