DGAP-News: Keryx Biopharmaceuticals, Inc. /
Keryx Biopharmaceuticals Appoints Greg Madison as Chief Operating
Officer
10.02.2014 / 14:30
---------------------------------------------------------------------
Renal Industry Veteran to Lead Commercialization Effort for Zerenex
NEW YORK CITY, 2014-02-10 14:30 CET (GLOBE NEWSWIRE) --
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(tm) 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(r), 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 Zerenex(TM) (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(r) 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.
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
News Source: NASDAQ OMX
End of Corporate News
---------------------------------------------------------------------
10.02.2014 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: Keryx Biopharmaceuticals, Inc.
United States
ISIN: US4925151015
End of News DGAP News-Service
---------------------------------------------------------------------
251891 10.02.2014
DGAP-News: Keryx Biopharmaceuticals Appoints Greg Madison as Chief Operating Officer
| Source: EQS Group AG