Release issued 22nd August 2008

TAIPEI, Taiwan, 19 August, 2008 -- PharmiGene Inc. (PharmiGene), a pharmacogenetic-based molecular diagnostic company, today announced that it had received approval from the Department of Health (DOH) in Taiwan to begin marketing the PG 1502 DNA detection kit, one in the line of the company's rapid genetic tests. This test can be used as an aid for clinicians in identifying patients at greater risk of Carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), life-threatening adverse drug reactions (ADR).

This approval also means that PharmiGene's product is the first regulated diagnostic test in the world to determine the ADR risks induced by Carbamazepine.

Carbamazepine is an anticonvulsant and mood-stabilizing drug which is used primarily in the treatment of epilepsy and bipolar disorder. It is also used to treat trigeminal neuralgia. However, Carbamazepine is also the most common cause of the serious ADR in Taiwan. Last year, both the DOH and US-FDA announced updated Carbamazepine labeling regulations to increase patient awareness regarding the use of drugs and the role of genetics in causing drug toxicity. The new re-labeling explains that those possessing the gene HLA-B*1502 may be at a higher risk of SJS/TEN. According to the FDA’s re-labeling information, the risk of the life-threatening skin reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in certain Asian countries.

CEO of PharmiGene Dr. Jerome Shen, explained the implications the granting of market approval meant for his company's product. 

"While Carbamazepine is a very effective and successful drug, it can be risky for some people. With 40,000 new users of this drug every year in Taiwan alone, our kit will surely reduce this risk for a large number of patients," explained Shen. "We've estimated the market to be worth around US$17 million per year," he added. 

Shen also expressed thanks to Taiwan's Department of Health and the non-governmental regulatory agency, the Center for Drug Evaluation, for the agencies' rapid market approval of PharmiGene's diagnostic kits. 

The Carbamazepine and HLA-B*1502 connection:
Taiwan was the first country to discover the close association between the HLA-B*1502 and Carbamazepine, (as published in Nature magazine, Vol 428, 1 April, 2004). This discovery also marked the first time the Taiwan government made a pharmacogenomic-related official drug announcement. The US-FDA announced and required a re-labeling of the Carbamazepine package insert on the 12th of December, 2007, and Canada’s announcement was made on March this year.

The HLA-B*1502 allele occurs with high frequency in populations across broad areas of Asia, including in South Asian Indians. As a result, the incidence of Carbamazepine-induced SJS/TEN in Asians is higher than in Caucasians. Accordingly, patients with Asian ancestry should be screened for the HLA-B*1502 allele before starting treatment with Carbamazepine.

http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm

About PharmiGene, Inc.:
Taipei, Taiwan-based PharmiGene, Inc. (PharmiGene) is a company spun-off from the research institute, Academia Sinica, in Taiwan. With primary focus in the field of pharmacogenetics, PharmiGene is dedicated to providing diagnostic products and services for the advancement of personalized medicine. PharmiGene has in-licensed several worldwide patents related to the genetic markers of drug-induced ADR, in which HLA-B*1502 was one of them.
 
In addition to the PG1502 kit, there are two proprietary products under development in PharmiGene's pipeline:

1. Allopurinol --SCAR: Prevents Allopurinol-induced severe cutaneous adverse reactions (SCAR). 
2. Warfarin Dosage Risk Assessment Kit: Provide a safer and more effective dosing strategy for Warfarin therapy.


Contact information:
Mr. Yu-ligh Liou
Director, Business Development
PharmiGene, Inc.
9F-3, No. 21, Lane 169, Kangning St.,
Xizhi City, Taipei County 221, Taiwan
Tel: +886-2-2695-9800
Fax: +886-2-2695-7707
E-mail: service@pharmigene.com
http://www.pharmigene.com

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