7th Dec 2007 10:00
AstraZeneca PLC07 December 2007 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 theheadquarters 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 leadersfrom MedImmune will present the Company's highly developed capabilities inantibody and vaccine discovery, development, production and commercialisationwithin the broader context of AstraZeneca's R&D activities. "Building a major international presence in the research, development andcommercialisation of biologics to complement our small molecule capabilities iskey to our sustained success," said David Brennan, Chief Executive Officer ofAstraZeneca. "The consolidation of all our biologics capabilities fromAstraZeneca, Cambridge Antibody Technology (CAT) and MedImmune into one unitimmediately creates one of the world's largest biologics pipelines andestablishes us as a leader in biotechnology among our pharmaceutical peers." As part of the event, David Mott, President and Chief Executive Officer of thenewly combined organisation that will continue to operate under the MedImmunename, will discuss AstraZeneca's biologics ambitions and vision and describe howMedImmune will be operationally independent but strategically aligned within theAstraZeneca group. "In MedImmune, AstraZeneca has a world-class biologics organisation withend-to-end capabilities from discovery through commercialisation," said Mr.Mott. "Since coming into AstraZeneca, we have strategically and operationallyintegrated the former Cambridge Antibody Technology group and other biologicsactivity within AstraZeneca. We have brought AstraZeneca's two pre-existingbiologics locations and approximately 300 more people under the MedImmuneumbrella to address unmet therapeutic needs within the central nervous,gastrointestinal and cardiovascular systems, in addition to our historical focuson the areas of infectious disease, inflammatory disease and cancer. As aresult, our biologics pipeline now has more than doubled in size to containapproximately 100 research projects and more than a dozen clinical productcandidates. We also have a stronger and more diverse discovery engine withaccess to a wider range of cutting-edge technologies. "Thanks to these new capabilities," Mr Mott continued, "we have also increasedour productivity targets, including having at least three new drug candidates inpivotal trials by 2010 and, at steady state, targeting an average of sixinvestigational 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 antiviralsand antibacterials. In MedImmune, AstraZeneca has established a significanttechnology base in monoclonal antibodies (MAbs) and vaccines, which maycontribute to important new solutions for the prevention and treatment ofinfectious diseases. While MedImmune's respiratory syncytial virus (RSV) franchise has been anchoredby the success of Synagis(R) (palivizumab), MedImmune is rapidly evolving itsRSV-prevention efforts through significant clinical developments for its latestanti-RSV drug candidate, motavizumab. Today, MedImmune physicians will describefindings from a pivotal Phase III trial of motavizumab, which is expected to befiled under a biologics license application (BLA) to the U.S. Food & DrugAdministration (FDA) in early 2008. MedImmune presenters will also highlightadditional RSV programmes, including RSV vaccine candidates and anext-generation anti-RSV MAb candidate that could follow motavizumab. Expanding on its product development experience with FluMist(R) (Influenza VirusVaccine Live, Intranasal), MedImmune also will outline its efforts to bring avaccine to market to help prevent pandemic influenza. MedImmune is currentlyengaged in dialogue with the U.S. government, the World Health Organisation andothers around the world on how it can help prepare for a potential pandemiccrisis. MedImmune currently plans to file an application for FluMist with the EuropeanAgency for the Evaluation of Medicinal Products (EMEA) in 2008. The companyintends to take maximum advantage of AstraZeneca's global platform tocommercialise FluMist across the world. Respiratory and Inflammatory Diseases: Today, MedImmune scientists will describe multiple programmes currently underwayto develop targeted treatments for a variety of respiratory and inflammatorydiseases. An important area of focus for MedImmune is the potential control ofasthma symptoms. MedImmune has a number of programmes evaluating this diseasestate including ongoing Phase I and II trials studying MAbs targeting theinterleukin-5 receptor (IL-5R) and interleukin-9 (IL-9) respectively; and aplanned Phase II trial studying a MAb targeting interleukin-13 (IL-13) inpatients with severe asthma. MedImmune will also highlight data from a Phase I study assessing the safety andefficacy of an anti-interferon-alpha treatment, which showed consistent evidenceof clinical activity across multiple measures of disease in patients withmild-to-moderate systemic lupus erythematosus. Furthermore, a Phase I clinicaltrial for a MAb targeting the alpha subunit of the granulocyte-macrophage colonystimulating factor receptor (GM-CSFR) is underway. The study, designed toevaluate the safety and tolerability of single doses of this MAb in patientswith rheumatoid arthritis, is the first clinical trial in which a MAb targetingthis receptor is being investigated in this patient population. Oncology: Traditionally a very strong growth area for biologics, MedImmune anticipatesdeveloping new cancer treatments using biological approaches with highly definedmolecular targets for patient populations with unmet medical needs. TodayMedImmune will describe numerous oncology trials that are underway and/orplanned, including those for IPI-504, MedImmune's partnered drug candidatedesigned to inhibit heat shock protein 90 (Hsp90). Hsp90 is an emerging cancertarget, which