Panion & BF Biotech Inc (寶齡富錦), which manufactures pharmaceuticals, cosmetics and consumer healthcare products, said yesterday that it expects its new drug for treating kidney disease to acquire a permit in Taiwan in three months.
The company’s optimism came after the Food and Drug Administration (FDA) on Feb. 19 rejected the company’s application to license new drug Nephoxil.
The FDA has agreed to conduct another review if the company is able to supplement its data within three months.
“The main concern for the administration is that the company cannot use data compiled by our US partner Keryx Biopharmaceuticals Inc because it used tablets for its clinical trials, while we used capsules,” president Michael Chiang (江宗明) told an investors’ conference in Taipei yesterday.
Chiang said the company has fully cooperated with the FDA to provide the necessary data for further review.
Nephoxil gained approval in Japan on Jan. 17 and has been under review for a new drug application in the US since August last year and in Europe since Monday last week, said Raymond Chuang (莊瑞元), a senior manager at the company.
The company has licensed the drug to US-based Keryx Biopharmaceuticals and Japan-based Torii Pharmaceutical Co, and it will receive milestone payments and single-digit percentage royalty payments on sales of the drug in those two countries, Chuang said.
The two companies will also pay a manufacturing fee for the active pharmaceutical ingredients to Panion & BF Biotech, he added.
However, the company has to pay 33.4 percent of the milestone payments and 50 percent of the royalties it receives in the US, Japan and in five European nations to the person who invented the drug, Chuang said.
Chuang said Nephoxil is currently the only drug in the world that can reduce both high serum phosphate level and anemia resulting from kidney problems, which will allow the drug to grab a large market share and sell at a higher price.
The combined sales of Sevelamer and Lanthanum, which are most commonly used together to treat high serum phosphate levels caused by kidney problems, were US$1.2 billion worldwide in 2012, Chuang said, citing the financial reports of Sanofi SA, which sells Sevelamer, and Shire PLC, which sells Lanthanum.
Chuang said patents for the drug last until 2024 at the earliest.
Last year, the company posted revenue of NT$847.78 million (US$27.93 million), up 26.76 percent from NT$668.79 million the previous year, according to a company filing to the Taiwan Stock Exchange.
In the first half of last year, the company swung into the black with a profit of NT$3.1 million, or earnings per share of NT$0.09, after it reported losses the previous three years because of high drug development costs, it said.
Panion & BF Biotech financial and accounting division vice president Eric Wang (王烽任) said the company’s profitability last year was “satisfactory.”
Panion & BF Biotech shares rose 1.58 percent to close at NT$393.5 yesterday on the Emerging Stock Market, outperforming the over-the-counter benchmark index, which was up 0.48 percent.