Research Update - Part 1 of 2
AstraZeneca PLC
08 June 2006
AstraZeneca Outlines Strategy to Further Strengthen Its Product Pipeline While
Delivering Continued Sales and Earnings Growth
AstraZeneca will provide an update on its strategy and development pipeline
through to the end of the decade at a business review meeting to be held in
London today.
David Brennan, Chief Executive Officer of AstraZeneca, will set the agenda for
the Company's business review by outlining the measures being taken to further
strengthen the new product pipeline and his expectations for sustaining the
current business momentum.
Commenting on the Company's pipeline, Mr Brennan said, 'There are three elements
to our strategy to strengthen the pipeline: improve the productivity of our
in-house Discovery and Development efforts; aggressively pursue promising
products and technologies from external sources; and, beginning with our offer
for Cambridge Antibody Technology, build a major international presence in the
research and development of biological therapeutics to complement our small
molecule capabilities.'
Commenting on AstraZeneca's ambitions to sustain its current business momentum,
Brennan said, 'We know what it will take to continue to deliver a strong
performance over the next five years. While new products will play a role, many
of the ingredients for continuing our momentum can be found in our current
product range. Effective lifecycle management and commercial excellence in
support of key growth products such as SymbicortTM, CrestorTM and SeroquelTM
should continue to drive top line growth. This will give us the potential to
grow sales in line with projected market growth and, in conjunction with
continued cost discipline, the delivery of earnings growth ahead of sales is
within our reach.'
Dr John Patterson, Executive Director of Development, will highlight progress
with the R&D pipeline:
• Expansion of the potential of key marketed products (SeroquelTM,
CrestorTM, SymbicortTM) through lifecycle management.
• Progress of the development pipeline within key therapy areas which
totals 103 projects, 79 of which involve new chemical entities (NCEs) and 24 for
the lifecycle management of products already on the market.
• Enhancement of the Company's discovery and development capability
through productivity improvements, the increased use of biomarkers and
translational science and investment in biological therapeutics.
• The recently announced recommended cash offer for Cambridge Antibody
Technology (CAT), adds to the momentum of the Company's expanded business
development activities and will supplement the progress being made internally to
deliver a flow of products that will meet its growth objectives in the next
decade.
• Excellent progress is being made through externally sourced products
and technologies from the following companies: Renovis Inc. (NXY-059),
AtheroGenics Inc. (AGI-1067), Abgenix Inc. (human monoclonal antibodies), Array
BioPharma Inc. (MEK inhibitors), Avanir Pharmaceuticals (reverse cholesterol
transport), CAT (human monoclonal antibodies, peptides and proteins), KuDOS
Pharmaceuticals Ltd (DNA repair), NPS Pharmaceuticals Inc. (treatment of
intractable pain), Protherics PLC (CytoFabTM), Targacept Inc. (neuronal
nicotinic agents for cognition) and Theravance Inc. (novel intravenous
anaesthetic agent).
Jonathan Symonds, Chief Financial Officer, will review the business performance
over the last two years and the potential for this to be sustained for the next
five years. Over the last two years the strong performance has been based on
five key growth products, excellent execution in the market and productivity
improvements across the whole business. AstraZeneca believes these performance
trends can continue. The Company has the potential to grow sales over the next
five years in line with projected market growth while absorbing generic
competition to a number of its products. This sales performance, when combined
with further productivity gains, is expected to lead to further improvements in
operating margin and to generation of substantial cash flow for reinvestment in
the business and for return to shareholders. Investment will be targeted at
accelerating internal innovation as well as improving the strength of the
pipeline through a combination of acquisition, licensing and collaboration,
leading to increased investment in research and development.
Progress in key therapy areas will be covered at the meeting:
Cardiovascular:
• The current market momentum of CrestorTM is based on its clearly
defined best in class efficacy as demonstrated by studies such as STELLAR and
ASTEROID.
• Positive results from EXPLORER, AstraZeneca's study comparing
CrestorTM (40mg) with CrestorTM (40mg) and ezetimibe in high-risk patients, are
due to report at the forthcoming International Symposium on Atherosclerosis.
