Drug maker PharmaEssentia Corp (藥華醫藥) said yesterday that its new drug for polycythemia vera, a blood disorder of the bone marrow, could be approved in Europe at the end of 2015.
PharmaEssentia licensed the drug to Austrian company AOP Orphan Pharmaceuticals AG in 2009 and will receive milestone payments and royalties from AOP after the drug is approved in Europe and goes on sale.
The drug has completed the second phase of clinical trials in Europe, and PharmaEssentia said it will discuss the European trial data with the US Food and Drug Administration to expedite the approval process to the US.
“We aim to launch the drug in the US and Europe at the beginning of 2016,” company president and chief executive officer Lin Ko-chung (林國鐘) said.
Sales of the drug are expected to reach US$500 million in both the US and Europe, benefiting from higher prices set by both regions as an incentive for drug companies to develop orphan drugs, Lin said.
The company has three patents for the new drug, which will expire in 2028, 2029 and 2030 respectively.
PharmaEssentia built a factory in Central Taiwan Science Park (中部科學園區) last year which has the capacity to produce 1 million units of the drug a year.
In April, the factory won regulatory approval by Taiwan and European medicine agencies for its quality manufacturing process, the company said.
Lin said the company plans to list on the smaller Emerging Stock Market in November or December, and will shift to list on GRETAI Securities Market or Taiwan Stock Exchange next year.
Nutek Corp (閎泰), which manufactures automotive security systems, is the company’s largest shareholder with a 20 percent stake, Lin said, adding that it counts Toyota Motor Corp as one of its major clients.
State-run National Development Fund owns a stake in PharmaEssentia of 12 percent to 13 percent, he said.
Meanwhile, another drug manufacturer SynCore Biotechnology Co (杏國新藥) debuted its shares on the Emerging Stock Market yesterday, seeing its shares rise to NT$114.98 from the initial pubilc offering price of NT$60.
The company's Veregen drug for genital warts has won government's approval and can contribute to its sales starting this quarter, SynCore said.