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Product Development Pipeline
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The NIH Intramural Research Program is exceptionally innovative as exemplified by the many products currently on the market that benefit the public everyday (see Product Showcase). There are also almost 1,400 inventions from the Intramural Program that are currently available for licensing to companies for commercial development (see Licensing Opportunities). Many inventions, however, have been licensed and are now in clinical development with the hope of eventually reaching the market. These inventions are shown below as a development pipeline and illustrate the valuable synergy between NIH and industry as well as the depth and richness of the science conducted at NIH.

A graphical representation of these products in the pipeline can be found here: Link: Product Pipeline

PRODUCT DEVELOPMENT » THERAPEUTICS

Indication IC Licensee Product Phase
I
Phase
II
Phase
III
NDA Market
Cancer NCI Schering AG Fludara® graphic bar indicating product status = Market
Cancer NCI Bristol-Myers Squibb Taxol® graphic bar indicating product status = Market
HIV NCI Barr Laboratories Didanosine Delayed-Release Capsules graphic bar indicating product status = Market
HIV NCI Roche Laboratories Hivid® graphic bar indicating product status = Market
HIV NCI Tibotec Pharmaceuticals Prezista® graphic bar indicating product status = Market
HIV NCI Bristol-Myers Squibb Videx® graphic bar indicating product status = Market
Multiple myeloma NCI Millennium Pharmaceuticals Velcade® graphic bar indicating product status = Market
Non-Hodgkin's lymphoma NCI Coulter Corporation Zevalin® graphic bar indicating product status = Market
Respiratory syncytial virus NIAID MedImmune Synagis® graphic bar indicating product status = Market
Severe mucositis associated with hematological cancers NCI Biovitrum Kepivance® graphic bar indicating product status = Market
Glioblastoma NCI
FDA
Neo-Pharm Cintredekin Besudotox (IL13-PE38QQR) graphic bar indicating product status = Phase III    
Metastatic melanoma NCI Medarex MDX-010 (gp100 peptide used in conjunction with Ipilimumab) graphic bar indicating product status = Phase III    
Multiple myeloma NCI KOSAN Biosciences KOS-953 [17-AAG (tanespimycin)] graphic bar indicating product status = Phase III    
Acute radiation syndrome NCI Humanetics BIO 300 graphic bar indicating product status = Phase II      
Anemia associated with uterine fibroids NICHD Repros Therapeutics Proellex® graphic bar indicating product status = Phase II      
Anestic mild cognitive impairment (aMCI)
Schizophrenic related cognitive impairment
NICHD Allon Therapeutics AL-108 (Davunitide intranasal) graphic bar indicating product status = Phase II      
Rheumatoid arthritis
Dry eye syndrome
Psoriasis
NIDDK Can-Fite Biopharma CF101 graphic bar indicating product status = Phase II      
Brain cancer NCI
NINDS
Protox Therapeutics PRX321 graphic bar indicating product status = Phase II      
Breast cancer NCI KOSAN Biosciences KOS-1022 [17-DMAG (alvespimycin)] graphic bar indicating product status = Phase II      
Cancer NCI
FDA
Ascenta Therapeutics AT-101 oral pan Bcl-2 inhibitor graphic bar indicating product status = Phase II      
Cancer NCI Centocor CNTO 888 (anti-MCP-1) graphic bar indicating product status = Phase II      
Cancer NCI Morphotek MORAb-009 graphic bar indicating product status = Phase II      
HPV cervical dysplasia NCI Eisai Inc. Amolimogene (ZYC101a) graphic bar indicating product status = Phase II      
Human papilloma virus NIAID Transgene S.A. TG 4001/R3484 graphic bar indicating product status = Phase II      
Inflammatory bowel disease NIAID Abbott Bioresearch Center ABT-874 graphic bar indicating product status = Phase II      
Inflammatory bowel disease
Idiopathic pulmonary fibrosis
NIAID Centocor CNTO 888 (anti-MCP-1) graphic bar indicating product status = Phase II      
Lipoprotein lipase deficiency NHLBI Amsterdam Molecular Therapeutics Glybera® (AMT-011) graphic bar indicating product status = Phase II      
Liver cancer
Hepatitis C virus
NIDDK Can-Fite Biopharma CF102 graphic bar indicating product status = Phase II      
Lung cancer NIAID Transgene S.A. TG 4010 graphic bar indicating product status = Phase II      
Mild cognitive impairment (MCI) as a complication of Coronary Bypass Graft Surgery (CABG) NICHD Allon Therapeutics AL-208 (Davunitide intravenous) graphic bar indicating product status = Phase II      
Schizophrenia NIMH HoustonPharma Oral idazoxan graphic bar indicating product status = Phase II      
Wound healing NIDCR RegeneRX Biopharmaceuticals Thymosin Beta 4 graphic bar indicating product status = Phase II      
Alzheimer's disease NICHD Allon Therapeutics AL-108 (Davunitide intranasal) graphic bar indicating product status = Phase I        
Cancer NCI Tigris Pharmaceuticals AFP-464 graphic bar indicating product status = Phase I        
Cancer NCI MedImmune CAT-3888 (BL22) graphic bar indicating product status = Phase I        
Cancer NCI MedImmune CAT-8015 (HA22) graphic bar indicating product status = Phase I        
Cancer NCI Introgen Therapeutics DOTAP:Chol Fus1 liposomal complex graphic bar indicating product status = Phase I        
Hepatitis C virus NIAID Transgene S.A. TG 4040 graphic bar indicating product status = Phase I        
HIV NCI Sarawak MediChem Pharmaceuticals Calanolide A graphic bar indicating product status = Phase I        
Hypertension NIEHS Arete Therapeutics AR9281 graphic bar indicating product status = Phase I        
Inflammatory bowel disease NIAID SBL Vaccine AB Recombinant cholera toxin B-subunit graphic bar indicating product status = Phase I        
Inflammatory diseases NICHD Clarassance rhCC10 uteroglobulin graphic bar indicating product status = Phase I        
Tuberculosis NIAID Sequella SQ109 graphic bar indicating product status = Phase I        


