2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1988-1998
Micromet and MedImmune present new clinical data for MT103 at the American Society of Hematology Annual Meeting. Phase 1 findings show potent activity of the BiTE® antibody in patients with late-stage non-Hodgkin’s lymphoma.
AstraZeneca presents its global biologics organization, MedImmune, at its 2007 analyst and investor R&D day at MedImmune headquarters.
November
MedImmune initiates first clinical trial of its monoclonal antibody (MAb) targeting granulocyte-macrophage colony stimulating factor receptor (GM-CSFR) in patients with rheumatoid arthritis (RA). The study represents the first clinical trial in which a MAb targeting GM-CSFR is being investigated in patients with RA.
The New England Journal of Medicine publishes first clinical results for MedImmune's chitinase-like protein YKL-40 in patients with asthma. Findings suggest the protein may play an important role in pathobiology of severe asthma, identifying it as a potential new biomarker for severity of disease.
Infinity and MedImmune initiate Phase 2 clinical trial of heat shock protein 90 inhibitor in patients with advanced hormone-refractory prostate cancer, marking the third solid tumor indication in which drug candidate IPI-504 is being evaluated.
MedImmune presents preclinical and early-phase data from its advancing inflammatory disease portfolio at the 71st Annual Meeting of The American College of Rheumatology.
October
MedImmune and Cambridge Antibody Technology (CAT) announce that CAT is changing its name to MedImmune to reflect AstraZeneca’s vision for its worldwide biologics business. The new business unit unites the resources and expertise from CAT, the pre-existing MedImmune and other biologics activities within the AstraZeneca Group, under the “MedImmune” name.
MedImmune recognized by Corporate Volunteer Council of Montgomery County (CVC-MC), MD for its employees' exceptional commitment to the community. MedImmune receives the CVC-MC's 2007 Corporate Volunteer Award for a large business.
MedImmune sponsors and participates in the Montgomery County, MD Light The Night Walk® for The Leukemia and Lymphoma Society®. A team of employees raises more than $10,000 in additional funds for the Society.
MedImmune and Crucell N.V. announce collaboration to develop new antibodies for the treatment and prevention of hospital-acquired bacterial infection.
September
MedImmune licenses reverse genetics technology to GlaxoSmithKline for use in influenza vaccine development and production.
FDA approves expanded label for FluMist® (Influenza Virus Vaccine Live, Intranasal) to include children two to five years of age.
Infinity and MedImmune receive orphan drug designation from the U.S. Food and Drug Administration for IPI-504 for treatment of gastrointestinal stromal tumors.
August
MedImmune holds ribboncutting ceremony for new pilot lab at Gaithersburg headquarters to meet increasing demands for clinical trial materials from company's expanding and advancing pipeline.
MedImmune licenses reverse genetics technology to Novartis for use in influenza vaccine development and production.
July
Biota Holdings and MedImmune initiate a Phase 1a clinical trial for their RSV antiviral drug, BTA9881.
June
AstraZeneca announced that it completed its acquisition of MedImmune pursuant to a short-form merger in which a subsidiary of AstraZeneca was merged with and into MedImmune, which is now wholly owned by AstraZeneca.
More than 600 MedImmune employees build a playground in one day at the Palomar YMCA in Escondido, CA with the help of community group KaBoom!
MedImmune is awarded contract by U.S. Department of Health and Human Services to retrofit manufacturing facilities for production of pandemic influenza vaccines.
May
U.S. Food and Drug Administration advisory committee recommends expanded use of FluMist® (Influenza Virus Vaccine Live, Intranasal) to include eligible children 2- - 5 years of age.
MedImmune provides fellowship grants totaling $210,000 to six pediatric respiratory researchers.
MedImmune and Pediatric Infectious Diseases Society present 2007 career development award and viral respiratory disease fellowship.
April
AstraZeneca to acquire MedImmune for $58 per share in a fully recommended, all-cash transaction with a total enterprise value of $15.2 billion.
March
MedImmune licenses reverse genetics technology to sanofi pasteur for use in influenza vaccine production.
MedImmune expands anti-interferon-alpha program by initiating Phase 1 trial in patients with psoriasis.
