Vifor Pharma Licenses Rights to Commercialize ChemoCentryx’s Orally-Administered Complement 5aR Inhibitor CCX168 for Orphan and Rare Renal Diseases in Europe and Certain Other Major Markets
Dienstag, 10. Mai 2016, ↓ direkt zum Download
- Vifor Pharma to market drug in selected territories outside the US, ChemoCentryx responsible for worldwide development of CCX168 -
- ChemoCentryx to receive USD 85 million comprising USD 60 million in cash and USD 25 million equity investment; Deal also includes regulatory and commercial milestone payments and royalties on net sales to ChemoCentryx in the Vifor Pharma territories -
- Agreement additionally includes exclusive option to negotiate worldwide license for development and commercialization of CCR2 inhibitor CCX140 -
Vifor Pharma, a company of Galenica Group, and ChemoCentryx, Inc. (Nasdaq: CCXI), a biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, announced today that Vifor Pharma has licensed rights to commercialize CCX168, a Complement 5a Receptor (C5aR) inhibitor ready for Phase 3 development for orphan and rare renal diseases, in Europe, Canada, Mexico, Central and South America and South Korea.
CCX168 is being developed by ChemoCentryx for the treatment of conditions including but not limited to anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) and has obtained orphan drug status in the US and Europe. This disease affects approximately 40,000 people in the US, with around 4,000 new cases identified each year, and more than 75,000 people in Europe, with at least 7,500 new cases each year. It is currently treated with courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with high-dose corticosteroid administration.
A Phase 3 study of CCX168 in the treatment of AAV is expected to begin later this year. CCX168 is also in development for other orphan and rare renal diseases, including atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy.
"The collaboration with ChemoCentryx underlines our increasing attraction as the partner of choice for innovative pharmaceuticals,” said Søren Tulstrup, CEO of Vifor Pharma. “CCX168 has the potential to address major unmet medical needs of patients in a number of different orphan indications, including AAV. In this field of rare diseases, current treatment options are often limited as well as associated with serious and often fatal side effects. We look forward to working with ChemoCentryx to bring this potentially important new treatment option to patients in Europe and other major markets as quickly as possible.”
“This unique kidney health alliance between Vifor Pharma and ChemoCentryx is an ideal partnership,” said Thomas J. Schall, Ph.D., President and CEO of ChemoCentryx. “Vifor Pharma, together with its nephrology partner company Vifor Fresenius Medical Care Renal Pharma, is a world leader in delivering quality care for patients with kidney disease. Their renal medicines specialization, including access to a vast patient database and nephrology-focused commercial expertise, will be a valuable resource as we develop and commercialize CCX168. We believe that this partnership further validates our approach to blocking chemoattractant receptors such as C5aR and CCR2 in the inflammatory processes in several important diseases.”
Under the terms of the agreement, ChemoCentryx will receive an upfront payment of USD 60 million in cash and a USD 25 million equity investment to purchase ChemoCentryx common stock at a price of USD 7.50 per share. ChemoCentryx will be eligible to receive additional payments on the achievement of certain regulatory and sales-based milestones, as well as tiered double-digit royalties on net sales of CCX168 in the licensed territories. The agreement is the first step of a potentially larger kidney health alliance as it also provides Vifor Pharma with an exclusive option to negotiate a worldwide license agreement for CCX140, ChemoCentryx’s orally-administered inhibitor of the chemokine receptor known as CCR2.
Vifor Pharma, ein Unternehmen der Galenica Gruppe, ist eine der weltweit führenden Gesellschaften im Bereich Erforschung, Entwicklung, Herstellung und Vermarktung von pharmazeutischen Produkten zur Behandlung von Eisenmangel. Das Unternehmen bietet zudem ein diversifiziertes Portfolio an verschreibungspflichtigen Medikamenten und nicht verschreibungspflichtigen (OTC) Produkten an. Vifor Pharma mit Sitz in Zürich, Schweiz, baut seine globale Präsenz laufend aus und verfügt über ein umfassendes Netzwerk aus Tochtergesellschaften und Partnern weltweit.
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Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care, develops and commercialises innovative and high quality therapies to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Galenica and 45% by Fresenius Medical Care.
CCX168 is an orally-administered complement inhibitor which specifically targets the receptor for the complement fragment C5a receptor (C5aR). This receptor is known to activate destructive cells in certain autoimmune diseases including AAV. CCX168 is the lead drug candidate in ChemoCentryx’s orphan and rare disease program. In January 2016, ChemoCentryx reported positive top-line data from the Phase II CLEAR trial with CCX168 in 63 evaluable patients with AAV. The objective of the trial was to eliminate chronic high dose steroids, which are associated with significant safety issues including death, from the standard of care (SOC) regimen in AAV and replace them with CCX168. ChemoCentryx plans to initiate a Phase 3 clinical trial with CCX168 for the treatment of AAV by the end of 2016. CCX168 is being developed for other autoimmune disorders including atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy.
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. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 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, without compromising efficacy or safety in clinical studies to date. CCX168 is also in Phase II studies for the treatment of atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy (IgAN). 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. 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.