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Note: "Merck & Co., Inc." has its headquarters in Whitehouse Station, NJ, USA and operates in most countries outside the U.S. as Merck Sharp & Dohme. "Merck KGaA" has its headquarters in Darmstadt, Germany; "Bayer Schering Pharma AG", with its headquarters in Berlin, Germany, is a division of "Bayer HealthCare AG", which has its headquarters in Leverkusen, Germany; "Schering-Plough" has its headquarters in Kenilworth, NJ, USA. Merck & Co. Inc., Merck KGaA, Bayer HealthCare and Schering-Plough are all members of the IFPMA.
INVESTMENT DRIVERS Our top picks for 2004 are Shionogi and Eisai, ahead of what will likely be another year of treading water for the Japanese pharma industry. While some valuations seem tempting, we recommend an equal weight with some dry powder should any upside surprise opportunities develop. Substantive "restructuring" of this moribund sector may be on the horizon if Yamanouchi Fujisawa create a smart merger and set off a trend. Younger managements are taking an upper hand, while `daiko henjo selling pressure' is waning, thus stabilizing an external negative. Inefficiencies in operations persist, and the outlook for earnings growth stagnates. Globalization is critical, but substantial investments are needed even by Takeda, Yamanouchi, Sankyo, Eisai, and Fujisawa. Few others have a chance beyond Japan. Regulatory reforms may take years, but will cause more dull rather than sharp pain near term. The April `04 price cuts will likely be modest, while efforts to speed new drug approval may finally bear fruit. A generic threat is the biggest negative looming long-term. Interesting pipeline drugs - MRA, capravirine, TAK-375, Vesicare, and DX-8951f, have potential to create positive surprise, though valuations reflect much of their promise. Mevalotin, Levaquin, Lupron, and Prevacid are completing their life cycle and pose major challenges for the originators. TOP PICKS FOR 2004 Eisai - Global growth of Aricept and Aciphe drives what is the third highest growth rate in the Japanese pharma sector. Expansion of the US sales force will be an important contributor to this growth; as plans to partner CNS drugs in the region progress including the recently in-licensed rasagiline for Parkinson's ; , Eisai will maximize its sales force productivity and prepare for its next major products. Shionogi - Crestor should drive industry high long term growth, supported by recent new product launches and promising late stage pipeline products. Shionogi's successful R&D organization is poised to be recognized as one of the better ones in Japan, as seen in the robust deal done with AstraZeneca for Crestor, the GlaxoSmithKline JV, and the partnership with Pfizer for S-1153 capravirine ; . Table 1 Outlook 2004 UNIVERSE RANKING JAPAN PHARMA and actos.
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To ensure the quality of the laboratory network, in 1996 an annual accreditation program was initiated to be completed by all national and regional laboratories by the end of 1997. Six criteria are used for accreditation: 1 ; completeness and timeliness of reporting; 2 ; minimum number of specimens tested; 3 ; nonpolio enterovirus isolation rate of 10% from all stool specimens; 4 ; accuracy of poliovirus detection and identification; 5 ; scores from annual proficiency tests; and 6 ; score from an annual on-site review of laboratory operating procedures and practices. The laboratory network must have the capacity and capability to process a minimum of 26, 000 stool specimens per year, based on the expected occurrence of at least one case of nonpolio AFP per 100, 000 population aged 15 years. To assess the quality of performance, during 19941996, a total of 100 proficiency tests were completed by the 67 national laboratories in five of the eight WHO regions. The proficiency test panels were prepared by the National Institute of Public Health and Environmental Protection RIVM ; in Bilthoven, Netherlands, and consisted of five stool samples containing zero, one, two, or three poliovirus serotypes and or nonpolio enteroviruses. Correct results were obtained for 332 66% ; of the 500 total samples. Of the samples containing one poliovirus type, 90% were correctly identified; of the samples containing two poliovirus types, 71% were correctly identified; and of the samples containing three poliovirus types, 33% were correctly identified. Of the 168 34% ; samples with incorrect results, 26% were caused by errors in virus isolation or typing and 8% by virus contamination of negative samples or cross-contamination of virus-containing samples. Samples containing any poliovirus, regardless of the number or type, were identified with a sensitivity and specificity of 92% and 91%, respectively. For all national and regional laboratories, the goal of proficiency testing is a score of 80%. In the 1997 proficiency tests, each of the 30 provincial laboratories in China scored 100%. All regional reference laboratories scored 100% on the most recent panels designed to test the proficiency in distinguishing wild from vaccine-derived polioviruses and adalat, because aciphex 200 mg.
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