Pipeline
Vaccines that are in the developmental stages
Merck & Co, Inc. Glaxo Wellcome-GlaxoSmithkline Beecham Berna Products
Aventis Pasteur, Inc, Ltd, SA, Aventis Behring, LLC Crucell Wyeth Laboratories
MedImmune BioPort Corp Chiron Behring GmbH & Co
Evans Vaccine Lederle Lab Div-American Cyanamid Co Acambis
Ross Products Division-Abbott Laboratories, Inc. Powderject Ipsen Limited
Massachusetts Public Health Biologic Lab North American Vaccine, Inc
Organon Teknika Corp AVAX Technologies, Inc. Medeva Pharma Ltd,/Celltech
Avant Immunotherapeutics Inc. DVC-DynPort Vaccine Company LLC Bavarian Nordic
VaxGen Nabi Biopharmaceuticals Novavax MediGene Xenova Protein SciencesImmune Response Corporation Vaxin Inc. Oxford BioMedica GenVec Inc.
Glaxo Wellcome-GlaxoSmithkline Beecham
GlaxoSmithKline Vaccine Pipeline
Hepatitis Vaccines:
Hepatitis E - recombinant - hepatitis E prophylaxis PhaseII
Fendrix Extra Strength hepatitis B - recombinant - extra strength hepatitis
B prophylaxis (pre-hemodialysis and hemodialysis patients) Submitted May 03
Paediatric Vaccines:
N. meningitidis combinations - conjugated - meningitis prophylaxis Phase II
Priorix-Tetra (MMR-varicella) - live attenuated - measles, mumps, rubella
and varicella prophylaxis Phase III
Rotarix - live attenuated - oral rotavirus prophylaxis Phase III
Streptorix - conjugated - S. pneumoniae disease prophylaxis for children Phase
III
Other Vaccines:
Dengue fever - attenuated tetravalent vaccine - prophylactic use Phase I
HIV - recombinant - HIV prophylaxis Phase I
New influenza - subunit - influenza prophylaxis - new delivery Phase I
S. pneumoniae elderly - recombinant - S. pneumoniae disease prophylaxis Phase
I
Varicella Zoster - recombinant - Varicella Zoster prevention Phase I
Cervarix - recombinant - prophylaxis of human papillomavirus (HPV) infections
Phase II
Epstein-Barr virus (EBV) - recombinant - EBV prophylaxis Phase II
Mosquirix - recombinant - malaria prophylaxis Phase II
Staphylococcal antibodies - monoclonal - antibody prevention of staphylococcal
infections Phase II
Simplirix - recombinant - genital herpes prophylaxis Phase III
Boostrix Polio - subunit - adolescent/adult booster for diphtheria, tetanus,
pertussis and polio Submitted Jul03
Boostrix - subunit - adolescent/adult booster for diphtheria, tetanus and
pertussis Approved
Aventis Pasteur, Inc, Ltd, SA, Aventis Behring, LLC
Key Compounds in Late-Stage Clinical Development:
Alvesco - Asthma Submitted
Apidra (insulin glulisine) - Type 1 and 2 diabetes - Submitted
Genasense - Malignant melanoma - Submitted
Menactra - Meningococcal meningitis (vaccine) - Submitted
Adacel Booster vaccine - BLA - Submitted
Exubera - Type 1 and 2 diabetes - Phase III
Pentacel - Pediatric combination vaccine - Phase III
Teriflunomide - Multiple sclerosis - Phase III
109,881 (new taxoid) - Breast cancer - Phase III
Otamixaban (0673) - Acute coronary syndrome - Phase IIb
100,907 - Sleep disturbance Phase - IIb
AVE-7688 - Hypertension; diabetic nephropathy - Phase IIb
Pralnacasan (on hold) - Rheumatoid arthritis - Phase IIb
Early-stage pipeline (phase I/II) includes
the following key projects:
AVE-8062 - Cancer
VEGF Trap - Cancer; Age-related Macular Degeneration
ALVAC-CEA vaccine - Colorectal tumors
ALVAC-gp100 vaccine - Melanoma
ALVAC-HIV vaccine - HIV
Dengue vaccine - Dengue fever and dengue hemorrhagic fever
RSV vaccine - Respiratory viral infections
Pralnacasan (on hold) - Osteoarthritis and psoriasis
AVE-3933 - Alzheimer's disease
HP-184 - Spinal cord injury
NV1FGF - Peripheral vascular disease
Anti-inflammatory compounds - Asthma
PPAR agonists - Diabetes
AVE-0010 - Diabetes
Antiobesics - Obesity
Guanylate cyclase activators - Angina
BARI - Metabolism (hypercholesteremia)
SERM 3471 - Postmenopausal osteoporosis
Ebola Vaccine
Influenza Vaccine
Malaria Vaccine
West Nile Vaccine
Tygacil™-(tigecycline) - is being developed
as an injectable antibiotic for treating serious polymicrobic infections in
hospitalized patients when resistant pathogens are known or suspected.
