After presenting a reasonable set of financials, and amid fears of generic competition to Nexium and Seroquel, AstraZeneca has been speaking at its results in London about the future and its bid to strengthen the pipeline.
As we reported yesterday, the Anglo-Swedish drugmaker’s big five – the cholesterol-lowerer Crestor (rosuvastatin), the asthma combination Symbicort (budesonide and formoterol), Seroquel (quetiapine) for schizophrenia, the breast cancer drug Arimidex (anastrozole) and, to admittedly a lesser extent, the gastrointestinal drug Nexium (esomeprazole) all performed well. Most striking, however, was the 33% growth in sales and up 45% outside in the USA.
When asked by PharmaTimes World News how much of a beneficiary Crestor has already been from the fall-out being suffered by Merck & Co and Schering-Plough over the disappointing data from the ENHANCE study of Vytorin (ezetimibe/simvastatin), AstraZeneca chief executive David Brennan noted that there had been some improvements in sales in the USA. However he noted that Crestor has been doing well since the firm got an additional approval to market the blockbuster lipid-lowerer to treat artherosclerosis in early November. This approval is what is driving Crestor ahead, Mr Brennan said, namely giving the firm’s reps the chance to differntiate the drug from competing statins.
Nexium is faring less well and sales of the drug were down 2% to $5.2 billion, hit by pricing issues and the amount of generic omeprazole on the market. Mr Brennan said that the branded proton pump inhibitor sector is indeed shrinking and while sales will fall again in 2008 by mid-single digits, AstraZeneca is still pushing the product on the basis of it being best-in-class and it could still be a $5 billion product.
AsraZeneca has suffered some major late-stage pipeline setbacks recently but the firm stressed during the meeting that it has been creating a ‘faster, leaner, better” R&D set-up. Mr Brennan said that “we now have a larger, stronger and less risky Phase III portfolio” and the firm’s executive director responsible for development, John Patterson pointed out how this has been done.
In the last year, Dr Patterson noted that the company has taken 18 months off the cycle time to get a drug through to the launch stage. Also the firm’s target of getting biologics to comprise 25% of all its late-phase development pipeline by 2010 is looking realistic following a reshaping of its biotech R&D that incorporates newly-acquired MedImmune, plus AstraZeneca’s existing research in that field.
Dr Patterson told PharmaTimes World News that rather than lumping all this biologics research together, MedImmune’s entrepreneurial spirit was actually being protected through this reshaping and the unit now gets “the best of both worlds”, enabling it to work in parallel and yet separately from the rest of the firm.
As for this year, Dr Patterson noted that the developmental diabetes compound saxagliptin, partnered with Bristol-Myers Squibb, should be filed in the USA around July, while a filing by the end of the year is imminent for the lung cancer treatment Zactima (vandetanib). A licence application is imminent for motavizumab, a new monoclonal antibody specifically designed to treat respiratory syncytial virus.
This did not appear to be enough to satisfy analysts, however. AstraZeneca forecast earnings per share excluding restructuring and acquisitions costs of $4.40-$4.70, versus $4.38 last year and the company reiterated that the cautious forecast was due to “pricing demands from payers and competition from generics in major therapeutic categories [which] will continue to pressure the top line”.
Given these pressures, Merill Lynch said, “we have little confidence on the top end of the guidance range,” noting that it is keeping its ‘sell’ rating on the stock.
