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
- 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 -
- ChemoCentryx to Host Conference Call Today at 8:30 a.m. Eastern Time -
MOUNTAIN VIEW, Calif., May 10, 2016 (GLOBE NEWSWIRE) -- 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.
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.
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.
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.
Conference Call and Webcast The Company will host a conference call and webcast today, May 10, 2016 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 5511529. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.ChemoCentryx.com. The archived webcast will remain available on the Company's website for fourteen (14) days following the conference call.
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 CCX168 will be shown to be effective in Phase 3 clinical trials in the treatment of AAV and other orphan and rare diseases, whether eligible milestone payments or royalties on net sales of CCX168 will be attained and whether ChemoCentryx will enter into a worldwide license agreement for CCX140 with Vifor Pharma. 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.