PRESS RELEASE: AstraZeneca Presents its Global Biologics Organisation, MedImmune, at 2007 Analyst and Investor R&D Day

AstraZeneca Presents its Global Biologics Organisation, MedImmune, at 2007 Analyst and Investor R&D Day

AstraZeneca (AZN) today holds an R&D day for analysts and investors at the headquarters of its global biologics organisation, MedImmune, in Gaithersburg, Maryland, USA, to present its recently expanded world-class biologics expertise. At the meeting, which will run from 9:00 AM to 3:00 PM EST, senior leaders from MedImmune will present the Company’s highly developed capabilities in antibody and vaccine discovery, development, production and commercialisation within the broader context of AstraZeneca’s R&D activities.
"Building a major international presence in the research, development and commercialisation of biologics to complement our small molecule capabilities is key to our sustained success,” said David Brennan, Chief Executive Officer of AstraZeneca. “The consolidation of all our biologics capabilities from AstraZeneca, Cambridge Antibody Technology (CAT) and MedImmune into one unit immediately creates one of the world’s largest biologics pipelines and establishes us as a leader in biotechnology among our pharmaceutical peers.”

As part of the event, David Mott, President and Chief Executive Officer of the newly combined organisation that will continue to operate under the MedImmune name, will discuss AstraZeneca’s biologics ambitions and vision and describe how MedImmune will be operationally independent but strategically aligned within the AstraZeneca group.

“In MedImmune, AstraZeneca has a world-class biologics organisation with end-to-end capabilities from discovery through commercialisation,” said Mr. Mott. “Since coming into AstraZeneca, we have strategically and operationally integrated the former Cambridge Antibody Technology group and other biologics activity within AstraZeneca. We have brought AstraZeneca’s two pre-existing biologics locations and approximately 300 more people under the MedImmune umbrella to address unmet therapeutic needs within the central nervous, gastrointestinal and cardiovascular systems, in addition to our historical focus on the areas of infectious disease, inflammatory disease and cancer. As a result, our biologics pipeline now has more than doubled in size to contain approximately 100 research projects and more than a dozen clinical product candidates. We also have a stronger and more diverse discovery engine with access to a wider range of cutting-edge technologies.

“Thanks to these new capabilities,” Mr Mott continued, “we have also increased our productivity targets, including having at least three new drug candidates in pivotal trials by 2010 and, at steady state, targeting an average of six investigational new drug applications for submission per year.”

Progress in the following key therapeutic areas will be covered at the meeting:

Infectious Diseases:
AstraZeneca believes that biologics will provide novel approaches for antivirals and antibacterials. In MedImmune, AstraZeneca has established a significant technology base in monoclonal antibodies (MAbs) and vaccines, which may contribute to important new solutions for the prevention and treatment of infectious diseases.

While MedImmune’s respiratory syncytial virus (RSV) franchise has been anchored by the success of Synagis® (palivizumab), MedImmune is rapidly evolving its RSV-prevention efforts through significant clinical developments for its latest anti-RSV drug candidate, motavizumab. Today, MedImmune physicians will describe findings from a pivotal Phase III trial of motavizumab, which is expected to be filed under a biologics license application (BLA) to the U.S. Food & Drug Administration (FDA) in early 2008. MedImmune presenters will also highlight additional RSV programmes, including RSV vaccine candidates and a next-generation anti-RSV MAb candidate that could follow motavizumab.

Expanding on its product development experience with FluMist® (Influenza Virus Vaccine Live, Intranasal), MedImmune also will outline its efforts to bring a vaccine to market to help prevent pandemic influenza. MedImmune is currently engaged in dialogue with the U.S. government, the World Health Organisation and others around the world on how it can help prepare for a potential pandemic crisis.

MedImmune currently plans to file an application for FluMist with the European Agency for the Evaluation of Medicinal Products (EMEA) in 2008. The company intends to take maximum advantage of AstraZeneca’s global platform to commercialise FluMist across the world.

Respiratory and Inflammatory Diseases:
Today, MedImmune scientists will describe multiple programmes currently underway to develop targeted treatments for a variety of respiratory and inflammatory diseases. An important area of focus for MedImmune is the potential control of asthma symptoms. MedImmune has a number of programmes evaluating this disease state including ongoing Phase I and II trials studying MAbs targeting the interleukin-5 (IL-5) and interleukin-9 (IL-9) receptor respectively; and a planned Phase II trial studying a MAb targeting interleukin-13 (IL-13) in patients with severe asthma.

MedImmune will also highlight data from a Phase I study assessing the safety and efficacy of an anti-interferon-alpha treatment, which showed consistent evidence of clinical activity across multiple measures of disease in patients with mild-to-moderate systemic lupus erythematosus. Furthermore, a Phase I clinical trial for a MAb targeting the alpha subunit of the granulocyte-macrophage colony stimulating factor receptor (GM-CSFR) is underway. The study, designed to evaluate the safety and tolerability of single doses of this MAb in patients with rheumatoid arthritis, is the first clinical trial in which a MAb targeting this receptor is being investigated in this patient population.

Traditionally a very strong growth area for biologics, MedImmune anticipates developing new cancer treatments using biological approaches with highly defined molecular targets for patient populations with unmet medical needs. Today MedImmune will describe numerous oncology trials that are underway and/or planned, including those for IPI-504, MedImmune’s partnered drug candidate designed to inhibit heat shock protein 90 (Hsp90). Hsp90 is an emerging cancer target, which is currently being evaluated as a potential treatment for three solid tumour indications.

MedImmune will also discuss new data from an ongoing Phase I clinical trial of MEDI-538 (also known as MT103) in patients with late-stage non-Hodgkin’s lymphoma. MEDI-538 is a recombinant single-chain bispecific T-cell engager, or BiTEâ, molecule targeting the CD19 antigen. This candidate drug is the only BiTE molecule in clinical trials, and is currently in Phase I and II clinical development for the treatment of various B-cell malignancies. In addition, MedImmune will also discuss its anti-CD22 programme in Phase I development for certain leukemias and lymphomas. Also expected in the next 24 months are Phase I trials of biologics candidates targeting: PDGFR-alpha, IGF, EphA2, CD19 and CEA.

Supporting this strong pipeline is MedImmune's rich body of knowledge in biologics process and analytical development. In this area, MedImmune is led by a seasoned work force with experience in helping to select and optimise drug candidates from product inception through commercialisation. As part of this process, MedImmune investigates new pathways to disease and produces targeted, novel therapeutic interventions. In addition, MedImmune has integrated high-productivity antibody platforms, purification processes achieving some of the highest yields in the industry, and proven scale-up capabilities to meet the production demands of a diverse portfolio. Clinical production and analytical capability are focused on support for the rapidly advancing biologics portfolio at MedImmune.

Mr Brennan concluded, “Through the acquisition of MedImmune, Inc. and the reorganisation of our existing biologics capabilities under the MedImmune brand, AstraZeneca has accelerated delivery of its biologics strategy while lowering its execution risk. I am confident that the business model we have created — with a strong reliance on balancing operational independence with strategic collaboration — will enable us to deliver on the potential of one of the largest biologics pipelines in the industry.”