Announcement no. 11

BioPorto’s NGAL patent approved for issue in Europe

BioPorto has been informed by the European Patent Office that the principal claims of the NGAL “cutoff” patent application, claims 1-17, have now been approved for issue in Europe. By obtaining this patent protection in Europe, BioPorto has markedly improved its negotiating position and has thus stepped very much closer to obtaining a share of the estimated billion dollar market for the NGAL test.

BioPorto’s NGAL cutoff patent concerns the determination of NGAL as a diagnostic marker of renal disorders and differs from other NGAL patent applications by establishing the cutoff levels that are needed to distinguish between the larger NGAL rises that indicate kidney injury and the smaller rises that can be due to other conditions. The protection afforded by the patent will prevent other NGAL test suppliers from marketing an NGAL test for the diagnosis of acute kidney injury without having acquired rights to BioPorto’s patent. The issuance of BioPorto’s cutoff patent in Europe will also increase the probability of the patent being issued in the USA and other countries.

NGAL as a biomarker

In recent years, NGAL has proved to be the most promising and fastest responding new biomarker for kidney disorders, being especially relevant for the detection of acute kidney injury. The development of this biomarker for the routine diagnosis of kidney injury and the acquisition of patent protection for the diagnostic method has been, and is, BioPorto’s primary focus. Acute kidney injury carries a high mortality and may occur in 30-50% of critically ill patients or in up to 5% of all hospitalized patients. Early diagnosis of the injury, now made possible by using the NGAL test, will permit treatment initiatives to be taken that hitherto have been impossible to apply early enough to benefit the patient.

Other NGAL patent applications

BioPorto is continually endeavoring to back up its original NGAL cutoff patent application with follow-up applications on further improvements. In one of these, here referred to as the NGAL “ratio” patent application, BioPorto seeks to protect the diagnosis of acute kidney injury by determining the ratio between NGAL levels in urine and plasma. This procedure makes it possible to increase the specificity of the NGAL test for kidney injury and achieve an even earlier diagnosis. BioPorto has received the International Search Report and Written Opinion on this PTC application, in which the patent authority acknowledges both novelty and inventive step. This provides a very promising starting point for the further examination process through to the issue of the patent. The NGAL ratio patent can be exploited or licensed independently of the previous NGAL patents, which creates a stronger base and augments the degrees of freedom for the company’s licensing negotiations.

Licensing negotiations

The patent rights in Europe to NGAL as a marker of kidney injury and the positive evaluation of the NGAL ratio patent application consolidate BioPorto’s position as an important player in the routine diagnostic market in collaboration with major diagnostic companies.

The overall effect of these events is a considerable strengthening of BioPorto’s patent situation, which will inevitably influence licensing negotiations. This brings the company very much closer to realizing the expectation of licensing income amounting to an eight-digit sum (DKR) from 2008 and in succeeding years.

Further information

Thea Olesen, Managing Director

Christina Tønnesen, Investor Relations

Telephone: +45 4529 0000

E-mail: investor@bioporto.com