Pneumococcal Conjugate Vaccines - Wyeth is evaluating new pneumococcal conjugate
vaccines
Infectious Disease:
Synagis®
FluMist®
Neutrexin®
CAIV-T
Epstein Barr Virus vaccine
NumaxTM
Pneumoccocal vaccine
hMPV/PIV-3/RSV vaccine
hMPV MAb
Oncology:
Ethyol®
HPV cervical cancer vaccine
Ethyol: mucositis
VitaxinTM: melanoma
VitaxinTM: prostate
Ethyol: AML
MT-103 non-Hodgkin's lymphoma
Siplizumab: T-cell lymphoma
EphA2 MAb
PCDGF MAb
EphA4 MAb
Immunology:
Cytogam®
IL-9 MAb
HMGB-1 MAb
Meningococcal Disease:
Menjugate® for meningococcal C disease (US)
Geography-specific meningococcal B vaccine (New Zealand)
Broad-coverage meningococcal B vaccine
Multivalent (ACYW) meningococcal vaccine
Viral Infection:
HCV vaccine in collaboration with CSL Ltd.
HCV vaccine in collaboration with St. Louis University
HIV vaccine in collaboration with the NIH
Flu cell culture for influenza
Intranasal flu vaccine
Lederle Lab Div-American Cyanamid Co
Smallpox: Modified Vaccinia Ankara (MVA) and
vaccinia immune globulin (VIG)
ChimeriVax-West Nile
ARILVAX™-Yellow Fever
ChimeriVax-JE-Japanese encephalitis
ChimeriVax-Dengue
C. difficile
Ross Products Division-Abbott Laboratories, Inc.
Massachusetts Public Health Biologic Lab
Reproductive medicine:
Org 36286: phase II, long-acting FSH as controlled ovarian stimulation in
IVF/ICSI and in ovulation induction treatment for infertility
Org 33628: phase II, progestagen/antiprogestogen combination as female contraceptive
Male contraception: phase II, progestagen/androgen combination as a male hormonal
method
Livial (USA)
Implanon (USA)
Psychiatry:
Org 34517: phase II, hypothalamus-pituitary-adrenal axis modulator for the
treatment of depression
Org 24448: phase II, AMPakine for the treatment of psychosis by stimulation
of the brain's glutamatergic system
Org 50081: phase II, serotonin-2-blocker for the treatment of sleep disorders
asenapine: phase III, dopamine-serotonin antagonist for the treatment of psychosis
Anesthesia:
Org 25969: phase II, neuromusclular binding agent for the reversal of neuromuscular
block
Immunology:
Org 39141: proof of concept, an auto-antigen for the treatment of rheumatoid
arthritis (phase IIA)
Org 37663: phase IIA, a immunomodulatory steroid for the treatment for rheumatoid
arthritis
Cancer:
CDP 791 - Anti-GFR antibody fragment - Cancer - Phase I
CDP 860 - Anti-PDGF beta-receptor antibody fragment - Cancer - Phase II
CMC-544 - Antibody-calicheamicin conjugate Non-Hodgkin's lymphoma - Partner:
Wyeth - Phase I
Immune and Inflammatory:
CDP 323 - Alpha4 integrin antagonist - Inflammatory disease - Phase I
CDP 484 - Anti-IL-1beta fragment - Inflammatory disease - Preclinical
CDP 870 - Anti-TNFalpha antibody fragment - Rheumatoid Arthritis - Phase III
CDP 870 - Anti-TNFalpha antibody fragment - Crohn's disease - Phase III
PDE4 - PDE-4 Inhibitor - Asthma, COPD - Partner: Merck - Phase I
Other:
CDP 923 - Inherited storage disorders - Phase I
Zavesca - Gaucher's Disease Partner: Actelion / Teva - Approved
Avant Immunotherapeutics Pipeline
Viral Vaccines:
Rotarix®, developed in collaboration with GlaxoSmithKline
HIV-Therapore®, partnered with the U.S. Army
Bacterial Vaccines:
CholeraGarde®
Typhoid Fever
ETEC - E. coli
Shigella
Campylobacter
Biodefense Vaccines:
Injectable Anthrax vaccine
Oral Anthrax/Plague Combination
Oral Anthrax
DVC-DynPort Vaccine Company LLC
DynPort Products:
Anthrax Vaccine (rPA)
Botulinum Multivalent Vaccine (rBoT)
Botulinum Polyclonal Anti-toxin
Plague Vaccine (F1-V)
Staphylococcal Enterotoxin Vaccine (rSEB)
Tularemia Vaccine
Smallpox Vaccine
Vaccinia Immune Globulin (VIG)
Venezuelan Equine Encephalitis (VEE) Vaccine
Smallpox Vaccines:
Elstree-BN*
MVA-BN*
* Ordered by governments as vaccines in development.
