PharmaEssentia Corp (藥華醫藥) yesterday said that phase-three European clinical trials for its bone marrow disease treatment may be completed three months earlier than expected, as its European partner is likely to register a sufficient number of subjects soon.
PharmaEssentia chairman Jan Ching-leou (詹青柳) said AOP Orphan Pharmaceuticals AG may be able to recruit 256 people with polycythemia vera in Europe by the end of next quarter, rather than by the end of this year as it projected earlier.
As a result, the two companies are expected to launch its P1101 (AOP2014) protein drug in Europe by the end of 2016, instead of 2017, Jan said.
Last month, the Taiwanese firm filed an investigational new drug (IND) application with US authorities, said Ellen Chang (張慧敏), a financial department director at PharmaEssentia.
It might take about a month for the US Food and Drug Administration (FDA) to decide whether the company can use the European clinical trial data for its permit application in the US, she added.
If the US FDA approves PharmaEssentia’s proposal, the company expects to launch the drug in the US at the same time as in Europe, Chang said.
Based on the company’s estimates, it will take three to five years for sales of the drug to reach peak sales, which are expected to be about US$1 billion a year in the US, and the same in Europe.
There are about 149,000 people in the US with polycythemia vera, a blood disorder in which the bone marrow makes too many red blood cells. In Europe, about 100,000 people have the disease.
The company said P1101 is more potent and has fewer side effects than the existing Jakafi treatment, launched by US-based Incyte Corp last year.
PharmaEssentia said it plans to price P1101 lower than Jakafi, which costs patients US$120,240 a year, to gain market share.
Meanwhile, PharmaEssentia on Monday applied to the Ministry of Economic Affairs to be recognized as a technology enterprise, so it can shift its stock listing to the GRETAI Securities Market next year.
In related news, drugmaker Medigen Biotechnology Corp (基亞生技) yesterday said that it is able to start the interim analysis of its data for phase three clinical trials of PI-88 treatment for liver cancer in Taiwan, China, Hong Kong and South Korea.
The company is to review the data on July 27 and disclose the results immediately after the reviewing meeting.
If the analysis yields positive results, Medigen expects to acquire a drug permit in Taiwan by the end of this year.