Keryx Biopharmaceuticals Announces Commencement of Phase 3 Program of Ferric Citrate (Zerenex(TM)) in Japan by Partner, Japan Tobacco and Torii Pharmaceutical

By Keryx Biopharmaceuticals Inc., PRNE
Sunday, April 17, 2011

Clinical Milestone Triggers Payment to Keryx

NEW YORK, April 18, 2011 - Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), announced today that its
Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd.
(Torii), JT's pharmaceutical business subsidiary, has commenced the Phase 3
clinical program of ferric citrate in Japan for the treatment of patients
with hyperphosphatemia. Under the license agreement with JT/Torii, within 30
days, Keryx will receive a non-refundable milestone payment of $5 million
from JT/Torii for the achievement of this milestone. Zerenex(TM) (ferric
citrate), a ferric iron-based phosphate binder, is also in Phase 3 clinical
development in the United States for the treatment of hyperphosphatemia
(elevated phosphate levels) in patients with end-stage renal disease on
dialysis.

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We congratulate
our partner, JT/Torii, on the initiation of the Phase 3 program in Japan and
are excited by their progress. We believe that this serves to further
validate the commercial potential for Zerenex worldwide."

Keryx holds a worldwide license (except for certain Asian Pacific
countries) to Zerenex from Panion & BF Biotech, Inc.

Sublicense Agreement with Japan Tobacco & Torii Pharmaceutical

In September 2007, Keryx sublicensed to JT and Torii the exclusive rights
for the development and commercialization of its hyperphosphatemia drug,
Zerenex (ferric citrate), in Japan. The licensing arrangement calls for JT
and Torii to pay to Keryx up to $100 million in up-front license fees and
payments upon the achievement of specified milestones, of which $28 million
has been received by Keryx to date. In addition, upon commercialization, JT
and Torii will make royalty payments to Keryx on net sales of the drug in
Japan. JT and Torii are responsible for all development and commercialization
costs in Japan.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and
commercialization of medically important pharmaceutical products for the
treatment of cancer and renal disease. Keryx is developing KRX-0401
(perifosine), a novel, potentially first-in-class, oral anti-cancer agent
that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway,
and also affects a number of other key signal transduction pathways,
including the JNK pathway, all of which are pathways associated with
programmed cell death, cell growth, cell differentiation and cell survival.
KRX-0401 has demonstrated both safety and clinical efficacy in several tumor
types, both as a single agent and in combination with approved therapies.
KRX-0401 is currently in Phase 3 clinical development for both refractory
advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2
clinical development for several other tumor types. Each of the KRX-0401
Phase 3 studies is being conducted under a Special Protocol Assessment (SPA)
agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an
oral, ferric iron-based compound that has the capacity to bind to phosphate
and form non-absorbable complexes. The Phase 3 clinical program of Zerenex
for the treatment for hyperphosphatemia (elevated phosphate levels) in
patients with end-stage renal disease on dialysis is being conducted pursuant
to an SPA agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those
anticipating future clinical trials and business prospects for Zerenex(TM)
(ferric citrate) 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: our ability, and
our Japanese partner's ability, to successfully and cost-effectively complete
clinical trials for Zerenex (ferric citrate); 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 www.keryx.com. The information found on our
website and the FDA website is not incorporated by reference into this press
release and is included for reference purposes only.

    KERYX CONTACT:
    Lauren Fischer
    Director - Investor Relations
    Keryx Biopharmaceuticals, Inc.
    Tel: +1-212-531-5965
    E-mail: lfischer@keryx.com

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