MedImmune, LLC was a wholly owned subsidiary of AstraZeneca before February 14, 2019, when it was announced that the MedImmune name and branding would be discontinued in favor of AstraZeneca.[1][2]
It produced Synagis, a drug for the prevention of respiratory infections in infants, which accounted for US$ 1.06 billion of its US$ 1.2 billion in revenue for 2005, and FluMist, a nasal sprayinfluenza vaccine introduced in 2004. MedImmune acquired FluMist when it purchased Aviron in 2002 for US$ 1.5 billion. FluMist sales totaled US$ 104 million in 2008, US$ 54.8 million in 2007, and US$ 36.4 million in 2006.[5]
FluMist was approved for children two years of age and older in 2007, but initially was approved only for healthy people ages 5 to 49, a significant limitation because it eliminated a significant market—young children who find injections objectionable. Sales of FluMist fell short of analysts' expectations for the first two years the drug was sold. FluMist was initially sold in a frozen form, which was difficult for doctors to store.[6]
MedImmune conducted successful clinical trials for a new generation of FluMist needle-free vaccine, called CAIV-T, which was approved by the U.S. Food and Drug Administration (FDA) in 2007, and is now the form offered on the market.
History
Molecular Vaccines, Inc. was founded by Wayne T. Hockmeyer, David Mott, and Dr. James Young in 1988.[6] In 1989, Molecular Vaccines, Inc changed its name to MedImmune, Inc.
On April 23, 2007, it was announced MedImmune and AstraZeneca entered into a definitive agreement under which AstraZeneca intended to acquire MedImmune in an all-cash transaction at US$ 58 per share, or about US$ 15.2 billion.[6] On 19 June 2007 AstraZeneca completed the acquisition paying US$ 15.2 billion primarily for its drug development pipeline. Analysts have criticised the take-over, claiming that AstraZeneca paid too much.[7] AstraZeneca chose to merge MedImmune with Cambridge Antibody Technology, which it had acquired in 2006, creating a new biologics division under the MedImmune name. AstraZeneca presented the new MedImmune to investors on 7 December 2007.[8]
MedImmune said it was making a significant, rapid response with a vaccine to the novel H1N1 variant of influenza, known as swine flu.[10] In June 2009 it won a Department of Health and Human Services (HHS) contract, worth $90m. Under the contract with HHS, MedImmune will continue to make its seasonal FluMist vaccine and also develop a vaccine targeted specifically at the novel H1N1 virus.[5] MedImmune then won a second contract to test its nasal spray flu technology as a viable treatment for the H1N1.[11]
MedImmune received approval from the U.S. FDA for its intranasal novel H1N1 influenza vaccine in September 2009.[10]
Pipeline
MedImmune had over 120 drugs in development for conditions including lupus, COPD, asthma, and many types of cancer. Major phase III trials included:[12]
↑ MedImmune Press release MedImmune and National Institutes of Health Begin Clinical Testing of a Live, Attenuated Intranasal Vaccine Against an H5N1 Avian Influenza Virus published June 15, 2007
AstraZeneca plc (AZ) is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It was involved in developing the Oxford–AstraZeneca COVID-19 vaccine.
Influenza vaccines, colloquially known as flu shots or the flu jab, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. Vaccination against influenza began in the 1930s, with large-scale availability in the United States beginning in 1945.
Live attenuated influenza vaccine (LAIV) is a type of influenza vaccine in the form of a nasal spray that is recommended for the prevention of influenza.
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. CSL's product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. The company was established in 1916 as Commonwealth Serum Laboratories and was wholly owned by the Australian federal government until its privatisation in 1994.
Swine influenza is an infection caused by any of several types of swine influenza viruses. Swine influenza virus (SIV) or swine-origin influenza virus (S-OIV) refers to any strain of the influenza family of viruses that is endemic in pigs. As of 2009, identified SIV strains include influenza C and the subtypes of influenza A known as H1N1, H1N2, H2N1, H3N1, H3N2, and H2N3.
