UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
_____________
FORM
8-K
_____________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of
report (Date of earliest event reported): September
26, 2007
Keryx
Biopharmaceuticals, Inc.
(Exact
Name of Registrant as Specified in Charter)
|
Delaware
(State
or Other Jurisdiction
of
Incorporation)
|
000-30929
(Commission
File Number)
|
13-4087132
(IRS
Employer Identification No.)
|
750
Lexington Avenue
New
York, New York 10022
(Address
of Principal Executive Offices)
(212)
531-5965
(Registrant's
telephone number, including area code)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
| £ |
Written
communications pursuant to Rule 425 under the Securities
Act.
|
| £ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange
Act.
|
| £ |
Pre-commencement
communications pursuant to Rule 14d-2b under the Exchange
Act.
|
| £ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange
Act.
|
Item
1.01. Entry
Into a Material Definitive Agreement.
On
September 26, 2007, Keryx Biopharmaceuticals, Inc. (“Keryx”) entered into a
sub-license agreement (the "Agreement") with Japan Tobacco Inc. (“JT”) and Torii
Pharmaceuticals Co., Ltd. (“Torii”), JT’s pharmaceutical business subsidiary,
under which JT and Torii will hold the exclusive rights for the development
and
commercialization of their hyperphosphatemia drug in Japan. The drug, currently
in phase II clinical development in the United States under the name “Zenerex™”,
is an iron-based phosphate binder for the treatment of hyperphosphatemia
(elevated phosphate levels) in patients with end stage renal disease. Keryx
holds a worldwide license (except for the Asian Pacific Region, but including
Japan) to Zerenex™ from Panion & BF Biotech, Inc.
The
licensing arrangement obligates JT and Torii to pay Keryx up to $100 million
in
up-front licensing fees and payments upon the achievement of pre-specified
milestones, including up to $20 million in up-front payments and near-term
milestones. JT and Torii have sole responsibility for the clinical development
of and commercialization of its drug in Japan, and will be responsible for
all
associated costs. Upon commercialization, JT and Torii will be obligated
to make
royalty payments to Keryx on net sales of the drug in Japan.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| |
|
|
| |
Keryx
Biopharmaceuticals, Inc.
(Registrant)
|
|
|
|
| Date: October 1, 2007 |
|
|
| |
By: |
/s/ Mark Stier |
| |
Mark
Stier |
| |
Chief
Accounting Officer |