07/04/2009 - 17:23
- (Bolsamania) - • AstraZeneca: Crédit Suisse à sous-pondérer
• Objectif de prix : 1890 pence
• Par les analystes de Crédit Suisse
• FDA has found US Symbicort to be non-approvable
• FDA has found AZN's Symbicort to be non-approvable in the treatment of asthma in paediatric patients (6-11yrs). FDA stated that AZN has provided inadequate dosing data. AZN is evaluating the CRL and will respond in due course.
• US Symbicort: Credit Suisse estimates US symbicort sales of $550m in 2009 (representing c.2% of earnings) and $900m in 2015 (respresenting c.5% of earnings).
• Doesn't help brand perception. We believe the paediatric population accounts for approximately 5% of the asthma combination treatment market. Failing to get this indication on the label will not help AstraZeneca as they try to build the Symbicort brand in the US. Primary care doctors in particular have been reluctant to prescribe Symbicort, still favouring GSK's Advair, the combination treatment with which they have years of experience.
• A positive for GSK: Any reduction to the marketing position of Symbicort has to help GSK defend Advair market share.
• Pulmicort respules: Late on Friday FDA announced that Apotex has received US approval for generic Pulmicort respules. We understand (from AZN) that Apotex has not launched and AZN will likely apply for an injunction. Pulmicort respules represent 2.5% of Credit Suisse 2009 sales and earnings estimates. In a worst case scenario where AZN loses an injunction and Apotex launches we would estimate a -2% reduction in 2009E EPS.
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