8th Jun 2006 07:02
AstraZeneca PLC08 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 pipelinethrough to the end of the decade at a business review meeting to be held inLondon today. David Brennan, Chief Executive Officer of AstraZeneca, will set the agenda forthe Company's business review by outlining the measures being taken to furtherstrengthen the new product pipeline and his expectations for sustaining thecurrent business momentum. Commenting on the Company's pipeline, Mr Brennan said, "There are three elementsto our strategy to strengthen the pipeline: improve the productivity of ourin-house Discovery and Development efforts; aggressively pursue promisingproducts and technologies from external sources; and, beginning with our offerfor Cambridge Antibody Technology, build a major international presence in theresearch and development of biological therapeutics to complement our smallmolecule 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 strongperformance over the next five years. While new products will play a role, manyof the ingredients for continuing our momentum can be found in our currentproduct range. Effective lifecycle management and commercial excellence insupport of key growth products such as SymbicortTM, CrestorTM and SeroquelTMshould continue to drive top line growth. This will give us the potential togrow sales in line with projected market growth and, in conjunction withcontinued cost discipline, the delivery of earnings growth ahead of sales iswithin our reach." Dr John Patterson, Executive Director of Development, will highlight progresswith 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 whichtotals 103 projects, 79 of which involve new chemical entities (NCEs) and 24 forthe lifecycle management of products already on the market. • Enhancement of the Company's discovery and development capabilitythrough productivity improvements, the increased use of biomarkers andtranslational science and investment in biological therapeutics. • The recently announced recommended cash offer for Cambridge AntibodyTechnology (CAT), adds to the momentum of the Company's expanded businessdevelopment activities and will supplement the progress being made internally todeliver a flow of products that will meet its growth objectives in the nextdecade. • Excellent progress is being made through externally sourced productsand technologies from the following companies: Renovis Inc. (NXY-059),AtheroGenics Inc. (AGI-1067), Abgenix Inc. (human monoclonal antibodies), ArrayBioPharma Inc. (MEK inhibitors), Avanir Pharmaceuticals (reverse cholesteroltransport), CAT (human monoclonal antibodies, peptides and proteins), KuDOSPharmaceuticals Ltd (DNA repair), NPS Pharmaceuticals Inc. (treatment ofintractable pain), Protherics PLC (CytoFabTM), Targacept Inc. (neuronalnicotinic agents for cognition) and Theravance Inc. (novel intravenousanaesthetic agent). Jonathan Symonds, Chief Financial Officer, will review the business performanceover the last two years and the potential for this to be sustained for the nextfive years. Over the last two years the strong performance has been based onfive key growth products, excellent execution in the market and productivityimprovements across the whole business. AstraZeneca believes these performancetrends can continue. The Company has the potential to grow sales over the nextfive years in line with projected market growth while absorbing genericcompetition to a number of its products. This sales performance, when combinedwith further productivity gains, is expected to lead to further improvements inoperating margin and to generation of substantial cash flow for reinvestment inthe business and for return to shareholders. Investment will be targeted ataccelerating internal innovation as well as improving the strength of thepipeline 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 clearlydefined best in class efficacy as demonstrated by studies such as STELLAR andASTEROID. • Positive results from EXPLORER, AstraZeneca's study comparingCrestorTM (40mg) with CrestorTM (40mg) and ezetimibe in high-risk patients, aredue to report at the forthcoming International Symposium on Atherosclerosis. • The Phase III programme for AZD6140 will evaluate the impact of thisreversible oral anti-platelet agent on morbidity and mortality in patients withAcute Coronary Syndrome. The pivotal Phase III trial (PLATO) is in the lateplanning phase. Discussions with regulatory authorities to finalise theprotocol are ongoing and are expected to be completed in time for a study startduring the second half of 2006. • The AGI-1067 ARISE trial is anticipated to reach its target number ofevents in the second half of 2006, with results anticipated in early 2007 andsubsequent regulatory submissions in the first half of 2007. If successful,AGI-1067 will herald a new approach to the treatment of atherosclerosis with aprofile that would make it complementary to statins including CrestorTM in themarket place. • Based on the results of early clinical studies, the Company plans totake the alpha-partial gamma PPAR agonist AZD6610 a treatment for combineddyslipidaemia, into Phase II later this year. • AZD9684 is the first member of a new anti-thrombotic class (CPUinhibitors). Results from an intravenous concept study evaluating its abilityto dissolve clots in patients with pulmonary embolism will be available duringthe second half of 2006. • One of the major focuses of the Company's early stage cardiovasculardevelopment pipeline is to build a strong anti-atheroma franchise, based onnovel 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 BOLDERstudies in bipolar depression, SeroquelTM is set to become the first medicationto 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 willbe filed in the US in Q3 2006. The formulation, has patent protection to 2017and is being used in a clinical programme now underway to study Seroquel SRTM inMajor Depressive Disorder (MDD) and Generalised Anxiety Disorder (GAD) designedto deliver indications from 2009, creating an opportunity to access up to 20percent of the depression and anxiety market. • At current recruitment rates, the NXY-059 SAINT II study is expectedto complete enrolment before the end of June with results during the fourthquarter of this year. First regulatory filings are planned for the first halfof next year. • AstraZeneca will develop the neuronal nicotinic receptor agonistAZD3480, licensed from Targacept Inc. for its first indications in Alzheimer'sdisease and cognitive deficits in schizophrenia. • A licensing deal has been signed with Theravance Inc. for developmentof a novel intravenous