PRODUCT DEVELOPMENT » VACCINES

Indication IC Licensee Product Phase
I
Phase
II
Phase
III
NDA Market
Hepatitis A virus NIAID GlaxoSmithKline Havrix® graphic bar indicating product status = Market
Hepatitis A & B viruses NIAID GlaxoSmithKline Twinrix® graphic bar indicating product status = Market
Hepatitis A virus & typhoid NIAID GlaxoSmithKline Hepatyrix® graphic bar indicating product status = Market
Human papilloma virus NCI GlaxoSmithKline Cervarix® graphic bar indicating product status = Market
Human papilloma virus NCI Merck Gardasil® graphic bar indicating product status = Market
Kidney cancer NIAID Oxford BioMedica TroVax® graphic bar indicating product status = Phase III    
Kidney disease NICHD North American Biologicals StaphVAX® graphic bar indicating product status = Phase III    
Hepatitis C virus NCI Intercell AG IC41 graphic bar indicating product status = Phase II      
Hepatitis E virus NIAID GlaxoSmithKline   graphic bar indicating product status = Phase II      
HIV NIDDK Targeted Genetics tgAAC09 graphic bar indicating product status = Phase II      
Hypertension NCI Cytos Biotechnology CYT006-AngQb graphic bar indicating product status = Phase II      
Inflammatory arthritis NIDDK Targeted Genetics tgAAC94 graphic bar indicating product status = Phase II      
Lung cancer NCI IDM Pharma IDM-2101 graphic bar indicating product status = Phase II      
Parainfluenza virus type 3 NIAID MedImmune MEDI-534 graphic bar indicating product status = Phase II      
Parvovirus B19 NHLBI Viral Antigens   graphic bar indicating product status = Phase II      
Cystic fibrosis NIAID
NCI
Trinity Biosystems   graphic bar indicating product status = Phase I        
HIV NCI Novartis HIV Subtype B DNA-PLG and gp140 delta V2 protein vaccine graphic bar indicating product status = Phase I        
HIV NCI Wyeth HIV-1 vaccine graphic bar indicating product status = Phase I        
Meningitis NIDCD
FDA
PATH Meningococcal Group A conjugate vaccine graphic bar indicating product status = Phase I        


