Keryx Biopharmaceuticals Appoints Greg Madison as Chief Operating Officer
February 10 2014 - 08:30AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), (the "Company"), a
biopharmaceutical company focused on the acquisition, development
and commercialization of medically important pharmaceutical
products for the treatment of renal disease, today announced the
appointment of Greg Madison as Executive Vice President and Chief
Operating Officer. In this role, Mr. Madison will lead the
build-out of the commercial organization and related functions to
support a potential Zerenex™ product launch in the United States
and internationally. The Company's New Drug Application for
Zerenex (ferric citrate coordination complex), an oral, ferric
iron-based compound, is currently under review by the FDA with an
assigned Prescription Drug User Fee Act (PDUFA) goal date of June
7, 2014. With Mr. Madison's appointment, Keryx will establish
an office in the Boston area.
"We believe that Mr. Madison's track record of success in
leadership roles spanning the various aspects of product launch and
sales in the renal space will be invaluable to the Company as we
prepare for the potential launch of Zerenex. We are thrilled
to welcome Greg to the Company and look forward to leveraging his
broad commercial expertise," said Ron Bentsur, CEO of Keryx
Biopharmaceuticals.
Daniel P. Regan, a member of the Company's Board of Directors,
commented, "I had the privilege of working with Greg for several
years, including at Genzyme/Sanofi, where in 2010 he succeeded me
as global head of the Renal division. I believe that Mr. Madison
has a strong understanding of the pillars of a successful launch
and product commercialization and proven execution capabilities of
such strategies."
Mr. Madison joins the Company from AMAG Pharmaceuticals
(Nasdaq:AMAG), where he served as the Executive Vice President and
Chief Commercial Officer. Prior to AMAG, Mr. Madison spent 12
years at Genzyme/Sanofi developing extensive commercial and general
management expertise as he progressed into roles of increasing
responsibilities and leadership, culminating in his most recent
role as Vice President and General Manager of the Renal division.
In this role, Mr. Madison led a global organization with three
marketed products in 76 countries and drove top-line growth, with
combined revenues exceeding $1 billion. Mr. Madison's prior
experience in the Renal division included serving as vice president
and general manager of the U.S. business; vice president of U.S.
sales; and vice president of U.S. marketing where he led all
pre-launch preparation for Renvela®, now the leading phosphate
binder in the U.S. market. During his tenure with Genzyme, Mr.
Madison also had roles in sales management, training, managed
markets and reimbursement. Prior to joining Genzyme, Mr.
Madison spent five years at Jannsen Pharmaceuticals in sales and
sales management roles, and began his career in the pharmaceutical
industry in sales with Wyeth-Ayerst. He holds a Bachelor of
Business Administration in Finance from the University of
Massachusetts, Amherst.
"I am pleased to join Keryx during this very important time
in the Company's development. There are a multitude of patients who
suffer from the devastating effects of hyperphosphatemia
and iron deficiency anemia, and are in need of effective new
treatment options," stated Mr. Madison. "Over the next
several months, we will accelerate our preparation for the
potential launch of Zerenex, pending regulatory approval. I
look forward to building and working with our team to bring
forward innovative solutions for patients and caregivers
alike."
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition,
development and commercialization of medically important
pharmaceutical products for the treatment of renal disease. Keryx
is developing ZerenexTM (ferric citrate coordination complex), an
oral, ferric iron-based compound. Zerenex has completed a
U.S.-based Phase 3 clinical program for the treatment of
hyperphosphatemia (elevated phosphate levels) in patients with
chronic kidney disease on dialysis, conducted pursuant to a Special
Protocol Assessment ("SPA") agreement with the FDA. Keryx's
New Drug Application ("NDA"), submitted to the FDA in 2013, is
currently under review and has an assigned Prescription Drug User
Fee Act ("PDUFA") goal date of June 7, 2014. Zerenex has also
completed a Phase 2 study in the U.S. for the management of
elevated serum phosphorus levels and iron deficiency anemia in
patients with Stage 3 to 5 non-dialysis dependent chronic kidney
disease. Top-line results from this Phase 2 study were
announced in November 2013. In addition, Keryx's Japanese
partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd.,
received marketing approval of ferric citrate in Japan for the
treatment of hyperphosphatemia in patients with chronic kidney
disease on January 17, 2014. Keryx is headquartered in New
York City.
Cautionary Statement
Some of the statements included in this press release,
particularly those relating to the results of clinical trials, the
clinical benefits to be derived from Zerenex, regulatory
submissions and approvals, the commercial opportunity and
competitive positioning, and any business prospects for Zerenex,
may be forward-looking statements that involve a number of risks
and uncertainties. For those statements, we claim the protection of
the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. Among the factors
that could cause our actual results to differ materially are the
following: acceptance of the NDA filing represents only a
preliminary evaluation of the application and is not indicative of
deficiencies that may be identified during the FDA's review; a
PDUFA goal date is subject to change and does not guarantee that
the review of the NDA will be completed on a timely basis; the risk
that the FDA, and/or EMA ultimately deny approval of the U.S. NDA,
and/or MAA, respectively; the risk that SPAs are not a guarantee
that the FDA will ultimately approve a product candidate following
filing acceptance; whether the FDA and EMA will concur with our
interpretation of our Phase 3 study results, supportive data, or
the conduct of the studies; whether Riona® will be successfully
launched and marketed by our Japanese partner, Japan Tobacco, Inc.
and Torii Pharmaceutical Co., Ltd.; whether, Zerenex, if approved
by the FDA and/or EMA, will be successfully launched and marketed;
and other risk factors identified from time to time in our reports
filed with the Securities and Exchange Commission. Any
forward-looking statements set forth in this press release speak
only as of the date of this press release. We do not undertake to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release
and prior releases are available at http://www.keryx.com. The
information found on our website is not incorporated by reference
into this press release and is included for reference purposes
only.
CONTACT: Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
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