FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For October 2002
AstraZeneca PLC
15 Stanhope Gate, London W1K 1LN, England
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F.
Form 20-F X Form 40-F
--- ---
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.
Yes No X
--- ---
If "Yes" is marked, indicate below the file number assigned to the Registrant
in connection with Rule 12g3-2(b): 82-_____________
AstraZeneca PLC
INDEX TO EXHIBITS
Item
----
1. Press release entitled 'Prilosec Patents ruled valid in US trial'
dated 14 October 2002.
2. Press release entitled 'AstraZeneca loses UK appeal on omeprazole
formulation patents' dated 22 October 2002.
3. Press release entitled 'Third Quarter and Nine Months Results
2002' Part I dated 24 October 2002.
4. Press release entitled 'Third Quarter and Nine Months Results
2002' Part II dated 24 October 2002.
5. Press release entitled 'AstraZeneca's New Oral Direct Thrombin
Inhibitor Exanta(TM) superior in reducing risk of Venous
Thromboembolism (VTE) following total hip or knee replacement
surgery' dated 28 October 2002.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AstraZeneca PLC
Date: 1 November 2002 By: /s/ G H R Musker
---------------------------------
Name: G H R Musker
Title: Company Secretary & Solicitor
Item 1
PRILOSEC PATENTS RULED VALID IN US TRIAL
AstraZeneca announced today that following a trial in the Southern District
Court of New York, Judge Barbara Jones ruled that two patents ('230 and '505)
relating to the formulation of omeprazole, the active ingredient in Prilosec,
are valid until 2007.
On the matter of infringement in the consolidated proceedings, the judge made
the following ruling:
Company Patent '230 Patent '505
----------------------------------------------------
Andrx infringed infringed
Genpharm infringed infringed
Cheminor infringed infringed
Kudco Not infringed Not infringed
The Judge did not render a decision on the '281 patent relating to a process
involved in the manufacture of omeprazole. AstraZeneca brought suit under this
patent against Andrx only.
The trial, which started on December 6, 2001, concluded in June of this year.
Sir Tom McKillop, Chief Executive Officer of AstraZeneca, said: "We are pleased
by today's judgment upholding the validity of our formulation patents and the
decision that Andrx, Genpharm and Cheminor have infringed the patents. We are
reviewing the Judge's ruling with respect to Kudco and are considering the
appropriate course of action."
Prilosec, a treatment for acid-related stomach disorders, is AstraZeneca's US
brand name for omeprazole. In 2001, Prilosec had sales of $3.7bn in the US.
- Ends -
Date: 14 October 2002
Media Enquiries: Investor Relations:
Rachel Bloom, Tel: + 1 302 886 7858 Jonathan Hunt, Tel: +44 (0) 207 304 5087
Steve Brown, Tel: +44 (0) 207 304 5033 Mina Blair-Robinson, Tel: +44 (0) 207 304 5084
Emily Denney, Tel: +44 (0) 207 304 5034 Ed Seage, Tel: +1 302 886 4065
Chris Major, Tel: +44 (0) 207 304 5028 Jorgen Winroth, Tel: +1 212 581 8720
Staffan Ternby, Tel: +46 (0) 70 557 4300
NOTE TO NEWS EDITORS:
The consolidated case in the South District Court of New York involving the
four generic manufacturers involved several patents, including those ('505 and'
'230) which were the subject of Judge Jones' decision today. Patent '281
involved Andrx alone.
The proceedings also involved these further patents:
Patent '499 (sulphenamide salt of omeprazole) was declared not infringed in
summary dismissal and may be appealed by AstraZeneca.
Patents '794 (omeprazole in combination with clarithromycin in the treatment of
H.pylori); '305 (combination therapy for H.pylori related disease); and '342
(H.pylori treatment) have all previously been declared invalid in summary
proceedings. AstraZeneca may also appeal these decisions as part of the overall
appeal process in the case.
Patent '431 relates to the substance of omeprazole, which expired in October,
2001, following six months' additional market exclusivity after AstraZeneca
complied with the FDA's formal request for information on the use of
prescription Prilosec in children. This was originally part of the case but, as
the patent has already expired, was not part of the judgment.
In 2001, the worldwide sales of AstraZeneca omeprazole brands totalled $5.7bn.
In a separate case, it was announced on June 25, that United States District
Court Judge Jed Rakoff, of the Southern District of New York, had dismissed
with prejudice two federal class action antitrust lawsuits brought by consumers
and third-party payors against AstraZeneca. In dismissing the cases, Judge
Rakoff concluded that the plaintiffs failed to demonstrate that the Prilosec
patent infringement litigation brought by AstraZeneca against 10 generic
manufacturers was a "sham" or an unlawful attempt to prevent generic
competitors from entering the market. The manufacturers included the four
companies involved in the consolidated trial relating to the infringement of
the patents. The third and only other consumer anti-trust case was voluntarily
dismissed by plaintiffs following Judge Rakoff's decision.
Item 2
ASTRAZENECA LOSES UK APPEAL ON OMEPRAZOLE
FORMULATION PATENTS
AstraZeneca today announced that the Court of Appeal in London has denied its
request for a re-trial following an earlier decision of the United Kingdom's
Patents Court in a dispute with the generic pharmaceutical companies, Arrow
Generics Limited (acting through Cairnstores Limited) and Generics UK Limited,
about formulation patents for omeprazole - the active substance used in Losec,
a treatment for acid-related disorders, such as peptic ulcers.
The Court of Appeal refused to allow a re-trial due to the bias shown by the
Patents Court judge in the original hearing, and the decision in March (2002)
of the Patents Court of the High Court Chancery Division, which declared the
formulation patents (EP 247 983 and EP 496 437) invalid due to obviousness, was
affirmed.
The UK represented 4.3 percent of Losec's worldwide sales in 2001.
22 October 2002
Media Enquiries:
Steve Brown, Tel: +44 (0) 207 304 5033
Emily Denney, Tel: +44 (0) 207 304 5034
Investor Relations:
Mina Blair-Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
- Ends -
Item 3
AstraZeneca PLC
Third Quarter and Nine Months Results 2002
"EPS up 10 percent for nine months. Earnings targets increased for the year.
Third quarter impacted by phasing of R&D spend and lower disposal gains."
