Core operating profit in the first quarter was up 12 percent to $2,765 million, as a result of improvement in Core gross margin and continued efficiencies in SG&A and R&D. Reported operating profit, which included restructuring and synergy costs ($117 million), Merck and MedImmune related amortisation ($134 million) and an intangible asset impairment charge as a result of the "at risk" launch of a generic competitor to MedImmune's oncology product Ethyol™ ($257 million) was $2,257 million, 5 percent lower than last year.
Core earnings per share in the first quarter were $1.28 compared with $1.07 in the first quarter 2007, a 9 percent increase at CER. The increase is the result of the growth in Core operating profit and the benefit of a lower number of shares outstanding, partially offset by increased net interest expense.
Research and Development Update
In the first quarter, the first of three planned regulatory submissions for 2008 was achieved, with the submission of the Biologics Licence Application in the US for motavizumab in January. The filing for saxagliptin is on track for mid-year, with Phase III clinical data to be presented at the upcoming American Diabetes Association meeting. The regulatory submission for Zactima™ is planned for the fourth quarter.
The large lifecycle management programme in support of Seroquel XR™ is nearing completion, culminating in a large number of regulatory submissions in 2008. Regulatory filings in the US and Europe for Seroquel XR™ for the treatment of Bipolar Mania and Bipolar Depression were announced early in the first quarter. The US submission for Seroquel XR™ for the treatment of major depressive disorder (MDD) was made on 29 February.
Submissions for MDD in Europe and filings for generalised anxiety disorder (GAD) in the US and Europe will follow later this year. Much of the clinical data supporting the MDD and GAD filings will be presented at the American Psychiatric Association meeting early next month.
On 31 March, AstraZeneca announced its decision to stop the Crestor™ JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on 29 March. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received Crestor™ when compared to placebo.
The JUPITER study team has initiated activities to close this large multi-centre study. Over 15,000 trial participants will be scheduled by their investigator for final assessments at over 1,200 sites in 26 countries. Data from these visits will generate 80,000 pages of case report forms. We plan to complete the analysis in the fourth quarter of this year.
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information, visit http://www.astrazeneca.com.