On April 7, 2014 Roche and Oryzon Genomics reported they have entered into a worldwide collaboration to research, develop and commercialize inhibitors of Lysine Specific Demethylase-1 (LSD1; KDM1A), an epigenetic modulator that regulates gene expression (Press release Oryzon, APR 7, 2014, View Source [SID:1234500879]).
The lead molecule, ORY-1001, was granted orphan drug status by EMA in August 2013 and is currently in phase I/IIA for acute myeloid leukaemia (AML). Roche will have sole responsibility for developing and commercializing ORY-1001 and/or its backup compounds. The agreement includes the licensing of two patent families that Oryzon has created in its pioneering research in LSD1, and includes options for other Oryzon programs to be incorporated in future. The agreement also includes an initial two-year collaborative research program between Oryzon and Roche’s New York-based Translational Clinical Research Center (TCRC), Roche’s hub for research and early development activities in North America, to better understand the potential of LSD1 inhibitors in oncology and haematology.
John Reed, Roche’s Head of Pharma Research and Early Development, commented, "Oryzon is working at the leading edge of LSD1 inhibition, a technology with great potential to bring genuine patient benefit. Our TCRC in New York has been launched with a mandate to identify partnerships that drive innovation, providing an industryleading conduit between sources of breakthrough science and the broader Roche organization. This collaboration on LSD1 inhibition with Oryzon fulfils that mandate perfectly."
Carlos Buesa, CEO of Oryzon, added, "We are excited to work with Roche in developing ORY-1001 to make a significant difference for patients with AML and, hopefully, for patients in other disease areas as well. Roche is the global leader in oncology and haematology, with a tremendous expertise in clinical development; this was the primary reason to prioritize this alliance. The collaboration is recognition of our cutting-edge science and our experience in epigenetics, an approach that we believe holds great promise for many patient groups."
Under the terms of the agreement, Oryzon will receive an upfront payment and near-term milestones totalling $21 million, plus potential development, commercial and sales milestone payments across haematology, cancer and non-malignant indications that could exceed $500 million, together with tiered royalties on sales which range up to mid-double digits.

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