PharmaEssentia Corp (藥華醫藥), which specializes in making new protein-based drugs to treat rare diseases, said yesterday that it is in talks with the Center for Drug Evaluation in Taiwan to introduce oral medication for treating breast cancer in the nation via an expedited process.
PharmaEssentia has been licensed by New York-based Kinex Pharmaceutical LLC to sell the drug — Oraxol — in Taiwan and Singapore.
The company has also obtained the rights to be the first to negotiate with Kinex to sell the drug in China and Southeast Asia, PharmaEssentia executive vice president Jack Hwang (黃正谷) said yesterday.
Kinex will receive an upfront payment, milestones and royalties, PharmaEssentia said, without disclosing the exact numbers.
Oraxol is the oral formulation of paclitaxel, an intravenous drug commonly used in first-line treatment for breast cancer, Hwang said, adding that the drug is currently under 505(b)(2) new drug application review in the US — an expedited measure designed to deal with new formulations of previously approved drugs.
“Officials of PharmaEssentia went to the center today [yesterday] to persuade it to adopt an expedited measure similar to the 505(b)(2) new drug application in the US,” Hwang said.
According to Hwang, Oraxol has less side effects than Paclitaxel, especially in terms of peripheral neuropathy.
“The drug concentration level for Oraxol is lower immediately after a patient takes the drug, which can reduce the side effects, while the concentration level for Oraxol can stay effective longer then Paclitaxel,” Hwang said.
Kinex and PharmaEssentia have been business partners since 2012, when the two companies inked a licensing agreement for PharmaEssentia to sell KX01, which is used to treat keratinocytes, in China, Taiwan and other Asian countries except South Korea, Japan, Australia and New Zealand, it said.
Meanwhile, PharmaEssentia expects that its factory in Greater Taichung will be inspected by the US Food and Drug Administration and the European Medicine Agency (EMA) in September and October next year, after it files a new drug application for P1101(AOP2014), its new drug to treat polycythemia vera — a rare blood disease in which the body makes too many red blood cells — a company official, who declined to be named, said yesterday.
The factory will serve as the manufacturing site for P1101 after the drug hits the market in the US and Europe, he said.
The factory, with a reactor volume of 40 liters, manufactures active pharmaceutical ingredients for drugs and sends the ingredients to subcontractors to make formulations, the official said, adding that the company plans to build a new reactor with a volume of 200 liters to make formulations itself in the near future.
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