HIV Vaccines:
MVA-BN HIV nef
MVA-BN HIV Polytope
MVA-BN HIV Multiantigen
Japanese Encephalitis Vaccine:
MVA-BN JEV
Dengue Fever Vaccine:
MVA-BN DF
rPA102: VaxGen's Anthrax Vaccine
LC16m8: VaxGen's Attenuated Smallpox Vaccine
AIDSVAX®
Nabi Biopharmaceuticals Pipeline
StaphVAX®-Staphylococcus aureus Polysaccharide
Conjugate Vaccine
Altastaph™-Staphylococcus aureus Immune Globulin Intravenous (Human)
NicVAX™-Nicotine Conjugate Vaccine
Civacir™-Hepatitis C Immune Globulin (Human)
Nabi-HB® Intravenous-Hepatitis B Immune Globulin
HEBIG™ (Europe)-Hepatitis B Immune Globulin
Nabi
Biopharmaceuticals begins human testing of novel vaccine to fight nicotine
addiction
Human Papilloma Virus vaccine/therapeutic - recombinant HPV-16 L1 virus-like particle (VLP) vaccine in phase II/III clinical development and HPV-16 chimeric VLP vaccine in pre-clinical development with the National Cancer Institute (NCI) and King Pharmaceuticals;
Hepatitis E vaccine - recombinant HEV ORF2 antigen as vaccine in Phase II clinical development with the National Institute of Allergy and Infectious Diseases (NIAID), Walter Reed Army Institute for Research, and Glaxo Smith Kline Pharmaceuticals;
Melanoma vaccine/therapeutic - recombinant human melanoma GP100 and NY-ESO-1 antigens for therapeutic use in pre-clinical development with the National Cancer Institute (NCI);
Malaria vaccine - recombinant MSP1 protein vaccines in pre-clinical development with the National Institute of Allergy and Infectious Diseases (NIAID);
Anti-Stroke therapeutic - recombinant E-selectin antigens for tolerization of high-risk stroke patients in pre-clinical development with the National Institute of Neurological Disorders and Stroke;
Influenza VLP vaccine - recombinant human and
avian influenza virus-like particle vaccines in pre-clinical development.
MediGene Projects in clinical development
TransMIDTM™
(XR311)
Indication High-grade glioma (brain cancer)
Design Modified diphtheria toxin (CRM107) conjugated to transferrin (Tf)
Status Phase III
Tariquidar
(XR9576)
Indication Multi-drug resistance in cancer
Design P-glycoprotein antagonist
Status Phase II
Novel
DNA Targeting Agents-Product XR11576, XR5944, XR11612
Indication Solid tumours
Design Novel mode of action
Status XR11576 and XR5944 both in Phase I XR11612 in pre-clinical testing
XR303
Indication Late stage pancreatic cancer
Design Radio-immunotherapy
Status Phase I/II
TA-CD
Indication Cocaine dependence
Design Therapeutic Vaccine (protein conjugate)
Status Phase II
TA-NIC
Indication Nicotine dependence
Design Therapeutic Vaccine (protein conjugate)
Status Phase I
0X40
Indication Inflammatory and autoimmune disease; infectious disease and cancer
Design Fusion protein
Status Pre-clinical
Technology evaluation: NeuroVax, immune response corp
New Breast Cancer Vaccine Passes First Hurdle Experimental Breast Cancer Vaccine Halts Tumors in Mice
New Vaccine for Treatment of Colorectal Cancer Shows Promise in Phase II Trial
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