Japan stock market week to September 10, 2007

Tokyo retreated in the week to September 10. The Nikkei 225 fell 4.6% to close below the 16,000 level, following a steep 2.2% daily decline in the last trading day, while the Topix index dropped 5.0%. The pullback was caused by downward revision of Japan's April-June Gross Domestic Product data, unexpectedly weak US employment figures for August and an appreciation of the yen against the US dollar and euro. Amid a dearth of positive incentives, short-term trading-oriented moves prevailed and banks and real-estate stocks met selling pressure. The pharmaceutical index was off 1.5% but outperformed the market.

Eisai gained 0.4% after it concluded a co-promotion agreement with Salix Pharmaceuticals of the USA, in which the Japanese firm obtains exclusive rights to co-promote Colazal (balsalazide disodium) 705mg capsule formulation (currently marketed) and new 1,100mg dosage when it is approved by the US Food and Drug Administration (Marketletter September 10). Colazal is for the treatment of mildly and moderately active ulcerative colitis. Eisai plans to strengthen its presence in gastroenterology by co-promotion of this drug, in addition to current marketing of the proton pump inhibitor AcipHex (rabeprazole sodium).

Astellas inched down 0.4%, reflecting an anticipated delay in the US approval of vernakalant HCl for the treatment of the acute conversion of atrial fibrillation co-developed with US firm Cardiome Pharma (Marketletter September 10). The US FDA requested that the two companies participate in a panel review of the Cardiovascular and Renal Drugs Advisory Committee scheduled for December 11-12. To prepare for the panel, Astellas was requested to file additional information including final safety and efficacy data from the clinical trial which was ongoing when the original New Drug Application was submitted. Due to the amendment of the NDA, the FDA indicated that the action date of the Prescription Drug User Fee Act will be extended by three months to January 19, 2008. The share performance was also negatively affected by the extension of US regulatory review of the additional indication of Mycamine (micafungin sodium) for the treatment of candidemia and other Candida infections. Astellas was notified by the FDA that the action date of the PDUFA was extended by three months for the Supplemental New Drug Application of Mycamine. Following the submission of the sNDA in December 2006, Astellas initially expected to receive the action letter in October. Mycamine has been on US market for the treatment of esophageal candidiasis and prophylaxis of Candida infections.