Taiwan Liposome Co (TLC, 台灣微脂體) yesterday said that its drug for treating breast and ovarian cancer is expected to hit the European market by the end of next year.
The company is conducting bioequivalence trials of the drug Doxisome in Europe, which it expects to complete in six to nine months. It will then move to do more such studies in the US, said an official who declined to be named.
The market potential of the new drug is about US$200 million a year in Europe and US$250 million in the US, the official said.
Doxisome is Taiwan Liposome’s answer to the ovarian and breast cancer drug Doxil by US health giant Johnson & Johnson, whose patents expired in 2009 in the US and 2010 in Europe, Taiwan Liposome said.
In November 2011, production of Doxil was suspended because Johnson & Johnson’s contract manufacturer, Ben Venue Laboratories, faced quality compliance issues, according to Citigroup.
However, Johnson & Johnson struck a deal with TTY Biopharm Co (台灣東洋藥品) in June last year, with the Taiwanese pharmaceutical company starting to manufacture Doxil on a contract basis in September last year.
In December last year, Johnson & Johnson also announced plans to purchase part of Ben Venue’s facilities to make Doxil, according to Taiwan Liposome.
Aside from Doxil, Taiwan Liposome faces competition from Sun Pharmaceutical Industries in the US market, after the Indian drugmaker’s Lipodox was approved by the US government in February last year.
“The production capacity of Sun Pharmaceutical can satisfy 40 percent of the US market,” the Taiwan Liposome official said, while adding that it should not affect the company’s sales in Europe, where Lipodox has not yet been approved for sale.
Taiwan Liposome is to apply for a drug permit for AmBiL, which is used to treat systemic fungal infection, in Europe this quarter, she said, adding that the approval process is expected to take nine months.
The company estimates the market for the drug at about US$250 million in Europe, she said.
Taiwan Liposome is to conduct bioequivalence trials of AmBiL in the US this year and apply for a drug permit next year, she added.
This year, the company plans to spend about US$20 million to US$25 million on research and development (R&D), up from NT$470.24 million (US$15.53 million) last year because of expenses for conducting bioequivalence trials.
Given the high R&D expenses, the company posted a loss of NT$400.97 million, or NT$8.22 per share, last year, compared with losses of NT$188.18 million, or NT$4.78 per share, in 2012.
Revenue for this year is expected to jump to NT$630 million this year, from NT$158.64 million last year, because of rising royalties and sales of AmBiL and ProFlow, a drug used to treat peripheral arterial disease, according to a report by SinoPac Securities Co (永豐金證券) on March 25.
As for next year, SinoPac expects the company to generate revenue of NT$1.01 billion and swing into profit as AmBiL, Doxisome and ProFlow enter the US and European markets.