Belimumab

Payments to Biogen will be spread over six quarters. Credit: PeopleImages via Getty Images. Royalty Pharma has signed a deal to pay Biogen $250m to support the development of its late-stage experimental lupus medication litifilimab. In return, Royalty Pharma will receive undisclosed milestone payments if the drug meets certain regulatory goals, as well as mid-single-digit royalties on worldwide sales. Payments up to $250m to Biogen will be spread over six quarters, Royalty said in the announcement. Litifilimab, an anti-BDCA2 antibody, is being evaluated in Phase III trials for both systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Biogen will use the funds to continue development, with trial results expected in 2026 and 2027. The market for SLE remains largely dominated by generic drugs, with few targeted biologics approved by the US Food and Drug Administration (FDA) in the last 50 years . These include GSK’s Benlysta (belimumab) and AstraZeneca’s Saphnelo (anifrolumab). The market for CLE, however, has seen even less innovation. CLE is a form of lupus that primarily affects the skin, leading to inflammation, rashes, and lesions, though it can sometimes be linked to SLE. Litifilimab showed promising results in the Phase II LILAC study (NCT02847598), where it significantly reduced skin disease activity in people with CLE compared to placebo as measured by the primary endpoint. If approved, the drug could generate up to $750m in global sales by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. This agreement expands Royalty’s portfolio, adding to a series of deals that the company has struck over recent years. This includes transactions with BridgeBio Pharma, ImmuNext, Cytokinetics and Agios Pharmaceuticals. Royalty’s deal with ImmuNext provided it with access to royalties and milestones on a drug to treat multiple sclerosis (MS) under development with Sanofi. Royalty also holds rights on Biogen’s MS medication Tysabri (natalizumab) and spinal muscular atrophy drug Spinraza (nusinersen), acquired through agreements with Ionis and Perrigo. The deal coincides with Biogen’s latest earnings report, in which the company exceeded Q4 2024 expectations due to cost-cutting measures and new product launches, including its Alzheimer’s drug Leqembi (lecanemab). However, Biogen expects reduced profits this year, citing currency fluctuations and competition in the MS market. The biotech also announced the discontinuation of four drug development programmes: a Phase II asset for diabetic peripheral neuropathic pain and three Phase I neurodegenerative disease candidates. Biogen hit the headlines last month when Sage Therapeutics rejected its $469m takeover offer, with the company’s board of directors unanimously concluding that the bid “significantly undervalues” the company. Made earlier this year, the proposal offered $7.22 per share, a 30% premium on Sage’s share price at the time. Sage responded by suing Biogen to “enforce a standstill agreement” between the two companies. Biogen currently co-markets Sage’s postpartum depression drug Zurzuvae (zuranolone).

With litifilimab, Biogen is going after the type 1 interferon signature by inhibiting BDCA2.\n Biogen has bagged $250 million to advance a key pipeline prospect. Royalty Pharma is providing the cash to bankroll phase 3 development of a lupus candidate that Biogen has named in a bunch of assets with potential peak sales of $14 billion.The candidate, the anti-BDCA2 antibody litifilimab, is in phase 3 development in systemic and cutaneous lupus erythematosus (SLE/CLE). There is unmet need in both diseases. SLE patients have limited choices, with GSK’s Benlysta and AstraZeneca’s Saphnelo the only options, but that is rich pickings compared to CLE. Physicians have been waiting decades for an advance in the treatment of the cutaneous disease.Biogen believes litifilimab can address the unmet needs. But, with a pipeline of other programs—including two other lupus assets—to develop, the biotech has opted to seek external money to fund phase 3 trials in SLE and CLE.Royalty is providing the money, agreeing to drip-feed Biogen $250 million over six quarters in exchange for regulatory milestones and mid-single-digit royalties on annual worldwide sales. Royalty, a buyer of biopharmaceutical royalties, already receives a cut of the sales of Biogen’s Tysabri and Spinraza. The firm secured those royalties through deals with Ionis and Perrigo rather than directly from Biogen. Biogen has prioritized its pipeline under CEO Christopher Viehbacher, helping it cut R&D spending by 17% last year. The Royalty deal supports ongoing cost management while still allowing Biogen to attempt to bring litifilimab to market.Viehbacher talked up litifilimab’s prospects on an earnings call in October, including the asset among a clutch of candidates that the CEO said could collectively generate peak sales of $9 billion to $14 billion. CLE is an untapped opportunity. Litifilimab will face competition if it comes to market in SLE, potentially from Biogen’s own dapirolizumab, but Viehbacher sees room for multiple molecules.“This is a complex disease that affects different organs at a time,” Viehbacher said at the J.P. Morgan Healthcare Conference last month. “I think it\'s going to be a little like MS. You\'re really going to decide which product is best at which point in time for every patient. And so I don\'t think this is one product for the whole disease.”Dapirolizumab inhibits the CD40 ligand to reduce activation of B and T cells and downregulate interferon. With litifilimab, Biogen is going after the type 1 interferon signature by inhibiting BDCA2 in the plasma delta. The biotech is aiming to file for approval of litifilimab in SLE and CLE from 2027 to 2029.