OPKO Health Announces Launch of 4Kscore™ in Europe

Strategic Partner, International Health Technology Ltd, Launches Laboratory Service

MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK) today announced strategic partner, International Health Technology (IHT) headquartered in Cambridge, UK, launched the OPKO 4Kscore™ in Europe as part of IHT’s ProstateCheck™ program being offered as an early detection service.

Earlier this year, OPKO executed a sublicensing deal with IHT to commercialize OPKO’s novel panel of kallikrein biomarkers and associated algorithm (4Kscore™) for the early detection of prostate cancer in a laboratory setting in the UK, Ireland, Sweden and Denmark. The OPKO panel represents the culmination of a decade of research by scientists in Europe and the U.S. and has been demonstrated in over 10,000 patients to predict the probability of cancer-positive biopsies in men suspected of having prostate cancer. Extensive studies have shown that the use of the panel could eliminate a significant number of unnecessary prostate biopsies, a possible reduction of over 50%, along with a high frequency of associated pain, bleeding and infection, sometimes requiring hospitalization. With this significant reduction in biopsy rate, the probability of delaying diagnosis of a high grade cancer is only 0.6% (and this small population of men would be followed with active surveillance).

IHT, through close cooperation with some of the largest private hospitals chains in the UK and abroad, has access to world class private facilities and specialists to provide testing services for corporate clients in the private sector.

“ProstateCheck has been very well received amongst our corporate customers and we have already signed up the first customers,” said Troels Jordansen, Chairman of International Health Technology. “The opportunity to identify high grade prostate cancers and focus clinical interventions on these is of great value to men but also to the health care sectors in general. We have very high expectations for this unique service.”

“The collaborative efforts with IHT have progressed at an impressive rate,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health. “As part of IHT’s ProstateCheck initiative, the 4Kscore™ will provide clinicians with a differentiated critical component in their overall diagnosis of prostate cancer, while providing patients with better and more efficient healthcare.”

About International Health Technology, Ltd.

IHT specializes in launching new diagnostic technology in the private sector as part of a clinical service and as a distribution partner. IHT mainly focuses on the UK market, but is expanding within the European Union and U.S.

About OPKO Health, Inc.

OPKO is a multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.

This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the potential benefits of the OPKO 4Kscore™, the ability to predict, reduce, or eliminate the need for biopsies, whether OPKO or IHT will be able to successfully commercialize the 4Kscore™ or any diagnostic product utilizing the new biomarkers, whether the product will provide an opportunity to identify high grade cancers and focus clinical interventions on these, the probability rate for delaying diagnosis of a high grade cancer, and whether the biomarkers will offer higher specificity or greater accuracy than current diagnostics or provide clinicians with a differentiated critical component in their overall diagnosis of prostate cancer while providing patients with better and more efficient healthcare, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

OPKO Health, Inc.
Steven D. Rubin, 305-575-4100

Source: OPKO Health, Inc.

Released October 1, 2012