is currently being evaluated as a potential treatment for threesolid tumour indications. MedImmune will also discuss new data from an ongoing Phase I clinical trial ofMEDI-538 (also known as MT103) in patients with late-stage non-Hodgkin'slymphoma. MEDI-538 is a recombinant single-chain bispecific T-cell engager, orBiTE(R), molecule targeting the CD19 antigen. This candidate drug is the onlyBiTE molecule in clinical trials, and is currently in Phase I and II clinicaldevelopment for the treatment of various B-cell malignancies. In addition,MedImmune will also discuss its anti-CD22 programme in Phase I development forcertain leukemias and lymphomas. Also expected in the next 24 months are Phase Itrials of biologics candidates targeting: PDGFR-alpha, IGF, EphA2, CD19 and CEA. Commercialisation: Supporting this strong pipeline is MedImmune's rich body of knowledge inbiologics process and analytical development. In this area, MedImmune is led bya seasoned work force with experience in helping to select and optimise drugcandidates from product inception through commercialisation. As part of thisprocess, MedImmune investigates new pathways to disease and produces targeted,novel therapeutic interventions. In addition, MedImmune has integratedhigh-productivity antibody platforms, purification processes achieving some ofthe highest yields in the industry, and proven scale-up capabilities to meet theproduction demands of a diverse portfolio. Clinical production and analyticalcapability are focused on support for the rapidly advancing biologics portfolioat MedImmune. Mr Brennan concluded, "Through the acquisition of MedImmune, Inc. and thereorganisation of our existing biologics capabilities under the MedImmune brand,AstraZeneca has accelerated delivery of its biologics strategy while loweringits execution risk. I am confident that the business model we have created -with a strong reliance on balancing operational independence with strategiccollaboration - will enable us to deliver on the potential of one of the largestbiologics pipelines in the industry." 7 December 2007 Media Enquiries: Jamie Lacey +1 301 398 4035 Analyst & Investor Enquiries:Jonathan Hunt +44 (0) 207 304 5087Karl Hard +44 (0) 207 304 5322Ed Seage +1 302 886 4065Jorgen Winroth +1 212 579 0506Peter Vozzo + 1 301 398 4358 Notes To Editors Interviews with some of the presenters at the R&D day can be found at: http://www.astrazeneca.com/biologics Broadcast quality footage of AstraZeneca and MedImmune products, activities andfacilities is available from the Broadcast Centre at: http://www.thenewsmarket.com/astrazeneca Presentations from today's R&D day will be available to download at the start ofthe event at: http://www.astrazeneca.com/article/511711.aspx An up to date development pipeline can be downloaded from: http://www.astrazeneca.com/article/511390.aspx ABOUT SYNAGIS Synagis is the only MAb approved by the FDA to help prevent an infectiousdisease. Synagis is indicated for the prevention of serious lower respiratorytract disease caused by RSV in children at high risk of RSV disease. Synagis wasapproved for use in the United States in 1998, Europe in 1999, and Japan in2002. Synagis is currently available in 62 countries. Abbott has exclusiverights to Synagis in markets outside the United States. MedImmune promotesSynagis in the United States. Important Safety Information Globally, prescribing information varies; refer to the individual countryproduct label for complete information. For U.S. safety information, visithttp://www.medimmune.com/pdf/products/synagis_pi.pdf. Synagis is indicated for the prevention of serious lower respiratory tractdisease caused by RSV in paediatric patients at high risk of RSV disease and isadministered by intramuscular injection. Safety and efficacy were established ininfants with bronchopulmonary dysplasia (BPD), infants with a history ofpremature birth (less than or equal to 35 weeks gestational age), and childrenwith hemodynamically significant congenital heart disease (CHD). Synagis hasbeen used in more than one million children in the U.S. since its introductionin 1998. The first dose of Synagis should be administered prior to commencementof the RSV season. Patients, including those who develop an RSV infection,should continue to receive monthly doses throughout the season. Very rare cases (less than one per 100,000 patients) of anaphylaxis and rare(less than one per 1,000 patients) hypersensitivity reactions have been reportedwith Synagis. Cases of anaphylaxis were reported following re-exposure toSynagis and rare severe hypersensitivity reactions occurred on initial exposureor re-exposure. If a severe hypersensitivity reaction occurs, therapy withSynagis should be permanently discontinued. If milder hypersensitivity reactionoccurs, caution should be used on re-administration of Synagis. Inpost-marketing reports, very rare cases (less than one case per 100,000patients) of severe thrombocytopenia (platelet count less than 50,000/microliter) have been reported. In clinical trials, the most common adverse events occurring at least 1 percentmore frequently in Synagis-treated patients than controls were upper respiratoryinfection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seenin children with CHD. There have also been post-marketing reports of injectionsite reactions. About FluMist * FluMist is a live attenuated influenza virus vaccine indicated for activeimmunization of individuals two-to-49 years of age against influenza diseasecaused by influenza virus subtypes A and type B contained in the vaccine. FluMist is contraindicated in individuals with history of hypersensitivity toeggs, egg proteins, gentamicin, gelatin or arginine or with life-threateningreactions to previous influenza vaccinations, and in children and adolescentsreceiving