Background

“Biologics” are complex medicines that are reviewed and approved by the U.S. Food & Drug Agency (FDA) under the provisions of the Public Health Service Act (PHSA) for use in the United States. The “biological standard” for approval requires demonstration that a biologic is “pure, potent, and safe” and that its manufacturing facility is designed to assure the product continues to be pure, potent, and safe. The recent passage of the Patient Protection and Affordable Care Act (PPACA) established a foundation for biosimilars to enter the U.S. marketplace. While the PPACA created a general framework, the law also provides FDA authority to establish rules and guidance that will govern the specific requirements and procedures for reviewing and approving biosimilars.

The terms “biosimilars” (also called “follow-on biologics”) refer to products that are intended to copy previously-approved, innovator biologics and are submitted for approval based on similarity to the innovator product. Biosimilars are fundamentally different from small molecule generic drugs, which are virtually identical versions of innovator products and can readily be characterized by comparison of the exact chemical composition to the innovator product. As such, even without clinical trials to show safety and efficacy, generic drugs are usually designated to be “therapeutically equivalent” with the innovator drug and therefore interchangeable under FDA generic regulations. Conversely, while a biosimilar may be similar to an innovator product, it currently cannot be proven to be identical based on the current state of science. Thus, there are unique and inherent characteristics of biologics that must be considered as FDA establishes a regulatory pathway for biosimilars:

• Biologics are manufactured using live cells and biologics, such as monoclonal antibodies manufactured by MedImmune, are larger and more complex than small molecule drugs.
• Biologics are more difficult to characterize using laboratory techniques and have a more complex manufacturing process.
• Every biologic is different – even slight differences between biosimilars and innovator biologics, including their manufacturing processes, can result in meaningful differences in the safety and efficacy profile of the products.

What we believe

We support a regulatory pathway for biosimilars that is based on patient safety, product efficacy and continued incentives for innovator companies to invest in the development of novel, life-changing biologic medicines. We believe a biosimilars pathway should ensure:

• Appropriate rigorous scientific standards and a robust regulatory review process;
• A determination that biosimilars demonstrate the purity, potency and safety of innovator biologics as proven through human clinical trials and post-market surveillance; and
• Implementation of effective innovator regulatory exclusivity and patent enforcement provisions.

Below is a detailed look at our position:

Patient Safety
Because of the complexities of biologics, we believe that patient safety must be paramount when evaluating the approval of biosimilars. The introduction of biosimilars into the marketplace must ensure the current purity, potency, and safety standards established for innovator products by FDA. In addition, because the manufacturing process can have a significant impact on a biologic’s structure and activity, a regulatory pathway should ensure a rigorous inspection and control process for the manufacture of biosimilars that is similar to the innovator product standards

Clinical Trials
We believe that all biosimilars applicants should be required to conduct clinical trials that demonstrate sufficiently similar product safety, efficacy and immunogenicity relative to the innovator product. Non-clinical methods of characterizing complex biotechnology drugs have not matured to the point where they can substitute for clinical studies. Therefore, to ensure patient safety, it is essential for biosimilar sponsors to demonstrate product safety and efficacy by testing their product in adequate and well-controlled clinical studies. Furthermore, immunogenicity testing in human subjects, an integral part of biologics drug development, is critical to help measure potential adverse immune response to the biosimilar product. Immunogenicity has been associated with allergic or anaphylactic reactions, as well as reduction in efficacy or autoimmunity. We believe the FDA should issue molecule-by-molecule guidance for clinical trials required for biosimilars to account for the particular characteristics of the product.

Post-Market Risk Management Programs
We believe that biosimilars, once approved, should have FDA-approved risk management plans to ensure the products are rigorously monitored for post-market safety and immunogenicity. If biosimilars are approved with less clinical data than innovator biologics, the FDA should ensure that longer-term post-marketing outcomes for biosimilars remain similar to those with the innovator product.

Interchangeability/Substitution
We do not support interchangeability between an innovator biologic and a biosimilar product. Current regulations allow small molecule generic drugs to be designated as “therapeutically equivalent” and dispensed interchangeably with innovator products without physician’s knowledge. Because biosimilars are not identical to innovator biologics, they should not be deemed therapeutically equivalent and dispensed interchangeably for innovator biologics absent clinical trials that adequately demonstrate such interchangeability.

Unique Naming and Product Identification
Because biosimilars are similar to innovator biologics (rather than identical), we believe biosimilars should have a unique common name to distinguish themselves for prescribing, dispensing and pharmacovigilance purposes. In the interest of patient safety, it is critical that any adverse events be accurately traced to the actual product administered so that the manufacturer can take immediate remedial actions.

Patent Rights
Strong patent protection is the cornerstone of preserving incentive for biologics innovation, and a biosimilars approval pathway must establish a fair, transparent and effective system for all parties to quickly resolve any patent disputes.

Incentives for Innovation
Because biologics generally have substantial research, development and manufacturing periods and costs, a significant period of non-patent data exclusivity for innovator biologics must be provided to maintain an environment that fosters discovery of new and innovative biotechnology therapies. Although patent protection is important, this alone may be insufficient to protect the substantial investment made by innovators. For example, a biosimilar may be similar enough to an innovator biologic to receive regulatory approval, but different enough to circumvent the innovator’s patents. We support the provisions in PPACA that provides a base 12-year period of data exclusivity for innovator biologics plus an additional 6 months for pediatric studies.

