Korea’s KHIDI Mobilizes Pharma Experts To Help Korean Pharma Go Global
This article was originally published in PharmAsia News
Executive Summary
KHIDI deploys pharma experts including former China FDA staffer to provide local Korean pharma with desperately needed advice for global regulatory submissions.
SEOUL – The Korea Health Industry Development Institute is looking to recruit global pharmaceutical experts to push Korea’s generic-dependent pharma companies to advance beyond their home market.
Under a new program, KHIDI has hired three regulatory and business development specialists in Korea for education and consultation services “that are needed for the development of new drugs and launch by Korean pharma in the global markets, particularly in the U.S. market,” KHIDI told PharmAsia News. All three have PhDs in their applicable fields with more than five years of work experience in the area of new drug development, clinical trials, FDA approval and global marketing.
The new recruits include Chinese national Zhao Lilli, former director of the New Drug Registration Division at China’s State FDA (now China FDA) from 1978 to 2010; John Reid, a U.S. citizen who worked for AstraZeneca PLC as director of strategic partnering and business development from 1998 to 2012; Shin Hun-woo, a Korean-American, who will become a U.S. citizen in November, and was former director of business development at SK Life Science Inc.
In addition, four more regulatory, GMP, marketing and clinical trial experts will join KHIDI in October.
Mark Paxton, who is currently working for U.S. FDA as a regulatory expert, will work at KHIDI USA in New York. The rest of the specialists will relocate to Korea. The GMP and clinical trial experts are Americans, and the marketing specialist is a citizen of Turkey, according to KHIDI.
Columbus Project For U.S. Market
Since March 2011 Korea's Ministry of Health and Welfare, to which KHIDI belongs, has been helping local pharma tap into the U.S. market through its ”Columbus Project,” which has provided consultations on procedures needed for drug approvals in the U.S. (Also see "Korea's Health Ministry Gets In The Act To Generate Korean Innovation For U.S. Markets" - Scrip, 9 Mar, 2011.).
“I am not sure whether there are many Korean pharma actually entering the U.S. market because of the Columbus Project,” the Korea Pharmaceutical Manufacturers Association told PharmAsia News, noting it would take time for the project to show some results.
The KPMA official said the U.S. state of Maryland is trying to invite Korean pharma to conduct business in the state. Maryland’s Department of Business and Economic Development is hosting the second annual Korea-Maryland, USA Bio Expo in Rockville in November.
To back up its Columbus Project, the ministry also selected 43 "innovative pharmaceutical companies” – all local firms, except for the Korean unit of Otsuka Pharmaceutical Co. Ltd. – for financial and tax incentives to spur R&D activity (Also see "Korea’s Health Ministry Selects 43 Innovative Companies For Tax/Funding Benefits" - Scrip, 20 Jun, 2012.).
This year, the ministry added more tools to drive globalization with the launch of a global M&A fund to help local pharma companies link with foreign pharmaceutical companies (Also see "South Korea To Launch Global M&A Fund Based On Israel’s Yozma Model" - Scrip, 20 May, 2013.).
A Few Stars
Under the government globalization efforts, some Korean pharma are beginning to shift their focus to innovative products. For example, Hanmi Pharmaceutical Co. Ltd. is gearing up for a U.S. launch of its modified version of AstraZeneca’s Nexium (esomeprazole). The Ministry of Health and Welfare attributed Hanmi’s entry into the U.S. market to the government projects (Also see "Korea’s Hanmi Hopes U.S. Esomeprazole Launch Will Counter Disappointing China Results" - Scrip, 8 Aug, 2013.).
Among Korean pharma, Hanmi is also at the forefront of deals with multinational companies. In 2012, Hanmi signed a global deal with GlaxoSmithKline PLC to co-develop what it calls evidence-based formulation products (Also see "Will GSK-Hanmi Deal Trigger Similar Tie-ups With Korean Pharmas?" - Scrip, 3 Apr, 2012.).
On the biosimilars front, Celltrion Inc. is about to launch Remsima, its biosimilar of Johnson & Johnson‘s blockbuster tumor necrosis factor inhibitor Remicade (infliximab), in Europe after it was approved by the European Commission Aug. 28 (Also see "Korea’s Celltrion Will Support Hospira On EU Infliximab Sales While Setting Sights On Japan" - Scrip, 11 Sep, 2013.).
In February, Korean vaccine maker Green Cross Corp. won U.S. FDA orphan drug designation for Hunterase, its biobetter of Shire PLC's Elaprase (idursulfase) to treat Hunter syndrome (Also see "Korea’s Green Cross Receives U.S. FDA Orphan Drug Status For Elaprase Biobetter" - Scrip, 22 Feb, 2013.).
While Korean pharma individually pursue deals with MNCs to gain entry into the U.S. market, the Korean government itself is investing in a Korea-Seoul Life Science Fund, a collaboration set up in part by Boston-based venture capital firm Oxford Bioscience Partners. Oxford Managing General Partner Jonathan Fleming told PharmAsia News in an earlier interview that the Korean government is bending over backwards to support innovation. He said stem-cell therapies in particular are a good opportunity (Also see "Oxford BioSciences Jonathan Fleming And Chris Kim On Investing in Korea: An Interview With PharmAsia News (Part 2 of 2)" - Scrip, 8 Mar, 2012.).