Result of Meeting - Part 1
AstraZeneca PLC
12 December 2000
Part 1
ASTRAZENECA REPORTS CONTINUED STRONG PROGRESS ACROSS R&D PORTFOLIO
AstraZeneca today presents an R&D update to a meeting of analysts, at its
Molndal site in Sweden.
- Recent investments, increased access to the US science and technology base
and reshaping, make AstraZeneca's Discovery organisation one of the largest
and most innovative in the pharmaceutical industry
- 10 new chemical entities into development so far this year
- 152 projects in AstraZeneca's R&D pipeline
- Further launches of Nexium in more than 20 countries planned in 2001
- AstraZeneca's statin, named Crestor, on track for filing in Q2 2001 with
highly competitive profile and impressive reduction in LDL-cholesterol
- Oral direct thrombin inhibitor - major indications on track - filing for
first indication now expected late 2002
- Regulatory submissions for Faslodex for breast cancer, Iressa for non
small-cell lung cancer, and Viozan for chronic obstructive pulmonary disease
scheduled for 2001
- Casodex - accelerated filing for early prostate cancer
- Line extensions and new indications underpin growth of new products
Significant Investment and Innovation in AstraZeneca Global Discovery
AstraZeneca presents details of the reshaping of its global Discovery
organisation over the past 12 months. With more than 3,300 staff working in
multi-disciplinary teams, covering eight research areas, in nine sites across
three regions - Sweden, UK and North America - AstraZeneca has one of the
largest and most productive Discovery organisations in the pharmaceutical
industry.
In North America the company has taken steps to optimise access to the US
science and technology base with a significant investment in new research
facilities in Boston where it is expanding its research capabilities in
cancer, infection and enabling science and technology (EST). Further
investment is also being made in the central nervous system (CNS) site at
Wilmington and the recently established pain research unit in Montreal.
AstraZeneca has established a structure which enhances the company's ability
to exploit the best new opportunities in breakthrough science and technology
and now has more than 300 external collaborations with leading universities
and biotech companies.
'Discovery will deliver more than 10 candidate drugs in 2000,' said Professor
Jan Lundberg, Senior Vice President and Head of Global Discovery. 'Ten
candidate drugs, meeting stringent quality criteria, have been taken into
development already and several more compounds will be nominated before the
end of the year.
'Overall, the changes we have introduced over the past year have generated all
the benefits of scale of a large organisation, while retaining the spirit and
innovation of a focussed biotech company,' he said.
AstraZeneca R&D on Track to Meet Challenging Targets
Dr Claes Wilhelmsson, Director of Research & Development, reports that the
company is on track to meet the challenging targets set 12 months ago:
- to deliver more than 15 candidate drugs per year by 2003
- to double the success rate of new drugs progressing through development to
the market to 20 per cent by 2005
- to reduce the target time, from candidate drug selection to registration, to
less than six years
- to deliver in the future three or more medically important and commercially
attractive new products per year
- to launch in all major markets within a time window of 12 months
- to contribute to doubling the value of the portfolio every five years.
Continued Progress across Development Portfolio
Cardiovascular
Dr Hamish Cameron, Vice President and Head of the Cardiovascular Therapy Area,
gives an update on this important area of AstraZeneca research and development
and reports substantial progress across a wide range of projects.
Ongoing studies on Zestril, Seloken ZOK/Toprol-XL, Plendil and Atacand
Plus/Atacand HCT are providing fuel for further growth of marketed products
with new indications.
The international tradename for ZD4522, AstraZeneca's cholesterol-lowering
drug, is announced today as Crestor. Phase II data on Crestor demonstrates
significant, dose-dependent reductions in low density lipoprotein
(LDL)-cholesterol of up to 65 per cent across the dose range with favourable
effects on high density lipoprotein (HDL)-cholesterol and triglycerides.
Phase III trials comparing Crestor with simvastatin, pravastatin and
atorvastatin in both 12 and 52-week studies, and with a variety of endpoints,
are now being completed, and regulatory submission in Europe and USA is on
track for Q2 2001, with Japan to follow shortly afterwards. These phase III
data for Crestor, some of which will be presented at the American College of
Cardiology (ACC) in March 2001, demonstrate statistically and clinically
significant greater reductions in LDL-cholesterol with Crestor, than with
simvastatin or pravastatin.
Pravastatin and simvastatin, administered at their recommended starting doses,
produced mean 28 and 37 per cent reductions in LDL-cholesterol respectively,
while Crestor, at doses of 5mg and 10mg yielded 42 and 49 per cent reductions.
These changes were reflected in the number of patients who reached the desired
target cholesterol levels. Comparative data with atorvastatin will be
presented at the ACC in March 2001.
As a result of these positive data, an extensive outcomes programme for
Crestor was announced to include approximately 40,000 patients. These
studies, which will begin in 2001, will define a new standard in the treatment
of lipid disorders and are expected to provide a significant commercial
opportunity for AstraZeneca.
The oral direct thrombin inhibitor, H376/95, is the first significant advance
in oral anti-coagulation therapy in 50 years. AstraZeneca is targetting the
key indications of long term treatment of deep vein thrombosis (DVT) and the
prevention of strokes in patients with atrial fibrillation.
The recently completed METHRO III trial and the US study 236 compared H376/95
against enoxaparin and warfarin respectively for the minor indication of
prevention of venous thromboembolism (VTE), following orthopaedic surgery.
Results confirm the efficacy and safety of H376/95 but the statistical
endpoint of superior efficacy was not met.