Next Generation Improved Biologics
We support measures that protect investment in improvements to innovator biologics through extension of data exclusivity and intellectual property protections. This will help encourage continued investment and discovery of enhanced versions of previously-approved biologics that are safer, more effective, easier to administer and more capable of meeting patient needs. Modifications such as changes in amino acid sequences involve fundamental changes to a biologic’s molecular structure, and generally require clinical trials to gain regulatory approval. The vital, step-by-step process for advancing these medicines is dependent upon continued incentives for next generation biologics.

Conclusion
As new, innovative biologics and biosimilars enter the marketplace, AstraZeneca and MedImmune believe patient safety and product efficacy are of utmost importance. As a result, we support the development of a regulatory pathway for biosimilars that is based on patient safety, product efficacy and incentives for innovation. We will continue to monitor policy discussions and proposed regulations as the FDA moves forward in establishing a biosimilars pathway, and share our expertise and views where appropriate.

Download POSITION ON BIOSIMILARS (PDF, 34KB)

“MedImmune is dedicated to conducting ground-breaking research on the prevention of respiratory syncytial virus (RSV) and influenza in children,” said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. “We believe the data being presented at the conference may help advance innovative healthcare solutions for these important causes of respiratory infections in children.”

MedImmune abstracts to be presented at IDSA on RSV include:

• Prophylaxis Utilizing Nebulized Motavizumab, a Monoclonal Antibody Against Fusion Protein of Respiratory Syncytial Virus (RSV) Zhang J, et al. Poster Session: October 30, 2009; 12:30 – 2:00 PM; Poster Hall A / Poster # 608

BACKGROUND: Respiratory syncytial virus (RSV) infection is the primary cause of pneumonia and bronchiolitis in young children, and also causes disease in older adults. This study evaluated the prophylactic use of nebulized motavizumab, an investigational anti-RSV humanized monoclonal antibody against RSV fusion protein, in cotton rats. The findings suggest that prophylaxis with nebulized motavizumab may inhibit RSV infection and spread in the lungs and may provide an alternative to the current intramuscular antibody delivery.

MedImmune abstracts to be presented at IDSA on influenza include:

• A Postmarketing Evaluation of the Frequency of Use and Safety of Live Attenuated Influenza Vaccine Use in Unapproved Children Less Than 59 Months of Age Tennis P, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1179

BACKGROUND: In September 2007, the approval of live attenuated influenza vaccine (LAIV) was expanded for use in children between 24 and 59 months in age. The vaccine was not approved for use in children younger than 24 months, or for use in children with asthma or recurrent wheezing, or those with altered immunocompetence. This study evaluates the usage and safety of the vaccine in those patient populations younger than 59 months of age that were not in the approved indication. The study found that healthcare providers appear to be complying with the indications for the use of LAIV in children <5 years, and no adverse safety outcomes were detected in the small number of children in unapproved groups who received the vaccine.

• Whole Genome Transcriptional Analysis of the Early Immune Responses Induced by Live Attenuated and Inactivated Influenza Vaccines in Young Children Zhu W, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1181

BACKGROUND: This study examined the early genomic immune response to live attenuated and inactivated vaccines in previously unvaccinated children 12 to 35 months of age. Among LAIV recipients, an increase in interferon (a natural anti-viral immune protein) production was seen, which may partly explain previous clinical study observations of LAIV-induced protection against illness in the first 2 weeks after administration.

• Influenza-Associated Antibiotic Use in Children Receiving Live Attenuated Influenza Vaccine Compared With Inactivated Influenza Vaccine Belshe R, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1180

BACKGROUND: Influenza illness in children commonly results in the unnecessary use of prescription antibiotics. This analysis evaluated the efficacy of live attenuated influenza vaccine (LAIV) and trivalent inactivated influenza vaccine (TIV) in preventing antibiotic use in children ranging from six months to 17 years in age. Overall, there was less influenza-associated antibiotic use in LAIV recipients due to a lower rate of culture-confirmed influenza with LAIV.

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Additional information about the 2009 IDSA conference can be found at http://www.idsociety.org/IDSA2009.htm.

About FluMist®

FluMist® (Influenza Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.medimmune.com/pdf/products/flumist_pi.pdf for additional information.

About MedImmune, Inc.

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, MedImmune aims to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

Background

Most state Medicaid drug reimbursement formulas are “one size fits all” in that they do not distinguish between biologics and chemical-based pharmaceuticals, nor do they fully recognize the extensive level of support services needed for patients using biologics. It is critical that states change this approach and recognize the unique nature of biologics and implement separate reimbursement mechanisms for biologics, since any reduction in reimbursement for biologics under existing Medicaid reimbursement formulas may result in inadequate compensation for patient support services and thereby reduce patient access to biologics; decrease the number of participating specialty distributor providers; and ultimately, increase costs to the state due to patients’ failure to obtain all necessary prescribed therapies.

Biotechnology drugs, or biologics, offer new hope to patients by providing novel therapies to treat unmet medical needs and debilitating health conditions. Biologics are complex medicines that are markedly different than most traditional chemistry-based pharmaceutical drugs in how they are developed, manufactured, stored, delivered and administered.

