ChemoCentryx Secures up to $100 Million in New Capital Commitments
January 04 2018 - 7:05AM
-- ChemoCentryx to Receive $50 Million Milestone
from Vifor Pharma for Validation of Conditional Marketing
Authorization Application for Avacopan for the Treatment of ANCA
Vasculitis --
ChemoCentryx, Inc., (Nasdaq:CCXI) today announced that it will
receive a $50 million milestone payment from Vifor Fresenius
Medical Care Renal Pharma (VFMCRP), a company of the Vifor Pharma
Group and Fresenius Medical Care. The milestone was triggered by
the European Medicines Agency (EMA)’s validation of the Company’s
Conditional Marketing Authorization (CMA) application for avacopan
in the treatment of patients with anti-neutrophil cytoplasmic
auto-antibody-associated vasculitis (ANCA-associated vasculitis),
announced earlier today. In addition to the $50 million milestone
from VFMCRP, the Company also entered into a $50 million growth
capital financing agreement with Hercules Capital, Inc.
(NYSE:HTGC), bringing total new capital commitments of up to $100
million to ChemoCentryx. Such additional capital is expected to
provide funding to advance avacopan through topline data from the
Phase III ADVOCATE trial as well as potential registration filings
in the U.S. and EU.
"The validation of our CMA application by the EMA is a pivotal
milestone in our Kidney Health Alliance with Vifor. It is also a
major advance in heightening the awareness of the plight of ANCA
vasculitis patients,” said Thomas J. Schall, Ph.D., President and
Chief Executive Officer of ChemoCentryx. “The status quo is simply
not good enough for ANCA patients and new therapies are desperately
needed. The decision of the EMA to validate our conditional
marketing application will enable a thorough examination of how we
at CCXI and our partners at Vifor may create just such a valuable
new paradigm for ANCA treatment.”
ChemoCentryx, which is responsible for the discovery and
development of avacopan, owns and retains the commercial rights to
the drug in the United States and China, and VFMCRP has licensed
the rights to commercialize the drug in all other countries. Under
the terms of the Kidney Health Alliance with Vifor Pharma, which
comprises both avacopan and CCX140, ChemoCentryx has received a
total of $155 million in upfront cash and cash commitments in
addition to the $50 million milestone announced today. ChemoCentryx
is eligible to receive additional payments upon the achievement of
certain development, regulatory and sales-based milestones, as well
as tiered double-digit royalties on potential net sales of avacopan
and CCX140 in the Vifor licensed territories.
The $50 million credit facility from Hercules Capital comprises
three tranches. The first tranche of $15 million, of which $5.0
million was funded upon closing of the agreement, is available
through June 2018. The remaining $35 million is available in two
additional tranches, subject to certain conditions. The term loan
has a 24-month interest-only period from initial funding, which is
extendable to 30 months upon the achievement of certain milestones
and matures in 48 months. Further information with respect to the
growth capital financing agreement with Hercules is contained on a
Form 8-K to be filed by ChemoCentryx with the Securities and
Exchange Commission.
About ChemoCentryx
ChemoCentryx is a biopharmaceutical company developing new
medications targeted at inflammatory and autoimmune diseases and
cancer. ChemoCentryx targets the chemokine and chemoattractant
systems to discover, develop and commercialize orally-administered
therapies. ChemoCentryx is currently focusing on its late stage
drug candidates for patients with rare kidney diseases, avacopan
(CCX168) and CCX140.
Avacopan is an orally-administered small molecule that is a
selective inhibitor of the complement C5a receptor, or C5aR.
Avacopan is in Phase III development for the treatment of
anti-neutrophil cytoplasmic auto-antibody-associated vasculitis
(ANCA Vasculitis). In clinical studies to date, avacopan was shown
to be safe, well tolerated and provided effective control of the
disease while allowing elimination of high-dose steroids, part of
the current standard of care. Avacopan is also being developed in
patients with C3 glomerulopathy (C3G) and atypical hemolytic uremic
syndrome (aHUS). The U.S. Food and Drug Administration has granted
avacopan orphan-drug designation for ANCA Vasculitis, C3G and aHUS.
The European Commission has granted orphan medicinal product
designation for avacopan for the treatment of two forms of ANCA
Vasculitis: microscopic polyangiitis and granulomatosis with
polyangiitis (formerly known as Wegener's granulomatosis), as well
as for C3G. 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.
The Company's other late stage drug candidate is CCX140, an
inhibitor of the chemokine receptor known as CCR2, which is
currently being developed for patients with focal segmental
glomerulosclerosis (FSGS), a debilitating kidney disease.
ChemoCentryx's Kidney Health Alliance with Vifor Pharma provides
Vifor Pharma with exclusive rights to commercialize avacopan and
CCX140 in markets outside of the U.S. and China.
ChemoCentryx also has early stage drug candidates that target
chemoattractant receptors in other Inflammatory and autoimmune
diseases and in cancer.
About Hercules Capital, Inc.
Hercules Capital, Inc. (NYSE:HTGC) is the leading and largest
specialty finance company focused on providing senior secured
venture growth loans to high-growth, innovative venture
capital-backed companies in a broad variety of technology, life
sciences and sustainable and renewable technology industries. Since
inception (December 2003), Hercules has committed more than $7.0
billion to over 390 companies and is the lender of choice for
entrepreneurs and venture capital firms seeking growth capital
financing.
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," "continue" or "project" or the negative of these terms
or other comparable terminology are intended to identify
forward-looking statements. These statements include the Company's
statements regarding the achievement of anticipated goals and
milestones, whether the additional up to $100 million in capital
will provide sufficient funding through topline data from the
avacopan ADVOCATE Phase III trial and potential registration
filings in the U.S. and EU and availability of the full $50 million
capital facility from Hercules Capital through the term of the
agreement. 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 on
March 14, 2017 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.
CCXI-G
Contacts:
Susan M.
Kanaya
Executive Vice President, Chief Financial and Administrative
Officer
investor@chemocentryx.com
Media:Stephanie Tomei408.234.1279media@chemocentryx.com
Investors:Burns McClellan, Inc. Steve
Klass212.213.0006
sklass@burnsmc.com
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