Vifor Pharma and ChemoCentryx Announce Expansion of Avacopan Agreement for Rare Renal Diseases
February 14 2017 - 7:00AM
-- ChemoCentryx retains all rights in the United
States and China; Vifor Pharma gains additional marketing rights in
Asia, including Japan and Middle Eastern markets --
Vifor Pharma, a company of the Galenica Group, and ChemoCentryx,
Inc., (Nasdaq:CCXI), announced today that Vifor Pharma has gained
rights to commercialize avacopan in Asia, including Japan and the
Middle-East. ChemoCentryx retains all rights in the United States
and China. Avacopan is an orally-administered inhibitor of the
complement 5a receptor (C5aR) and is currently in Phase III
development for rare renal diseases.
The expanded agreement effectively gives Vifor Pharma rights to
commercialize avacopan for orphan and rare renal diseases in all
markets outside the United States and China, building on the
original licensing agreement signed in May 2016.
ChemoCentryx will receive an upfront cash commitment of USD 20
million in return for the new rights, plus tiered double-digit
royalties on potential net sales. This is in addition to the USD 85
million upfront paid under the original May 2016 licensing
agreement.
Avacopan is being developed by ChemoCentryx for the treatment of
orphan and rare renal conditions including but not limited to
anti-neutrophil cytoplasmic auto-antibody (ANCA)-associated
vasculitis (AAV). AAV is a systemic disease which most commonly
presents as kidney dysfunction. AAV is currently treated with
courses of non-specific immuno-suppressants (cyclophosphamide or
rituximab), combined with high-dose corticosteroid administration,
which is associated with significant safety issues, including
premature death. Avacopan is in Phase III development (the ADVOCATE
trial) for the treatment of AAV and is also in development for
other orphan and rare renal diseases, including C3 glomerulopathy
(C3G) and atypical hemolytic uremic syndrome (aHUS).
“The expansion of avacopan territory rights with renal care
leader Vifor Pharma, and with ChemoCentryx retaining all US and
China rights, expertly positions our rare renal disease portfolio
for global commercialization,” said Thomas J. Schall, Ph.D.,
President and CEO of ChemoCentryx. “We have now harmonized both the
avacopan and the subsequent agreement which we signed in late
December for another rare renal asset, CCX140, in our highly
productive Kidney Health Alliance with Vifor Pharma. ChemoCentryx
also has greater than USD 200 million in proforma reserves, based
on our last filings, providing for an ambitious development plan
for avacopan and CCX140 in orphan and rare renal diseases. We and
Vifor Pharma believe these two unique clinical assets have the
potential to transform lives of those with devastating rare renal
diseases, and to build extraordinary value for both of our
enterprises.”
"The acquisition of global commercialization rights outside the
US and China demonstrates our strong belief in the potential of
avacopan in a wide range of rare and orphan renal diseases,” said
Gianni Zampieri, CEO of Vifor Pharma. “This agreement further
strengthens our growing partnership with ChemoCentryx, and
underlines our commitment to bring highly innovative therapies to
patients with serious renal conditions around the world.”
Avacopan is an orally-administered complement
inhibitor which specifically targets the receptor for the
complement C5a receptor (C5aR). This receptor is known to activate
destructive cells in certain autoimmune diseases including AAV.
Avacopan is the lead drug candidate in ChemoCentryx’s orphan and
rare disease program. The U.S. Food and Drug Administration granted
orphan-drug designation for avacopan for the treatment of patients
with AAV, (which includes Wegener's granulomatosis, microscopic
polyangiitis, and Churg-Strauss syndrome) and also for the
treatment of patients with atypical hemolytic uremic syndrome
(aHUS). The European Commission has granted orphan medicinal
product designation for avacopan for the treatment of microscopic
polyangiitis and granulomatosis with polyangiitis (formerly known
as Wegener's granulomatosis). Both conditions are forms of
AAV. Avacopan was also granted access to the European
Medicines Agency's (EMA) PRIority MEdicines (PRIME) initiative,
which supports accelerated assessment of investigational therapies
addressing unmet medical need. Avacopan successfully completed
Phase II development where it was shown to be safe and effective in
eliminating chronic high dose steroids, which are associated with
significant safety issues including death, from the standard of
care (SOC) regimen in AAV and is now in Phase III development.
Avacopan is also being developed for other autoimmune disorders
including C3 Glomerulopathy (C3G) and atypical hemolytic uremic
syndrome (aHUS).
ChemoCentryx is a clinical-stage
biopharmaceutical company primarily focused on developing new
medicines for patients with rare renal diseases. ChemoCentryx
targets the chemokine and chemoattractant systems to discover,
develop and commercialize orally-administered therapies to treat
orphan and rare diseases. Avacopan (CCX168), an inhibitor of the
complement 5a receptor (C5aR), is in Phase III development for the
treatment of anti-neutrophil cytoplasmic auto-antibody-associated
vasculitis (AAV). Avacopan was 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 being developed in patients with
atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy
(C3G). CCX140, an inhibitor of the chemokine receptor known as
CCR2, successfully completed a Phase II clinical trial where it was
shown to be safe and well tolerated while demonstrating
statistically significant improvement in proteinuria in patients
with diabetic nephropathy and is currently being developed in a
rare kidney disease known as focal segmental glomerulosclerosis
(FSGS). Both avacopan and CCX140 are part of a Vifor
Pharma-ChemoCentryx Kidney Health Alliance which provides Vifor
Pharma with exclusive rights to commercialize avacopan and CCX140
in certain markets outside of the U.S. and China. ChemoCentryx has
an immuno-oncology program, which includes a distinct CCR2
inhibitor, CCX872, currently in development for the treatment of
advanced non-resectable pancreatic cancer.
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 CCX168 will
be shown to be effective in Phase III clinical trials in the
treatment of AAV and other rare renal diseases and whether eligible
milestone payments or royalties on net sales of CCX168 will be
attained and the potential of avacopan and CCX140 to build value
for ChemoCentryx. 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.
For further information, please contact:
Vifor Pharma - Media Relations:
Beatrix Benz, Head of Global Communications & Public Affairs
Tel.: +41 58 851 80 16
E-mail: media@viforpharma.com
ChemoCentryx Contacts:
Susan M. Kanaya
Executive Vice President, Chief Financial and Administrative Officer
E-mail: investor@chemocentryx.com
Media:
Denise Powell
Tel.: +1 510.703.9491
E-mail: denise@redhousecomms.com
Investors:
Steve Klass
Burns McClellan
Tel.: +1 212.213.0006
E-mail: sklass@burnsmc.com
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