• Biologics consist of large, protein-based molecules that are manufactured using living organisms, and as such, are far more complex to produce than small molecule products.
• Biologics are generally prescribed by physician specialists (e.g., oncologists, rheumatologists, dermatologists, pediatricians, etc.) and historically target hard-to-treat diseases for which there are few, if any, effective therapeutic or preventive options.
• Biologics are most commonly administered via injection or infusion.
• Biologics are usually shipped by specialty distributors directly to the healthcare provider to ensure the proper storage and handling (referred to as maintaining proper “cold chain”) from manufacturer to the end user.
• Biologics require a variety of critical support services (often provided by the specialty distributors) to help ensure successful patient outcomes, including:
  • coordination of the drug’s delivery with scheduled patients’ visits to the provider;
  • patient tracking services (requiring compilation of data from several sources) to ensure patients receive follow-up doses as prescribed;
  • patient counseling and compliance education; and
  • educational services and product information for healthcare providers and office staff.

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Policy Position Current on October 1, 2009

Download POSITION ON STATE MEDICAID DRUG REIMBURSEMENT FOR BIOLOGICS (PDF, 30.4KB)

MedImmune Announces Influenza Vaccination Awareness Campaign with Women’s Professional Soccer

GAITHERSBURG, Md., July 28 /PRNewswire/ — MedImmune announced today that it has begun shipping its seasonal influenza vaccine FluMist (Influenza Vaccine Live, Intranasal) to vaccine distributors who service health care providers throughout the United States. MedImmune expects approximately 10 million doses of its trivalent (three-strain) nasal spray flu vaccine will be available for the 2009-2010 influenza season through a variety of private health care practices, public health departments, school-based vaccination programs, military bases, and other locations.

The U.S. Centers for Disease Control and Prevention (CDC) and American Academy of Pediatrics advise that flu vaccine be administered every year as soon as it becomes available. A MedImmune analysis suggests that starting influenza vaccination in August instead of October may help reach an additional 11.5 million children at already-scheduled healthcare provider visits.

The 2009-2010 influenza season is the first for full implementation of the recommendations by the CDC’s Advisory Committee on Immunization Practices (ACIP) that children six months through the age of 18 years be vaccinated annually against influenza, meaning 30 million additional children 5 through 18 years of age now fall within influenza vaccination recommendations.

“MedImmune is committed to delivering our seasonal nasal spray influenza vaccine in the summer months in order to increase opportunities for vaccination,” said Alex Zukiwski, MD, MedImmune’s Executive Vice President, Clinical Research & Chief Medical Officer. “If more eligible children can be vaccinated against seasonal influenza while attending back-to-school checkups, sports physicals, and clinics early in the school year, the country will be better prepared for the flu season ahead.”

FluMist is available in every state through the federally funded Vaccines for Children (VFC) program, which provides vaccines at no cost to eligible children. FluMist is also covered by approximately 95 percent of private health plans which offer immunization benefits.

FluMist Becomes Sponsor of Women’s Professional Soccer

To help communicate the importance of seasonal flu vaccination efforts, MedImmune has teamed up with Women’s Professional Soccer (WPS) for “Don’t Play with the Flu”(TM) (www.dontplaywiththeflu.com), a national health awareness campaign with the goal of increasing seasonal flu vaccination rates among eligible kids and families across the country. As part of the multi-faceted campaign, FluMist has become an official sponsor of WPS, the world’s premier women’s professional soccer league, working with real-life soccer moms and the league to reach families during flu vaccination season, including back-to-school visits.

“Our ‘Don’t Play with the Flu’ efforts are directed toward parents to help them understand the importance of annual influenza vaccination and reminds them not to wait to put up a defense against the flu, particularly with seasonal vaccine becoming available during the summer,” said Peter Greenleaf, MedImmune’s Senior Vice President, Commercial Operations, Corporate Development & Strategy. “We’re proud to partner with the WPS in its inaugural season to bring this fun, educational and interactive campaign to the families across America.”

Important Safety and Eligibility information for FluMist

Who may be eligible for FluMist (Influenza Vaccine Live, Intranasal)?

FluMist is a vaccine approved for the prevention of certain types of influenza disease in children, adolescents and adults 2-49 years of age. FluMist may not protect everyone who gets it. FluMist is for intranasal administration only.

Who may not be able to get FluMist?

FluMist is not right for everyone. FluMist must not be given to: people with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine; people with life-threatening reactions to previous influenza vaccinations; and children and adolescents receiving aspirin or aspirin-containing therapy. Children less than 24 months of age are not eligible for FluMist.

The following people may not be able to get FluMist or may be able to get it only in certain situations: people with asthma or active wheezing, or children less than 5 years of age with recurrent wheezing; people with a history of Guillain-Barre syndrome; people with a weakened immune system; people with long-term medical conditions including heart disease, kidney disease, and metabolic diseases, such as diabetes; and pregnant women.

If your child falls into one of these groups, be sure to tell your healthcare provider. They will decide if FluMist is right for your child.

What are the most common side effects of FluMist?

Most common side effects included runny nose or nasal congestion, sore throat, and fever. For a full list of side effects, please see section 6.1 in the following product information.

Please see the complete product information.

For more information, please visit www.FluMist.com.

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

SOURCE MedImmune

CONTACT: Karen Lancaster of MedImmune, +1-301-398-5864, lancasterk@medimmune.com/

GAITHERSBURG, Md., June 1 /PRNewswire/ — MedImmune announced today that the U.S. Department of Health and Human Services (HHS) has awarded the company a contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders. This project has been funded in whole or in part with the Federal funds from HHS/ASPR/BARDA, under Contract No. HHSO100200900002I.