concomitant aspirin or aspirin-containing therapy. Do not administer FluMist to children less than 24 months of age due to anincreased risk of hospitalisation and wheezing that was observed in clinicaltrials. FluMist should not be administered to any individual with asthma and tochildren less than five years of age with recurrent wheezing unless thepotential benefit outweighs the potential risk. Do not administer FluMist toindividuals with severe asthma or active wheezing. If Guillain-Barre syndrome has occurred with prior influenza vaccination or ifan individual is immunocompromised, the decision to give FluMist should be basedon careful consideration of the potential benefits and risks. FluMist shouldnot be administered to individuals with underlying medical conditionspredisposing them to wild-type influenza infection complications unless thepotential benefit outweighs the potential risk. FluMist should be given to apregnant woman only if clearly needed. Most common adverse reactions (occurring at greater than or equal to 10 percentin individuals receiving FluMist and at least five percent greater than inplacebo) are runny nose or nasal congestion in recipients of all ages, fevergreater than 100 degrees Fahrenheit in children two-to-six years of age, andsore throat in adults. FluMist may not protect all individuals receiving the vaccine. FluMist is forintranasal administration only. Please see complete prescribing information athttp://www.medimmune.com/pdf/products/flumist_pi.pdf. ABOUT MEDIMMUNE As one of the few biotech companies in the world to have a track record ofcommercial success and profitability, MedImmune has demonstrated its ability tobring innovative vaccines and biologics speciality products to market throughits 600-person commercial organisation in the United States. Over the lastdecade, MedImmune's revenues have grown at a compound annual rate of 36 percentfrom under $50 million in 1996 to almost $1.5 billion in 2006, thanks primarilyto MedImmune's blockbuster product, Synagis, which is the first and onlyrecombinantly produced MAb licensed by the FDA for prevention of an infectiousdisease. Approved now in more than 60 countries, Synagis is the standard of carefor helping to prevent RSV disease in infants and young children at high-riskfor RSV. MedImmune's vaccine franchise is anchored by FDA-approved FluMist, whichrepresents the first licensed advance in flu vaccine technology in more than 60years. The first nasal mist flu vaccine approved in the U.S., FluMist is partof a platform of technology around live, attenuated vaccines that have beendeveloped at MedImmune. In 2007, the FDA approved MedImmune's application toexpand the vaccine's label to include eligible children two to five years ofage, as well as a new refrigerated formulation of FluMist. The vaccine waspreviously approved by the FDA for use in children and adults five to 49 yearsof age and was stored as a frozen formulation.* MedImmune was also at the forefront of the work to develop a vaccine to preventcervical cancer caused by human papilloma virus (HPV). The company partneredwith GSK for the completion of the clinical development and thecommercialisation of the vaccine. In early 2005 the agreement was amended toallow Merck, which has also been developing an HPV vaccine, to be granted asublicense to MedImmune's intellectual property. As a result, MedImmunereceives milestone payments and royalties on HPV vaccines marketed by bothpharmaceutical companies. To complement its in-house discovery and research capabilities, MedImmune hasbeen among the most active biotech strategic players, having executed almost 40significant business development, licensing and acquisition-related transactionsbetween 2004 and 2007. MedImmune strives to provide better medicines to patients, new medical optionsfor physicians and rewarding careers to employees. With approximately 3,000employees worldwide and headquarters in Maryland, MedImmune is dedicated toadvancing science and medicine to help people live better lives and is whollyowned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visitMedImmune's website at http://www.medimmune.com. ABOUT ASTRAZENECA AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $26.47 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4 Good Index. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTSIn 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 research and development efforts within MedImmune, the biologicsorganization within AstraZeneca. By their nature, forward-looking statements andforecasts involve risk and uncertainty because they relate to events and dependon circumstances that will occur in the future. There are a number of factorsthat could cause actual results and developments to differ materially from thatexpressed or implied by these forward-looking statements. These factors include,among other things, the risk that research and development efforts will notyield new products that achieve commercial success; the loss or expiration ofpatents; difficulties in the manufacturing processes for biological products;the risk of delay to new product launches; and the difficulties of obtaining andmaintaining governmental approvals for products. For a more complete list ofrisks associated with the AstraZeneca businesses, please refer to theAstraZeneca filings with the Securities and Exchange Commission. TRADEMARKSMedImmune and Synagis are registered trademarks of MedImmune, Inc. and FluMistis a registered trademark of MedImmune Vaccines, Inc. Both MedImmune, Inc. andMedImmune Vaccines, Inc. are members of the AstraZeneca group of companies. BiTEis a registered trademark of Micromet, Inc. SYN07-203FLU07-213 - ENDS - This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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