Shares of local drug developer Orient Pharma Co (友霖生技) rose 6.1 percent yesterday after the company said its new drug for treating attention deficit hyperactivity disorder (ADHD) would soon enter the third stage of clinical trials.
The company announced on Thursday it would expedite the process of clinical trials on the new drug by skipping second-stage clinical trials.
After gaining approval from the Taiwan Food and Drug Administration, the company said it plans to launch the new drug — Oradur-Methylphenidate — in Taiwan by the end of 2016.
“By skipping the second-stage of clinical trials, Orient Pharma can save tens of millions of New Taiwan dollars and shorten the period for obtaining a drug permit in Taiwan by two years,” Hua Nan Securities Investment (華南證券投顧) said in a note yesterday.
The company’s shares closed at NT$53.8 on the Emerging Stock Market yesterday, pulling back from as high as NT$55.5 in the morning session.
Based on statistics from the National Health Insurance Administration and IMS Health, about 9 percent of children in Taiwan suffer ADHD, and the market value for drugs treating the disorder is up to NT$310 million (US$10.33 million) a year.
“We are currently discussing with the administration about phase-three clinical trials and we aim to start the trials by the end of this year,” Orient Pharma spokesperson Anita Chen (陳嬿娟) said by telephone.
Oradur-Methylphenidate is being co-developed by Orient Pharma and US-based drugmaker Durect Corp, with the Taiwanese company responsible for manufacturing the drug for Durect in all territories other than the US.
Orient Pharma said it has development and commercialization rights for the drug in certain Asian and South Pacific countries, while Durect retains the rights to North America, Europe, Japan and all other countries not licensed to Orient Pharma.
In addition, Durect will be entitled to receive a royalty on sales of Oradur-Methylphenidate by Orient Pharma.
“In addition to the market in Taiwan, we plan to sell the drug in China, Singapore, the Philippines and Malaysia, where we have subsidiaries,” Chen said.
From January through June, Orient Pharma saw its revenue grow 0.33 percent to NT$80.3 million from a year ago, company data showed.
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