Key additions will help drive strategic growth and advance lead
clinical programs
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company
focused on harnessing the potential of hypoxia-inducible factor (HIF)
biology to develop and commercialize novel therapeutics to treat kidney
disease, today announced the expansion of its senior management team
with three key additions: Brad Maroni, M.D., as Senior Vice President
and Chief Medical Officer, Mark De Rosch, Ph.D., as Vice President of
Regulatory Affairs and Tamara Dillon as Vice President of Human
Resources.
The new additions to Akebia bring individuals with deep and relevant
experience to support the company through its next critical stages,
including completion of its Phase 2b study for AKB-6548, initiation and
execution of a global Phase 3 program, expanded interactions with
regulatory authorities and the early stage development of additional
novel products in the company's pipeline.
"Collectively, Brad, Mark and Tamara bring a tremendous breadth and
depth of experience to Akebia that will help strengthen our ability to
accomplish our goal of delivering innovative products to patients in
need," said John P. Butler, President and Chief Executive Officer of
Akebia. "We are confident they will make an immediate and important
contribution to Akebia as we advance our lead programs, engage in
critical regulatory discussions and continue to scale the organization
in anticipation of the global Phase 3 clinical development of AKB-6548."
Robert Shalwitz, M.D., co-founder of Akebia and current Chief Medical
Officer, will take on the role of Executive Vice President and work
closely alongside Dr. Maroni and Dr. De Rosch through the end of this
year, at which time he will transition to a multi-year assignment as
senior scientific advisor to the company. In this capacity, Dr. Shalwitz
will continue to lend his expertise to the clinical and regulatory
advancement of AKB-6548, and will also focus on leveraging Akebia's HIF
platform and knowledge in a variety of promising future applications.
"Our management team expansion and the evolution of Bob's role will
provide Akebia with near-term continuity, while also enabling Bob to
focus sufficient attention on the large number of intriguing therapeutic
opportunities beyond our initial indication," said Mr. Butler. "Bob's
expertise and guidance will be a critical asset as we approach the next
phase of the AKB-6548 clinical development program. In the long term,
his scientific and strategic insights will be invaluable in guiding the
direction of our important early-stage pipeline candidates."
Brad Maroni, M.D., most recently served as Vice President,
Medical Research at Biogen Idec. Prior to that role, Dr. Maroni served
as Chief Medical Officer of Stromedix, Inc. until the company was
acquired by Biogen Idec in 2012. His previous experience also includes
serving as Executive Vice President and Chief Medical Officer at RenaMed
Biologics, as well as multiple roles at Amgen Inc., including Vice
President, Clinical Development and Anemia/Nephrology Therapeutic Area
Head. At Amgen, Dr. Maroni led the cross-functional team responsible for
the registration program and global regulatory approval of Aranesp®,
a novel long-acting recombinant erythropoietic protein, indicated for
the treatment of anemia in chronic kidney disease. During his tenure,
Amgen also received approval for Sensipar®, a first-in-class
small molecule for the treatment of bone disease in dialysis patients.
Dr. Maroni trained as a nephrologist at Brigham and Women's Hospital in
Boston, Massachusetts, after which he spent 10 years in academia at
Emory University.
Mark De Rosch, Ph.D., brings to Akebia over two decades of
experience guiding global regulatory strategies for clinical,
nonclinical and chemistry, manufacturing and controls (CMC) in multiple
therapeutic areas including renal, hemophilia, autoimmune, pulmonary and
oncology/hematology, among others. Most recently, Dr. De Rosch served as
Vice President, Regulatory Drugs/Biologics & Head, U.S. Operations for
Voisin Consulting Life Sciences, where he served as the organization's
lead U.S. Food & Drug Administration (FDA) regulatory expert.
Previously, Dr. De Rosch served as Vice President, Head of Global
Regulatory Affairs for Inspiration Biopharmaceuticals, Inc., leading the
development and implementation of global regulatory strategies for the
hemophilia-focused company. He also served in multiple key roles at
Vertex Pharmaceuticals, Inc., including Senior Director, Global Clinical
Regulatory Strategy, where he led the regulatory strategy and
submissions process for Kalydeco® in cystic fibrosis leading
to approvals in the U.S. and E.U.
Tamara Dillon joins Akebia from Novartis Institutes for
BioMedical Research, where she served as Head of Human Resources, Global
Discovery Chemistry, responsible for all aspects of human resources
across five sites and four countries. Previously, she held several key
roles at Genzyme, a Sanofi Company, including Senior Director Human
Resources, Global Research and Development. In this global leadership
role, Ms. Dillon oversaw expansive human resources management and
coordinated closely with the senior management team to ensure that
overall business strategies were translated into effective human
resources programs.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered
in Cambridge, Massachusetts, focused on harnessing the potential of
hypoxia-inducible factor (HIF) biology to develop and commercialize
novel, proprietary therapeutics to treat kidney disease. Akebia's lead
clinical program, AKB-6548, is a once-daily, oral therapy currently in
Phase 2b clinical development for the treatment of anemia related to
chronic kidney disease, a serious medical condition that leads to
increased morbidity and mortality if left untreated. For more
information on Akebia, please visit www.akebia.com.
Forward-Looking Statements
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-6548 and the development plan for
AKB-6548 and additional product candidates. 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
ability of Akebia to successfully complete the clinical development of
AKB-6548 or any other product candidate; the ability of Akebia to
successfully complete pre-clinical development of additional product
candidates; the content and timing of decisions by the FDA and other
regulatory authorities; the funding required to develop Akebia's product
candidates and operate the company, and the actual expenses associated
therewith; the content of decisions made by the FDA and other regulatory
authorities; 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-6548 or any other
product candidates. Other risks and uncertainties include those
identified under the heading "Risk Factors" in Akebia's Quarterly Report
on Form 10-Q for the quarter ended March 31, 2014, 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.
Source: Akebia Therapeutics, Inc.
Investors:
Argot Partners, LLC
David Pitts,
+1-212-600-1902
david@argotpartners.com
or
Susan
Kim, +1-212-203-4433
susan@argotpartners.com
or
Media:
Feinstein
Kean Healthcare
Liz Falcone, +1-617-761-6727
liz.falcone@fkhealth.com
Source: Akebia Therapeutics, Inc.
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