Financial Highlights (before Exceptional Items)
---------------------------------------------------------------------------------------------------------------------------------
-------------------------------------------- ------------------------------------------------
Group 3rd Quarter 3rd Quarter Constant Nine Months Nine Months Constant
----- 2002 2001* Currency 2002 2001* Currency
(Continuing operations*) $m $m % $m $m %
-- -- - -- -- -
Sales 4,350 3,950 +6 13,153 12,040 +9
Operating Profit 921 1,015 -9 3,282 3,066 +8
Profit before Tax 923 1,038 -11 3,306 3,167 +5
Earnings per Share
Group $0.39 $0.42 -7 $1.39 $1.28 +10
-------------------------------------------- ------------------------------------------------
Group (Statutory FRS3) $0.39 $0.40 $1.39 $1.23
----------------------------- ---------------------------------
* Restated to be on a consistent basis under FRS19. See note 1 on page 12 for
further information.
All narrative in this section refers to growth rates at constant exchange rates
(CER)
o Earnings targets increased; company anticipates earnings per share for the
year around 4 to 5 percent above the $1.73 reported last year.
o Sales for the nine months increased by 9 percent. Sales in the quarter
were impacted by US wholesaler stocking trends for Seroquel(TM) and
Toprol-XL(TM) as well as by the expiration of tamoxifen distribution
agreement with Barr Laboratories.
o Operating profits were up 8 percent in the nine months. In the third
quarter operating profits were down 9 percent, chiefly due to lower other
operating income, which in the third quarter 2001 included disposal of the
multi-vitamins products and royalty income from agreements which have now
expired.
o Nexium(TM) sales reached $493 million in the third quarter and over $1.3
billion for the nine months. Nexium(TM) new prescriptions in the US are
now exceeding those for Prilosec(TM).
o On 11 October the Prilosec(TM) formulation patents were ruled valid in the
Southern District Court in New York. Three of the four defendants were
found to infringe these patents. AstraZeneca is reviewing the Judge's
ruling finding non-infringement by Kudco.
o Iressa(TM) was fully launched for the treatment of non-small cell lung
cancer in Japan on 30 August. Sales reached $26 million in the third
quarter.
o On 24 September the Oncology Drugs Advisory Committee to the US FDA voted
in favour of accelerated approval for Iressa(TM) for advanced non-small
cell lung cancer.
Tom McKillop, Chief Executive, said: "Prescriptions for our key growth products
continue to grow strongly. I am encouraged by the excellent start for
Iressa(TM) in Japan and the Advisory Committee recommendation for approval in
the US. The court ruling upholding the validity of our formulation patents for
Prilosec(TM) is excellent news, allowing us to upgrade our earnings
expectations for the full year."
London, 24 October 2002
AstraZeneca press office and investor relations contact details are on page 3.
Business Highlights All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
For the nine months sales increased by 9 percent and operating profits by 8
percent. Exchange rate movements against the US dollar had no effect on
reported sales growth, but reduced reported operating profit growth rate by 1
percent. Earnings per share (before exceptional items) rose by 10 percent to
$1.39. There have been no exceptional items in the current year.
Sales in the third quarter increased by 6 percent at constant exchange rates.
The weakening of the US dollar against all major currencies had a beneficial
effect on sales, lifting reported sales growth to 10 percent. The weakening of
the US dollar against Sterling and Krona has resulted in an adverse effect on
operating costs, which offset the benefit on sales. As a result, the currency
effect on operating profits was neutral. Operating profits declined by 9
percent on both an "as reported" and CER basis, chiefly attributed to lower
other operating income versus the third quarter 2001, which included a gain on
the disposal of the multi-vitamin product line and income from royalty
agreements that expired last year. Earnings per share (before exceptional
items) in the third quarter were 7 percent lower, to $0.39.
Sales for the nine months grew by 8 percent in the US and by 9 percent in the
rest of the world, including continued strong growth in Japan (up 19 percent).
In the third quarter, sales outside the US grew by 10 percent, and by 4 percent
in the US. Wholesaler purchasing patterns affected the reported ex-factory
sales in the US. Prescription trends in the US remain consistently strong for
Toprol-XL(TM) and Seroquel(TM), but reported ex-factory sales growth was well
below prescription growth. In addition, Nolvadex(TM) sales were significantly
lower in the third quarter as orders for generic tamoxifen were sharply
curtailed ahead of the August expiration of the company's distribution
agreement with Barr Laboratories.
The strong performance of Nexium(TM), where sales reached $1.3 billion for the
nine months, fuelled the 7 percent increase in GI product sales. In the US,
Nexium(TM) share of new prescriptions for PPI products was 22 percent in the
week ending 11 October, and Nexium(TM) now accounts for more than 50 percent of
new prescriptions for AstraZeneca PPI products.
On 11 October, following a trial in the Southern District Court of New York,
Judge Barbara Jones ruled that two patents ('230 and '505) relating to the
formulation of omeprazole, the active ingredient in Prilosec(TM), are valid
until 2007. In addition, the Judge ruled that Andrx, Genpharm, and Cheminor
have infringed these patents. The court ruled that Kudco did not infringe. The
company is reviewing the ruling with respect to Kudco and continues to evaluate
its options for further action.
Sales outside the GI franchise grew by 10 percent for the nine months.
Respiratory product sales grew by 14 percent, on the launch roll-out of
Symbicort(TM) and the performance of Pulmicort(TM) Respules(TM) and
Rhinocort(TM) Aqua in the US. The continued strong growth in demand for
Seroquel(TM) fuelled the 42 percent increase in CNS product sales.
Oncology sales growth was 13 percent for the nine months. In the third quarter,
Iressa(TM) was approved in Japan for the treatment of inoperable or recurrent
non-small cell lung cancer (NSCLC). The product was fully launched following
NHI Price listing on 30 August. The uptake has been encouraging, with sales
reaching $26 million in the quarter. On 24 September the Oncology Drugs
Advisory Committee to the US Food and Drug Administration voted in favour of
accelerated approval for Iressa(TM) for advanced NSCLC.
As reported in August, following a constructive meeting with the US Food and
Drug Administration to discuss the company's response to the approvable letter
for Crestor(TM), the company has undertaken to provide further information from
its ongoing study programme for Crestor(TM) to supplement that already
submitted to the agency. This response to the approvable letter will support
the use of Crestor(TM) over the dose range of 10-40mg in the general population
of patients with lipid disorders and is scheduled for submission during the
first quarter of 2003.
Results from the EXPRESS study of Exanta(TM), which supported the regulatory
submission in Europe for prevention of venous thromboembolism in orthopaedic
surgery, will be presented next week at the International Congress on
Thrombosis. Further information on Exanta(TM) and other products in the
company's R&D portfolio will be featured at the Annual Business Review analyst
meeting on 7 November in Alderley Park, UK.
