December 30, 2013

New liver cancer drug expected to be approved in 2015 in most Asian countries

2013/12/30 22:49:49

Taipei, Dec. 30 (CNA) A new drug targeted at preventing the recurrence of liver cancer after it is treated surgically is expected to receive approval in most Asian countries by 2015, according to the company authorized to develop, produce and market the drug.

Third stage clinical trials of the drug, known as PI-88, reached their 500-patient target on Dec. 27, said Stanley Chang, chairman of Taipei-based Medigen Biotechnology Corp., and if the results meet expectations, drug approval applications will be filed sometime next year.

In Taiwan, the Food and Drug Administration has already launched a rolling review procedure for PI-88, and the company expects the new drug to obtain approval and marketing authorization by the end of 2014 at the earliest, Chang said.

According to Medigen, third-stage experimental trials on PI-88 were conducted at 25 medical centers in Taiwan, mainland China, Hong Kong and South Korea.

The Medigen chairman touted the drug in a press briefing as the world's first drug approved for post-surgical therapy for early-stage liver cancer.

The company won global commercialization rights for PI-88 from Progen Pharmaceuticals of Australia in 2010, and it has since attracted global attention, being recognized as an orphan drug in Europe and the United States, Chang said.

The new drug has also been taken seriously by authorities in Taiwan and China, and it is eligible for a cross-Taiwan Strait cooperation program for new drug research and development.

In the future, efforts will be taken to seek joint certification of the drug by Taipei and Beijing so that it can be sold throughout Greater China, where liver cancer is highly prevalent, Chang said.

In terms of PI-88's market scale, an assessment by the Academia Sinica's Institute of Biomedical Science found that the drug could generate between NT$52 billion (US$1.7 billion) and NT$73.8 billion in annual sales once it enters the global market.

(By Luo Hsiu-wen and Elizabeth Hsu)


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