Alder BioPharmaceuticals Regains Worldwide Rights To Clazakizumab

Alder BioPharmaceuticals, Inc.

, a clinical-stage company developing antibody therapeutics, today announced that it has regained the worldwide rights to clazakizumab, a humanized monoclonal antibody to the pro-inflammatory cytokine IL-6, from Bristol-Myers Squibb based on BMS' decision to end further development following a portfolio prioritization and not based on any new or unexpected efficacy or safety data or technical issues. Alder plans to continue the clinical development of the therapeutic antibody in autoimmune/inflammatory disease based on the positive study results reported to date. "We view BMS's decision as a significant opportunity for Alder," said Randall Schatzman, president and CEO of Alder. "This positions us with two programs with positive Phase II data for which we control the timelines and how we move forward with development. The first one is ALD403, which we will continue to develop aggressively based on the promising Phase II data in migraine prevention. The second, clazakizumab, has strong data that were presented at the most recent ACR and EULAR conferences. These data demonstrate the potential for clazakizumab to fulfill the unmet need in patients with rheumatoid arthritis (RA) to achieve disease control and remission. At this time we are reviewing our options to expedite the development of clazakizumab while maintaining our focus on the continuing development of ALD403 for migraine on the current timelines." As presented at the American College of Rheumatology and European League Against Rheumatism conferences in October 2013 and June 2014, respectively, data from a Phase IIb study of clazakizumab in adults with moderate-to-severe active RA and an inadequate response to methotrexate showed that: All clazakizumab treatment arms, both as monotherapy and in combination with methotrexate (MTX), met the primary endpoint of ACR20 response at 12 weeks, compared to MTX alone. Clazakizumab had promising rates of low disease activity and remission based on Disease Activity Score (DAS)28, Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) criteria in the study that included MTX and anti-TNF comparator arms. Remission rates by CDAI and DAS28-CRP were numerically greater for clazakizumab than for the active comparator anti-TNF, adalimumab. The safety profile of clazakizumab was consistent with the known pharmacology of IL-6 blockade. The results of a Phase IIb dose-ranging clinical trial of clazakizumab in patients who suffer from active psoriatic arthritis (PsA) will be the focus of an oral presentation at the American College of Rheumatology's 2014 Annual Meeting, which takes place Nov. 14-19 in Boston.