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PharmiGene obtains European patent for genetic discovery predicting warfarin sensitivity

Release issued 24th March 2009

TAIPEI, Taiwan, 23 March, 2009 / PharmiGene, Inc. / Pharmacogenetics company PharmiGene, Inc. announced this week that it had received a patent from the European Patent Office for the identification of genetic variations in the human VKORC1-1639 gene, related to an individual's sensitivity to the widely-prescribed anti-coagulant drug warfarin

The patent relates to technology at the heart of the company's CE marked Warfarin Sensitivity Detection Kit. This gene detection diagnostics product is designed to assist in the building of a safer and more effective dosing strategy for warfarin.

"Receiving a European patent for our discovery is an important milestone for our company, and will allow us to enter into technology collaboration partnerships with confidence, and help attract qualified product distributors of our Warfarin Sensitivity Detection Kit, " said Dr. Jerome Shen, CEO and president of PharmiGene. "In doing so, we continue to build on our mission of providing clinical tools to reduce the incidence of adverse drug reactions worldwide," he added.

In addition to the IP protection that this patent allows, the quality of the kit was also recognized when it was used by the only QC Center in a recently-concluded multi-national warfarin dosage determination study, published in the New England Journal of Medicine on February 19, 2009.

Warfarin, a widely-prescribed oral anti-coagulant (blood thinner), is prescribed for the prevention of blood clots, atrial fibrillation, or prosthetic heart valve replacement. The drug has a narrow therapeutic window, with the optimum dose for each patient varying widely. Furthermore, the drug causes massive internal bleeding if too much of the drug is prescribed, and if too little is given, the patient is at risk of their serious cardiovascular condition being unattended.

With the aid of PharmiGene's Warfarin Sensitivity Detection Kit, a proper dosage for each specific patient can be determined, and thus the likelihood of serious complications can be greatly reduced.

PharmiGene also recently announced that it had received CE Mark approval for additional two genetic diagnostics products; the PG1502 Gene Detection Kit, and the PG5801 Gene Detection Kit. These tests can be used by clinicians to identify patients at greater risk of Carbamazepine-induced Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (SJS/TEN), and Allopurinol-induced severe cutaneous adverse reactions (SCAR), both life-threatening adverse drug reactions (ADR).

PharmiGene received CE Mark authorization from KEMA Medical, a Notified Body from The Netherlands, adding to the existing European market approval of its Warfarin Sensitivity Detection Kit.

About PharmiGene:
PharmiGene, Inc. (PGI) is focused on advancing the field of pharmacogenetics. PGI is dedicated to providing innovative diagnostic products and services for the advancement of personalized medicine to improve patient care, and to reducing morbidity and mortality caused by adverse drug reactions (ADR).

Currently, there are three products in PGI's pipeline:
1) PG1502 Gene Detection Kit: Designed to assess the risk of Carbamazepine induced SJS/TEN (Stevens-Johnson syndrome and toxic epidermal necrolysis).
2) PG5801 Gene Detection Kit: Designed to assess the risk of Allopurinol-induced severe cutaneous adverse reactions (SCAR), which include hypersensitivity syndrome (HSS) and SJS/TEN.
3) Warfarin Sensitivity Detection Kit: Designed to assist in the building of a safer and more effective dosing strategy for the drug warfarin.

Contact information:
Yu-ligh Liou
Director, Business Development
PharmiGene, Inc.
9F-3, No. 21, Lane 169, Kangning St.,
Xi-Zhi City, Taipei, Taiwan
Tel: +886-2-2695-9800
Fax: +886-2-2695-7707
E-mail: pedro.liou@pharmigene.com
http://www.pharmigene.com

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