2
Future Prospects All narrative in this section refers to growth rates at
constant exchange rates (CER) unless otherwise indicated.
Following the rulings in the Prilosec(TM) patent case, the company does not
expect a generic omeprazole product in the US market in 2002. On this basis and
taking other factors into account, the company has increased its outlook for
full year earnings, and now anticipates growth in earnings per share of around
4 to 5 percent above the $1.73 reported last year (restated under FRS 19).
The company will address the 2003 outlook in conjunction with the presentation
of its 2002 annual results on 30 January.
Disclosure Notice: The preceding forward looking statements relating to
expectations for earnings and business prospects for AstraZeneca PLC are
subject to risks and uncertainties, which may cause results to differ
materially from those set forth in the forward looking statements. These
include, but are not limited to: the timing of the launch of generic omeprazole
in the USA, the successful registration and launch of new products (in
particular Crestor(TM), Iressa(TM), and Exanta(TM)), continued growth of
currently marketed products, the growth in costs and expenses, interest rate
movements, exchange rate fluctuations, and further improvements in the tax
rate. For further details on these and other risks and uncertainties, see
AstraZeneca PLC's Securities and Exchange Commission filings, including the
2001 annual report on Form 20-F.
Media Enquiries: Steve Brown/Emily Denney (London) (020) 7304 5033/5034
Staffan Ternby (Sodertalje) (8) 553 26107
Rachel Bloom (Wilmington) (302) 886 7858
Analyst/Investor Enquiries: Mina Blair-Robinson (London) (020) 7304 5084
Jonathan Hunt (London) (020) 7304 5087
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage (Wilmington) (302) 886 4065
Jorgen Winroth (New York) (212) 581 8720
3
Sales
-------------------------------------------------------------------------------
Except where stated, all narrative in this section refers to the third quarter.
Growth rates are at constant exchange rates (CER).
Gastrointestinal
----------------------------------------------------------------------------
Third Quarter CER % Nine Months CER %
------------------------ ------------ ------------
2002 2001 2002 2001
----------------------------------------------------------------------------
Losec(TM)/Prilosec(TM) 1,223 1,421 -16 3,578 4,287 -17
Nexium(TM) 493 168 n/m 1,323 295 n/m
----------------------------------------------------------------------------
Total 1,731 1,598 +6 4,946 4,612 +7
----------------------------------------------------------------------------
o Nexium(TM) sales in the US were over $1 billion for the nine months, and
were $378 million in the third quarter. Nexium(TM) share of new
prescriptions in the US PPI market increased to 20.7 percent in September.
In recent weeks, more than half of all new prescriptions for AstraZeneca's
PPI products are for Nexium(TM).
o Nexium(TM) sales outside the US were $292 million in the nine months, with
$115 million in the third quarter. As for recent launches, market share is
over 7 percent after six months in France, and more than 8 percent in five
months since launch in Italy.
o Losec(TM)/Prilosec(TM) sales were down 16 percent in the quarter, chiefly
on the 18 percent decline in the US (which was broadly in line with the
trend in prescriptions) and generic competition in the UK.
o Total GI franchise sales, however, grew both in the US (up 6 percent in
the quarter and 7 percent YTD) and in the rest of the world (up 4 percent
in the quarter and by 8 percent YTD).
Cardiovascular
----------------------------------------------------------------------------
Third Quarter CER % Nine Months CER %
------------------------ ------------ ------------
2002 2001 2002 2001
----------------------------------------------------------------------------
Zestril(TM) 189 188 -3 748 832 -10
Atacand(TM) 132 93 +33 413 289 +41
Seloken(TM)/Toprol-XL(TM) 206 204 -2 652 554 +17
Plendil(TM) 149 120 +20 355 332 +6
----------------------------------------------------------------------------
Total 850 786 +3 2,713 2,621 +4
----------------------------------------------------------------------------
o As expected, prescriptions for Zestril(TM) in the US experienced a sharp
decline in the third quarter following the launch of generics in July, but
reported sales in the US in the third quarter actually rose 2 percent
against the weak third quarter of 2001. A rapid fall-off in reported sales
in the fourth quarter is anticipated.
o Good growth in sales of Atacand(TM) products was reported in Europe (up 32
percent) and in the US (up 31 percent) in the third quarter. Total
prescriptions for Atacand(TM) and Atacand(TM) HCT in the US are up by 32
percent through September.
o Prescription growth for Toprol-XL(TM) in the US remains strong (up 39
percent through September). Reported sales in the US in the third quarter
were down 1 percent on wholesaler destocking combined with a strong third
quarter last year.
4
Respiratory
----------------------------------------------------------------------------
Third Quarter CER % Nine Months CER %
------------------------ ------------ ------------
2002 2001 2002 2001
----------------------------------------------------------------------------
Pulmicort(TM) 150 161 -12 580 570 +1
Accolate(TM) 28 20 +40 95 115 -16
Rhinocort(TM) 80 64 +22 226 194 +15
Oxis(TM) 30 29 -7 91 94 -5
Symbicort(TM) 72 20 n/m 194 34 n/m
----------------------------------------------------------------------------
Total 394 329 +13 1,292 1,123 +14
----------------------------------------------------------------------------
o Symbicort(TM) sales reached $72 million in the quarter. Encouraging
results were presented last month at the European Respiratory Society
congress, showing that Symbicort(TM) significantly reduces the number of
exacerbations and improves lung function in patients with COPD.
AstraZeneca has submitted a regulatory package in the EU seeking approval
for Symbicort(TM) in COPD treatment.
o Pulmicort(TM) sales in the third quarter were down by 10 percent in the
US, and by 13 percent in the rest of the world. The strong underlying
prescription performance for Pulmicort(TM) Respules(TM) in the US
continues (total prescriptions up 75 percent through September), but
fluctuations in wholesaler purchase patterns led to a 4 percent decline in
reported US sales in the quarter.
o Steady growth in prescriptions for Rhinocort(TM) Aqua in the US (up 43
percent through September) is the chief contributor to sales growth for
the Rhinocort(TM) franchise globally.
