Late Stage Development Progress and Product Line Extensions
CRESTOR has received its first approval in The Netherlands, and will enter European Mutual Recognition Procedure in December. The US NDA will be supplemented with a data package in 1Q 2003; the Japan NDA was submitted in 2Q 2002.
EXANTA is set to be the first new oral anticoagulant for 50 years:
IRESSA, the first epidermal growth factor receptor inhibitor, is already approved in Japan. In the US, IRESSA is under active review by the FDA, following a positive US Oncology Drugs Advisory Committee (ODAC) recommendation. A further ODAC meeting is not anticipated. The European filing is now scheduled for 1Q 2003.
The completion of the EU Mutual Recognition Procedure for approval of ARIMIDEX in early breast cancer, a significant market opportunity, was announced today. An approval has been granted in the UK and other European approvals (Austria, Germany, Italy, Portugal and Spain) will follow. ARIMIDEX was approved for early breast cancer in 3Q 2002 in the US, and other reviews are ongoing in the rest of world.
CASODEX is now approved for early prostate cancer (EPC) in 26 markets. An EPC indication for CASODEX in the US will be the subject of a US ODAC meeting scheduled for December 18th.
FASLODEX has been approved for second-line treatment of breast cancer in the US. European submission for this indication is scheduled for 2003, while the Japanese submission is under consideration.
NEXIUM is growing strongly with sales of $1.6 billion (MAT 3Q). New indications for treatment of NSAID GI side effects and a new parenteral formulation for the hospital setting will be submitted for approval in 2Q 2003.
SEROQUEL, now a $1 billion brand, has demonstrated efficacy in treating bipolar disease (mania). Filing for this indication is scheduled for 1Q 2003 in the US and Europe.
Promising results for SYMBICORT in the treatment of chronic obstructive pulmonary disease (COPD) (a $2.9 billion global market) were announced, supporting the filing submitted to the EU earlier in 2002.
Additional significant line extensions are planned for FASLODEX, IRESSA, EXANTA, ATACAND, SEROQUEL and CRESTOR.
New Cancer Therapies
Further information was provided on new cancer therapies that target tumour growth mechanisms:
New Cardiovacular Therapies
Phase II data has been generated with GALIDA (AZ242), a new treatment for type II diabetes.
AZD6140, an anti-platelet approach to prevent blood clots (which can lead to heart attacks and strokes) is currently in phase I development.
AZD7009, a new treatment for atrial fibrillation, is also now in phase I development.
New CNS/Pain Therapies
Phase III clinical trials for NXY-059, a novel neuroprotectant for acute stroke, will commence in early 2003.
Encouraging clinical data was presented on AZD3582, the first Cox Inhibiting Nitric Oxide Donator (CINOD) for pain control, further demonstrating its attractive efficacy and side effect profile, versus COX-2 selective NSAID’s.
The full AstraZeneca development pipeline update is attached.
Drug Discovery Enhancements
Candidate drug (CD) delivery has increased by 20 per cent in the last three years - one quality CD is now entering preclinical development each month.
The number of CD’s that have progressed to clinical development has doubled this year.
To increase the likelihood that CD’s will progress through late-stage development to market, AstraZeneca is:
200 new collaborations with leading academic centres and biotech companies have been initiated in 2002, supporting AstraZeneca’s drug discovery strategy.
Tom McKillop, Chief Executive, AstraZeneca, said:
“The transformation of AstraZeneca's product portfolio continues apace with today’s significant news of CRESTOR's first approval in Europe; progress with other late stage development projects; and the announcement of a raft of exciting new compounds in early development. A changing external environment and the rapid adoption of new technologies are combining to provide new challenges for the pharmaceutical industry, but they will also bring new opportunities. We are driving productivity not only in R&D, but also in our overall business—bringing forward new indications for our key growth products and enhancing our sales forces effectiveness. By operating in a creative, fast and efficient manner, I am confident that AstraZeneca will continue to deliver important new medicines and deliver top-tier financial performance.”
Jan Lundberg, Executive Vice President, Head of Global Discovery Research, in an overview of the company’s discovery strategy said:
“With the research environment increasingly focused on finding disease relevant mechanisms combined with a plethora of fantastic new technologies, AstraZeneca is working as one global team to improve the predictability of drug discovery. We are introducing elements of clinical development in the earliest stages of our activities to make our research as relevant to man as possible, and using the latest technology for the early identification of projects unlikely to succeed in development. These actions will result in a much better ratio of CD’s reaching the market. AstraZeneca has already been able to deliver a fruitful pipeline that is admired across the industry, and we will continue to populate that pipeline with novel quality compounds to provide added value and benefits to patients worldwide, faster than ever before.”
Martin Nicklasson, Executive Vice President, Head of Clinical Development, in an overview of the AstraZeneca portfolio said:
“AstraZeneca’s key growth products have delivered strong business performances in the past year, and will continue to as their indications are broadened through aggressive life-cycle management programmes. Underpinning an already impressive portfolio of products in our key therapeutic areas, we are happy to announce the progression of several promising early-stage research projects including NXY-059, a novel neuroprotectant agent for stroke, GALIDA, a new treatment for type II diabetes and lipid disorders, and our CINOD, AZD3582, a new treatment for pain. These projects along with a score of others will ensure the future success of AstraZeneca as a global leader in pharmaceutical research and development.”
For copies of the presentations from today’s annual business review, please visit www.AstraZeneca.com.
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties 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. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2001.
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Steve Brown (London) +44 (0)20 7304 5033
Emily Denney (London) +44 (0)20 7304 5034
Steffan Ternby (Sodertalje) +46 (8) 553 26107
Rachel Bloom (Wilmington) (302) 886 7858
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Mina Blair-Robinson (London) +44 (0)20 7304 5084
Jonathan Hunt (London) +44 (0)20 7304 5087
Steffan Ternby (Sodertalje) +46 (8) 553 26107
Ed Seage (Wilmington) (302) 886 4065
Jorgen Winroth (New York) (212) 581 8720
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- The following brand names are trade marks of AstraZeneca group of companies : ARIMIDEX, ATACAND, CASODEX, CRESTOR, EXANTA, FASLODEX, GALIDA, IRESSA, NEXIUM, SYMBICORT and SEROQUEL.
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