MedImmune scientists have identified several promising vaccine candidates against the Novel Influenza A (H1N1) strain, and are currently evaluating their growth properties and antigenicity (i.e., their ability to stimulate antibodies) for mass production as part of the vaccine manufacturing process.

“MedImmune is pleased to be able to contribute our scientific expertise in influenza vaccine development and manufacturing to help combat this unpredictable public health threat,” said Ben Machielse, Drs., executive vice president of operations, MedImmune. “We are confident that our vaccine technology has several attributes that may be useful in protecting people with limited exposure to influenza against the Novel Influenza A (H1N1) strain.”

MedImmune’s live attenuated influenza vaccine (LAIV) technology may be particularly well-suited for vaccinating against emerging influenza strains. LAIV is different from the injectable influenza vaccine (“flu shot”) in that it is a gentle mist sprayed into the nose, where the influenza virus usually enters the body. It contains live vaccine virus strains that are weakened so as not to cause the flu, but prompt the body to mount an immune response after the first dose. Because it is live and stimulates a broad range of immune responses, LAIV may offer some cross-protection against circulating flu strains that are “drifted” – meaning they are very closely-related but not perfectly matched to the flu strains in the vaccine.

As a needle-free nasal spray, LAIV is well suited to facilitate mass vaccination, and has been widely used for school-based vaccinations and to help protect active-duty military personnel.

While MedImmune is committed to supporting global efforts to help protect individuals against the Novel Influenza A (H1N1) virus, its vaccine technology is currently only licensed in the United States. MedImmune is willing to make additional vaccine available to other governments if any capacity remains after fulfilling obligations to the U.S. government, assuming that necessary regulatory approval can be obtained.

Seasonal FluMist(R) on Track to Begin Shipping in August

MedImmune believes that the best way to help protect all eligible age groups against seasonal influenza is to vaccinate prior to and during the back-to-school period. The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccination for all age groups as soon as seasonal vaccine is available each year. MedImmune plans to begin shipping the first of approximately 10 million doses of seasonal FluMist(R) (Influenza Virus Vaccine Live, Intranasal) to health care providers in August. This early availability of vaccine significantly widens the window of opportunity to vaccinate more eligible individuals and improve seasonal influenza vaccination rates, as patients seeing their providers for routine office visits can be vaccinated without waiting for the rush of fall vaccination clinics.

About Seasonal FluMist

FluMist(R) (Influenza Virus Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

The opinions expressed herein do not represent opinions or statements made or expressed by the U.S. Department of Health and Human Services.

http://www.medimmune.com

SOURCE MedImmune

CONTACT: Karen Lancaster of MedImmune, +1-301-398-5864

GAITHERSBURG, MD, May 5, 2009 — Data presented suggest that FluMist® (Influenza Vaccine Live, Intranasal) has an acceptable safety profile among mild to moderately immunocompromised children with cancer.   The immune systems of children with cancer can be weakened due to cancer treatments, making them vulnerable to influenza or other infections.   The small multi-center, randomized, double-blind pilot study compared FluMist to placebo in 20 children, five to 17 years of age.   The results, along with data from 10 other MedImmune-sponsored, influenza-related studies, were presented at the 2009 Pediatric Academic Societies (PAS) annual meeting in Baltimore, MD.

In our pilot study, immunocompromised children with cancer who received FluMist had no related serious adverse events, explained Pat Flynn M.D., director, clinical research, infectious diseases, St. Jude Children’s Research Hospital. We believe these data are promising and add to the extensive body of evidence supporting the overall safety of FluMist in the population for whom it is approved.   A larger study will help us confirm the safe use of FluMist in immunocomprised patients.     The value of this type of research is even more apparent today as we all consider how best to protect all of our patients against the threat of emerging, new influenza viruses.

FluMist, a live attenuated influenza vaccine (LAIV), is the only nasal spray influenza vaccine approved in the United States to help prevent influenza in eligible individuals ages two to 49 years of age.   (Please see About FluMist for important safety and eligibility information later in this release).

Additional studies presented at PAS explored various aspects of FluMist, including its efficacy as a function of age from six months to 17 years of age*, results with only a single dose in previously unvaccinated children, and data regarding influenza-related ear infections.   Research also evaluated the effect of FluMist against opposite-lineage influenza B strains.  Other research focused on influenza vaccination practices of U.S. pediatricians during the 2007 — 2009 flu seasons and the impact of respiratory illness in children on parent work absenteeism and productivity.  

In a time when influenza prevention is receiving so much attention, MedImmune is pleased to share a number of new studies and analyses with the medical community as we work together to help protect our children and families from influenza, said Chris Ambrose, M.D., senior director, medical affairs, MedImmune.

Brief summaries of the ten (10) MedImmune-sponsored abstracts presented at PAS are provided below.

