Hanmi Pharmaceutical(www.hanmipharm.com) is launching the US clinical phase Ⅲ clinical trial on Hyalrheuma Injection for treatment of osteoarthritis.
On March 27, Hanmi(CEO&President. LEE, Gwansun) announced that Actavis, its trading partner received FDA approval of IDE (Investigational Device Exemption), the procedure of clinical test on medical device.
Hyalrheuma is a proven medicine in Korea, but it is classified as a medical device.
According to IDE approval, Actavis has a plan to evaluate the safety and effectiveness of the drug for fifteen months by injecting Hyalrheuma once a week for three weeks to 600 osteoarthritis patients in 50 U.S. institutions.
“Hyalrheuma Inj. is the first to be launched in the American market among Korean osteoarthritis treatment for inkection,” said an official from Hanmi, “We will make our best efforts to penetrate the market with Actavis.”
Meanwhile, Hanmi Pharmaceutical signed an agreement of $84 million export deal for twelve years with Actavis last July. Actavis, which was established in 1956, recorded its annual revenue of 10 trillion KRW, the No. 1 in the U.S. generic market.
By Lee Jae-seung