Xcimzane (certolizumab pegol biosimilar) / Xbrane, Alvotech - LARVOL DELTA

Xbrane has entered into an agreement to sell XB003 (Cimzia biosimilar candidate) and parts of its organization to Alvotech for a total consideration of SEK 275 million (Xbrane Press Release) - "Xbrane Biopharma...has entered into an agreement to sell XB003 (biosimilar candidate to Cimzia) and parts of its organization, including approximately 40 employees and laboratory equipment, to Alvotech for a total consideration of approximately SEK 275 million. XB003 is the most advanced biosimilar candidate to Cimzia under development, representing approx. 25% of the competitive adjusted adressable market of Xbranes portfolio...Closing of the transaction is subject to approval from Xbrane's shareholders at an Extraordinary General Meeting (the 'EGM') to be held on 14 April 2025 as well as FDI approval...Xbrane will retain Ximluci (biosimilar to Lucentis) and Xdivane (biosimilar candidate to Opdivo)....A service agreement will be established between the parties under which Xbrane can get support from the transitioned part of the organization. The reduction in Xbrane's organization will reduce annual fixed costs by approximately SEK 120 million."

Commercial • Diabetic Macular Edema • Diabetic Retinopathy • Head and Neck Cancer • Immunology • Kidney Cancer • Liver Cancer • Psoriasis • Rheumatoid Arthritis • Skin Cancer • Wet Age-related Macular Degeneration

XBRANE BIOPHARMA IS FOCUSING THE DEVELOPMENT PORTFOLIO AND INTRODUCING A COST-SAVINGS SCHEME (Xbrane Press Release) - "Xbrane Biopharma AB...announced today that it is focusing the company's development portfolio and, consequently, the development of Xtrudane (biosimilar candidate to Keytruda) has been terminated. Furthermore, a cost-savings scheme is being introduced which is expected to result in around SEK 50 million in annual savings when fully implemented. Xbrane's main aim is to achieve a positive cash flow as soon as possible and as previously announced, by no later than Q1 2025. Therefore, Xbrane’s board has decided to focus the development portfolio on biosimilar candidates with established commercialization partners: Ximluci (Lucentis biosimilar), BIIB801 (Cimzia biosimilar candidate), and Xdivane (Opdivo biosimilar candidate) with the ambition of out-licensing the latter in the near future. Xdarzane (Darzalex biosimilar candidate) is being maintained in the portfolio..."

Clinical • Age-related Macular Degeneration • Crohn's disease • Diabetic Macular Edema • Immunology • Inflammatory Bowel Disease • Ophthalmology • Psoriatic Arthritis • Retinal Vein Occlusion • Rheumatoid Arthritis • Wet Age-related Macular Degeneration

Interleukin Inhibitors for Moderate to Severe Psoriasis (HMP Global) - "Dr Armstrong moved on to a discussion of the biologics available to treat plaque psoriasis. The first class is anti-TNα therapies, which 'can work 'upstream' as well as 'downstream.' The FDA-approved TNF inhibitors are etanercept, adalimumab, infliximab, and certolizumab. Next are the FDA approved IL-17 inhibitors: secukinumab, ixekizumab, brodalumab. Secukinumab and ixekizumab have 'identical mechanism of action, binding to IL-17A, and they treat both psoriasis as well as psoriatic arthritis,' stated Dr Armstrong.'"

Media quote

Biogen, Xbrane Enter Commercialization Agreement for Cimzia Biosimilar (Center for Biosimilars) - "Biogen and Xbrane Biopharma have entered into a commercialization and license agreement for a biosimilar candidate referencing Cimzia (UCB; certolizumab pegol), Xcimzane, for the treatment of rheumatologic conditions....Under the agreement, Biogen will be responsible for exclusive global regulatory application and approvals...Biogen will make an $8 million up-front payment to Solna, Sweden–based Xbrane. As certain development and commercial milestones are achieved, Xbrane will be eligible to receive up to $80 million in milestone payments. Xbrane will also be responsible for the preclinical development of the drug and Biogen will be in charge of all remaining development activities."

Licensing / partnership • Ankylosing Spondylitis • Crohn's disease • Immunology • Psoriasis • Rheumatoid Arthritis

Q&A: Biologics Versus Targeted Therapies in Psoriatic Arthritis (Rheumatology Network) - "'Our results suggest that there are likely to be certain treatments that will confer preferential response in psoriatic arthritis (PsA), including tumor necrosis factor (TNF) inhibitors and IL-17 medications, compared to other options,' stated Jeffrey Curtis, MD."

Interview