LAIV Use in Children

• In an abstract that reviewed data from multiple randomized, controlled studies among children six months to 17 years of age, LAIV efficacy against culture-confirmed influenza did not vary with age.   Compared to placebo, LAIV had high efficacy and this efficacy did not vary among children 15 to 84 months of age.     LAIV had higher efficacy in children six months to 17 years of age compared to the traditional injectable vaccine.* (Belshe R, #5529.501)    
• In an analysis of three randomized, double-blind studies, a single dose of LAIV in previously unvaccinated children two to six years of age provided significant protection against culture-confirmed influenza compared to placebo.   These findings are significant because most children who are recommended to receive two doses of influenza vaccine only receive one dose. The efficacy of one LAIV dose was approximately 90 percent of the efficacy of two doses.   Efficacy after revaccination in year two with a single dose was comparable whether the child received one or two doses in the previous year.   (Block, #5529.505)
• Across eight randomized, controlled studies, LAIV reduced influenza-associated acute otitis media (AOM) — commonly referred to as an ear infection — caused by influenza strains matched to the vaccine by 73 percent to 98 percent.   These data suggest that FluMist has the potential to reduce the burden of AOM in young children with influenza.   (Block S, #5529.504)
• An analysis of LAIV efficacy against opposite-lineage influenza B strains, against which efficacy of all influenza vaccines has been believed to be low or zero, was conducted with data from six randomized, double-blind studies.   In young children, LAIV may provide some efficacy against opposite-lineage influenza B strains, but this efficacy is lower than efficacy against influenza B strains of the same lineage as the vaccine.     Based on these findings, study authors suggest that quadrivalent vaccines containing influenza B strains of both lineages should be considered.   (Belshe R, #4357.473)
• In an analysis of a previously conducted study that compared LAIV and injectable influenza vaccine in children six to 59 months of age* and found 51 percent  fewer cases of influenza illness among LAIV recipients compared to injectable vaccine recipients, the amount of viral RNA recovered from subjects with breakthrough influenza illness was analyzed.   No statistically significant differences were seen, and analysis of infectious virus by cell culture will gather additional data.(Belshe R, 5529.502)

      *LAIV is not approved for use in children under two years of age.  

Influenza Vaccination Practices of U.S. Pediatricians

• Four additional MedImmune-sponsored studies evaluated influenza vaccination practices among U.S. pediatricians, based on a prospective, observational study of pediatric offices during the 2007-2009 flu seasons.   The principal conclusions of the studies included the following:
• Pediatric influenza vaccination rates in pediatric offices may have increased in 2008-09 compared to the previous year, and LAIV represented approximately one-third of the vaccinations given to children two to 18 years of age during the 2008-2009 season (Bhatt P, #5529.499)
• Pediatricians may be able to vaccinate more children by offering flu vaccine to their patients before October and after December (Bhatt P, #5529.500)
• Pediatricians are supportive of vaccinating parents in their offices (Toback S, # 5529.498)
• Generally, pediatric offices have little influenza vaccine left-over at the end of the influenza season (Block S, #5529.503)

Increased Employee Absenteeism Seen Among Adults from Homes Where Kids Had Influenza-like-Illness

• A final MedImmune-sponsored study presented at PAS prospectively followed 2,298 households during the 2007-2008 influenza season. (Rousculp M, #3866.255)  
• The research found that employed adults had increased work absenteeism in homes where children had influenza-like illnesses, as well as other acute respiratory illnesses.
• The study’s authors conclude that employers should evaluate opportunities to reduce influenza-like illnesses and other acute respiratory illnesses in both the employee and employee’s children in order to maximize employee productivity.

About FluMist

FluMist® (Influenza Virus Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

NIJMEGEN, The Netherlands, January 6, 2009 — MedImmune, the global biologics unit of AstraZeneca, announced today that it has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). The proposed indication in the MAA is for prevention of seasonal influenza.

The MAA submission for LAIV is based on data from 73 global clinical and U.S. post-marketing studies of more than 141,000 subjects ranging in age from 7 weeks to 97 years and conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

Influenza creates a heavy medical and economic burden on Europe and throughout the world, and we are hopeful that the future availability and product characteristics of this novel nasal spray influenza vaccine will contribute to an increase in vaccination rates and reduce the spread of influenza around the world, said Alex Zukiwski, M.D., executive vice president, clinical affairs and chief medical officer. MedImmune is pleased to submit this application for approval of our nasal spray influenza vaccine in Europe.

About LAIV
Each dose of LAIV is formulated to contain three live attenuated influenza virus strains, which are weakened as to not cause illness: Two Type A influenza strains (A/H1N1 and A/H3N2) and one Type B strain. The vaccine strains are selected annually by the World Health Organization (WHO) based on anticipated circulating influenza strains for the upcoming season. The vaccine is sprayed into the nose, rather than by injection as with other licensed influenza vaccines, where it induces protective immunity.

In the U.S., LAIV is marketed under the trade name FluMist® (Influenza Virus Vaccine Live, Intranasal). It was approved by the U.S. Food and Drug Administration in 2003. The vaccine included in the MAA has not been registered in the European Union (EU) and is not available outside of the United States.

About Influenza
Influenza is the most common vaccine-preventable disease in the developed world. According to WHO estimates, seasonal influenza results in three to five million cases of severe illness and up to half a million deaths globally each year, primarily among the elderly. Rates of infection are highest among children, with school-aged children significantly contributing to spread of disease to their families, communities and high-risk individuals.

Influenza also has socioeconomic consequences related to both direct and indirect health care costs, including hospitalizations, work absence and loss of work productivity when either a caregiver or child is sick with influenza.

In the EU, current guidelines recommend annual influenza vaccination for the elderly as well as those with underlying medical conditions such as chronic heart or lung disease. However, vaccination rates in the recommended groups throughout Europe are estimated to be only 35 percent (Ryan, Vaccine, August 2006).

To date, six EU countries (Finland, Austria, Estonia, Latvia, Slovakia and Slovenia) recommend routinely vaccinating young children against influenza with varying age limits. EU and Member State policymakers continue to evaluate data on the impact of influenza in children to best inform the potential expansion of recommendations.