Oncology
----------------------------------------------------------------------------
Third Quarter CER % Nine Months CER %
------------------------ ------------ ------------
2002 2001 2002 2001
----------------------------------------------------------------------------
Casodex(TM) 191 149 +22 465 393 +18
Arimidex(TM) 96 47 +98 242 139 +73
Nolvadex(TM) 86 160 -47 348 446 -21
Zoladex(TM) 208 175 +14 595 519 +16
Faslodex(TM) 11 - n/m 19 - n/m
Iressa(TM) 26 - n/m 26 - n/m
----------------------------------------------------------------------------
Total 622 538 +12 1,710 1,519 +13
----------------------------------------------------------------------------
o Good growth in Europe (up 42 percent) and in Japan (up 40 percent) led to
the 22 percent increase in Casodex(TM)sales in the third quarter.
o Sales of Casodex(TM) in the US ($73 million in the third quarter)
rebounded sharply from the low levels seen in the first six months ($65
million in the first half 2002), and were up 3 percent versus the strong
third quarter 2001.
o Arimidex(TM) sales continue to reflect positive reception to the ATAC
trial results showing benefit in the adjuvant treatment of early breast
cancer. The US FDA approval for this new indication was announced on 6
September. Sales outside the US were up 50 percent for the nine months,
and by 119 percent in the US. The US performance is based on strong
prescription demand (up 71 percent through September) and some building of
wholesaler inventories.
o Nolvadex(TM) sales in the US in the third quarter were $74 million lower
than last year, as orders for generic tamoxifen were sharply curtailed
ahead of the expiration of our distribution agreement with Barr
Laboratories at the end of August.
o The encouraging initial uptake continues in the US for Faslodex(TM), the
new medicine for the treatment of advanced breast cancer. Sales were $11
million in the third quarter, bringing year to date sales to $19 million.
o Full launch of Iressa(TM) in Japan occurred on 30 August following NHI
price listing. The uptake has been encouraging, with sales in the quarter
reaching $26 million.
5
CCS
----------------------------------------------------------------------------
Third Quarter CER % Nine Months CER %
------------------------ ------------ ------------
2002 2001 2002 2001
----------------------------------------------------------------------------
Seroquel(TM) 200 169 +16 804 526 +53
Zomig(TM) 69 55 +18 237 209 +12
----------------------------------------------------------------------------
Total 277 237 +14 1,064 751 +42
----------------------------------------------------------------------------
o At the half year, reported sales for Seroquel(TM) in the US were running
ahead of prescription growth, an indicator of rising trade inventories.
Wholesaler destocking in the third quarter has resulted in reported growth
of 5 percent. Prescription demand remains firmly on trend, up 47 percent
through September.
o Seroquel(TM) sales outside the US grew by 62 percent in the third quarter.
o Sales for Zomig(TM) outside the US increased by 18 percent in the nine
months, with strong growth reported in France (up 35 percent). The 67
percent increase in the US in the third quarter is a function of
destocking in the third quarter of last year. Prescriptions for Zomig(TM)
in the US are up 12 percent through September as a result of continued
growth of the Zomig(TM)-ZMT formulation.
Pain, Infection and Other Pharma
----------------------------------------------------------------------------
Third Quarter CER % Nine Months CER %
------------------------ ------------ ------------
2002 2001 2002 2001
----------------------------------------------------------------------------
Merrem(TM) 76 56 +34 218 162 +35
Diprivan(TM) 105 114 -10 331 329 +2
Xylocaine(TM) 43 52 -17 128 155 -15
Marcaine(TM) 19 20 -10 54 61 -11
----------------------------------------------------------------------------
Total 352 361 -4 1,065 1,103 -3
----------------------------------------------------------------------------
o Merrem(TM) sales continued to grow in all major markets. Sales in the US
were up 43 percent and sales increased by 32 percent outside the US in the
nine months.
Geographic Sales
----------------------------------------------------------------------------
Third Quarter CER % Nine Months CER %
------------------------ ------------ ------------
2002 2001 2002 2001
----------------------------------------------------------------------------
USA 2,244 2,166 +4 6,963 6,425 +8
Europe 1,390 1,170 +6 4,195 3,819 +7
Japan 251 202 +23 663 591 +19
RoW 465 412 +15 1,332 1,205 +13
----------------------------------------------------------------------------
o Sales growth of 8 percent in the US for the nine months was fuelled by the
continued strong performances of Nexium(TM), Seroquel(TM), and
Toprol-XL(TM), although uneven wholesaler purchasing patterns in the
latter two affected the third quarter growth rate.
o In Europe, sales increased by 7 percent for the nine months. France and
Italy are driving this growth. As for products, growth in Europe is due to
the performance of Nexium(TM), Symbicort(TM), the oncology product range,
and Seroquel(TM).
o The oncology products, including an encouraging start to Iressa(TM), were
responsible for much of the strong growth reported in Japan, with
additional contribution from Losec(TM) and Seroquel(TM).
6
Operating Review
-------------------------------------------------------------------------------
Nine Months
In constant currency terms, sales increased by 9 percent to $13,153 million and
operating profit before exceptional items increased by 8 percent to $3,282
million. Operating margin of 25.0 percent of sales was 0.5 points below prior
year. Currency accounted for 0.3 points of the margin reduction. The other 0.2
points reduction comprised lower other operating income partially offset by
lower cost of sales. SG&A and R&D were at similar percentages to sales as 2001.
Currency was broadly neutral on sales and slightly adverse on costs, leading to
an adverse currency variance of 1 percent on operating profit as compared to
last year.
Third Quarter
Sales increased by 6 percent in constant currency to $4,350 million and
operating profit before exceptional items declined by 9 percent to $921
million. Operating margin declined by 4.5 percentage points, to 21.2 percent of
sales.
Currency increased sales growth in the third quarter by 4 percent, primarily
attributable to the weaker dollar against the Euro. This benefit was offset by
higher costs due to the weaker dollar versus Sterling and Swedish Krona,
leading overall to a neutral effect on operating profit. Currency accounted for
nearly half of the increase in SG&A, and around a third of the increase in R&D
expense reported in the quarter.
Cost of sales at 27.1 percent was broadly similar to 2001, with higher payments
to Merck offset by lower manufacturing costs. SG&A expenditure (33.7 percent of
sales) grew in line with sales. R&D expenditure was 17.4 percent of sales in
the quarter, 1.9 points higher than 2001. This was due to a lower comparator in
2001 (where the third quarter represented only 23 percent of 2001 full year R&D
expenditure), currency, and underlying growth in clinical trials. Other
operating income at 0.3 percent of sales was 2.1 percentage points behind 2001
due to the multi-vitamins disposal in 2001 as well as income from royalty
agreements that expired last year.
