Receptos agreed to license a humanized anti-interleukin-13 (IL-13) antibody from AbbVie, the branded-drug developer spun off earlier this year from Abbott, with an option to co-develop the drug following a Phase II proof-of-concept trial. Financial terms were not disclosed.
Receptos, a San Diego developer of drugs for immune and metabolic diseases, said it plans to conduct a Phase II study intended to demonstrate proof-of-concept of the antibody RPC4046 in eosinophilic esophagitis (EoE), an FDA-designated orphan disease indication.
AbbVie holds an exclusive option to enter into a global co-development collaboration for RPC4046 with Receptos following results of the planned Phase II study and regulatory discussions with FDA. Under co-development, the companies would equally share global costs of the Phase III clinical program and future development.
Receptos would retain a right to co-promote RPC4046 and share equally in profits in the U.S. Outside of the U.S., however, AbbVie would hold sole commercial rights and Receptos would be eligible for undisclosed double-digit royalties on net sales.
Under the collaboration, additional indications may be pursued. The mechanism of action has been shown to have potential in various immunological and allergic disorders, Receptos said in a statement.
"We believe that AbbVie's exceptional track record in immunology will be a strong asset in this collaboration," Faheem Hasnain, Receptos’ president and CEO, said in a statement.
AbbVie’s immunology pipeline is anchored by Humira, which has either submitted or is pursuing Phase III trials for indications that include the chronic skin disease hidradenitis suppurativa; peripheral spondyloarthritis, an arthritis-causing disease which affects mainly the arms and legs; uveitis, inflammation of the eye’s uvea; and two U.S. indications: axial spondyloarthritis, another arthritis-causing disease affecting mainly the spine and pelvic joints; and pediatric Crohn's disease.
Last month, AbbVie announced that pediatric Crohn’s patients aged 6–17 taking Humira in the Phase III IMAgINE-1 trial experienced a significant improvement in select measures of health-related quality of life at 12 weeks.
Humira is the most successful of the branded drugs AbbVie inherited from Abbott, and was last year’s top-selling drug according to GEN’s recently-published list of Top 20 Best Selling Drugs of 2012, with $9.265 billion in sales in 2012, up 19.3% from $7.932 billion in 2011. The drug is approved for numerous indications, including moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe Crohn’s disease; moderate to severe ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and moderate to severe polyarticular juvenile idiopathic arthritis.
The AbbVie immunology pipeline also includes two Phase II drug candidates—BT-061 for rheumatoid arthritis (RA) and psoriasis, and GLPG0634, also for RA.
AbbVie completed a first-in-human Phase I study of RPC4046, demonstrating that it was well tolerated in healthy subjects as well as in patients with mild to moderate persistent asthma, and supports both single dose IV administration and multiple subcutaneous doses.
Should AbbVie pass on exercising its co-development option for RPC4046, Receptos said, it would obtain a worldwide exclusive commercial license to all indications for the antibody.
Immunology is one of five disease areas identified by AbbVie for future activity and growth; the others were HCV, oncology, renal disease, and Alzheimer's disease.
Receptos is also focused on immunology. Its lead drug development program, RPC1063, is an oral, once-daily modulator of the sphingosine 1-phosphate 1 receptor (S1P1R) pathway, a G protein-coupled receptor (GPCR) target for relapsing multiple sclerosis (RMS) and inflammatory bowel disease. RPC1063 is enrolling patients into the randomized Phase II portion of a Phase II/III study examining the efficacy of RPC1063 in RMS and a randomized Phase II study examining the efficacy of RPC1063 in ulcerative colitis.