Korea's Boryung Pharma Seeking MNCs To Sell Hypertension Product Abroad
This article was originally published in The Pink Sheet Daily
Executive Summary
Boryung hopes to find alternatives like out-licensing for Kanarb in order to get around the expense of meeting EU and U.S. manufacturing standards.
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SEOUL - South Korea's Boryung Pharma is seeking multinational partners to out-license its angiotensin receptor blocker Kanarb (fimasartan) in the U.S. and Europe. Plans for the product's sales beyond Korea are being expedited as Boryung awaits Korea FDA approval this fall following its application submission in early March. It expects to begin selling the ARB product in Korea during the first half of next year. Currently, seven products, including Novartis' Diovan FCT (valsartan), dominate the local Korean hypertension market in the absence of rival products offered by Korean pharmas. "In order to meet with U.S. and EU requirements, we have to satisfy their cGMPs, which is tough at this point for us because of the heavy investment demanded for the facility, thus we are looking for alternatives such as out-licensing and transfer of sales and technology to MNCs in the regions," Boryung spokesman Kwon Hyuk-Bum told PharmAsia News. "We are basically trying to sell the product in the U.S., Europe and China, and possibly India." "Our product is listed on WHO's INN [international nonproprietary name], and we have secured 32 types of compound and method patents in the U.S. Japan, Australia, Europe, Mexico and Russia," he said, adding that the pharma completed Phase III clinical trials last year in 24 hospitals across Korea. For the development of Kanarb, Boryung has invested KRW50 billion ($41.29 million) during the past 12 years, including KRW3.5 billion ($2.89 million) provided by the Korean government in its financing initiative for local pharmas. That initiative is part of the government's effort to build up the biopharma sector (Also see "Korean Government Announces Joint Fund To Beef Up Local Pharma Industry" - Scrip, 10 Feb, 2010.). Once approved by KFDA, Boryung's Kanarb will be the 15th new product developed and produced by a Korean pharma. "Even though there are 14 products already developed and produced by Korean pharmas, none of them were sold outside Korea, thus we expect Kanarb to be the first Korean product that will be sold in foreign markets," Kwon said. Contrary to what Kwon said, LG Life Sciences' antibiotic Factive (gemifloxacin), which was approved in 2003, is the first South Korean product to be approved by U.S. FDA (Also see "LG Life Science Tops R&D Investment List of Korea-Listed Pharmas" - Scrip, 8 Oct, 2009.) South Korea's leading pharmas, such as Dong-A, Hanmi, Daewoong, Green Cross and LG Life Sciences are increasingly seeking out partnerships with MNCs (Also see "South Korean Pharmas Clamber For Partnerships To Survive Rapidly Changing Environment" - Scrip, 15 Jun, 2010.). - Peter Chang ([email protected]) [Editor's note: This article appears courtesy of PharmAsiaNews.com, Elsevier Business Intelligence's source for Asian biotech and pharmaceutical news. Register for a 30-day risk free trial.] [PharmAsia News will host the 2nd PharmAsia Summit: Taking the Risk Out of Asia (Oct. 25-26, San Francisco). For a list of speakers and topics, click here.] |