Development License and Option Agreement Represents Blueprint for Innovation between Pharma and Biotech
SAN DIEGO, CA, USA I March 13, 2013 I 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 (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.
About 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.
About Receptos
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 www.receptos.com.
SOURCE: Receptos
Post Views: 173
Development License and Option Agreement Represents Blueprint for Innovation between Pharma and Biotech
SAN DIEGO, CA, USA I March 13, 2013 I 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 (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.
About 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.
About Receptos
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 www.receptos.com.
SOURCE: Receptos
Post Views: 173