MedImmune leases Human Genome Sciences facility to expand cell culture influenza vaccine manufacturing capabilities.
February
Infinity and MedImmune initiate Phase 1/2 clinical trial of IPI-504 for patients with non-small cell lung cancer.
Study published in The New England Journal of Medicine: 55 percent fewer cases of flu reported in a Phase 3 trial in young children vaccinated with FluMist® (Influenza Virus Vaccine Live, Intranasal) vs. flu shot. Results from large head-to-head study conducted during the 2004-2005 flu season reinforce ability of FluMist to help protect against matched and drifted strains.
January
U.S. Food and Drug Administration approves MedImmune's refrigerated formulation of FluMist® (Influenza Virus Vaccine Live, Intranasal).
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MedImmune enters into licensing agreement with Japan Tobacco, Inc. to develop a monoclonal antibody (MAb) targeting pathways within the CD28 receptor family for potential treatment of inflammatory diseases.
CSL Limited of Australia licenses MedImmune's reverse genetics technology for use in influenza vaccine production.
MedImmune enters into collaboration and licensing agreement with BioWa, Inc. to develop and commercialize new inflammatory disease therapies targeting the interleukin-5 (IL-5) receptor, adding a Phase 1 MAb to the company's pipeline.
Sale of CytoGam® (cytomegalovirus immune globulin intravenous (human)) to ZLB Behring is completed.
November
MedImmune files an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to begin clinical testing of a cell culture-based seasonal influenza vaccine using its proprietary, live, attenuated, needle-free influenza vaccine technology.
MedImmune announces its intent to sell CytoGam to ZLB Behring.
Results from a Phase 3 pivotal study show that Motavizumab met its primary endpoint of non-inferiority by reducing the incidence of hospitalizations caused by respiratory syncytial virus (RSV) in infants at high risk for serious RSV disease by 26 percent when compared to ® (palivizumab). The data also indicate that movavizumab showed superiority over Synagis in a secondary endpoint by reducing the incidence of RSV-specific medically attended outpatient lower respiratory infections (LRI) by approximately 52 percent.
September
MedImmune breaks ground on a new biologics manufacturing facility in Frederick, Maryland, highlighting the company's expertise in cell culture-based manufacturing.
August
MedImmune and Infinity Pharmaceuticals form alliance for the development of novel, targeted small molecule cancer therapies focused on Heat Shock Protein 90 (Hsp90) and the Hedgehog cell-signaling pathway.
MedImmune files an IND with the FDA for MT103 for the treatment of patients with B-cell-derived non-Hodgkins lymphoma (NHL) who are not eligible for curative therapy.
July
MedImmune submits a supplemental Biologics License Application (sBLA) to the FDA for approval for use of the refrigerated formulation of FluMist® in children 12 months to 59 months who do not have a history of wheezing or asthma.
The FDA approves MedImmune's sBLA to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines.
June
MedImmune closes its sale of $1.15 billion convertible senior notes.
The National Institutes of Health (NIH) begins enrolling participants in a Phase 1 study of an intranasal H5N1 influenza vaccine candidate based on MedImmune's live, attenuated vaccine technology.
May
MedImmune is awarded an approximately $170 million, five-year contract from U.S. Health and Human Services (HHS) to develop cell-based influenza vaccines.
Data from a pivotal Phase 3 study show that the refrigerated formulation of MedImmune's influenza vaccine was 55 percent more effective than the trivalent injectable inactivated influenza vaccine (TIV) in reducing influenza illness caused by any influenza strain in children 6 months to 59 months of age.
April
MedImmune licenses technology from Elusys Therapeutics for use in developing new therapies targeting infectious diseases.
MedImmune begins dosing lupus patients in a Phase 1 clinical trial to evaluate the safety and tolerability of its MAb targeting interferon-alpha, being developed for the potential treatment of patients with systemic lupus erythematosus (SLE or lupus).
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MedImmune completes enrolling approximately 6,600 high-risk infants in a Phase 3 study comparing the safety and efficacy of NumaxTM (motavizumab) to Synagis® (palivizumab).
MedImmune and Biota Holdings Limited announce a collaboration to develop new small-molecule therapies for the prevention of respiratory syncytial virus (RSV).