Filings for the initial indication in prophylaxis of venous thromboembolism,
in total knee and hip replacement surgery, will not take place before the
second half of 2002 while AstraZeneca conducts further phase III studies to
support registration of this indication. Registration plans for the major
indication for patients with atrial fibrillation, currently in phase III
development, are on track for filings in 2003.
H376/95 will represent a significant advance in the treatment of
thromboembolic disease, meeting the needs of physicians and patients. The aim
of the development programme is to deliver an effective, convenient, easy to
use, oral anticoagulant with a wide margin for safety, thus free of the need
for routine laboratory monitoring, and this ambition remains unchanged.
Several new developments in the earlier stage of the cardiovascular portfolio
were presented, including the new oral anti-arrhythmic AR-H050642 which is
about to enter clinical development. In thrombosis, two further compounds,
the factor Xa inhibitor and the novel P2T agonists are progressing and have
both yielded important data from preclinical studies. In addition, work on
PPAR agonists in insulin resistance has yielded a lead compound, AZ242, now in
phase II, which is a potent, once-daily, well tolerated compound with a
promising profile.
Gastro-intestinal
Nexium, the first proton pump inhibitor (PPI) to show clinical advantages over
Losec in the healing and symptom relief of GERD, is on track with launches in
six European markets in less than 12 months since NDA submission. Further
launches in more than 20 countries are planned for next year, including the
USA.
Market reactions to Nexium have been very favourable. In the UK it has been
one of the most successful launches of a new chemical entity, while in
Germany, Nexium has had a rapid sales take-off despite a highly genericised
market place. In Sweden, where the launch to GPs has not yet taken place,
Nexium sales have outperformed all the other PPIs based on monthly sales
performance from launch.
Other development opportunities in the GI franchise are presented, including
an update on AR-H047108, a reversible acid pump inhibitor and a novel
GABAb-mediated reflux inhibitor, which represents a completely new approach to
the treatment of gastroesophageal reflux disease (GERD). Two projects are
also underway in the discovery phase to develop a monotherapy and a vaccine
for helicobacter pylori, which affects approximately 50 per cent of the
population, leading to peptic ulcer disease in 10 per cent of those infected.
Highlights of the other therapy areas
In Oncology, progress being made in the large-scale trial for the treatment of
early prostate cancer with Casodex is such that the company is working towards
a filing early next year - much earlier than planned.
The regulatory submissions for Faslodex in second-line advanced breast cancer,
based on clinical studies published last week, are due to be filed in Q1 next
year, with first-line treatment expected to follow within one year.
Iressa, the signal transduction inhibitor in phase III development for lung,
prostate, stomach, breast and other types of cancer is on track for initial
submissions to regulatory authorities at the end of 2001, with the majority of
clinical studies being completed within three years from the start of the
programme.
In Respiratory, Viozan, the novel treatment for the symptoms of chronic
obstructive pulmonary disease, is scheduled for European and US regulatory
submission in Q4 2001. Symbicort, first launched in Sweden in August 2000 is
progressing towards European Mutual Recognition and a European launch roll out
is planned in 2001. Initial sales are very encouraging.
In CNS, Zomig continues to show strong growth with the development of the
Rapimelt and nasal spray formulations. Bridging studies have been used to
gain approval for Zomig in Japan this year, illustrating the significant
progress being made by AstraZeneca in expediting regulatory approval for new
products in this important market. Seroquel also continues to grow strongly
with new results supporting the product's claims of excellent tolerability and
efficacy. Further trials are now underway for the new indication of bipolar
disorder, with granule and sustained release formulations in development to
offer additional advantages in patient acceptance.
Concluding the presentation, Dr Tom McKillop, Chief Executive of AstraZeneca,
said: 'I am pleased with the progress we have made with our pipeline which
forms the basis of transforming the company and delivering strong future
growth.'
AstraZeneca, Atacand, Crestor, Faslodex, Iressa, Losec, Nexium, Plendil,
Seloken ZOK, Symbicort, Toprol-XL, Viozan, Zestril, Zomig, Rapimelt and
Seroquel are trade marks of the AstraZeneca group.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
In order to utilise the 'Safe Harbour' provisions of the United States Private
Securities Litigation Reform Act of 1995, AstraZeneca is providing the
following cautionary statement. This Report contains certain forward-looking
statements about AstraZeneca. We intend to identify the forward-looking
statements in this report, by using the words 'anticipates,' 'believes,'
'expects,' 'intends,' and similar expressions in such statements. Although we
believe our expectations are based on reasonable assumptions, our
forward-looking statements are subject to numerous risks and uncertainties and
factors that could cause actual outcomes and results to be materially
different from those projected or implied. Important factors that could cause
actual results to differ materially from those in our forward-looking
statements, certain of which are beyond our control, include, among other
things: risk of loss or expiration of patents or trademarks (in particular,
the expiration in the near future of patents covering Losec and Zestril); the
difficulty of integrating Zeneca's and Astra's large and complex businesses on
a timely basis and realizing synergies; the risk that R&D will not yield new
products that achieve commercial success; the impact of competition, price
controls and price reductions; the difficulties of obtaining governmental
regulatory approvals for new products; the risk of substantial product
liability claims; exposure to fluctuations in exchange rates for foreign
currencies and exposure to US environmental liabilities. No assurances can be
given that any of the events anticipated by our forward-looking statements
will transpire or occur, or if any of them do so, what impact they will have
on the results of operations and financial condition of AstraZeneca.
12 December 2000
Further Enquiries:
Investor Relations:
Michael Olsson, tel +44 (0)20 7304 5087
Jorgen Winroth, tel +1 609 896 4148
More to follow...
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