SAN DIEGO—Biopharmaceutical company Receptos Inc. hasannounced the establishment of a development license and option agreement withAbbVie—established from Abbott's separated research pharmaceuticals business on Jan. 1—toin-license a humanized anti-interleukin-13 (IL-13) antibody asset, designatedRPC4046 by Receptos.
No financial terms were disclosed.
Per the terms of the agreement, Receptos will conduct aPhase II clinical study seeking to demonstrate proof of concept in eosinophilicesophagitis, a chronic, allergic/immune-mediated disease that typicallydisplays symptoms related to esophageal dysfunction and eosinophil-predominantinflammation. The indication has been designated as an orphan disease by theU.S. Food and Drug Administration (FDA). For its part, AbbVie has an exclusiveoption to begin a global co-development collaboration with Receptos for thecompound following the results of the study and regulatory discussions with theFDA.
Should AbbVie exercise its option, the two companies wouldestablish a collaboration agreement in which they would equally share the costsof a Phase III clinical program as well as future development on a globalbasis. Receptos would have the right to co-promote RPC4046 and an equal shareof profits in the United States, while AbbVie, outside of the United States,would have sole commercial rights, with Receptos retaining eligibility fordouble-digit royalties on net sales. If AbbVie declines to exercise its option,Receptos will obtain a worldwide exclusive commercial license to the compoundfor all indications.
"We are honored that AbbVie has entrusted a promising PhaseII-ready therapeutic candidate to the Receptos development team to pursueproof-of-concept in [eosinophilic esophagitis], an Orphan Disease growing inprevalence for which there are no approved treatment options," Faheem Hasnain,president and CEO of Receptos, said in a press release. "We believe thatAbbVie's exceptional track record in immunology will be a strong asset in thiscollaboration."
As it stands, there are no FDA-approved drugs for treatingeosinophilic esophagitis. Existing options see patients treated with topicalsteroids; however, most relapse within four months. Recent estimates for theeosinophilic esophagitis patient population in 2012, based on diagnosis andprevalence rates, were approximately 160,000 patients in the United States androughly 145,000 patients in the European Union.
RPC4046 is a recombinant humanized antiinterleukin-13(IL-13) monoclonal antibody that is selective with a high affinity. The antibodybinds an IL-13 epitope that prevents its binding with interleukin-13 receptor(IL-13R)(alpha)1 and IL-13R(alpha)2, which could offer advantages in terms ofefficacy and/or safety. In a Phase I study of the compound, AbbVie showed thatRPC4046 was well tolerated in healthy subjects and patients presenting withmile to moderate persistent asthma. In addition, RPC4046 supports single-doseIV administration as well as multiple subcutaneous doses.
SOURCE: Receptos press release