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.
Luxury hotel Mandarin Oriental Taipei (文華東方酒店) plans to reopen its guestrooms in December to take advantage of a boom in domestic travel. The reopening would come six months after the five-star facility suspended room operations to cut costs as countries across the region impose border controls to contain the COVID-19 pandemic, diminishing demand for business travel. “We are delighted to share that Mandarin Oriental Taipei will resume room operations on December 1,” the hotel said in a statement yesterday. The hotel in Songshan District (松山) said it would adopt stringent health and safety practices to ensure the well-being of its guests and employees. It
India’s COVID-19 economic gloom turned into despair this week, on news that its per capita GDP for this year might be lower than that of Bangladesh. “Any emerging economy doing well is good news,” Kaushik Basu, a former World Bank chief economist, said on Twitter after the IMF updated its World Economic Outlook. “But it’s shocking that India, which had a lead of 25% five years ago, is now trailing.” Ever since it began opening up the economy in the 1990s, India’s dream has been to emulate China’s rapid expansion. After three decades of persevering with that campaign, slipping behind Bangladesh hurts
When the COVID-19 pandemic shut down bars and concert halls in the US in March, a new phenomenon was born: the vacation-rental nightclub. Professional party promoters started scanning Airbnb, Vrbo and other short-term rental sites for mansions and luxury condos for hire. Tickets were going for US$90 on Eventbrite and TikTok for soirees with bottle service and DJs. “People were looking to escape from their own homes and came into our tiny neighborhood to party all day, every day,” said Kristen Robinson Doe, a resident of a quiet suburban Dallas neighborhood, where a party pad was being rented out for more than
HSBC Bank (Taiwan) Ltd (匯豐台灣商銀) has approved two sustainability-linked loans totaling NT$450 million (US$15.55 million) for Taya Group (大亞集團) and Sinbon Electronics Co (信邦電子), the bank said yesterday, adding that interest rates would fall if the borrowers’ sustainability performance improves. Those marked the first sustainability-linked loans granted by HSBC Taiwan, it said. While HSBC Taiwan has experience providing green loans for the nation’s developers of renewable energy sources to support their projects, the bank began focusing on sustainability-linked loans to meet rising demand from companies in other sectors planning to undertake sustainability programs, it said. “As we reward our clients who reach their