Ludwigshafen, Germany, December 17, 2012 / B3C newswire / - Phenex Pharmaceuticals AG (Phenex) today announced it has entered into an agreement with Janssen Biotech, Inc. and its affiliates (Janssen) to jointly discover compounds that target the nuclear hormone receptor ROR?T and may have utility in the treatment of chronic autoimmune and inflammatory disorders including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Under the terms of the agreement Phenex will receive an upfront payment and milestone payments upon the achievement of specific development and regulatory events that could total as much as US$135 million. In addition, Phenex will also be eligible to receive tiered royalties and milestones on the worldwide sales of products that arise from the collaboration.
Researchers from Phenex and Janssen will work collaboratively towards the goal of identifying compounds that are active against ROR?T and optimized for preclinical development. Thereafter, Janssen will have sole responsibility for the continued development and worldwide commercialization of any compounds that arise from the collaboration.
“This collaboration represents a landmark deal for Phenex” comments Dr. Claus Kremoser, CEO of Phenex. “It combines Phenex’s nuclear receptor expertise, the accomplishments of its ROR?T program and the immunology expertise of Janssen so that we will work together to discover new ROR?T based treatments for autoimmune diseases. We hope that small molecule drugs that target ROR?T will prove to be a safe, effective and affordable means to treat autoimmune disease, a marketplace within which there remains a need for differentiated therapies. ”
Thomas Hoffmann, CFO of Phenex complements: “The upfront payment and near-term milestones that may be achieved through this collaboration are quite important for Phenex as the funds received will make it possible for us to both collaborate with Janssen on ROR?T and continue the clinical development of our proprietary FXR program through the next few years. By way of this agreement Phenex will be able to fund its operations and does not expect to seek further equity financing. Phenex maintains a favourable and exciting position in its ability to both help the patients who could benefit from ROR?T based therapies and provide our shareholders with a satisfactory return on their investments.”
About the target RORgamma(t):
RORgamma(t) (ROR?T) is a Nuclear Receptor that was recently identified as a key differentiation factor of Th-17 cells; immune cells that produce and secrete Interleukin-17, which is believed to be a key player in chronic autoimmune-related inflammation. The relevance of the IL-17 pathway has been highlighted by the fact that antibodies that target key cytokines in this pathway have demonstrated impressive efficacy in reducing symptoms in patients with plaque psoriasis. ROR?T induces the production of IL-17 and is known to bind small molecules. Thus, small molecule therapies that act on ROR?T have the potential to block the IL-17 pathway in a similar fashion to monoclonal antibodies. The effectiveness of inhibiting the IL-17 pathway through small molecule ROR?T inhibitors was recently demonstrated in animal models in two adjacent publications in Nature (Huh et al., Nature 472(7344) 486-90(2011); Solt et al., Nature 472(7344) 491-4 (2011)).
About Phenex Pharmaceuticals AG:
Phenex is a privately held drug discovery and development company headquartered in Ludwigshafen and with a research site in Heidelberg. The company focuses on novel attractive nuclear receptor targets to develop innovative small molecule therapeutics, including in the fields of liver diseases / Non-Alcoholic Steatohepatitis (FXR program) and autoimmune diseases / inflammatory disorders (ROR?T program).
Phenex’s most advanced program is based on Px-102, for which two Phase I studies have recently been completed. Px-102 targets and is an agonist of the nuclear bile acid receptor FXR. Px-102 has unique properties in showing beneficial effects of lipid lowering, improving insulin sensitivity, reducing body weight and ameliorating the liver inflammation and fibrosis that is a hallmark of Non-Alcoholic Steatohepatitis (NASH). NASH is a metabolically induced liver disease having a worldwide prevalence of at least 25 million affected individuals. If untreated, NASH can progress towards liver cirrhosis and liver failure, or even to Hepatocellular Carcinoma (HCC). There is no approved treatment for NASH. Px-102 addresses this medical need and presents a significant commercial opportunity.
Phenex is financed through four consecutive rounds of funding totalling 22 million Euros. The current circle of investors into Phenex includes EVP Capital Partners/VRP, LBBW Venture, Creathor Venture, KfW, and CD Venture, as well as private individuals and key people from the pharmaceutical and high-tech industry.
Phenex Pharmaceuticals AG
Dr. Claus Kremoser