Preliminary data from MedImmune's CAIV-T (cold adapted influenza vaccine, trivalent) pivotal Phase 3 trial demonstrates clinical efficacy over the traditional flu shot in a head-to-head influenza study, showing a 55 percent relative reduction in influenza illness.
A licensing agreement with the Burnham Institute for Medical Research expands MedImmune's oncology pipeline, with an increased focus on Eph proteins as potential targets for new cancer therapies.
MedImmune expands its patent estate for reverse genetics with the acquisition of new rights from Mount Sinai School of Medicine.
October
MedImmune enters into a licensing and collaboration agreement with Avidia, Inc. to develop anti-cancer products targeting cMET, a receptor tyrosine kinase found in high levels in certain cancer cells; the collaboration also calls for development of two additional targets using Avidia's Avimer technology.
MedImmune completes acquisition of Cellective Therapeutics, adding preclinical cancer and inflammatory disease product candidates to MedImmune's pipeline.
MedImmune and Medarex file an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for MEDI-545, a monoclonal antibody (MAb) targeting interferon-alpha, for the treatment of lupus.
September
MedImmune announces a collaboration with National Institutes of Health to develop investigational pandemic influenza vaccines.
MedImmune and Georgetown University enter into a licensing and collaboration agreement for the development of cancer-focused MAbs targeting anaplastic lymphoma kinase (ALK), a member of the insulin receptor family of tyrosine kinases.
MedImmue submits refrigerator-stable formulation of FluMist® (Influenza Virus Vaccine Live, Intranasal) to the FDA for approval in healthy individuals 5 to 49 years of age.
MedImmune and VasGene Therapeutics announce a collaboration to develop cancer-focused monlclonal antibodies targeting a novel member of a subfamily of receptor tyrosine kinases, EphB4, as well as its ligand, EphrinB2.
Data from a Phase 1 study was announced demonstrates that Numax appears to have an acceptable safety profile in infants infected with RSV and may have the potential to help reduce RSV in the upper respiratory tracts of children infected with the virus.
August
MedImmune amends U.S. co-promotion agreement for Synagis with Abbott; under the terms of the amendment, MedImmune will assume full responsibility for U.S. product sales after June 30, 2006.
June
MedImmune and Avalon Pharmaceuticals announce collaboration to discover and develop small molecule therapeutic drugs in the area of infectious disease, using Avalon's AvalonRxTM drug discovery engine to identify lead compounds.
MedImmune announces preliminary results of a Phase 3 bridging study showing comparable immunogenicity of frozen FluMist and its investigational, next-generation, refrigerator-stable formulation, CAIV-T.
May
Citing preclinical study data demonstrating a correlation between interleukin-9 (IL-9) and increased airway hyperreactivity (AHR), a key component of asthma, MedImmune announces plans to initiate a second Phase 1 study with its anti-IL-9 MAb as a potential asthma therapy.
MedImmune announces that preliminary data from a Phase 2 study in patients with stage IV metastatic melanoma showed 53 percent of patients survived the one-year mark when treated with Vitaxin®, with a median survival of 12.7 months.
April
MedImmune begins dosing in Phase 1 clinical trial with its RSV vaccine candidate.
February
MedImmmune expands ex-U.S. distribution agreement with Abbott for MAbs against RSV.
MedImmune amends agreement for cervical cancer with GlaxoSmithKline.
January
MedImmune files an IND with the FDA for nasally delivered RSV/PIV-3 vaccine.
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MedImmune and Medarex announce collaboration to develop and commercialize fully human antibodies for autoimmune diseases.
MedImmune initiates a Phase 3 study evaluating the safety and efficacy of Numax in reducing respiratory syncytial virus (RSV) disease in healthy, full-term Native American infants.
MedImmune initiates a Phase 3 study for Numax to evaluate the MAb's potential to prevent serious RSV in high-risk infants.
OctoberMedImmune increases its planned delivery of FluMist up to a total of three million doses in response to the shortage of the injectable influenza vaccine.
