Biogen NASDAQ: BIIB is continuing to position immunology as a larger part of its strategy, with late-stage lupus and kidney disease programs expected to shape the company’s next phase of growth, Adam Meyers, head of the company’s immunology and new disease areas franchise, said at Bank of America’s annual healthcare conference in Las Vegas.
Meyers said immunology is a “growing space” for Biogen and that his team is focused on preparing late-stage immunology assets for the market. He framed the shift as an extension of Biogen’s long-standing multiple sclerosis business, noting that many MS therapies target underlying inflammation.
“The time that we’ve spent building expertise around the biology of MS helps us as we expand into new areas of immunology with different specialty call points,” Meyers said.
Biogen Sees Immunology as an Extension of MS Expertise
Meyers said Biogen’s immunology capabilities began with research and development, but also carry over into medical affairs and commercialization. He pointed to the company’s MS franchise as an example of building specialist relationships, patient services and access support that could be applied to areas such as lupus and IgA nephropathy.
“All of these things I think are immediately transferable from what we’ve done, say, with an MS neurologist to a rheumatologist for lupus or a nephrologist for IgAN,” Meyers said.
Asked how far Biogen is willing to stretch beyond neurology, Meyers said the company needed to diversify, but that decisions would continue to be guided by science and unmet patient need. He cited nephrology as one area where Biogen sees both strong scientific rationale and commercial opportunity.
Lupus Readouts Put Litifilimab in Focus
Biogen’s next potential commercial immunology asset is litifilimab, which has two Phase 3 studies in systemic lupus erythematosus, or SLE, expected to read out. Meyers said the company’s Phase 2 program provided proof of concept in both skin and joint manifestations of lupus, with the SLE portion focused on joint activity and a separate cutaneous lupus erythematosus, or CLE, study evaluating skin disease.
In Phase 2, Biogen also measured SRI-4, the regulatory endpoint now being used in Phase 3. Meyers said the company saw a treatment effect of more than 25% on SRI-4 in Phase 2, compared with low- to upper-teen outcomes for some approved lupus therapies using SRI-4 or BICLA composite measures.
Still, Meyers cautioned that SRI-4 will be only one part of the assessment. He said Biogen will look at the totality of the data, including skin, joint and patient-reported outcomes, as well as convenience and safety.
“Right now we’re at subQ monthly delivered at home,” Meyers said, contrasting that with weekly subcutaneous or intravenous therapies. He added that litifilimab’s targeted mechanism could have safety advantages, including potentially around infections, though that remains to be shown in Phase 3 data.
Meyers also discussed dapirolizumab, another late-stage lupus asset in Biogen’s portfolio. He said lupus is heterogeneous enough that “one therapy is not going to be the answer for all patients.” The second dapirolizumab study is due to read out in 2028, he said.
Apellis Deal Seen as Supporting Nephrology Buildout
Meyers said Biogen’s pending Apellis transaction is intended to add growing products to revenue while also bringing nephrology expertise and an established field force. He said nephrology has “exploded in activity” in recent years, but that deep field experience in the specialty remains limited.
He highlighted SYFOVRE and EMPAVELI as assets that could contribute to near-term growth. Meyers said Biogen believes those products can grow in the “mid to upper teens” range over the next couple of years, broadly in line with consensus. For SYFOVRE, he said the opportunity is tied to educating physicians and patients in an under-penetrated market. For EMPAVELI, he noted the product is early in its launch cycle, has a broad label and fits Biogen’s experience in rare disease commercialization.
Meyers said the Apellis infrastructure could also help prepare Biogen for felzartamab, a CD38-targeted therapy being developed in kidney-related indications.
Felzartamab Targets AMR, IgAN and PMN
Biogen is evaluating felzartamab across antibody-mediated rejection, or AMR, IgA nephropathy, or IgAN, and primary membranous nephropathy, or PMN. Meyers separated the opportunity into transplant-related diseases, including AMR and microvascular inflammation, and glomerulonephritis indications such as IgAN and PMN.
In AMR, Meyers said there are potentially 11,000 patients, and the condition is a leading cause of kidney rejection. He said Phase 2 data showed about 80% of patients had a reduction in disease activity, while two-thirds had full biopsy-confirmed resolution of AMR. Biogen is seeking to replicate those findings in an ongoing Phase 3 study of 120 patients.
For IgAN, Meyers said felzartamab’s CD38 biology is distinct from APRIL-targeted therapies because it aims to deplete CD38-positive plasma cells that produce autoantibodies tied to immune complex formation in the kidney. He said Phase 2 data showed roughly a 50% reduction in proteinuria, and that some patients showed potential durability out to two years after an initial five-month course of therapy.
“At least to start, the view is, this is a very viable alternative to an APRIL,” Meyers said, adding that combination approaches remain difficult to assess at this stage because combining immunomodulators raises uncertainties.
MS Pipeline Work Continues With BIIB091
Meyers also addressed BIIB091, Biogen’s BTK inhibitor for multiple sclerosis. He said he would not characterize the program as a reinvestment in MS, but rather as a continuation of work the company has been pursuing for years. He said Biogen has focused on finding a BTK inhibitor with the right benefit-risk profile, given learnings around covalent versus non-covalent approaches and potential hepatotoxicity.
Biogen also has a BTK degrader, with a readout pending mid-year, Meyers said.
On the company’s existing MS portfolio, Meyers said VUMERITY has continued to grow and is the No. 1 prescribed branded oral MS therapy in the U.S. He acknowledged that other MS products in the portfolio have continued a slow decline. He said patients with relapsing MS are relatively better served than those with progressive disease, particularly patients experiencing disability progression without active lesions.
Looking ahead, Meyers said immunology and inflammation targets can often support multiple indications and generate proof-of-concept data more quickly than some other areas. He said Biogen will continue making selective investments where it sees strong science, less saturated disease areas and significant unmet need.
“I think the future is bright for I&I at Biogen, starting with the lupus readouts end of year and going into next year with Felza for AMR,” Meyers said.
About Biogen NASDAQ: BIIB
Biogen Inc is a multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases. Headquartered in Cambridge, Massachusetts, the company has a longstanding emphasis on neuroscience, with research and commercial activities spanning multiple therapeutic areas including multiple sclerosis, spinal muscular atrophy and Alzheimer's disease. Biogen was founded in 1978 and has grown into a global biopharmaceutical firm with operations and commercial presence across North America, Europe, Japan and other international markets.
The company's marketed portfolio has historically included several well-known therapies for multiple sclerosis such as Avonex, Tysabri and Tecfidera, and it has pursued treatments for rare neurological conditions and genetic neuromuscular disorders.
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