2011 Scrip Asia 100 - South Korea's top five pharma companies
This article was originally published in Scrip
Executive Summary
South Korea's top five pharma companies
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2011 Scrip Asia 100 - Asia clinical trial starts
For companies headquartered in the 11 countries selected for inclusion in Scrip Asia 100, there were a total of 127 industry-sponsored Phase II-III trials initiated between 1 June 2010 and 31 May 2011. This was an increase of 20 starts (19%) from last year. Fully 59 unique sponsors were represented, up from 38. As expected, Japanese firms dominated, with a total of 35 companies initiating 91 separate trials (even excluding Chugai's seven trial starts), with the remainder comprising 14 from South Korea, 11 from China, plus four conducted by companies in Taiwan.
Astellas topped the rankings with nine starts (see Figure 1), although Otsuka and its subsidiary Taiho Pharma initiated six trials each over the period, and Takeda's seven were augmented by an additional two Phase III trials of TAK-700 (orteronel) in combination with the corticosteroid prednisolone for the treatment of metastatic prostate cancer, conducted by Millennium Pharmaceuticals, which Takeda acquired in May 2008.
Source: TrialTrove; accessed 6 June 2011
Takeda also commenced four trials from its licensed-in portfolio; two investigating originator Lundbeck's antidepressant vortioxetine (Lu-AA-21004), and a Phase III trial in each of two therapies licensed by Takeda from Amgen for commercialisation in Japan; AMG-479 (ganitumab) to treat pancreatic tumours, and AMG-386 in combination with paclitaxel in patients with ovarian, peritoneal or fallopian tube cancer.
In terms of sheer quantity, Astellas undertook a total of five Phase III starts for its antidiabetic agent, ipragliflozin (ASP-1941), four of which were combination trials comparing glycaemic control of ASP-1941 plus another oral hypoglycaemic versus the comparator product alone. Ipragliflozin is under co-development with Kotobuki.
Chugai's seven starts included three Japanese trials investigating a compound developed in its own research laboratories, the oral antihyperglycaemic agent tofogliflozin (CSG-452/RG-7201). In total, more than 950 patients are targeted for enrolment in the Phase II/III and two Phase III trials.
Among the South Korean companies, Boryung initiated a 250-patient study of its oral antihypertensive, fimasartan, and Bukwang opened a trial investigating the use of its small-molecule tablet (BK-C-0701) to treat patients with diabetic neuropathy (both in Phase III).
Among China's 11 starts, the private developer of recombinant protein drugs, Amoytop Biotech, commenced two trials of its Ypeginterferon alpha-2b biologic (manufactured using its Y-shaped branched PEGylation technology platform) – one to treat patients with chronic hepatitis B infection and another for chronic hepatitis C sufferers. Also during this period, Taiwan-based Phytohealth initiated a Phase II trial to monitor the effects of its natural plant extract product PHN-031 on patients with diabetic nephropathy, a life-threatening complication of both type 1 and type 2 diabetes. PHN-031 is also under development as a hormone-replacement therapy to prevent osteoporosis in post-menopausal women.
With regards to therapy areas investigated in Japan, oncology led the way, with a total of 35 trials (see Figure 2), spread over 13 different indications, with non-small cell lung cancer (NSCLC) therapies being represented in eight starts; four Phase II and four Phase III trials investigating a total of seven different compounds, with Otsuka's subsidiary Taiho initiating two trials of its TS-1 combination tablet (5-fluorouracil prodrug plus 5-chloro-2,4-dihydroxypyridine, plus oxonic acid). The next most frequent oncology indication was for the treatment of hepatic cancer with five starts, with OSI Pharmaceuticals (Astellas) commencing trials in both NSCLC and liver cancer in the past 12 months, using its small-molecule IGF-1R inhibitor, linsitinib (OSI-906).
Source: TrialTrove; accessed 6 June 2011
Overall, the data suggest that clinical trials activity has increased throughout the Far East since last year, with Japanese, South Korean, Chinese and Taiwanese companies all initiating more trials than were reported in the period between June 2009 and May 2010.
view from India
In comparison, trial starts conducted in India by Indian-headquartered companies over the same 12-month period totalled 23 (see Figure 3), with Intas Pharmaceuticals leading the way with five trials, including one each for generic paclitaxel and docetaxel, both in Phase II to treat breast cancer.
Source: TrialTrove; accessed 6 June 2011
Bangalore-based Biocon was next in the rankings with three starts, including a 20-site, 250-patient Phase III trial investigating its anti-CD6 monoclonal antibody biologic itolizumab for the treatment of plaque psoriasis. The company also expects to progress itolizumab therapy into an Indian Phase III trial for the additional indication of rheumatoid arthritis later this year.
In trials by Indian companies in their home market, cardiovascular and neurology came out on top, with six trial starts each (see Figure 4). Closer examination revealed no significant underlying trends from either therapy area, as the indications represented were many and varied.
Source: TrialTrove; accessed 6 June 2011
Norman Oxlade is managing editor of the IBI Pharmaceutical Intelligence Unit. This article is part of the 2011 Scrip Asia 100 Clinical Trials chapter. Also featured in this section:
CMIC shows first-mover advantage in Japan's CRO market
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Read the full Scrip Asia 100 analysis, including league tables of Asia's top pharmaceutical players, interviews with the leaders of domestic companies and multinationals, product approval and clinical trials data, and analysis of how pharma should address Asia's diverse and evolving regulatory systems at scripasia100.com.
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