About MedImmune
MedImmune is a leading innovation-focused biotechnology company whose mission is to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide and is the wholly owned biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune’s website at http://www.medimmune.com.

Contacts
Media:
Chris Sampson, +44 (0)207 304 5130 (AstraZeneca)
Sarah Lindgreen, +44 (0)207 304 5033 (AstraZeneca)
Karen Lancaster, +1-301-398-5864 (MedImmune)

“MedImmune is committed to conducting innovative infectious disease research to determine how best to prevent serious illness that can negatively impact pediatric health, especially during this time of year,” said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. “We believe the data being presented at this meeting will help lead to important new healthcare solutions, and our company is proud to advance our already robust research base to identify the best ways to help protect children.”

MedImmune abstracts to be presented at ICAAC/IDSA on RSV include:

• Respiratory Syncytial Virus Therapy Utilizing Intranasally Delivered Motavizumab, a Monoclonal Antibody Against the Viral Fusion Protein (#V-4145) B. Richter, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: A primary cause of pneumonia and bronchiolitis in young children is RSV infection. This preclinical study examined the therapeutic effect of topically administered motavizumab.

• Therapeutic Addition of Motavizumab, a Monoclonal Antibody Against Respiratory Syncytial Virus, Modulates Epithelial Cell Responses to RSV Infection (#V-4146) S. Krishnan, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: RSV infection of epithelial cells leads to inflammatory host responses. This preclinical study tested whether motavizumab, a humanized monoclonal antibody against the RSV fusion (F) protein, could modulate epithelial cell immune responses to RSV. Lower and upper airway epithelial cells were infected with RSV and motavizumab or a control antibody was subsequently administered at various points post-infection to evaluate the therapeutic addition.

• Total Healthcare Costs of Preterm Infants with Medically Attended Respiratory Syncytial Virus Lower Respiratory Infection (#K-1429 ) D. Stewart, Sunday, October 26, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: While RSV lower respiratory infection (LRI) is the most common cause of hospitalization among infants under one year of age, the total healthcare costs of medically attended RSV LRI for babies of this age group is unknown. This retrospective, propensity-matched cohort assessment sought to determine first-year healthcare costs by examining premature infants born over a five-year period who were insured by a national U.S. health plan, including a subgroup analysis of babies born between 33 and 36 weeks gestation.

• In Vitro Mechanism of Action Studies of the RSV-Neutralizing Monoclonal Antibodies Palivizumab and Motavizumab (#V-4146) K. Huang, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: Synagis is the only licensed drug product available to help prevent lower respiratory tract RSV infection in premature infants, a leading cause of hospitalizations in this patient population. An affinity-optimized version of Synagis, motavizumab, has been subsequently developed. Since both Synagis and motavizumab bind the RSV fusion (F) protein, which plays a role in virus attachment and mediates the process of virus-cell fusion and cell-to-cell fusion, this study aimed to determine exactly how the drugs neutralize RSV. Four assays were used, which target four distinct steps during virus replication, to identify the mechanism.

• In Vitro and In Vivo Characterization of a Motavizumab-Resistant RSV A Mutant (#V-4148) F. J. Palmer-Hill, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: This study investigated the growth characteristics – both in vitro and in vivo – of an RSV mutant that was created in the laboratory and is resistant to neutralization by motavizumab, an affinity-optimized MAb directed against the RSV fusion (F) protein. The F protein of the MAb differs from a wild type RSV F protein, so comparisons were made.

• Characterization of Respiratory Syncytial Virus (RSV)Mutants Resistant to Antibody Neutralization with Novel Amino Acid Changes in the RSV Fusion Protein (#V-4149) N. K. Patel, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: Synagis is a MAb approved for the prevention of serious lower respiratory tract RSV infection in premature infants. Motavizumab was developed by affinity optimization of Synagis and is characterized by greater in vitro and in vivo neutralization activity against RSV. Previously, the selection of RSV mutants resistant to Synagis has been reported, characterized by amino acid changes in the RSV fusion (F) protein. This study sought to identify the selection and characterization of additional Synagis MAb-resistant mutants, as well as a novel motavizumab MAb-resistant mutant.

MedImmune abstracts to be presented at ICAAC/IDSA on influenza include:

• Influenza-like Illness and Employee Productivity – Results from the Child and Household Influenza-illness and Employee Function (CHIEF) (#K-4207) M. D. Rousculp, Tuesday, October 28, Room 150B from 2:450 PM to 3:00 PM

BACKGROUND: This prospective cohort study of nearly 2,293 U.S. households evaluated the effect of employee and household member influenza-like illness on worker productivity. The households studied were employees from three large Fortune 500 companies. All households included in the study had at least one child. Households were surveyed monthly throughout the 2007-2008 influenza season to determine the impact of influenza-like illness on employees’ work absenteeism and decreased productivity while on the job.

• Impact of Early and Late Influenza Vaccine Availability on In-Office Vaccination Opportunities (#G1-1208) R. Judelsohn, Sunday October 26, Hall C from 11:15 AM to 12:15 PM

BACKGROUND: The CDC now recommends all children from six months to 18 years of age receive an annual influenza vaccination; however, a key barrier to implementation is the inconvenience to parents and providers around scheduling additional office visits to administer the vaccination. This study examined how many more vaccination opportunities exist if influenza vaccination availability were expanded beyond the typical October-to-December timeframe.

