TAIPEI, Taiwan, June 22, 2018 /PRNewswire/ -- GNT Biotech & Medicals Co., Ltd. (GNTbm, TPEx Emerging: 7427) announced that it has awarded exclusive sales and marketing rights in Taiwan of anticancer drug Chidamide to pharmaceutical distribution company Taiwan Specialty Pharma Corp. (TSPC) for two indications; hormone receptor-positive, HER-2 negative late stage breast cancer in post-menopausal patients; and peripheral T-cell lymphoma (PTCL). The licensing agreement includes upfront and milestone payments of up to NT$30 million (approx US$1mil), with royalties from sales to be awarded separately.
GNTbm also announced that it had already begun its Phase III clinical trial for Chidamide when administered together with exemestane (Aromasin®), an aromatase inhibitor, for the treatment of late stage breast cancer after receiving approval in 2017 for the trial by the Taiwan Food and Drug Administration (TFDA). The trial in six medical centers in Taiwan is being conducted in collaboration with Chipscreen Biosciences Ltd., of Shenzhen, China, using the same clinical trial protocol as its Phase III trial for the same drug combination in China.
Chidamide, a new generation of epigenetic regulator and subtype-selective HDAC inhibitor, was originally developed by Chipscreen Biosciences in 2003. HUYA Bioscience International, LLC, of San Diego, USA, received the exclusive license from Chipscreen Biosciences to develop and commercialize Chidamide outside Greater China in 2006, while GNTbm received the rights for the drug in Taiwan from Chipscreen Biosciences in 2013. Meanwhile, in 2016 HUYA granted Eisai Co., Ltd. of Tokyo, Japan, exclusive rights to develop and commercialize the drug for cancer indications in Japan, South Korea, Thailand, Malaysia, Indonesia, the Philippines, Vietnam and Singapore. Each licensee has Chipscreen Bioscience's authority to initiate clinical trials for new indications in their respective territories.
The first approved indication of Chidamide was the rare disease refractory/recurrent peripheral T-cell lymphoma. Chipscreen Biosciences received China FDA (CFDA) approval for treatment of this condition in China in December 2014. A successful and popular drug, Chidamide was then included in China's Category B medical insurance list in July 2017. To date, more than 4,000 patients with PTCL have been treated with Chidamide. GNTbm is expected to submit an NDA to the TFDA for PTCL in 2019, and hopes to receive market approval sometime in 2020. The second indication for Chidamide is in combination with Aromasin for the treatment of hormone receptor-positive, HER-2 negative late stage breast cancer in post-menopausal patients. With Chipscreen Biosciences announcing the preliminary results from its recent Phase III trial for the same indication in China, this has allowed GNTbm to move forward at full speed its own clinical trial for this indication in Taiwan.
Dr. Chia-Nan (Alex) Chen, Chairman of GNTbm, stated that GNTbm had in-licensed Chidamide with the intent to invest in the development of new indications through locally-conducted clinical trials, and also intend to produce the API for this drug locally. The company will invest large sums of money and manpower to do so, he said.
"We will partner with local drug companies Formosa Laboratories and Sinphar Pharmaceutical to manufacture the API and for formulation, respectively," said Chen.
"We are very pleased to choose Taiwan Specialty Pharma Corp. (TSPC) as our sales partner in Taiwan. TSPC has many years of experience in pharmaceutical sales and marketing, especially in treatments for rare diseases, and in particular blood cancer. GNTbm and TSPC are very optimistic about the sale of Chidamide for peripheral T-cell lymphoma and advanced breast cancer patients in Taiwan," added Chen.
Ming-Yi (Milton) Huang, chairman of TSPC, said "TSPC has long focused on hematology, oncology, and nephrology therapeutic areas, and also on medical nutrition. In 2002, it exclusively represented Baxter's chemotherapy and radiotherapy nutrition product Sympt-X in Taiwan and purchased the global marketing right and trademark from Baxter in 2012. We have long admired GNTbm's dedication to drug development and look forward to representing GNTbm's anti-cancer drug Chidamide in Taiwan and to continue to improve patients' quality of life."
About GNT Biotech & Medicals Corp. (GNTbm)
Taipei, Taiwan-headquartered GNT Biotech & Medicals Co., Ltd. (GNTbm, TPEx Emerging: 7427) focuses on the development of new drugs and drug delivery systems. It uses nano-gold as the core technology of its drug delivery platform, Vaucarrin®, and in the development of drugs for the treatment of cancer and rheumatoid arthritis. Through cooperation with international pharmaceutical companies, the company aims to develop Chidamide, a new generation epigenetic regulator, for the treatment of peripheral T cell lymphoma, breast cancer, and other cancers. Targeting unmet clinical needs, GNTbm develops highly active and innovative formulations of nano-drugs to meet the urgent needs of patients.
About Taiwan Specialty Pharma Corp. (TSPC)
Taipei, Taiwan-headquartered Taiwan Specialty Pharma Corp. (TSPC) is a pharmaceutical sales and marketing company, specializing in the fields of hematology, oncology, nephrology and medical nutrition. Its sales team manages sales channels through hospitals, GPs and drug stores. Chairman Ming-Yi Huang has extensive industry experience, having previously headed the local offices of some of the world's largest pharmaceutical firms, including Pfizer, GSK and Novartis.
About Chipscreen Bioscience Ltd.
Shenzhen, China-headquartered Chipscreen Bioscience Ltd. was established as Sino-foreign joint venture in 2001 by several Chinese returnees from the United States with academic, scientific, and industrial experience, and is an integrated biotech company specialized in discovery and development of novel small molecule pharmaceuticals. Chidamide, a new generation of epigenetic regulator and subtype-selective HDAC inhibitor, was originally developed by Chipscreen Biosciences.
Dr. Yesu Chao
GNT Biotech & Medicals Corp.
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