Interest
-------------------------------------------------------------------------------
Interest income in the quarter of $2 million was lower than the third quarter
2001 ($23 million) because of a combination of lower interest rate return on
cash investments and a higher charge arising from the annual revaluation of
long-term employee healthcare liabilities.
Taxation
-------------------------------------------------------------------------------
Excluding exceptional items, the effective tax rate for the third quarter 2002
was 26.25 percent, compared with 28.4 percent for 2001. This brought the
year-to-date tax rate to 26.8 percent (28.4 percent for 2001). The 2001 tax
rate has been restated under FRS 19. See note 1 to the interim financial
statements for more detail.
Cash Flow
-------------------------------------------------------------------------------
Cash generated from operating activities amounted to $4.1 billion for the nine
months. This was applied to capital expenditures of $1.0 billion, taxation paid
of $0.7 billion, dividends of $0.8 billion, and share repurchases of $0.9
billion to give an increase in net cash funds of $0.8 billion.
At 30 September 2002 the Group had net cash funds of $ 3.6 billion.
7
Share Repurchase Programme
-------------------------------------------------------------------------------
During the quarter, 4.6 million shares (nominal value $0.25 each) were
repurchased for cancellation at a total cost of $148 million, bringing the
total for the year to 20.6 million at a cost of $896 million.
The total number of shares repurchased for cancellation since the beginning of
the programme now stands at 57.8 million at an aggregate cost of $2,510
million. The total number of shares in issue as at 30 September 2002 is 1,725
million.
Under the extended share repurchase programme announced with the 2001 year end
results, $1,490 million remains, which it is anticipated will be completed by
the end of 2003.
Upcoming Milestones and Key Events
-------------------------------------------------------------------------------
7 November Annual Business Review meeting
30 January 2003 Announcement of 2002 Full Year Results
Tom McKillop
Chief Executive
8
Item 4
Consolidated Profit & Loss Account For Continuing Operations
2002 2001
For the nine months ended 30 September (Restated)
$m $m
------------------------------------------------------------------------ ------------- -------------
Sales 13,153 12,040
Cost of sales (3,480) (3,250)
Distribution costs (102) (89)
Research and development (2,177) (1,955)
Selling, general and administrative expenses (4,337) (3,984)
Other operating income 225 304
------------------------------------------------------------------------ ------------- -------------
Operating profit before exceptional items 3,282 3,066
Exceptional items charged to operating profit - (126)
------------------------------------------------------------------------ ------------- -------------
Operating profit 3,282 2,940
Share of joint ventures' and associates' operating profits - -
Profit on sale of fixed assets - 10
Net interest and dividend income 24 101
------------------------------------------------------------------------ ------------- -------------
Profit on ordinary activities before taxation 3,306 3,051
Taxation (886) (864)
------------------------------------------------------------------------ ------------- -------------
Profit on ordinary activities after taxation 2,420 2,187
Attributable to minorities (12) (7)
------------------------------------------------------------------------ ------------- -------------
Net profit for the period 2,408 2,180
Dividends to Shareholders (398) (405)
------------------------------------------------------------------------ ------------- -------------
Profit retained for the period 2,010 1,775
------------------------------------------------------------------------ ------------- -------------
Earnings per Ordinary Share before exceptional items $1.39 $1.28
Earnings per Ordinary Share $1.39 $1.23
Diluted earnings per Ordinary Share $1.39 $1.23
------------------------------------------------------------------------ ------------- -------------
Weighted average number of Ordinary Shares in issue (millions) 1,736 1,762
------------------------------------------------------------------------ ------------- -------------
Diluted average number of Ordinary Shares in issue (millions) 1,739 1,764
------------------------------------------------------------------------ ------------- -------------
9
Consolidated Profit & Loss Account For Continuing Operations
2002 2001
For the quarter ended 30 September (Restated)
$m $m
------------------------------------------------------------------------ ------------- -------------
Sales 4,350 3,950
Cost of sales (1,181) (1,064)
Distribution costs (37) (29)
Research and development (757) (614)
Selling, general and administrative expenses (1,468) (1,324)
Other operating income 14 96
------------------------------------------------------------------------ ------------- -------------
Operating profit before exceptional items 921 1,015
Exceptional items charged to operating profit - (45)
------------------------------------------------------------------------ ------------- -------------
Operating profit 921 970
Share of joint ventures' and associates' operating profits - -
Profit on sale of fixed assets - -
Net interest and dividend income 2 23
------------------------------------------------------------------------ ------------- -------------
Profit on ordinary activities before taxation 923 993
Taxation (242) (280)
------------------------------------------------------------------------ ------------- -------------
Profit on ordinary activities after taxation 681 713
Attributable to minorities (6) (2)
------------------------------------------------------------------------ ------------- -------------
Net profit for the period 675 711
Dividends to Shareholders - -
------------------------------------------------------------------------ ------------- -------------
Profit retained for the period 675 711
------------------------------------------------------------------------ ------------- -------------
Earnings per Ordinary Share before exceptional items $0.39 $0.42
Earnings per Ordinary Share $0.39 $0.40
Diluted earnings per Ordinary Share $0.39 $0.40
------------------------------------------------------------------------ ------------- -------------
Weighted average number of Ordinary Shares in issue (millions) 1,728 1,757
------------------------------------------------------------------------ ------------- -------------
Diluted average number of Ordinary Shares in issue (millions) 1,730 1,759
------------------------------------------------------------------------ ------------- -------------
10
Consolidated Balance Sheet
2002 2001
As at 30 September (Restated)
$m $m
------------------------------------------------------------------------ ------------- -------------
Fixed assets 9,023 7,929
Current assets 11,557 11,137
------------------------------------------------------------------------ ------------- -------------
Total Assets 20,580 19,066
Creditors due within one year (6,916) (6,391)