• The Phase III programme for AZD6140 will evaluate the impact of this
reversible oral anti-platelet agent on morbidity and mortality in patients with
Acute Coronary Syndrome. The pivotal Phase III trial (PLATO) is in the late
planning phase. Discussions with regulatory authorities to finalise the
protocol are ongoing and are expected to be completed in time for a study start
during the second half of 2006.
• The AGI-1067 ARISE trial is anticipated to reach its target number of
events in the second half of 2006, with results anticipated in early 2007 and
subsequent regulatory submissions in the first half of 2007. If successful,
AGI-1067 will herald a new approach to the treatment of atherosclerosis with a
profile that would make it complementary to statins including CrestorTM in the
market place.
• Based on the results of early clinical studies, the Company plans to
take the alpha-partial gamma PPAR agonist AZD6610 a treatment for combined
dyslipidaemia, into Phase II later this year.
• AZD9684 is the first member of a new anti-thrombotic class (CPU
inhibitors). Results from an intravenous concept study evaluating its ability
to dissolve clots in patients with pulmonary embolism will be available during
the second half of 2006.
• One of the major focuses of the Company's early stage cardiovascular
development pipeline is to build a strong anti-atheroma franchise, based on
novel approaches to this disease. AZD4121, a cholesterol absorption inhibitor,
will be taken into Phase I early next year.
Neuroscience:
• Following the recent regulatory submissions based on the BOLDER
studies in bipolar depression, SeroquelTM is set to become the first medication
to offer a single treatment effective at both poles of bipolar disease
(depression and mania).
• An NDA for the use of Seroquel SRTM formulation in schizophrenia will
be filed in the US in Q3 2006. The formulation, has patent protection to 2017
and is being used in a clinical programme now underway to study Seroquel SRTM in
Major Depressive Disorder (MDD) and Generalised Anxiety Disorder (GAD) designed
to deliver indications from 2009, creating an opportunity to access up to 20
percent of the depression and anxiety market.
• At current recruitment rates, the NXY-059 SAINT II study is expected
to complete enrolment before the end of June with results during the fourth
quarter of this year. First regulatory filings are planned for the first half
of next year.
• AstraZeneca will develop the neuronal nicotinic receptor agonist
AZD3480, licensed from Targacept Inc. for its first indications in Alzheimer's
disease and cognitive deficits in schizophrenia.
• A licensing deal has been signed with Theravance Inc. for development
of a novel intravenous anaesthetic agent, currently at the pre-clinical phase of
development.
• Eight new molecules have been added to the Neuroscience pipeline and
four projects have progressed into clinical Phase I.
Respiratory/Inflammation:
• The COMPASS and SMILE studies illustrate the benefits of Symbicort
Maintenance and Reliever TherapyTM (SMART) when compared with current asthma
treatments.
• FDA review of the use of the SymbicortTM pMDI device for the treatment
of asthma is on track, with a scheduled first PDUFA date in July 2006. The
Company anticipates more than one review cycle.
• Post-hoc analysis of previous COPD trials with SymbicortTM shows that
budesonide reduces the mortality risk when added to either formoterol or the
short acting beta agonist terbutaline. These data will be presented at the
forthcoming COPD 5 conference at the end of June.
• Phase II trials of the P2X7 antagonist AZD9056 in COPD and
inflammatory bowel disease will read out in the next nine months. A positive
clinical signal has already been shown in rheumatoid arthritis.
• The protease inhibitor AZD3342 has completed Phase I studies and is
scheduled to progress to Phase II studies in the second half of 2006.
• Excellent progress is being made through the existing alliance with
CAT. All of the portfolio targets have been met or exceeded. It is on track to
deliver at least two new monoclonal antibodies for human testing per year. The
first fully human monoclonal candidate from this collaboration may enter
development by the end of the year.
Infection:
• CytoFabTM is an ovine polyclonal anti-TNF-alpha antibody fragment for
the treatment of sepsis. Recently licensed from Protherics PLC, the development
programme for CytoFabTM, including key modifications to the route of
manufacture, remains on track to begin its pivotal Phase III trial in 2007.
