Pharmadax Inc (法德生技藥品) yesterday said that it aims to gain approval to market two of its generic drugs — one for high blood pressure and one for schizophrenia — in the US and China by the end of this year.
The US Food and Drug Administration’s (FDA) approval process for the company’s hypertension tablet, Metoprolol Succinate ER — the generic version of Toprol-XL sold by AstraZeneca PLC — has entered the final stage, Pharmadax founder Huang Yi-pin (黃逸斌) told a media briefing in Taipei.
The company last month submitted more documents to the FDA, which is expected to reply within three months, Huang said, adding that Pharmadax is confident of gaining approval in the second half of this year.
The company first applied for approval from the FDA in 2010, Huang said, adding that the long approval process has not reduced the hypertension drug’s business potential, as demand is high, but suppliers are few.
“Americans consume an average of 2.7 billion Metoprolol Succinate ER tablets per year. AstraZeneca’s patent in the US expired more than 10 years ago, but few pharmaceutical companies know how to produce the drug, enabling AstraZeneca and its authorized companies to hold onto more than 40 percent of the market,” Huang said.
Pharmadax aims to win at least a 25 percent of the US market, and plans to expand production capacity at its Chinese plant in Foshan, Guangdong, to supply more than 600 million tablets per year after gaining approval, Huang said.
“Economies of scale matter. If we cannot provide enough for our distributors, they will be reluctant to help us promote the product,” Huang said.
Pharmadax also expects to gain marketing approval in China for its Quetiapine Fumarate ER tablet, the generic version of AstraZeneca’s Seroquel XR tablet, which is used to treat schizophrenia.
The business potential for the psychotropic drug would be good, as there is only one brand of the drug in the Chinese market, Huang said.
Meanwhile, the company plans to develop a new drug to treat dry eye syndrome in cooperation with Boston-based Glia LLC, Pharmadax board director Francis Chung (鍾裕民) said.
Unlike artificial tears, it would be a gel-like compound that people would apply to their foreheads to encourage the cranial nerves to secrete more tears, Chung said.
Pharmadax plans to move its shares from the less-active Emerging Stock Board to the Taipei Exchange by the end of this year, thanks to a recommendation letter the Industrial Development Bureau wrote last month, the company said.
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