ScinoPharm Taiwan (台灣神隆), which makes active pharmaceutical ingredients, said yesterday that a generic drug codeveloped with US-based drugmaker Sagent Pharmaceutical Inc for the treatment of leukemia is expected to enter the US market by the end of 2016, once patents on the original drug expire.
ScinoPharm Taiwan and its partner filed for permission to sell the drug in the US market last month, ScinoPharm Taiwan said.
ScinoPharm Taiwan estimated that sales of the non-generic drug were US$250 million in the US last year.
ScinoPharm Taiwan was responsible for developing the active pharmaceutical ingredients and formulation of the generic drug.
The company is set to use its plant in Changshu, China, to make the active pharmaceutical ingredients of the drug, while outsourcing the manufacture of the drug itself to Sagent’s division in China, vice president Portia Lin (林靜雯) said at an investors’ conference yesterday.
Sagent is also to oversee the abbreviated new drug application in the US and is to be responsible for marketing and selling the drug, Lin said.
“This application is likely to trigger the US Food and Drug Administration to send people to inspect ScinoPharm Taiwan’s plant in Changshu, China,” Lin said, adding that after the inspection the company would be able to use the new plant to make products for other clients.
The company also said yesterday that it reported profits of NT$193 million (US$6.43 million) last quarter, up 16 percent from the NT$165 million seen a quarter ago and down 53 percent from the NT$406 million posted a year earlier.
The company saw a gross margin of 44 percent last quarter, up from the 40 percent posted in the previous quarter and down from the 54 percent booked for the previous year, it said.
Chief financial officer Patricia Chou (周珮芬) said the company’s gross margin last quarter improved from the previous quarter because it faced less pressure to acquire paclitaxel, which is used to make “10 dab” — used to manufacture pharmaceutical ingredients for the cancer drugs Docetaxel anhydrous and Paclitaxel.
As for the year-on-year decline in gross margin, Chou said it was because sales for pharmaceutical ingredients used in Viibryd, an anti-depressant, and Qsymia, a weight-loss drug, had declined.
The two products have higher gross margins than other products, she added.
The company was also required by the European Medicines Agency to meet the agency’s new standard.
This meant it had to separate production lines for pharmaceutical ingredients with different levels of toxicity, resulting in a lower gross margin last quarter compared with a year ago, Chou said.
ScinoPharm Taiwan president and CEO Fred Chen (陳勇發) said that although the company had to adjust its production to meet the new regulation, the new rule would also create a higher entry level for its competitors.
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