------------------------------------------------------------------------ ------------- -------------
Net current assets 4,641 4,746
------------------------------------------------------------------------ ------------- -------------
Total assets less current liabilities 13,664 12,675
------------------------------------------------------------------------ ------------- -------------
Creditors due after more than one year (491) (909)
Provisions for liabilities and charges (1,596) (1,795)
------------------------------------------------------------------------ ------------- -------------
Net assets 11,577 9,971
------------------------------------------------------------------------ ------------- -------------
Capital and reserves
Shareholders' funds and minority interests 11,577 9,971
------------------------------------------------------------------------ ------------- -------------
Consolidated Cash Flow Statement
2002 2001
For the nine months ended 30 September $m $m
------------------------------------------------------------------------ ------------- -------------
Cash flow from operating activities
Operating profit before exceptional items 3,282 3,066
Depreciation and amortisation 700 633
Decrease/(increase) in working capital and other non-cash movements 153 (436)
------------------------------------------------------------------------ ------------- -------------
Net cash inflow from operating activities before exceptional items 4,135 3,263
Outflow related to exceptional items (74) (280)
------------------------------------------------------------------------ ------------- -------------
Net cash inflow from operating activities 4,061 2,983
Returns on investments and servicing of finance 42 137
Tax paid (678) (631)
Capital expenditure and financial investment (1,034) (990)
Acquisitions and disposals - (44)
Equity dividends paid to Shareholders (820) (830)
------------------------------------------------------------------------ ------------- -------------
Net cash inflow before management of liquid resources and financing 1,571 625
Net (purchase)/issues of shares (871) (702)
Exchange and other movements 56 (51)
------------------------------------------------------------------------ ------------- -------------
Increase/(decrease) in net cash funds in the period 756 (128)
Net cash funds at beginning of period 2,867 3,605
------------------------------------------------------------------------ ------------- -------------
Net cash funds at end of period 3,623 3,477
------------------------------------------------------------------------ ------------- -------------
11
Notes to the Interim Financial Statements
1 BASIS OF PREPARATION AND ACCOUNTING POLICIES
The unaudited financial statements for the nine months ended 30 September
2002 have been prepared in accordance with UK generally accepted
accounting principles. The accounting policies applied are those set out
in AstraZeneca PLC's 2001 Annual Report and Form 20-F except that, in the
current period, AstraZeneca adopted Financial Reporting Standard No. 19
"Deferred Tax". Prior periods have been restated and the effects of this
restatement were to reduce profits for the nine months ended 30 September
2001 by $28m and reduce net assets at that date by $164m. On adoption net
assets at 1 January 2002 were reduced by $193m. The table below
illustrates the effect on EPS before exceptional items of this
restatement.
The statements do not constitute statutory accounts of the group within
the meaning of Section 240 of the Companies Act 1985. Statutory accounts
for the year ended 31 December 2001 have been filed with the Registrar of
Companies. The auditor's report on those accounts was unqualified and did
not contain any statement under Section 237 of the Companies Act 1985.
2001 TAXATION AND EARNINGS PER SHARE BEFORE EXCEPTIONAL ITEMS
Q1 2001 Q2 2001 Q3 2001 Q4 2001 Year
------------------------------------------------- --------- --------- --------- --------- ----------
Tax charge before adoption of FRS 19 ($m) (316) (269) (286) (282) (1,153)
Tax charge after adoption of FRS 19 ($m) (315) (289) (295) (315) (1,214)
Published EPS before adoption of FRS 19 ($) 0.45 . 0.42 0.43 0.47 1.77
Adjusted EPS after adoption of FRS 19 ($) 0.45 0.41 0.42 0.45 1.73
------------------------------------------------- --------- --------- --------- --------- ----------
2 JOINT VENTURES AND ASSOCIATES
The group's share of joint ventures' sales for the nine months to 30
September 2002 amounted to $184m and $171m for the comparative period.
Share of joint ventures' operating profits for the nine months to 30
September 2002, and for the comparative period, were $nil.
3 NET CASH FUNDS
The table below provides an analysis of net cash funds and a
reconciliation of net cash flow to movement in net cash funds.
At 1 Jan Cash Other Exchange At 30 Sept
2002 flow non-cash movements 2002
$m $m $m $m $m
----------------------------------------- ------------- --------------- ------------- ------------- ------------
Loans due after 1 year (635) 14 284 - (337)
Current instalments of loans (107) 41 (284) (3) (353)
----------------------------------------- ------------- --------------- ------------- ------------- ------------
Total loans (742) 55 - (3) (690)
----------------------------------------- ------------- --------------- ------------- ------------- ------------
Short-term investments 3,118 596 - 32 3,746
Cash 705 (11)* - 22 716
Overdrafts (195) 48* - (1) (148)
Short-term borrowings, excluding overdrafts (19) 12 - 6 (1)
----------------------------------------- ------------- --------------- ------------- ------------- ------------
3,609 645 - 59 4,313
----------------------------------------- ------------- --------------- ------------- ------------- ------------
Net cash funds 2,867 700 - 56 3,623
----------------------------------------- ------------- ------------- ------------- ------------
Issue of AstraZeneca PLC Ordinary Shares (25)
Repurchase of AstraZeneca PLC
Ordinary Shares 896
----------------------------------------- ---------------
Net cash inflow before management of
liquid resources and financing 1,571
----------------------------------------- ---------------
* Movement of $37m on cash and overdrafts corresponds to increase in cash
during period as defined under UK GAAP.
12
4 LEGAL PROCEEDINGS
Further to note 36 to the Financial Statements found on page 94 in the
AstraZeneca 2001 Annual Report and Form 20-F wherein reference is made to
various investigations into drug marketing and pricing practices in the
US, the US Department of Justice has been conducting an investigation into
the sales and marketing of Zoladex (goserelin acetate implant). The
Company has been informed that the investigation was prompted by the
filing of a qui tam complaint by a private party and involves allegations
of improper submission of claims to the Medicare program. The Company is
cooperating with the investigation, which is ongoing. While it is not
possible to predict the outcome of the investigation, management is of the
opinion that the ultimate disposition should not have a material adverse
effect on AstraZeneca's financial position or results.
