Keryx Biopharmaceuticals Strengthens Leadership Team With Key Additions in Sales, Corporate Development and Legal
NEW YORK, April 15, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals,
Inc. (Nasdaq:KERX), a biopharmaceutical company focused on the
acquisition, development and commercialization of pharmaceutical
products for the treatment of renal disease, today announced the
appointment of three key executives in high priority strategic roles
integral to the preparation for the potential Zerenex(TM) (ferric
citrate coordination complex) product launch. The Company's New Drug
Application for Zerenex(TM), an oral, ferric iron-based compound, is
currently under review by the FDA with an assigned Prescription Drug
User Fee Act (PDUFA) target goal date of June 7, 2014.
Brian R. Adams has been appointed Vice President, General Counsel. Mr.
Adams comes to the Company with significant legal and business
management experience within the pharmaceutical industry. Mr. Adams
joins the Company from Algeta ASA, where he served as its General
Counsel, with oversight of all global legal matters, corporate
governance, alliance management and strategic transactions, including
the highly successful launch of of Xofigo(R) in prostate cancer,
resulting in a $2.9B acquisition bid for Algeta by Bayer AG. Prior to
joining Algeta in 2012, Mr. Adams spent six years as an in-house
counsel for Genzyme Corporation and AVEO Oncology. Throughout his
career, Mr. Adams has provided domestic and international legal support
for product development, operations, commercialization, securities,
healthcare compliance and licensing/M&A transactions. Prior to joining
Genzyme, Mr. Adams practiced in the Boston office of Bingham McCutchen
LLP, where he advised private equity sponsors, biotech and other
emerging technology companies on a broad range of corporate matters and
financing transactions. Mr. Adams received a BA from Harvard University
and a law degree (JD) from the Catholic University of America's
Columbus School of Law.
Thomas M. Edwards has been appointed Vice President, US Sales, and will
focus on building and leading the US Sales and Sales Training
organization. With a pharmaceutical sales career spanning more than 22
years, Mr. Edwards brings a strong background in sales management,
training and leadership development, with extensive product launch
experience across multiple specialty indications. Over the course of
his career, Mr. Edwards has built and led high-performing teams that
have contributed to the overall success of specialty pharmaceutical
products at Eli Lilly, Genentech and Genzyme. Mr. Edwards comes to the
Company from Genzyme Corporation, where, since 2006, he has served in
positions of increasing leadership responsibility, culminating in the
role of Head of US Sales for the Metabolic and Cardiovascular division.
Mr. Edwards received his Bachelors of Science in Business
Administration from Boston University.
Amy B. Sullivan has been appointed Vice President, Corporate
Development and Public Affairs, and will be responsible for strategic
planning, corporate reputation management, corporate communications,
investor relations, government affairs and employee communications. Ms.
Sullivan has more than two decades of experience working with life
science companies at every stage of development, helping organizations
to position and differentiate themselves and their products in
competitive environments. Most recently, and since 2009, Ms. Sullivan
served as Vice President of Investor Relations and Corporate
Communications for AMAG Pharmaceuticals, overseeing the company's
investor relations, public relations, and employee communications
activities. Previous experience includes Idenix Pharmaceuticals,
Genencor International, Perkin Elmer and Thermo Fisher. Ms. Sullivan
holds a Masters in Business Administration degree from Bentley
University and her Bachelor of Science degree from Salem University.
Greg Madison, the Company's Executive Vice President and Chief
Operating Officer, commented, "Tom, Amy and Brian are valuable
additions to the Keryx team, and I am excited to be welcoming them to
the Company. They each bring with them a wealth of industry leadership,
experience and knowledge, which will be instrumental in driving our
ability to maximize the sales and marketing potential of Zerenex(TM)
and position the Company for future commercial success."
Keryx plans to establish a Boston, MA office, in which Messrs. Adams
and Edwards, and Ms. Sullivan, will be based.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals focuses on the acquisition, development and
commercialization of pharmaceutical products for the treatment of renal
disease. Keryx is developing Zerenex (ferric citrate coordination
complex), an oral, ferric iron-based compound. Keryx has completed a
U.S.-based Phase 3 clinical program for Zerenex for the treatment of
hyperphosphatemia (elevated phosphate levels) in patients with chronic
kidney disease (CKD) on dialysis, conducted pursuant to a Special
Protocol Assessment (SPA) agreement with the Food and Drug
Administration (FDA). The Company's New Drug Application (NDA) is
currently under review by the FDA with an assigned Prescription Drug
User Fee Act (PDUFA) goal date of June 7, 2014, and its Marketing
Authorization Application, seeking the approval of Zerenex as a
treatment of hyperphosphatemia in patients with CKD, including dialysis
and non-dialysis dependent CKD, is currently under review by the
European Medicines Agency (EMA). The Company is also developing Zerenex
in the U.S. for the management of iron deficiency anemia and elevated
serum phosphorus in patients with Stage 3 to 5 non-dialysis dependent
CKD. In addition, Keryx's Japanese partner, Japan Tobacco Inc. and
Torii Pharmaceutical Co., Ltd. has received marketing approval of
ferric citrate (branded Riona(R)) in Japan for the improvement of
hyperphosphatemia in patients with CKD, including dialysis and
non-dialysis dependent CKD. 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.
CONTACT: KERYX CONTACT:
Amy Sullivan
Vice President - Corporate Development and Public Affairs
Keryx Biopharmaceuticals, Inc.
Tel: 508.479.3480
E-mail: [email protected]