Annual Business Review
AstraZeneca PLC
02 October 2003
ASTRAZENECA SET TO DELIVER TOP-TIER FINANCIAL PERFORMANCE THROUGH
US MARKETING AND R&D SUCCESS
CRESTOR and IRESSA US Launches Show Early Promise
London - 2 October 2003 - AstraZeneca is well positioned to compete in the
dynamic, US marketplace where the demand for new, innovative medicines continues
to be strong, the company's executives reported today at its Annual Business
Review.
The meeting, held at AstraZeneca's North American headquarters in Wilmington,
Del., included highlights on the positive progress of the US launches of CRESTOR
and IRESSA and an in-depth review of AstraZeneca's US sales and marketing
effectiveness. A report on the R&D pipeline outlined the opportunities for
growth presented by new drugs and new treatment indications in development,
focusing on EXANTA, NEXIUM, SYMBICORT, IRESSA, GALIDA and ATACAND, among others.
Sir Tom McKillop, Chief Executive said:
'AstraZeneca is set to deliver top-tier financial performance through
successful marketing of our exciting, patent-protected range of growth and newly
launched products in the USA and other major markets. In addition, productivity
improvements in R&D are delivering a flow of new product opportunities, which
together with growth in many markets, will form the basis of sustained long-term
performance.'
US Business Highlights
• CRESTOR captured one per cent share of new prescriptions in the US statin
market in the first full week of launch ending 19 September with total
prescription volume of 18,000. More recent daily data has shown over two
percent market share of new prescriptions with 25,000 total prescriptions.
- Within two weeks of FDA approval, AstraZeneca reached nearly
three-quarters of the target physician audience with an early adopter
sampling programme.
- Pharmacies were fully stocked with CRESTOR in just eight days.
- By 15 September, the official field launch of CRESTOR, AstraZeneca had
secured formulary positions on numerous PBMs and health plans.
• With the launch of CRESTOR, AstraZeneca now competes in three of the five
top therapeutic categories in the US market (cholesterol reducers, PPIs
and antipsychotics).
• TOPROL-XL is now the most prescribed medicine by US cardiologists.
• An estimated 10,000 patients are receiving IRESSA in the US.
- Current ex-factory US sales of IRESSA are averaging $3m/week.
- The company has successfully completed the transition of patients from
the Expanded Access Program.
• NEXIUM continues its strong performance despite entry of generic
omeprazole. As the fastest growing PPI in terms of total prescriptions,
NEXIUM is poised to become the market leader.
• NDA filing in the US of SYMBICORT for asthma treatment expected in 2005.
• Other key products, including TOPROL-XL, ARIMIDEX, PULMICORT RESPULES and
RHINOCORT AQUA continue to gain market share, outpacing the market, in both
sales and prescriptions.
• Investment in technology, award-winning training and strategic alignment of
the company's 6,500 person sales force has significantly increased
productivity and customer satisfaction, improving an already high industry
ranking.
In the US, recently launched products and key growth products now comprise 51
percent of the portfolio, up from 19 percent 18 months ago.
Commenting on this success, David R. Brennan, President and CEO of AstraZeneca
US, said:
'AstraZeneca continues to deliver impressive results in the US because we have
marshalled the energy and commitment of the entire organization to compete in
this challenging yet dynamic marketplace.'
Development Pipeline and New Indications
Improved flow of high-quality new development projects leads to more compounds
entering clinical development.
• 21 NCE's (New Chemical Entities) are in pre-clinical testing. A strong
movement of NCE Projects into clinical phase I and II has taken place
since last year's Annual Business Review.
• EXANTA continues to confirm promise as the first new anticoagulant in 50
years.
- Risk/benefit data from Exanta studies to date confirm efficacy
equivalent to warfarin with a profile based on fixed dosing; no
coagulation monitoring; low potential of food/drug interactions and
acceptable bleeding. Elevated liver enzyme levels that decrease with
treatment continuation or discontinuation and which are not typically
associated with specific clinical symptoms have also been observed.