• Benefits Versus Risks of Live Attenuated Influenza Vaccine (LAIV) in Young Children (#G1-1204) G. Oster, Sunday October 26, Hall C from 11:15 AM to 12:15 PM

BACKGROUND: In September 2007, approved use of LAIV in the U.S. was expanded to include children aged 24-59 months but with warning/precautions against use in younger children and children 24-59 months with a history of recurrent wheezing or asthma. Since some latter children may receive LAIV in clinical practice, its risks and benefits versus trivalent influenza vaccine (TIV) in this setting must be considered.

Additional information about the 2008 ICAAC/IDSA conference can be found at http://www.icaacidsa2008.org/.

About Synagis
Synagis(R) (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.

Synagis should not be used in patients with a history of severe prior reaction to Synagis or its components. Cases of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with Synagis. These reactions may occur when any dose of Synagis is given, not just the first one. Another serious side effect, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin, has been reported.

Most common side effects with Synagis may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Side effects, such as, skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) have also been reported.

Please see accompanying full prescribing information at http://www.synagis.com.

About FluMist
FluMist(R) (Influenza Virus Vaccine Live, Intranasal) is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune
MedImmune is a leading innovation-focused biotechnology company whose mission is to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/ gastrointestinal disease and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide and is the wholly owned biologics business for AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune’s website at http://www.medimmune.com.

Contacts:
Media: Tor Constantino, 301-398-5801
Investors: Peter Vozzo, 301-398-4358
http://www.medimmune.com

“As MedImmune prepares for the next phase of its corporate growth — including dramatic acceleration within its product portfolio, it is imperative that we have strong leadership at the helm of all aspects of our business, but particularly within the research, HR and regulatory affairs functions,” said David M. Mott, chief executive officer and president.

“Peter is now driving forward our global research efforts, which span from our core antibody research center in Maryland’s biotech corridor to our discovery and development center in Cambridge, UK to our vaccine research facilities in the San Francisco Bay area of California. Katy is ensuring that we have the right people — with the right skills — at the right time, which is critical for us to deliver on the promise of our pipeline. Eileen’s contributions will grow significantly with our maturing product portfolio and its need for regulatory affairs and compliance oversight. And, as we carry forward the potential next-generation of innovative vaccines, Shou-Bai is a welcome addition to the organization,” Mott added.

Management Promotions

Dr. Peter Kiener has been promoted from senior vice president, research to executive vice president, research, overseeing all global research activities for the company. Since joining MedImmune in 2001, Dr. Kiener has made expert and strategic contributions in supervising MedImmune’s rapidly expanding product portfolio, particularly in the areas of cancer and inflammatory disease research as well as translational sciences. Prior to joining MedImmune, Dr. Kiener spent 18 years with Bristol-Myers Squibb’s (BMS) Pharmaceutical Research Division, finally holding the position of director, immunology, inflammation, pulmonary and oncology drug discovery at the BMS facility in Princeton, NJ. Before his employment at Bristol-Myers, Dr. Kiener previously served as assistant professor at the University of North Texas/Texas College of Osteopathic Medicine’s Department of Anatomy; as a research associate at the Department of Biochemistry, University of Massachusetts (Amherst); and as a postdoctoral research assistant, Medical Research Council, Sir William Dunn School of Pathology, University of Oxford. Dr. Kiener holds a bachelor of science degree with honors in chemistry from Lancaster University, Lancaster, UK, and a doctorate of philosophy in biochemistry from the Sir William Dunn School of Pathology, Oxford University, Oxford, UK.

Ms. Katy Strei, who has been promoted from senior director, corporate capabilities to vice president, people and organization development within MedImmune’s human resources function, brings nearly 20 years strategic leadership and talent development experience to her role at MedImmune. She is responsible for the strategy and implementation of the company’s key people processes and programs, including performance management, succession planning and leadership development. In addition she oversees training and development initiatives. Prior to joining MedImmune in 2005, Ms. Strei served as director of executive development for Fannie Mae and had served in various training and organization development roles at ManorCare Health Services and Sallie Mae. She holds an undergraduate degree in sociology from Lawrence University; a master’s in organization development from American University; and completed the leadership coaching program at Georgetown University.

Ms. Eileen Valenta has been promoted from senior director, product promotion review, regulatory affairs to vice president, operations and compliance, regulatory affairs. In her expanded role, she is responsible for guiding product promotion review and for ensuring that overall operations of the regulatory affairs group are compliant with federal guidelines and consistent with the company’s global regulatory strategy. Prior to joining MedImmune in 2005, Ms. Valenta served as senior director, global regulatory affairs specializing in advertising and promotion for Baxter Healthcare Corporation, where she developed and managed promotional standards and processes and drove strategy for promotional efforts in the U.S. and Europe. Throughout her career she has served in regulatory affairs roles at Takeda Pharmaceuticals North America, Wellmark International and Schering Plough Animal Health Corporation (formerly Mallinckrodt Veterinary, Inc.). Ms. Valenta earned a bachelor of science degree in biology from Colorado State University and a master of business administration degree from the Lake Forest Graduate School of Management. She is a member of the Drug Information Association, Food and Drug Law Institute and the Regulatory Affairs Professional Society.