• AstraZeneca's leading genomic approach to anti-bacterials is yielding
its first candidates. AZD1279, a novel bactericidal antibiotic from a totally
new chemical class, shows in vitro activity against resistant organisms
including S. pneumoniae and will enter Phase I for respiratory infections later
this year.
Oncology:
• Data from pivotal studies of ZactimaTM in second and third line NSCLC
are anticipated in mid-2008. It is being developed as monotherapy and
combination therapy in lung cancer. ZactimaTM has also been granted Orphan Drug
Designation for a rare form of thyroid cancer by the FDA and EMEA and the FDA
has granted fast-track status for this indication. Data from the randomised
thyroid cancer study are anticipated in 2009.
• AZD2171's combination of potency, selectivity and pharmacokinetics
gives it the potential to be the best in class VEGFR-TKI, with activity in all
forms of lung cancer including squamous cell carcinoma. A Phase II/III study in
first line NSCLC is underway with the National Cancer Institute of Canada and a
second study in this indication will start next year. Data from these studies
will be available in 2009. Data from Phase III studies in colorectal cancer
will be available in 2010. This programme will be supported by US NCI-sponsored
studies in other tumours under the auspices of the recently finalised
Collaborative Research and Development Agreement (CRADA).
• ZD4054 has the potential to be best in class endothelin A antagonist.
The results of a study in hormone resistant prostate cancer will determine the
progression into Phase III and will complete by the end of Q3 2006.
• The first molecule from AstraZeneca's collaboration with Array
BioPharma Inc., the MEK inhibitor AZD6244 (ARRY-142886), has entered Phase II in
malignant melanoma, the first of a range of tumour types. AZD6244 is
potentially first in class.
• Phase II trials will start in the second half of this year for the Src
kinase inhibitor AZD0530 in multiple tumour types including breast and
pancreatic cancer.
• The anti-angiogenic monoclonal antibody AZD5180 is the first candidate
drug to emerge from the collaboration with Abgenix/Amgen. First time in man is
anticipated early next year.
• The KuDOS PARP Inhibitor AZD2281 will start studies in breast cancer
in the next few weeks.
• Clinical decision points will be reached in the next few months on the
KuDOS development compounds, AZD1689, a topoisomerase inhibitor targeted at
hypoxic tissue, and AZD5896 (PatrinTM), a drug targeted at another enzyme in the
DNA repair cascade.
• Changes in AstraZeneca's research approach to cancer therapy and to '
personalised medicine' are paying dividends, delivering a range of targeted
agents into development. In total, the oncology portfolio now contains 15 NCEs
in pre-clinical or Phase I testing. Three compounds will reach first time in
man and six further NCEs are expected to enter development in oncology in 2006.
Development Portfolio:
AstraZeneca's development portfolio now contains 103 projects involving 79 NCEs:
• 5 NCEs in Phase III development
• 13 NCEs in Phase II development
• 20 NCE projects in Phase I development
• 41 NCEs in pre-clinical testing
A full updated summary of AstraZeneca's R&D pipeline, including life cycle
management projects being undertaken with marketed products, is appended to this
press release. It is also available on the Company's website:
www.astrazeneca.com under information for investors.
-Ends-
Thursday 8th June 2006
Media Enquiries:
London:
Steve Brown +44 (0) 207 304 5033
Edel McCaffrey +44 (0) 207 304 5034
Wilmington:
Carla Burigatto +1 302 886 5953
Sodertalje:
Staffan Ternby +46 (8) 553 26107
Analyst & Investor Enquiries:
Jonathan Hunt +44 (0) 207 304 5087
Mina Blair +44 (0) 207 304 5084
Ed Seage +1 302 886 4065
Jorgen Winroth +1 212 579 0506
Notes to Editors:
For copies of the presentations from today's business review and an updated copy
of AstraZeneca's development pipeline please visit www.astrazeneca.com. Photos
are available on www.newscast.co.uk. Broadcast footage of AstraZeneca products
and activities is available on www.thenewsmarket.com/astrazeneca.
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.
TRADEMARKS
The following brand names used in this release are trademarks of the AstraZeneca
group of companies:
Crestor, Seroquel, Seroquel SR, Symbicort, Symbicort Maintenance and Reliever
Therapy, Zactima
This information is provided by RNS
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