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BioPorto

Registration Form Dec 11, 2012

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BioPorto has received notice from its patent advisor that the NGAL cutoff
patent is approved for issuance in China. Thus, Bioporto has obtained the
crucial IP rights for NGAL as a method for diagnosing acute kidney injury in
India, Europe, Japan, New Zealand, Singapore, Hong Kong, South Africa, South
Korea, Australia and Israel. The last two patent applications are under
examination in USA and Canada.

China is one of BioPorto’s priority markets and obtaining IP rights is of great
importance in the marketing of The NGAL Test in China.

BioPorto’s NGAL cutoff patent covers the cutoff or threshold level above which
NGAL indicates acute kidney injury, and a higher cutoff indicating an impending
dialysis requirement. In addition, BioPorto has filed in selected countries a
NGAL “exclusion” patent application, which is complementary to the cutoff
patent and concerns lower values of NGAL that exclude an immediate risk of
kidney damage. The NGAL patents allow BioPorto both to secure the placement of
its own products and enforce its rights in relation to competitors, if these
should sell NGAL tests for the diagnosis of acute kidney injury without license
access to the patents.

The kidney biomarker NGAL

Every year about 13 million people are struck by acute kidney injury worldwide,
of whom about 4 million die. Nevertheless, there has been no real progress in
methods of diagnosing kidney injury over the last half century. Existing
methods, such as serum creatinine determination, only signal kidney failure
24-72 hours after the injury has taken place. In contrast, NGAL rises to
diagnostic levels within a few hours of kidney injury and thus enables the
physician to make vital clinical decisions before the damage progresses to
potentially fatal renal shutdown. In addition to helping the patient,
cost-benefit analyses show that implementing NGAL testing will contribute to
reducing hospital costs in the management of kidney injury and its
consequences.

Further details from:

Theo Olesen, CEO

Christina Thomsen, IR

Phone 45 29 00 00, mail [email protected]

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