New Leadership

As the newest senior addition, Dr. Shou-Bai Chao joins MedImmune as vice president of vaccine manufacturing, responsible for all aspects of global vaccine manufacturing and supply. Dr. Chao will also contribute to MedImmune’s commitments to pandemic preparedness. Prior to joining the company, Dr. Chao most recently served as assistant vice president, technical operations and product supply at Wyeth Biotech, where he gained experience bringing FluMist(R) (Influenza Virus Vaccine Live, Intranasal) through development at Wyeth Pharmaceuticals. He was also responsible for global technical operations for the flagship vaccine, Prevnar(R). He brings comprehensive perspective with more than 15 years experience at Wyeth, Sanofi-Pasteur and Philom Bios in global vaccine and bio/pharmaceutical process and product development, manufacturing operations and quality assurance. Dr. Chao earned his doctorate and completed his postdoctoral fellowship at the Industrial Biotechnology Center, University of Waterloo, Ontario, Canada.

About MedImmune

MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases; cancer; inflammatory diseases; cardiovascular and metabolic diseases; pain and central nervous system disorders and gastrointestinal diseases. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune’s website at www.medimmune.com.

SOURCE MedImmune

CONTACT: Media, Jamie Lacey, +1-301-398-4035, or Investors, Peter Vozzo, +1-301-398-4358, both of MedImmune

“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 receptor (IL-5R) and interleukin-9 (IL-9) 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.

Oncology:
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 BiTE, 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.

Commercialisation:
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.

Media Enquiries:
Jamie Lacey +1 301 398 4035

Analyst & Investor Enquiries:
Jonathan Hunt +44 (0) 207 304 5087
Karl Hard +44 (0) 207 304 5322
Ed Seage +1 302 886 4065
Jorgen Winroth +1 212 579 0506
Peter 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 and facilities 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 of the 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 infectious disease. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. Synagis was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002. Synagis is currently available in 62 countries. Abbott has exclusive rights to Synagis in markets outside the United States. MedImmune promotes Synagis in the United States.
Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.medimmune.com/pdf/products/synagis_pi.pdf.
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in paediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). Synagis has been used in more than one million children in the U.S. since its introduction in 1998. The first dose of Synagis should be administered prior to commencement of 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 reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis. In post-marketing reports, very rare cases (less than one case per 100,000 patients) 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 percent more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD. There have also been post-marketing reports of injection site reactions.

ABOUT FLUMIST
* FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two-to-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.
Do not administer FluMist to children less than 24 months of age due to an increased risk of hospitalisation and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.
If Guillain-Barré syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.
Most common adverse reactions (occurring at greater than or equal to 10 percent in individuals receiving FluMist and at least five percent greater than in placebo) are runny nose or nasal congestion in recipients of all ages, fever greater than 100 degrees Fahrenheit in children two-to-six years of age, and sore throat in adults. FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only. Please see complete prescribing information at http://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 of commercial success and profitability, MedImmune has demonstrated its ability to bring innovative vaccines and biologics speciality products to market through its 600-person commercial organisation in the United States. Over the last decade, MedImmune’s revenues have grown at a compound annual rate of 36 percent from under $50 million in 1996 to almost $1.5 billion in 2006, thanks primarily to MedImmune’s blockbuster product, Synagis, which is the first and only recombinantly produced MAb licensed by the FDA for prevention of an infectious disease. Approved now in more than 60 countries, Synagis is the standard of care for helping to prevent RSV disease in infants and young children at high-risk for RSV.

MedImmune’s vaccine franchise is anchored by FDA-approved FluMist, which represents the first licensed advance in flu vaccine technology in more than 60 years. The first nasal mist flu vaccine approved in the U.S., FluMist is part of a platform of technology around live, attenuated vaccines that have been developed at MedImmune. In 2007, the FDA approved MedImmune’s application to expand the vaccine’s label to include eligible children two to five years of age, as well as a new refrigerated formulation of FluMist. The vaccine was previously approved by the FDA for use in children and adults five to 49 years of age and was stored as a frozen formulation.*

MedImmune was also at the forefront of the work to develop a vaccine to prevent cervical cancer caused by human papilloma virus (HPV). The company partnered with GSK for the completion of the clinical development and the commercialisation of the vaccine. In early 2005 the agreement was amended to allow Merck, which has also been developing an HPV vaccine, to be granted a sublicense to MedImmune’s intellectual property. As a result, MedImmune receives milestone payments and royalties on HPV vaccines marketed by both pharmaceutical companies.

To complement its in-house discovery and research capabilities, MedImmune has been among the most active biotech strategic players, having executed almost 40 significant business development, licensing and acquisition-related transactions between 2004 and 2007.

MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune’s website at http://www.medimmune.com.

ABOUT ASTRAZENECA
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
In order to utilise the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, AstraZeneca is providing the following cautionary statement. This Review contains forward-looking statements with respect to the research and development efforts within MedImmune, the biologics organization within AstraZeneca. By their nature, forward-looking statements and forecasts involve risk and uncertainty 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 from that expressed or implied by these forward-looking statements. These factors include, among other things, the risk that research and development efforts will not yield new products that achieve commercial success; the loss or expiration of patents; difficulties in the manufacturing processes for biological products; the risk of delay to new product launches; and the difficulties of obtaining and maintaining governmental approvals for products. For a more complete list of risks associated with the AstraZeneca businesses, please refer to the AstraZeneca filings with the Securities and Exchange Commission.

TRADEMARKS
MedImmune and Synagis are registered trademarks of MedImmune, Inc. and FluMist is a registered trademark of MedImmune Vaccines, Inc. Both MedImmune, Inc. and MedImmune Vaccines, Inc. are members of the AstraZeneca group of companies. BiTE is a registered trademark of Micromet, Inc.