- Akebia Expands Pipeline and Leverages Expertise in HIF Biology with
Access to Extensive Library of Compounds Addressing Multiple Therapeutic
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company
focused on delivering innovative therapies to patients through the
biology of hypoxia-inducible factor (HIF), today announced that it has
entered into an exclusive agreement with Janssen Pharmaceutica, NV, one
of the Janssen Pharmaceutical Companies of Johnson & Johnson, to license
HIF-targeting product candidates. The portfolio includes AKB-5169
(formerly JNJ5169), a differentiated preclinical compound in development
as an oral treatment for inflammatory bowel disease (IBD). The
agreement, facilitated by Johnson & Johnson Innovation, also provides
Akebia with access to an extensive proprietary library of
well-characterized HIF pathway compounds with potential applications
across multiple therapeutic areas.
"This research agreement accelerates our strategy to develop a portfolio
of HIF-targeted products that address the unmet medical needs of
patients, and builds long-term value for Akebia," said John P. Butler,
President and Chief Executive Officer of Akebia. "While our global Phase
3 development program for vadadustat remains the core focus of our
company, this agreement with Janssen allows us to build upon our
expertise in HIF biology and will accelerate our efforts to maximize the
potential of this pathway across multiple indications."
Under the terms of the multi-year research agreement, Akebia will pay
Janssen $1.0 million in cash to access their collection of hundreds of
HIF-targeted compounds and associated intellectual property.
Importantly, Akebia obtains worldwide rights to AKB-5169, a non-absorbed
oral HIF stabilizer in preclinical development for the treatment of IBD.
Preclinical data have shown that AKB-5169 may be highly differentiated
from standard of care systemic therapies in its potential to reduce
inflammation and promote mucosal healing at the site of disease. The
company plans to conduct additional preclinical studies of AKB-5169 and
submit an Investigational New Drug (IND) application to the U.S. Food
and Drug Administration in the next 12-18 months. IBD affects an
estimated 1.6 million patients in the U.S. and represents a
multi-billion dollar global market opportunity.1
"Janssen invested in building this comprehensive and structurally
differentiated collection of HIF compounds and this agreement allows us
to advance this important research while expanding our knowledge and
understanding of the HIF pathway to develop innovative therapies for
patients," said Michael Rabinowitz, Ph.D., Vice President, Research of
Akebia. "In addition to the diverse library of HIF compounds to which we
now have access, we are looking forward to conducting additional
preclinical studies of AKB-5169 to confirm the unique localized mucosal
healing and inflammation-reducing properties observed in early
In connection with the Research and License Agreement, Johnson & Johnson
Innovation - JJDC, Inc. (JJDC) has an opportunity to take an ownership
interest in Akebia through a Common Stock Purchase Warrant issued by
Akebia to JJDC for 509,611 shares of Akebia's common stock. The Warrant
is exercisable by JJDC, in whole or in part, at any time prior to the
fifth anniversary of the date of issuance with a payment to Akebia of up
to $5.0 million.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered
in Cambridge, Massachusetts, focused on delivering innovative therapies
to patients with kidney disease through hypoxia-inducible factor (HIF)
biology. Akebia's lead product candidate, vadadustat, is an
investigational oral therapy in development for the treatment of anemia
related to chronic kidney disease in both non-dialysis and dialysis
patients. Akebia's global Phase 3 program for vadadustat, which includes
the PRO2TECT studies for non-dialysis patients with anemia
associated with chronic kidney disease and the INNO2VATE
studies for dialysis-dependent patients, is currently ongoing. For more
information, please visit our website at www.akebia.com.
This press release includes forward-looking statements. Such
forward-looking statements include those about Akebia's strategy, future
plans and prospects, including statements regarding the potential
indications and benefits of AKB-5169 and the research and development
plan for the portfolio of HIF compounds licensed from Janssen. The words
"anticipate," "appear," "believe," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied in such statement, including the risk that existing preclinical
and clinical data may not be predictive of the results of ongoing or
later clinical trials;; the funding required to develop Akebia's product
candidates and operate the company, and the actual expenses associated
therewith; the timing and content of decisions made by the FDA and other
regulatory authorities; the actual time it takes to initiate and
complete research and development;; the success of competitors in
developing product candidates for diseases for which Akebia is currently
developing its product candidates; and Akebia's ability to obtain,
maintain and enforce patent and other intellectual property protection
for AKB-5169 and its other product candidates. Other risks and
uncertainties include those identified under the heading "Risk Factors"
in Akebia's Annual Report on Form 10-Q for the quarter ended September
30, 2016, and other filings that Akebia may make with the Securities and
Exchange Commission in the future. Akebia does not undertake, and
specifically disclaims, any obligation to update any forward-looking
statements contained in this press release.
1 Crohn's & Colitis Foundation of America Inflammatory Bowel
Diseases Fact Book (2014).
View source version on businesswire.com: http://www.businesswire.com/news/home/20170213005321/en/
AJ Gosselin, 617-844-6130
Source: Akebia Therapeutics, Inc.
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