Vifor Pharma and ChemoCentryx Announce Expansion of Kidney Health Alliance to Include CCX140 to Treat Renal Diseases
Vendredi 23 décembre 2016, ↓ accès direct au téléchargement
– ChemoCentryx to retain commercialization rights in the United States and China, Vifor Pharma gains rights in all other markets
– ChemoCentryx to receive upfront cash commitment of USD 50 million plus potential milestones and royalties
– Vifor Pharma receives an option to develop and commercialize CCX140 in chronic kidney disease (CKD) with U.S. co-promotion rights retained by ChemoCentryx
Vifor Pharma, a company of the Galenica Group, and ChemoCentryx, Inc., (Nasdaq: CCXI), announced today the expansion of their existing kidney health alliance to include the development and commercialization of CCX140, an orally-administered inhibitor of the chemokine receptor known as CCR2, for renal diseases. CCX140 has previously completed a successful Phase II clinical trial in patients with diabetic kidney disease.
The alliance will initially focus on the joint development of CCX140 in rare kidney diseases, with Vifor Pharma retaining an option to solely develop and commercialize CCX140 in more prevalent forms of chronic kidney disease (CKD). Under the agreement, ChemoCentryx retains marketing rights for rare renal disease in the U.S. and China, while Vifor Pharma has commercialization rights in the rest of the world.
In May 2016, the two companies announced that Vifor Pharma had licensed rights to commercialize CCX168 (international nonproprietary name: avacopan), a Complement 5a Receptor (C5aR) inhibitor ready for Phase III development for orphan and rare renal diseases, in Europe, Canada, Mexico, Central and South America and South Korea.
“Expanding our kidney health alliance with Vifor Pharma to include CCX140 is an important step in our vision to establish ChemoCentryx as a leader in new medicines for rare renal diseases,” said Thomas J. Schall, Ph.D., President and CEO of ChemoCentryx. “We and Vifor Pharma believe that CCX140 has the potential to address life threatening renal diseases for which there are currently very limited treatment options. Building upon the extremely productive relationship with our partner so far, we very much look forward to expanding that relationship with this unique clinical asset.”
"The expansion of our partnership with ChemoCentryx demonstrates Vifor Pharma’s commitment to remain at the forefront of new treatments for patients with renal diseases,” said Gianni Zampieri, CEO of Vifor Pharma. “CCX140 is a highly innovative approach, which is implicated in a number of kidney diseases, including diabetic nephropathy. We look forward to working with ChemoCentryx to develop both CCX140 and the C5aR inhibitor avacopan as potential new treatment options for patients suffering from serious kidney diseases.”
Under the terms of the agreement, ChemoCentryx will receive an upfront cash payment of USD 50 million. In addition, ChemoCentryx will be eligible to receive additional payments upon the achievement of certain development, regulatory and sales-based milestones, as well as tiered double-digit royalties on net sales of CCX140 in the licensed territories.
ChemoCentryx will be responsible for the clinical development of CCX140 in rare renal diseases, while sharing the cost of such development with Vifor Pharma. Should Vifor Pharma later exercise the CKD option, Vifor Pharma would then be responsible for all development and would receive worldwide rights to CCX140, while ChemoCentryx would receive co-promotion rights in CKD in the U.S.
Vifor Pharma, une entreprise du Groupe Galenica, est l’un des leaders mondiaux en matière de découverte, développement, fabrication et commercialisation de produits pharmaceutiques utilisés dans le traitement de la carence en fer. La société propose également un portefeuille diversifié de produits de prescription et de produits délivrés sans ordonnance (OTC). Vifor Pharma, dont le siège est à Zurich (Suisse), étend sans cesse sa présence mondiale et dispose d’un vaste réseau de filiales et de partenaires dans le monde.
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CCX140 targets the chemokine receptor known as CCR2 and has successfully completed a Phase II clinical trial in patients with diabetic nephropathy where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function. CCR2 is found on subsets of monocytes and macrophages, which are cells of the immune system believed to play an important role in inflammatory processes. Blocking CCR2 is intended to reduce the abnormal monocyte- and macrophage-driven inflammatory response implicated in renal diseases such as diabetic nephropathy. CCR2 may also have a direct role in the function of other specialized cells in the kidney, where its inhibition would correlate with a positive therapeutic effect.
ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. Avacopan (CCX168), a C5aR inhibitor, has successfully completed Phase II development for the treatment of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV). Avacopan appears to be safe, well tolerated and successful in allowing reduction and elimination of high-dose steroids, part of standard of care for AAV patients, while providing effective control of the disease in clinical studies to date. Avacopan is also in Phase II studies for the treatment of atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy (IgAN). ChemoCentryx has licensed exclusive rights to Vifor Pharma to commercialize avacopan in Europe and certain other markets outside of the U.S. and most of Asia. CCX872, a CCR2 inhibitor, successfully completed Phase I development and is in development for the treatment of non-resectable pancreatic cancer. CCX140, a distinct CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvement in albuminuria in patients with diabetic nephropathy. ChemoCentryx has licensed exclusive rights to Vifor Pharma to commercialize CCX140 in markets outside of the U.S. and China. Other clinical programs include CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development, vercirnon (also known as Traficet-EN or CCX282) a specific CCR9 inhibitor for the treatment of inflammatory bowel disease, and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com.
ChemoCentryx Forward-Looking Statements
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential" or "continue" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include statements regarding whether CCX140 will be shown to be effective in the treatment of chronic kidney disease and other rare renal diseases, whether eligible milestone payments or royalties on net sales of CCX140 will be attained and whether Vifor Pharma will exercise its option to obtain a worldwide license agreement for CCX140 to include chronic kidney disease. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K filed with the SEC March 14, 2016 and its other reports which are available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Head of Global Communications & Public Affairs