MedImmune initiates a pivotal head-to-head Phase 3 clinical trial designed to compare its next-generation, refrigerator-stable intranasal influenza vaccine (CAIV-T) with the injectable flu shot (TIV: trivalent influenza vaccine)
MedImmune appoints Edward Connor, M.D., formerly senior vice president of clinical development and chief medical officer, to executive vice president and chief medical officer.
AugustMedImmune begins dosing patients in a Phase 1 clinical trial with an anti-IL-9 MAb. The company is evaluating this molecule as a potential new treatment for symptomatic, moderate-to-severe persistent asthma.
JuneMedImmune presents data from a Phase 3 clinical trial involving 303 head and neck cancer patients showing that Ethyol® (amifostine) reduced the incidence of moderate-to-severe dry mouth (xerostomia) in patients receiving radiation therapy for their disease.
JulyThe FDA approves a new liquid formulation of Synagis.
MayMedImmune presents data from two Phase 3 studies showing that a live, attenuated intranasal influenza vaccine had higher efficacy rates and a similar safety profile to the traditional flu shot.
MedImmune announces that the Federal Trade Commission has terminated the review period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for the company's reacquisition of FluMist and related technology from Wyeth.
AprilMedImmune and Cerus Corporation announce an agreement to develop and commercialize a novel therapeutic vaccine designed to treat cancers of the breast, prostate and colon, as well as metastatic melanomas.
MedImmune appoints Lota S. Zoth, formerly vice president and controller, as senior vice president and chief financial officer.
MedImmune and Wyeth announce the dissolution of their collaboration for the nasal flu vaccine FluMist and an investigational second-generation liquid formulation, CAIV-T.
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MedImmune announces the initiation of two additional Phase 2 clinical trials, in prostate cancer and psoriasis, for Vitaxin, a development-stage MAb.
OctoberMedImmune submits an IND to the FDA to evaluate Numax as a potential new product to help prevent serious RSV disease.
SeptemberMedImmune announces the initiation of two Phase 2 clinical trials, in melanoma and rheumatoid arthritis, for Vitaxin, a development-stage MAb.
MedImmune announces that the FDA has approved the addition of new safety and efficacy data to the prescribing information of Synagis, supporting its use in young children with hemodynamically significant congenital heart disease (CHD) to prevent hospitalization caused by RSV.
JulyMedImmune and Critical Therapeutics, Inc. (CTI), a private biopharmaceutical company, announce the signing of an agreement to co-develop biologic products targeting a novel pro-inflammatory cytokine to treat severe inflammatory diseases.
MedImmune announces that its board of directors has authorized a repurchase, over a two-year period, of up to $500 million of its common stock in the open market or in privately negotiated transactions.
MedImmune issues $500 million of 1% convertible senior notes due in 2003.
JuneMedImmune and Micromet AG (private) announce an agreement to jointly develop Micromet's B cell tumor drug, MT-103, the most-advanced representative of a novel class of antibody derivatives called Bi-Specific T Cell Engagers (BiTETM).
The FDA approves FluMist, the first influenza vaccine delivered as a nasal mist available in the United States for healthy people.
FebruaryMedImmune completes submission of information requested by the FDA for FluMist.
JanuaryMedImmune receives a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for FluMist.
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On December 17, 2002, the company announced that the FDA's Vaccines and Related Biological Products Advisory Committee recommended approval of FluMist to prevent influenza in healthy children, adolescents and adults ages 5 through 49.
AugustMedImmune submits information requested by the FDA for FluMist in response to the second CRL received by the company on July 10, 2002.
MedImmune licenses the worldwide rights to develop vaccines and antibody products against a newly-discovered virus called human metapneumovirus (hMPV), believed to be responsible for a significant number of serious lower respiratory tract infections in children.
JulyMedImmune announces the formation of MedImmune Ventures, Inc., a venture capital subsidiary seeking to discover and invest in companies and organizations developing therapeutic products or technologies with significant potential to improve the treatment or prevention of human disease.
On July 10, 2002, MedImmune receives a second CRL from the FDA for its BLA for FluMist. The first CRL was received in August 2001 and responded to by the company on January 8, 2002.