anaesthetic agent, currently at the pre-clinical phase ofdevelopment. • Eight new molecules have been added to the Neuroscience pipeline andfour projects have progressed into clinical Phase I. Respiratory/Inflammation: • The COMPASS and SMILE studies illustrate the benefits of SymbicortMaintenance and Reliever TherapyTM (SMART) when compared with current asthmatreatments. • FDA review of the use of the SymbicortTM pMDI device for the treatmentof asthma is on track, with a scheduled first PDUFA date in July 2006. TheCompany anticipates more than one review cycle. • Post-hoc analysis of previous COPD trials with SymbicortTM shows thatbudesonide reduces the mortality risk when added to either formoterol or theshort acting beta agonist terbutaline. These data will be presented at theforthcoming COPD 5 conference at the end of June. • Phase II trials of the P2X7 antagonist AZD9056 in COPD andinflammatory bowel disease will read out in the next nine months. A positiveclinical signal has already been shown in rheumatoid arthritis. • The protease inhibitor AZD3342 has completed Phase I studies and isscheduled to progress to Phase II studies in the second half of 2006. • Excellent progress is being made through the existing alliance withCAT. All of the portfolio targets have been met or exceeded. It is on track todeliver at least two new monoclonal antibodies for human testing per year. Thefirst fully human monoclonal candidate from this collaboration may enterdevelopment by the end of the year. Infection: • CytoFabTM is an ovine polyclonal anti-TNF-alpha antibody fragment forthe treatment of sepsis. Recently licensed from Protherics PLC, the developmentprogramme for CytoFabTM, including key modifications to the route ofmanufacture, remains on track to begin its pivotal Phase III trial in 2007. • AstraZeneca's leading genomic approach to anti-bacterials is yieldingits first candidates. AZD1279, a novel bactericidal antibiotic from a totallynew chemical class, shows in vitro activity against resistant organismsincluding S. pneumoniae and will enter Phase I for respiratory infections laterthis year. Oncology: • Data from pivotal studies of ZactimaTM in second and third line NSCLCare anticipated in mid-2008. It is being developed as monotherapy andcombination therapy in lung cancer. ZactimaTM has also been granted Orphan DrugDesignation for a rare form of thyroid cancer by the FDA and EMEA and the FDAhas granted fast-track status for this indication. Data from the randomisedthyroid cancer study are anticipated in 2009. • AZD2171's combination of potency, selectivity and pharmacokineticsgives it the potential to be the best in class VEGFR-TKI, with activity in allforms of lung cancer including squamous cell carcinoma. A Phase II/III study infirst line NSCLC is underway with the National Cancer Institute of Canada and asecond study in this indication will start next year. Data from these studieswill be available in 2009. Data from Phase III studies in colorectal cancerwill be available in 2010. This programme will be supported by US NCI-sponsoredstudies in other tumours under the auspices of the recently finalisedCollaborative 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 theprogression into Phase III and will complete by the end of Q3 2006. • The first molecule from AstraZeneca's collaboration with ArrayBioPharma Inc., the MEK inhibitor AZD6244 (ARRY-142886), has entered Phase II inmalignant melanoma, the first of a range of tumour types. AZD6244 ispotentially first in class. • Phase II trials will start in the second half of this year for the Srckinase inhibitor AZD0530 in multiple tumour types including breast andpancreatic cancer. • The anti-angiogenic monoclonal antibody AZD5180 is the first candidatedrug to emerge from the collaboration with Abgenix/Amgen. First time in man isanticipated early next year. • The KuDOS PARP Inhibitor AZD2281 will start studies in breast cancerin the next few weeks. • Clinical decision points will be reached in the next few months on theKuDOS development compounds, AZD1689, a topoisomerase inhibitor targeted athypoxic tissue, and AZD5896 (PatrinTM), a drug targeted at another enzyme in theDNA repair cascade. • Changes in AstraZeneca's research approach to cancer therapy and to "personalised medicine" are paying dividends, delivering a range of targetedagents into development. In total, the oncology portfolio now contains 15 NCEsin pre-clinical or Phase I testing. Three compounds will reach first time inman 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 cyclemanagement projects being undertaken with marketed products, is appended to thispress 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 5033Edel 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 5087Mina Blair +44 (0) 207 304 5084Ed Seage +1 302 886 4065Jorgen Winroth +1 212 579 0506 Notes to Editors: For copies of the presentations from today's business review and an updated copyof AstraZeneca's development pipeline please visit www.astrazeneca.com. Photosare available on www.newscast.co.uk. Broadcast footage of AstraZeneca productsand 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 PrivateSecurities Litigation Reform Act of 1995, AstraZeneca is providing the followingcautionary statement. This Review contains forward-looking statements withrespect to the financial condition, results of operations and businesses ofAstraZeneca. By their nature, forward-looking statements and forecasts involverisk and uncertainty because they relate to events and depend on circumstancesthat will occur in the future. There are a number of factors that could causeactual results and developments to differ materially from that expressed orimplied by these forward-looking statements. These factors include, among otherthings, the loss or expiration of patents, marketing exclusivity or trade marks;exchange rate fluctuations; the risk that R&D will not yield new products thatachieve commercial success; the impact of competition; price controls and pricereductions; taxation risks; the risk of substantial product liability claims;the impact of any failure by third parties to supply materials or services; therisk of delay to new product launches; the difficulties of obtaining andmaintaining governmental approvals for products; and the risk of environmentalliabilities. TRADEMARKS The following brand names used in this release are trademarks of the AstraZenecagroup of companies: Crestor, Seroquel, Seroquel SR, Symbicort, Symbicort Maintenance and RelieverTherapy, Zactima This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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