PharmaEngine Inc (智擎) yesterday announced that its new pancreatic cancer drug, Onivyde, has seen rapid sales growth in the US market since gaining regulatory approval in October last year.
Sales of Onivyde totaled US$4.3 million in the final two months of last year, and the figure amounted to US$10 million in the first quarter of this year, the company said.
As each patient in the US contributes about US$43,000 in sales for every four-month regimen — which requires three to four vials every two weeks at US$1,620 per dose, the market potential in the US is estimated at about US$800 million, the company said.
PharmaEngine said the pace of commercialization of Onivyde in Europe is likely to be quickened by Shire PLC’s recent acquisition of PharmaEngine’s licensing partner Baxalta Inc.
Onivyde is expected to be approved for sale in Europe in the first half of this year, and in a number of Asian markets before the end of next year, Masterlink Securities Investment Advisory Corp (元富投顧) researcher Frank Fu (傅恒聿) said in a note on Tuesday.
Dublin-based pharmaceutical group Shire, which is to oversee sales of the drug in Europe, is expected to see aggregate sales of NT$3 billion (US$91.73 million) by the year 2020 on the back of its strong distribution channels, while bringing steady milestone payments to PharmaEngine, Fu said.
PharmaEngine submitted a new drug application for Onivyde to health authorities in South Korea on Thursday last week and is preparing applications with European authorities.
The company said it is to book milestone payment gains of US$10 million from its licensing partners in the South Korean market and expects another US$25 million in gains from the European business.
As for the domestic market, Onivyde was approved by the Food and Drug Administration in October last year.
“We are working with the National Health Insurance Administration on bringing Onivyde to Taiwan at a more accessible price,” company president and chief executive officer Grace Yeh (葉常菁) told an investors’ conference.
“Company morale was also boosted recently when Onivyde’s largest rival, a drug developed by US-based Nektar Therapeutics, reported unfavorable clinical trials results,” Yeh said.
In the first quarter, the company’s net losses narrowed to NT$56.94 million from NT$351.77 million a year ago, with losses per share of NT$0.42.
The company is expected to see earnings per share of NT$12.1 at the end of this year, and NT$16.85 per share at the end of next year, if Onivyde sees commercialization as planned in Asia and Europe, Fu said.
PharmaEngine shares yesterday dropped 0.42 percent to NT$234.5 in Taipei trading.
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