Drug maker PharmaEssentia Corp (藥華醫藥) yesterday said that the US Food and Drug Administration will decide in two weeks whether its new drug P1101 for treating blood disorders can enter phase-three clinical trials directly.
P1101 has passed phase-two trials in Europe, and the Taipei-based pharmaceutical company’s European partner, AOP Orphan Pharmaceuticals AG, has also agreed to share the study data with the company.
That means PharmaEssentia could use the data to apply with the US Food and Drug Administration for clinical trials in the US and thus possibly skip phase-one and phase-two clinical trials there, PharmaEssentia president and chief executive officer Lin Ko-chung (林國鐘) said.
Lin said at a press conference that PharmaEssentia will be responsible for conducting the phase-three study and sell the drug in the US by itself, although it granted AOP Orphan Pharmaceuticals the exclusive rights to sell the drug in Europe.
About 120,000 people in Europe and 200,000 in the US are expected to use the drug, and each will spend US$50,000 a year, Lin said while celebrating the 10th anniversary of the founding of the company, which was started by a group of Taiwanese-American scientists in 2003.
PharmaEssentia plans to launch the drug in both the US and Europe at the beginning of 2016, he added.
Lin said AOP Orphan Pharmaceuticals will give 30 percent of its sales of the drug to PharmaEssentia for royalties and drug manufacturing after it hits the European market.
Lin said the company is also conducting tests to determine whether the drug can treat hepatitis B and C. In Taiwan, hepatitis B and C are the main causes of liver cancer, with between 20 and 25 percent of liver cancer cases triggered by the hepatitis C virus and between 70 and 75 percent by the hepatitis B virus, said Academia Sinica vice president Chen Chien-jen (陳建仁), a former health department minister.
The company has started the phase-two clinical trials of the drug for hepatitis B this quarter and plans to begin the phase-three study of the drug for hepatitis C next quarter, PharmaEssentia said.
“Since liver diseases are most common among Asians, PharmaEssentia will launch the drug for hepatitis B and C in Korea, Thailand and China,” Lin said.
PharmaEssentia will also start the phase-two clinical trials of its drug for treating psoriasis, which will be sold in Taiwan, China and the US this year.
The firm plans to list on the Emerging Stock Market in November or December, and will move to the GRETAI Securities Market or Taiwan Stock Exchange next year.