Influenza A virus subtype H1N1 (A/H1N1) is a subtype of influenza A virus (IAV). Some human-adapted strains of H1N1 are endemic in humans and are one cause of seasonal influenza (flu). Other strains of H1N1 are endemic in pigs and in birds. Subtypes of IAV are defined by the combination of the antigenic H and N proteins in the viral envelope; for example, "H1N1" designates an IAV subtype that has a type-1 hemagglutinin (H) protein and a type-1 neuraminidase (N) protein.
An influenza pandemic is an epidemic of an influenza virus that spreads across a large region and infects a large proportion of the population. There have been six major influenza epidemics in the last 140 years, with the 1918 flu pandemic being the most severe; this is estimated to have been responsible for the deaths of 50–100 million people. The 2009 swine flu pandemic resulted in under 300,000 deaths and is considered relatively mild. These pandemics occur irregularly.
Influenza A virus subtype H3N2 (A/H3N2) is a subtype of influenza A virus (IAV). Some human-adapted strains of A/H3N2 are endemic in humans and are one cause of seasonal influenza (flu). Other strains of H1N1 are endemic in pigs and in birds. Subtypes of IAV are defined by the combination of the antigenic H and N proteins in the viral envelope; for example, "H1N1" designates an IAV subtype that has a type-1 hemagglutinin (H) protein and a type-1 neuraminidase (N) protein.
Transmission and infection of H5N1 from infected avian sources to humans has been a concern since the first documented case of human infection in 1997, due to the global spread of H5N1 that constitutes a pandemic threat.
Treatments for influenza include a range of medications and therapies that are used in response to disease influenza. Treatments may either directly target the influenza virus itself; or instead they may just offer relief to symptoms of the disease, while the body's own immune system works to recover from infection.
H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.
Serum Institute of India (SII) is an Indian multinational biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines by volume. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.
Pandemrix is an influenza vaccine for influenza pandemics, such as the 2009 flu pandemic. The vaccine was developed by GlaxoSmithKline (GSK) and patented in September 2006.
The pandemic H1N1/09 virus is a swine origin influenza A virus subtype H1N1 strain that was responsible for the 2009 swine flu pandemic. This strain is often called swine flu by the public media due to the prevailing belief that it originated in pigs. The virus is believed to have originated around September 2008 in central Mexico.
The 2009 swine flu pandemic vaccines were influenza vaccines developed to protect against the pandemic H1N1/09 virus. These vaccines either contained inactivated (killed) influenza virus, or weakened live virus that could not cause influenza. The killed virus was injected, while the live virus was given as a nasal spray. Both these types of vaccine were produced by growing the virus in chicken eggs. Around three billion doses were produced, with delivery in November 2009.
A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.
A universal flu vaccine would be a flu vaccine effective against all human-adapted strains of influenza A and influenza B regardless of the virus sub type, or any antigenic drift or antigenic shift. Hence it should not require modification from year to year in order to keep up with changes in the influenza virus. As of 2024 no universal flu vaccine had been successfully developed, however several candidate vaccines were in development, with some undergoing early stage clinical trial.
A nasal vaccine is a vaccine administered through the nose that stimulates an immune response without an injection. It induces immunity through the inner surface of the nose, a surface that naturally comes in contact with many airborne microbes. Nasal vaccines are emerging as an alternative to injectable vaccines because they do not use needles and can be introduced through the mucosal route. Nasal vaccines can be delivered through nasal sprays to prevent respiratory infections, such as influenza.
Type A influenza vaccine is for the prevention of infection of influenza A virus and also the influenza-related complications. Different monovalent type A influenza vaccines have been developed for different subtypes of influenza A virus including H1N1 and H5N1. Both intramuscular injection or intranasal spray are available on market. Unlike the seasonal influenza vaccines which are used annually, they are usually used during the outbreak of certain strand of subtypes of influenza A. Common adverse effects includes injection site reaction and local tenderness. Incidences of headache and myalgia were also reported with H1N1 whereas cases of fever has also been demonstrated with H5N1 vaccines. It is stated that immunosuppressant therapies would reduce the therapeutic effects of vaccines and that people with egg allergy should go for the egg-free preparations.
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