Alder BioPharmaceuticals has licensed exclusive worldwide rights to its Phase II inflammation candidate clazakizumab to a newly formed company for an undisclosed sum, the companies said today.
In return, Alder has received an equity stake in the new company Vitaeris, formed to commercialize clazakizumab and other treatments for chronic inflammatory diseases. Alder will also be eligible for royalties and other unspecified payments.
Clazakizumab, a monoclonal antibody candidate discovered by Alder, is designed to block the proinflammatory cytokine interleukin-6 (IL-6).
Alder has developed clazakizumab as a treatment for rheumatoid arthritis and psoriatic arthritis. According to the company’s most recent quarterly report, filed April 28, Clazakizumab has successfully completed two Phase IIb clinical trials establishing proof-of-concept in patients with rheumatoid arthritis.
“We believe that clazakizumab has the potential for further development as a therapeutic agent for one or more additional diseases where high levels of IL-6 are believed to play a role,” Alder stated. “We are actively pursuing strategic alternatives for the further development of clazakizumab to leverage its ability to effectively inhibit IL-6.”
Clazakizumab has been administered in clinical trials involving more than 1000 patients, Alder and Vitaeris said today.
“Clazakizumab holds significant potential as a treatment for inflammatory diseases, and we will leverage the robust clinical trial data in hand to chart its development path,” Noel Hall, co-founder and chairman of Vitaeris, said in a statement
As part of the licensing deal, Alder’s president and CEO Randall C. Schatzman, Ph.D., has joined Vitaeris’ board of directors, as has Andreas Wicki, Ph.D., CEO of HBM Healthcare Investments, a founding investor in the new company.
Alder obtained full development rights to clazakizumab in 2014 from Bristol-Myers Squibb (BMS) following the termination of a license and collaboration agreement signed in 2009. Under that agreement, Alder received $85 million upfront from BMS and could have received another $764 million in milestone payments.
Alder has been among several companies developing IL-6 inhibitors to treat arthritis. GlaxoSmithKline and Johnson & Johnson announced positive Phase III results for their candidate sirukumab in December. GSK has said it will file for FDA approval this year for sirukumab.
The FDA is reviewing the IL-6 inhibitor sarilumab developed by Sanofi and Regeneron. The companies reported positive Phase III results for the compound in November, and again in March, when Sanofi and Regeneron said sarilumab had shown superiority to AbbVie’s Humira® (adalimumab) in patients with active rheumatoid arthritis at week 24.
Roche won initial FDA approval in 2010 for its first-in-class IL-6 inhibitor Actemra® (tocilizumab), whose indications include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Actemra can be used alone or in combination with methotrexate or other disease-modifying antirheumatic drugs.