5 NINE MONTHS TERRITORIAL SALES ANALYSIS
% Growth
-------------------------------
Nine Months Nine Months
2002 2001 Constant
$m $m Actual Currency
------------- ------------- ------------- -------------
USA 6,963 6,425 8 8
Canada 423 383 10 12
---------------------------------------------- ------------- ------------- ------------- -------------
North America 7,386 6,808 8 8
---------------------------------------------- ------------- ------------- ------------- -------------
France 826 701 18 15
UK 486 551 (12) (13)
Germany 512 511 - (3)
Italy 551 457 21 18
Sweden 210 199 6 5
Europe others 1,610 1,400 15 12
---------------------------------------------- ------------- ------------- ------------- -------------
Total Europe 4,195 3,819 10 7
---------------------------------------------- ------------- ------------- ------------- -------------
Japan 663 591 12 19
Rest of World 909 822 11 14
---------------------------------------------- ------------- ------------- ------------- -------------
Total 13,153 12,040 9 9
---------------------------------------------- ------------- ------------- ------------- -------------
6 THIRD QUARTER TERRITORIAL SALES ANALYSIS
% Growth
-------------------------------
3rd 3rd
Quarter Quarter
2002 2001 Constant
$m $m Actual Currency
------------- ------------- ------------- -------------
USA 2,244 2,166 4 4
Canada 150 129 16 16
---------------------------------------------- ------------- ------------- ------------- -------------
North America 2,394 2,295 4 4
---------------------------------------------- ------------- ------------- ------------- -------------
France 289 219 32 17
UK 156 181 (14) (20)
Germany 177 163 9 (3)
Italy 172 120 43 26
Sweden 72 57 26 10
Europe others 524 430 22 9
---------------------------------------------- ------------- ------------- ------------- -------------
Total Europe 1,390 1,170 19 6
---------------------------------------------- ------------- ------------- ------------- -------------
Japan 251 202 24 23
Rest of World 315 283 11 13
---------------------------------------------- ------------- ------------- ------------- -------------
Total 4,350 3,950 10 6
---------------------------------------------- ------------- ------------- ------------- -------------
13
7 NINE MONTHS PRODUCT SALES ANALYSIS
World US
--------------------------------------------------- -----------------------
Nine Nine Constant Nine
Months Months Actual Currency Months Actual
2002 2001 Growth Growth 2002 Growth
$m $m % % $m %
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Gastrointestinal:
Losec 3,578 4,287 (17) (17) 2,221 (22)
Nexium 1,323 295 n/m n/m 1,031 n/m
Others 45 30 50 50 13 -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Gastrointestinal 4,946 4,612 7 7 3,265 7
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Cardiovascular:
Zestril 748 832 (10) (10) 435 (12)
Seloken 652 554 18 17 445 27
Atacand 413 289 43 41 155 48
Plendil 355 332 7 6 151 13
Tenormin 275 300 (8) (6) 42 (2)
Others 270 314 (14) (15) 14 (70)
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Cardiovascular 2,713 2,621 4 4 1,242 6
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Respiratory:
Pulmicort 580 570 2 1 246 23
Rhinocort 226 194 16 15 160 26
Symbicort 194 34 n/m n/m - -
Accolate 95 115 (17) (16) 66 (20)
Oxis 91 94 (3) (5) - -
Others 106 116 (9) (10) - -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Respiratory 1,292 1,123 15 14 472 15
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Oncology:
Zoladex 595 519 15 16 163 6
Casodex 465 393 18 18 138 (18)
Nolvadex 348 446 (22) (21) 244 (27)
Arimidex 242 139 74 73 105 119
Iressa 26 - n/m n/m - -
Faslodex 19 - n/m n/m 19 n/m
Others 15 22 (32) (32) - -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Oncology 1,710 1,519 13 13 669 (5)
-------------------------------------- ---------- --------- --------- --------- --------- ----------
CNS:
Seroquel 804 526 53 53 651 49
Zomig 237 209 13 12 128 8
Others 23 16 44 44 5 -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total CNS 1,064 751 42 42 784 40
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Pain, Infection and Other Pharma:
Diprivan 331 329 1 2 163 10
Merrem 218 162 35 35 53 43
Local anaesthetics 311 332 (6) (5) 76 (17)
Other Pharma Products 205 280 (27) (27) 59 (31)
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Pain, Infection and Other
Pharma 1,065 1,103 (3) (3) 351 (3)
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Salick Health Care 170 144 18 18 170 18
Astra Tech 108 90 20 19 8 60
Marlow Foods 85 77 10 9 2 -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total 13,153 12,040 9 9 6,963 8
-------------------------------------- ---------- --------- --------- --------- --------- ----------
n/m not meaningful
14
8 THIRD QUARTER PRODUCT SALES ANALYSIS
World US
--------------------------------------------------- -----------------------
3rd 3rd Constant 3rd
Quarter Quarter Actual Currency Quarter Actual
2002 2001 Growth Growth 2002 Growth
$m $m % % $m %
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Gastrointestinal:
Losec 1,223 1,421 (14) (16) 798 (18)
Nexium 493 168 n/m n/m 378 n/m
Others 15 9 67 67 4 -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Gastrointestinal 1,731 1,598 8 6 1,180 6
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Cardiovascular:
Zestril 189 188 1 (3) 84 2
Seloken 206 204 1 (2) 139 (1)
Atacand 132 93 42 33 38 31
Plendil 149 120 24 20 76 33
Tenormin 85 87 (2) (5) 5 (38)
Others 89 94 (5) (14) 3 (79)
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Cardiovascular 850 786 8 3 345 4
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Respiratory:
Pulmicort 150 161 (7) (12) 52 (10)
Rhinocort 80 64 25 22 60 30
Symbicort 72 20 n/m n/m - -
Accolate 28 20 40 40 19 73
Oxis 30 29 3 (7) - -
Others 34 35 (3) (12) - -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Respiratory 394 329 20 13 131 14
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Oncology:
Zoladex 208 175 19 14 58 12
Casodex 191 149 28 22 73 3
Nolvadex 86 160 (46) (47) 51 (59)
Arimidex 96 47 104 98 42 163
Iressa 26 - n/m n/m - -
Faslodex 11 - n/m n/m 11 n/m
Others 4 7 (43) (43) - -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Oncology 622 538 16 12 235 (11)
-------------------------------------- ---------- --------- --------- --------- --------- ----------
CNS:
Seroquel 200 169 18 16 144 5
Zomig 69 55 25 18 30 67
Others 8 13 (38) (38) 2 -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total CNS 277 237 17 14 176 12
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Pain, Infection and Other Pharma:
Diprivan 105 114 (8) (10) 50 (18)
Merrem 76 56 36 34 20 33
Local anaesthetics 155 136 14 12 43 2
Other Pharma Products 16 55 n/m n/m 3 n/m
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total Pain, Infection and Other
Pharma 352 361 (2) (4) 116 (17)
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Salick Health Care 57 49 16 16 57 16
Astra Tech 37 28 32 18 3 50
Marlow Foods 30 24 25 17 1 -
-------------------------------------- ---------- --------- --------- --------- --------- ----------
Total 4,350 3,950 10 6 2,244 4
-------------------------------------- ---------- --------- --------- --------- --------- ----------
n/m not meaningful
15
Shareholder Information
ANNOUNCEMENTS AND MEETINGS
-------------------------------------------------------------------------------
Annual Business Review 7 November 2002
Announcement of fourth quarter and full year 2002 results 30 January 2003
Announcement of first quarter 2003 results 30 April 2003
Annual General Meeting 2003 30 April 2003
Announcement of second quarter and half year 2003 results 24 July 2003
Announcement of third quarter 2003 results 23 October 2003
DIVIDENDS
-------------------------------------------------------------------------------
The record date for the first interim dividend paid on 7 October 2002 (in the
UK, Sweden and the US) was 23 August 2002. Ordinary Shares traded ex-dividend
on the London and Stockholm Stock Exchange from 21 August 2002. ADRs traded
ex-dividend on the New York Stock Exchange from the same date.
