May 14, 2012 -- Australian drug company Agenix Limited (ASX: AGX) today announced that Japan's Patent Office had granted a key patent covering the manufacturing process of its ThromboView® imaging agent for the detection of blood clots in humans.
Agenix Chairman and Chief Executive Officer, Nicholas Weston said, "The granting of patent protection in Japan confers further certainty and significantly increases the commercial value of the ThromboView diagnostic technology globally. In conjunction with the other patents covering the use and production of ThromboView, this new patent delivers a major commercial advantage to Agenix in one of the world's leading markets for diagnostic imaging and manufacturing.”
Japanese Patent Application Number 2003-507139 covers humanized antibodies derived from DD-3B6/22 specific for the D-dimer fragment of fibrin provides long-term protection for the company's technology through broad claims over methods of manufacture and use.
It is a major asset in the commercialisation of ThromboView and establishing strategic business partnerships with global pharmaceutical and medical diagnostic companies.
ThromboView is now protected by multiple patents in the Japan, the United States, Europe, Singapore, Australia and New Zealand, with the granting of patents for China and Canada pending. The patents provide protection for ThromboView out to 2022 with possible Hatch-Waxman term extension out to 2027.
Legislation in the EU, US and Japan grant biologics a period of 10, 12 and 6 years of data exclusivity, respectively, from the time of registration and this is likely to considerable enhance ThromboView’s protection in those markets.
Building upon and continuing to expand its international patent portfolio is fundamental to the commercial strategies of Agenix.
ThromboView will potentially provide medical professionals with a new way to accurately detect live blood clots and pulmonary embolisms in the human body without the exposure to high chest radiation and toxic chemicals used currently.
ThromboView has successfully completed two Phase II human clinical trials in the United States and there is a large body of independent clinical evidence that shows ThromboView is safe and effective.
Agenix is in discussions with potential partners in multiple geographies to partner or license the technology in order to complete its Phase III clinical study ahead of its market launch. Follow Agenix on Twitter or LinkedIn.
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ThromboView® is a registered trademark of Agen Biomedical Limited, a wholly owned subsidiary of Agenix Limited.
Agenix is a public, clinical-stage company focused on the discovery and development of innovative monoclonal antibody blood clot diagnostics, and small molecule drugs for the treatment of hepatitis B and other serious diseases. Agenix is a leading Australian biotechnology company and was developer of the widely used in vitro D-dimer diagnostic blood test. Agenix Limited is committed to generating next generation drugs and diagnostics. Agenix’s most advanced diagnostic candidate, ThromboView®, a novel radio-labelled monoclonal antibody imaging agent, has completed two FDA Phase 2 clinical trials, and is ideal to diagnose patients indicated for suspected acute pulmonary embolism (PE), with a positive D-dimer blood test or moderate to high pre-test probability of PE, as a replacement diagnostic test for patients with suspected PE where V/Q scans are a first line choice and are unlikely to deliver a diagnostic result, as a confirmatory diagnostic where CT is used as a first-line diagnostic test, the scan result is negative and the clinical probability of disease is high or moderate and as a replacement diagnostic where CTPA is an inappropriate choice based on radiation exposure, renal impairment or contrast allergy. Agenix is also developing AGX 1009, a next-generation reverse transcriptase inhibitor (NtRTI) prodrug of tenofovir, for which a CTA is planned to be filed with the Chinese FDA in the second half of 2012 and for which the Company plans to advance into Phase 1 in the second half of 2013. Agenix owns all the patent rights to both ThromboView® and AGX 1009. In August 2010, Agenix entered into a collaborative partnership with the Institute of Medicinal Biotechnology of the Chinese Academy of Medical Sciences, part of the Ministry of Health to purchase AGX 1009 and preclinical work is being conducted in Beijing, China by the Institute of Pharmacology and Toxicology of the Academy of Military Medical Sciences. Agenix has taken successfully from laboratory to global commercialisation then commercial exit more than 20 products over four technology platforms since listing on the Australian Securities Exchange in 1987.