- Filing in Europe for use in orthopaedic surgery is under regulatory
review.
- Regulatory submission for major indications of stroke prevention in
atrial fibrillation and treatment of long-term prevention of venous
thromboembolism isexpected in Q4 2003.
• SYMBICORT continues to grow in Europe.
- Recent data (SUND study) show that SYMBICORT adjustable dosing
provides a 40 per cent greater reduction in severe exacerbations than
both SYMBICORT and Seretide fixed dosing.
- Regulatory filing in EU for Single inhaler Therapy (SiT) use of
SYMBICORT for control and treatment of asthma is expected in Q4, 2003.
• SEROQUEL bipolar mania filings are under review in the US & EU with first
approvals expected before the end of 2003.
• CHARM study shows ATACAND is the only Angiotensin Receptor Blocker to
reduce cardiovascular death and hospitalisation in chronic heart failure
when given together with conventional therapy including an ACE inhibitor.
- Filing for this indication will be made in EU, US and other major
markets during Q1 2004.
• New Phase II data on GALIDA, an oral anti-diabetic medicine confirms dual
PPAR alpha/gamma activity that results in improvement in dyslipidemia and
improvement of glycemic control. GALIDA is now entering Phase III
development.
• AZD0865 for the treatment of GERD (gastro-oesophageal reflux disease)
enters Phase II following promising early clinical studies showing
advantages over Nexium.
• AZD7009 for the treatment of atrial fibrillation and AZD6140 for arterial
thrombosis enter Phase II.
• ZD6126 for solid tumours and AR-A2 for anxiety and depression enter Phase
II development.
Martin Nicklasson, Executive Vice President, Development said:
'Major regulatory approvals have transformed AstraZeneca's product portfolio in
2003. With the emphasis on productivity and quality, we have added several new
candidate drugs to the R&D pipeline in the last 12 months; made rapid progress
with our early phase portfolio; and progressed major new treatment indications
for existing products.'
-Ends-
Trade Marks
The following brand names are trade marks of the AstraZeneca group of companies:
EXANTA, NEXIUM, SYMBICORT, IRESSA, GALIDA, ATACAND, TOPROL-XL, ARIMIDEX,
CRESTOR, SEROQUEL, PULMICORT RESPULES and RHINOCORT AQUA.
Media Enquiries:
Steve Brown, +44 (0) 207 304 5033
Chris Major, +44 (0) 207 304 5028
Rachel Bloom-Baglin, +1 302 886 7858
Analyst Enquiries:
Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
Jorgen Winroth, +1 212 581 8720
Ed Seage, +1 302 886 4065
For copies of the presentations from today's annual business review and an
up-date of AstraZeneca's development pipeline please visit http://
www.astrazeneca.com from 14:15 BST onwards.
Interviews with Sir Tom McKillop, Chief Executive Officer, Dr Martin Nicklasson,
Executive Vice President, Global Development and Adele Gulfo, Vice President,
Cardiovascular Therapy US, in video, audio and text will be available from 13:
00h BST on Thursday 2nd October 2003 at http://www.astrazeneca.com and http://
www.cantos.com.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
In order to utilise the 'Safe Harbor' provisions of the United States Private
Securities Litigation Reform Act of 1995, AstraZeneca is providing the following
cautionary statement. This Review contains forward-looking statements with
respect to the financial condition, results of operations and businesses of
AstraZeneca. By their nature, forward-looking statements and forecasts involve
risk and uncertainty because they relate to events and depend on circumstances
that will occur in the future. There are a number of factors that could cause
actual results and developments to differ materially from that expressed or
implied by these forward-looking statements. These factors include, among other
things, the loss or expiration of patents, marketing exclusivity or trade marks;
exchange rate fluctuations; the risk that R&D will not yield new products that
achieve commercial success; the impact of competition; price controls and price
reductions; taxation risks; the risk of substantial product liability claims;
the impact of any failure by third parties to supply materials or services; the
risk of delay to new product launches; the difficulties of obtaining and
maintaining governmental approvals for products; and the risk of environmental
liabilities.
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