The record date for the second interim dividend for 2002 payable on 7 April
2003 (in the UK, Sweden and the US) will be 21 February 2003. Ordinary Shares
will trade ex-dividend on the London and Stockholm Stock Exchange from 19
February 2003. ADRs will trade ex-dividend on the New York Stock Exchange from
the same date.
Future dividends will normally be paid as follows:
First interim Announced in July and paid in October
Second interim Announced in January and paid in April.
TRADEMARKS
-------------------------------------------------------------------------------
The following brand names used in this interim report are trade marks of the
AstraZeneca group of companies:
Accolate Arimidex Astra Tech Atacand Atacand HCT Casodex Crestor Diprivan
Exanta Faslodex Iressa Losec Merrem Nexium Nolvadex Oxis Plendil Prilosec
Pulmicort Pulmicort Respules Rhinocort Rhinocort Aqua Seloken Seroquel
Symbicort Tenormin Toprol-XL Zestril Zoladex Zomig Zomig ZMT
ADDRESSES FOR CORRESPONDENCE
-------------------------------------------------------------------------------
Registrar and Depositary Registered Office Swedish Securities Register Centre
Transfer Office for ADRs VPC AB
The AstraZeneca Registrar JPMorgan Chase Bank 15 Stanhope Gate PO Box 7822
Lloyds TSB Registrars PO Box 43013 London S-103 97 Stockholm
The Causeway Providence, W1K 1LN Sweden
Worthing RI 02940-3013 UK
West Sussex US
BN99 6DA
Tel: +44 (0)121 433 8000 Tel: +1 (781) 575 4328 Tel: +44 (0)20 7304 5000 Tel: +46 (0)8 402 9000
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 Interim Report 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, exchange rate fluctuations, the risk that research
and development will not yield new products that achieve commercial success,
the impact of competition, price controls and price reductions, the risk of
loss or expiration of patents or trade marks, difficulties of obtaining and
maintaining governmental approvals for products, the risk of substantial
product liability claims and exposure to environmental liability.
16
Item 5
ASTRAZENECA'S NEW ORAL DIRECT THROMBIN INHIBITOR EXANTA(TM)SUPERIOR IN
REDUCING RISK OF VENOUS THROMBOEMBOLISM (VTE) FOLLOWING TOTAL HIP OR KNEE
REPLACEMENT SURGERY
AstraZeneca announced today, from the 17th International Congress on Thrombosis
(ICT) in Bologna, results from the EXPRESS phase III clinical trial with
Exanta(TM) (oral ximelagatran and its active form, melagatran) that showed the
drug's superior efficacy in reducing risk of major venous thromboembolism (VTE)
compared with a routinely used prophylactic treatment, enoxaparin, in major
orthopaedic surgery.
Results showed a significant 63 per cent relative risk reduction (2.3% vs 6.3%:
p=0.0000018) in major venous thromboembolism (VTE) (proximal deep vein
thrombosis (DVT) and pulmonary embolism (PE)) when treated with 'Exanta',
compared to standard prophylaxis with enoxaparin (40mg od). A relative risk
reduction in major VTE of 67 per cent (1.8% vs 5.5%) was noted for total hip
replacement and a 60 per cent relative risk reduction (3.3% vs 8.2%) for total
knee replacement surgery. Additionally, there was a 24 per cent (20.3% vs
26.6%) reduction in the risk of total VTE (proximal and distal DVT and PE)
following prophylactic treatment (thromboprophylaxis) with 'Exanta', compared
to enoxaparin.
The 'Exanta' treatment regimen in EXPRESS shows a good balance between efficacy
and safety. A small increase in surgery-related bleeding was observed compared
to enoxaparin, although importantly, there were no differences between
treatments in clinically important bleeding events (defined as fatal, critical
organ or requiring re-operation).
Between 45-57 per cent of patients undergoing total hip replacement without
thromboprophylaxis develop DVT (deep vein thrombosis), a potentially fatal
condition. Similarly, the rate of DVT for patients undergoing total knee
replacement is 40-84 per cent. The market for anticoagulants is currently
valued at $3.1 billion.
'Exanta' is the first Oral DTI to be submitted for regulatory approval and
works by inhibiting thrombin, a key enzyme involved in the blood clotting
(coagulation) process. AstraZeneca submitted a filing for a European licence
for 'Exanta' (ximelagatran / melagatran) for the prevention of VTE following
major orthopaedic surgery in July 2002. This was the first regulatory
submission for 'Exanta'. In the
2
United States, the parallel phase III clinical trial programme in orthopaedic
surgery, EXULT, remains on track.
Fifteen additional abstracts presented at the ICT highlighted the potential of
'Exanta' to meet a clear unmet medical need in the prevention and treatment of
thromboembolism and demonstrated its benefit in terms of efficacy, safety,
predictable pharmacokinetic results and tolerability across a wide patient
population.
Thrombosis is one of the largest causes of morbidity and mortality in the
Western world. There are nearly four million events of thromboembolic disease
(including stroke, deep vein thrombosis/pulmonary embolism and myocardial
infarction) each year throughout the EU and Japan.
EXPRESS is a randomised, double-blind study of 2,800 patients that compares the
efficacy and safety of 'Exanta', with that of commonly used prophylactic
treatment with subcutaneous enoxaparin (40mg od), for the prevention of venous
thromboembolism (VTE) following major hip and knee replacement surgery.
Patients received 2 mg subcutaneous 'Exanta' immediately before surgery,
followed by 3 mg subcutaneous 'Exanta' in the evening after surgery, and then
24 mg oral 'Exanta' as a fixed dose. EXPRESS was carried out in 12 European
countries and South Africa.
'Exanta' is a trademark of the AstraZeneca group of companies.
28 October 2002
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Chris Major, Tel: +44 (0) 207 304 5028
Investor Relations:
Mina Blair-Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087