JanuaryMedImmune completes acquisition of Aviron. The acquisition strengthens MedImmune's franchise in infectious disease research and adds several investigational product opportunities, including FluMist, a nasally delivered flu vaccine, under FDA review.
Synagis is approved for marketing in Japan by the Japanese Ministry of Health, Labor, and Welfare.
Aviron submits to the FDA a formal reply to the CRL the FDA issued on August 31, 2001 for FluMist.
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MedImmune enters a definitive agreement to acquire Aviron, Inc., a California-based biopharmaceutical company focused on prevention of disease through innovative vaccine technologies.
NovemberData from Phase 2 clinical trial with subcutaneous Ethyol presented at the 43rd Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO).
OctoberMedImmune licenses worldwide rights to EphA2 from Purdue Research Foundation. Products directed against this target will potentially be used to treat a variety of aggressive tumors, including breast, colon, prostate, lung and skin cancers, as well as to prevent metastasis.
MedImmune acquires the U.S. rights to Ethyol from ALZA Corporation.
SeptemberMedImmune presents long-term follow up data from Phase 1/2 data for siplizumab at the European Society of Dermatological Research meeting.
AugustEnhanced Yield Process (EYP) approved by the FDA. Through this fermentation enhancement process, MedImmune scientists can produce approximately four-fold more Synagis per production run (approximately 2.8 grams per liter).
JunePhase 1/2 data for siplizumab in patients with psoriasis is presented at the International Psoriasis Symposium and European Congress on Psoriasis.
AprilMedImmune signs research collaboration and worldwide exclusive licensing agreement with Genaera Corporation to develop and commercialize antibodies or recombinant molecules against IL-9 for use in asthma and other respiratory diseases.
FebruaryMedImmune signs agreement with Targesome for development of Vitaxin for targeted radiotherapy. The combination could generate a targeted nanoparticle capable of delivering a payload of a therapeutic or imaging agent for the treatment and/or diagnosis of cancer.
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The FDA approves MedImmune's plasma production module at the Frederick Manufacturing Center for the production of CytoGam® (cytomegalovirus immune globulin intravenous (human)) intermediate paste.
NovemberMGI Pharma enters into an asset purchase agreement with a subsidiary of MedImmune, Inc. for Hexalen® (altretamine), an orally administered chemotherapeutic agent approved in the United States for treatment of ovarian cancer in patients with persistent or recurrent disease following first-line therapy with cisplatin and/or alkylating agent-based combination chemotherapy.
OctoberDavid M. Mott becomes MedImmune's chief executive officer; Wayne T. Hockmeyer resigns as CEO but continues as the company's chairman.
JulyMedImmune and GlaxoSmithKline Biologicals announce Streptococcus pneumoniae product development alliance utilizing MedImmune's vaccine technology.
MedImmune scientists present human papillomavirus (HPV) vaccine Phase 1 data in Barcelona at International Papillomavirus Conference.
JuneMedImmune signs collaborations with Medarex and Alkermes to expand its RSV franchise.
MedImmune announces the intent to develop Numax, the next generation of Synagis.
FebruaryMedImmune's Board of Directors announces 3:1 stock split effective June 2, 2000.
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MedImmune announces FDA licensure of Frederick Manufacturing Center for Synagis production.
NovemberMedImmune completes acquisition of US Bioscience. This acquisition provides MedImmune with three marketed oncology and infectious disease products, as well as development capabilities and an oncology sales and marketing infrastructure.
SeptemberMedImmune and Abbott International announce the approval of Synagis in Europe by the European Commission.
MedImmune announces intent and definitive agreement to acquire U.S. Bioscience, a specialty pharmaceutical company that develops and markets products for patients with cancer.
MayEuropean Union's Committee for Proprietary Medicinal Products (CPMP) adopts positive opinion of Synagis for RSV prevention.
MedImmune announces that it would call for redemption its outstanding 7 percent convertible subordinated notes due 2003.
FebruaryMedImmmune and Applied Molecular Evolution, Inc. (formerly Ixsys, Inc.) announce a four-antibody agreement; lead product is Vitaxin.
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CytoGam receives label expansion to include CMV prophylaxis in kidney, lung, liver, pancreas and heart transplant patients.
