Receptos Licenses Anti-Interleukin-13 Antibody from AbbVie for Phase 2
Development in Orphan Disease
Development License and Option Agreement Represents Blueprint for Innovation
between Pharma and Biotech
SAN DIEGO, March 13, 2013
SAN DIEGO, March 13, 2013 /PRNewswire/ --Receptos Inc. announced today that
it has entered a Development License and Option Agreement to in-license a
humanized anti-interleukin-13 (IL-13) antibody asset from AbbVie (NYSE: ABBV).
The asset, designated RPC4046 by Receptos, has completed a first-in-human
Phase I study. Under the agreement, Receptos will conduct a Phase 2 clinical
study to demonstrate proof-of-concept in Eosinophilic Esophagitis (EoE), an
indication designated as an Orphan Disease by the US FDA. AbbVie holds an
exclusive option to enter into a global co-development collaboration for
RPC4046 with Receptos following results of the planned Phase 2 study and
regulatory discussions with the FDA.
"We are honored that AbbVie has entrusted a promising Phase 2-ready
therapeutic candidate to the Receptos development team to pursue
proof-of-concept in EoE, an Orphan Disease growing in prevalence for which
there are no approved treatment options," said Faheem Hasnain, President and
Chief Executive Officer of Receptos. "We believe that AbbVie's exceptional
track record in immunology will be a strong asset in this collaboration."
Upon exercise of the co-development option, AbbVie and Receptos would enter
into a collaboration agreement in which the parties would equally share costs
of the Phase 3 clinical program and future development on a global basis.
Receptos would retain a right to co-promote RPC4046 and share equally in
profits in the United States. Outside of the US, AbbVie would hold sole
commercial rights and Receptos would be eligible for double digit royalties on
net sales. Additional indications may be pursued under the collaboration, as
the mechanism of action has been shown to have potential in various
immunological and allergic disorders.
Should AbbVie decline to exercise its co-development option for RPC4046,
Receptos would obtain a worldwide exclusive commercial license to all
indications for RPC4046.
RPC4046 is a recombinant humanized, high affinity, selective,
anti–interleukin-13 (IL-13) monoclonal antibody. RPC4046 binds an IL-13
epitope that prevents its binding to both interleukin-13 receptor
(IL-13R)(alpha)1 and IL-13R(alpha)2, providing potential advantages in
efficacy and / or safety. A Phase I study completed by AbbVie demonstrated
that RPC4046 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. IL-13 antagonists have
demonstrated efficacy in preclinical models of allergic and other
immunological disorders. Human proof of concept for the anti-IL-13 mechanism
of action has recently been demonstrated in a positive Phase 2 asthma clinical
study, in which the anti-IL-13 antibody lebrikizumab was associated with
improved lung function.
About Eosinophilic Esophagitis (EoE)
EoE is a chronic, allergic/immune-mediated disease characterized clinically by
symptoms related to esophageal dysfunction and eosinophil-predominant
inflammation. Quality of life is often significantly decreased due to food
impaction, swallowing difficulty, and other disease effects. Designated an
Orphan Disease in the United States, there are currently no FDA approved drugs
for the treatment of EoE. Although the majority of patients are treated
chronically with topical steroids, patients relapse rapidly within four
months, creating high unmet need for drugs that reduce clinical symptoms,
modify disease progression through tissue remodeling, and / or increase
duration of treatment response. Over the course of the last decade, there has
been a steady rise in incidence and diagnosis of EoE due to increases in
atopic diseases in the general population and adoption of diagnostic
guidelines. Based on reported prevalence and diagnosis rates, estimates for
the 2012 diagnosed EoE patient population are approximately 160,000 patients
in the United States and approximately 145,000 patients in the European Union.
Receptos is a biopharmaceutical company developing therapeutic candidates for
the treatment of immune and metabolic diseases. The company's lead program,
RPC1063, is a potential best-in-class S1P1R small molecule modulator candidate
for immune indications, including relapsing multiple sclerosis (RMS) and
inflammatory bowel disease (IBD). RPC1063 is currently enrolling patients into
the randomized Phase 2 portion of a Phase 2/3 study examining the efficacy of
RPC1063 in the indication of RMS and a randomized Phase 2 study examining the
efficacy of RPC1063 in ulcerative colitis (UC). Receptos has established
expertise in high resolution protein crystal structure determination, biology
and drug discovery for G-protein-coupled receptors (GPCRs). This expertise has
formed the basis of collaborations with Eli Lilly and Ono Pharmaceutical and a
partnership with Janssen Pharmaceuticals, Inc. For more information visit
Media and Investor Contacts:
Ian Stone or David Schull (media)
(619) 308-6541 or (212) 845-4271
SOURCE Receptos Inc.
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