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20 December 2001
AstraZeneca and Lilly Collaborate on Clinical Trial Programmes To Study IRESSA™ (ZD1839) In Combination With Gemzar® (Gemcitabine) For the Treatment of Various Cancers

AstraZeneca and Eli Lilly Company today announced their clinical collaboration to evaluate the benefits of IRESSA™ (ZD1839) in combination with Gemzar® (gemcitabine) for the treatment of various cancers. The clinical collaboration, which will be jointly funded by both companies, will initially assess the combination of the two treatments as part of a Phase II clinical trial programme involving patients with advanced stage non-small cell lung cancer (NSCLC) and bladder cancer. The companies also plan to extend their collaboration to a clinical trial programme which will evaluate the combination of IRESSA and Gemzar in the treatment of various cancers, including breast and ovarian cancers. The clinical collaboration supplements an ongoing Phase III clinical trial, which is investigating the benefits of IRESSA in combination with Gemzar and cisplatin in NSCLC.

“As a leading company in this area, we have been committed to cancer research for over 20 years and we are encouraged by the clinical progress made with IRESSA. It is anticipated that our collaboration with Lilly will expand the options available to cancer patients and will enable us to further assess the potential role of IRESSA as a valuable new treatment. The combination with Gemzar marks an important step towards achieving this,” said Dr George Blackledge, Medical Vice-President, Oncology, at AstraZeneca.

“At Lilly, we are interested in providing answers to patients with a wide variety of cancers. By collaborating with AstraZeneca on clinical trials testing their new targeted therapy with Gemzar, a standard of care in the treatment of pancreas, bladder and non-small cell lung cancers, we hope we can provide better treatment options for cancer patients,” said Alfonso Zulueta, President Oncology and Critical Care Product Group at Lilly.

About IRESSA

IRESSA is a once daily, orally active, selective EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor), which targets and blocks the activity of the EGFR-TK – an enzyme that regulates intracellular signalling pathways implicated in cancer cell proliferation and survival.

Pivotal Phase II data demonstrate that IRESSA treatment leads to objective response or disease stabilisation in patients with (NSCLC) who had failed on previous treatments.  [1] Importantly, the results were achieved without the accompanying heavy side effect burden typically seen with lung cancer therapies. IRESSA is currently in Phase III studies for the treatment of NSCLC and results from these important trials are expected next year. Since receptors for EGF play a major role in the biology of cancer cells in many solid tumours, IRESSA offers potential for the treatment of a broad range of common solid malignancies and has also entered Phase II clinical trials in a variety of tumours including breast, colorectal, gastric and hormone refractory prostate cancers. IRESSA is not currently licensed in any country world-wide.

About Gemzar

Gemzar is a nucleoside analogue that interferes with the processes of DNA production; by doing so, Gemzar prevents cancer cells from replicating and thus slows or stops tumour growth. Gemzar is approved in 92 countries and is the standard of care worldwide for pancreatic cancer. In most European countries, Gemzar has been approved as a single agent or in combination with cisplatin for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemzar has also been approved in dozens of countries for the treatment of locally advanced or metastatic bladder cancer, and has emerged as a standard of care in treating this disease.

In the United States, Gemzar has been approved for the treatment of locally advanced or metastatic pancreatic cancer since 1996 and, in combination with cisplatin, for the treatment of locally advanced or metastatic (NSCLC) since 1998.

Clinical trials are currently underway to evaluate Gemzar in the treatment of breast, ovarian, colorectal, non-hodgkin’s lymphoma and other cancers. The global cancer-research community has made this novel molecule among the most widely studied oncology agents in recent years. There are currently hundreds of studies underway around the world.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. Additional information about AstraZeneca is available at www.astrazeneca.com

About Lilly

Lilly (NYSE:LLY), a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaboration with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com

Reference:

Further enquires to:

AstraZeneca

Steve Brown
+44 (0)20 7304 5033

Louise Marland
+44 (0) 1625 510782


Lilly

Doyia Chadwick (Lilly Global)
+1 317 433 9271

Judy Kay Moore (Lilly US)
+1 317 277 6265


Note to News Editors:

  • ·AstraZeneca expects to launch IRESSA in the US from the middle of next year (2002).
  • ·Please visit the World Wide Web for further press information regarding IRESSA and other AstraZeneca cancer therapies at www.cancerpressoffice.com.
  • ·Please visit the World Wide Web for the information on Epidermal growth factor receptors (EGFR) and their potential role in the treatment of cancer at www.EGFR-INFO.com.
  • ·Please visit the World Wide Web for information on Gemzar at www.gemzar.com.


[1] Baselga J. et al. Initial results from a Phase II trial of ZD1839 (IRESSA) as second- and third-line monotherapy for patients with advanced non-small cell lung cancer (IDEAL I). 12th AACR-NCI-EORTC International Conference on ‘Molecular Targets and Cancer Therapeutics’. Miami, 2001


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