NovemberMedImmune's Board of Directors votes to declare a 2:1 stock split of the company's common stock payable in the form of a 100 percent stock dividend.
SeptemberSynagis is launched in the U.S. in time for 1998/1999 RSV season.
The FDA approves the Boeringer Ingelheim facility for manufacture of Synagis.
JuneSynagis is approved for marketing by the FDA for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease.
MedImmune's Gaithersburg Manufacturing and Development Facility (GMDF) approved by the FDA for manufacture of Synagis.
MedImmune enters into a manufacturing agreement with Boehringer Ingleheim Pharma to supplement manufacturing capacity of Synagis, and a global alliance with Abbott Laboratories to market Synagis.
MedImmune requests marketing clearance for Synagis from the FDA.
MedImmune and GlaxoSmithKline (formerly SmithKline Beecham) form worldwide human papillomavirus vaccine alliance.
AugustMedImmune receives Canadian marketing approvals for RespiGam® and CytoGam.
JulyMedImmune reports positive Phase 3 "Impact-RSV" trial data evaluating Synagis in patients at high risk of RSV.
AprilMedImmune and BioTransplant submit IND to begin human clinical testing with MEDI-507.
March/April/MayMedImmune reports data from Phase 1 and Phase 1/2 trials evaluating Synagis.
FebruaryPhase 1 trial initiated with HPV-11 candidate vaccine. This trial would be used as proof-of-principle for future clinical evaluation of HPV virus-like particle vaccines for cervical cancer.
MedImmune initiates Impact-RSV Phase 3 trial with Synagis.
AugustMedImmune announces plan to build its own manufacturing facility, the Maryland Frederick Manufacturing Center (FMC).
JulyMedImmune issues $60 million of 7 percent convertible subordinated notes.
JuneMedImmune in-licenses HPV intellectual property from German Cancer Research Center.
AprilMedImmune and Rockefeller University establish collaboration to develop Streptococcus pneumoniae products.
FebruaryMedImmune sells 3,450,000 million shares of common stock in public offering and over-allotment of public offering.
JanuaryMedImmune expands sales force in advance of RespiGam approval. Additionally, MedImmune receives FDA clearance to market RespiGam for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease, and sales of the drug commence.
FDA Blood Product Advisory Committee recommends approval of RespiGam.
OctoberMedImmune and BioTransplant sign strategic alliance to develop anti-rejection products for transplantation; this alliance includes BTI-322 and any products derived from it. MEDI-507 will eventually be derived from BTI-322.
MedImmune acquires exclusive worldwide rights to human papillomavirus technology developed at the University of Rochester.
JulyMedImmune and Human Genome Sciences sign alliance to develop antibacterial vaccines. MedImmune also reports positive RespiGam Phase 3 PREVENT trial data.
JuneMedImmune forms alliance with Baxter Healthcare Corporation to commercialize RespiGam outside the U.S. MedImmune also commences Phase 2 clinical evaluation of Synagis.
MedImmune initiates Phase 1 clinical testing of Synagis.
OctoberMedImmune outlines RespiGam PREVENT trial plans; this trial will be essential to the eventual approval of the drug.
FDA panel votes not to recommend the approval of RespiGam.
JanuaryMedImmune files RespiGam product license agreement with the FDA.
MedImmune acquires rights for CytoGam distribution from Connaught Laboratories and becomes the sole distributor of the product.
NovemberMedImmune begins hiring its sales force in preparation for the relaunch of CytoGam.
AprilMedImmune completes Phase 2/3 clinical trial with RespiGam.
MedImmune sells an additional 2,875,000 shares of common stock at $43.50 per share (pre split), or $7.25 per share (adjusted for subsequent stock splits).
MayMedImmune completes its initial public offering of 2,875,000 shares of common stock at $9.25 per share (pre split), or $1.54 per share (adjusted for subsequent stock splits), resulting in net proceeds of $23,987,000 in proceeds to the company.
Molecular Vaccines, Inc.'s name is changed to MedImmune, Inc.
Molecular Vaccines, Inc., founded by Wayne T. Hockmeyer, commences operations.
MedImmune is incorporated under the name Molecular Vaccines, Inc.
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