PRODUCT DEVELOPMENT » DIAGNOSTICS/DEVICE PRODUCTS  
REQUIRING IND/IDE/NDA REGULATORY PROCESSES

Indication IC Licensee Product Phase
I
Phase
II
Phase
III
NDA Market
Cancer NCI Ventana Medical Systems CONFIRM™ anti-HER-2 (CB11) PAB graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems CONFIRM™ anti-C-erbB-2 graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems CONFIRM™ anti-HER-2/neu (4B5) CE graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems HER-2 FISH graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems HER-2 SISH graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems HER-2/neu Slides graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems INFORM® HER-2 DNA Probe graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems PATHWAY® anti-HER-2 PAB graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems PATHWAY® anti-HER-2/neu (4B5) graphic bar indicating product status = Market
Cancer NCI Ventana Medical Systems PATHWAY® HER-2/neu CPT graphic bar indicating product status = Market
Cardiovascular NIA Angiotech Pharmaceuticals / Boston Scientific TAXUS® paclitaxel-eluting stent systems graphic bar indicating product status = Market
Cardiovascular NIA Angiotech Pharmaceuticals / Cook Medical Zilver-PTX drug-eluting peripheral stent graphic bar indicating product status = Market
HIV NCI LabCorp GenoSURE™ graphic bar indicating product status = Market
HIV NCI LabCorp GenoSURE™ PLUS graphic bar indicating product status = Market
HIV NCI Abbott Labs HIV-1 diagnostic test graphic bar indicating product status = Market
HIV NCI PerkinElmer HIV-1 diagnostic test graphic bar indicating product status = Market
HIV NIAID
NCI
NIMH
Monogram Biosciences HIV-1 genotyping and phenotyping graphic bar indicating product status = Market
HIV NCI Trinity Biotech Capillus™ HIV-1/HIV-2 antibody test graphic bar indicating product status = Market
HIV NCI Trinity Biotech Uni-Gold™ HIV-1/HIV-2 antibody test graphic bar indicating product status = Market
HIV NCI Trinity Biotech Uni-Gold™ Recombigen® HIV-1 antibody test graphic bar indicating product status = Market
HIV NCI Abbott Labs HTLV-I/II tests graphic bar indicating product status = Market
HTLV-I NCI bioMerieux Vironostika® HTLV-I / HTLV-II graphic bar indicating product status = Market
HTLV-III NCI OraSure Technologies OraQuick ADVANCE® Rapid HIV 1/2 Antibody Test graphic bar indicating product status = Market
HTLV-III NCI bioMerieux Vironostika® HIV-1 graphic bar indicating product status = Market
Research reagent NCI
NIAID
BD Biosciences Cytochrome P450 isoenzymes graphic bar indicating product status = Market
Thyroid cancer NIDDK Genzyme Diagnostics Thyrogen® graphic bar indicating product status = Market
Colorectal cancer NCI Dow Chemical / Neoprobe RIGScan CR® (CC49) graphic bar indicating product status = Phase III    
Drug delivery NINDS NeoPharm Delivery mechanism for Cintredekin Besudotox graphic bar indicating product status = Phase III    
Cancer NCI BSD Medical Corporation BSD-2000/Sigma Eye graphic bar indicating product status = Phase II      
Mental health NIDA
NINDS
Brainsway Deep TMS H system graphic bar indicating product status = Phase I        
Research tool NCI Ludwig Institute for Cancer Research CHX-A-DTPA graphic bar indicating product status = Phase I        


PRODUCT DEVELOPMENT » DIAGNOSTICS/DEVICE PRODUCTS  
REQUIRING 510K REGULATORY PROCESSES

Indication IC Licensee Product Prototype Registration Trial(s) 510(k)/PMA Application Market
Breast cancer NCI Abbott Molecular Vysis Path Reagents graphic bar indicating product status = Market
Cancer NCI Fujirebio Diagnostics CA 72-4 in vitro radioimmunoassay graphic bar indicating product status = Market
Cancer NCI Stratagene QuikChange® XL Site-Directed Mutagenesis Kit graphic bar indicating product status = Market
Device NCI
NIBIB
Molecular Devices Corporation PixCell laser capture microdissection system graphic bar indicating product status = Market
Imaging NHLBI General Electric Angiography MRI software graphic bar indicating product status = Market
Imaging NICHD General Electric MRI systems utilizing tensor diffusion pulse sequence graphic bar indicating product status = Market
Imaging NICHD
NINDS
Siemens AG Diffusion tensor evaluation, imaging, and tractography software graphic bar indicating product status = Market
Imaging NHLBI Siemens Medical Solutions USA syngo imaging software graphic bar indicating product status = Market
Norwalk-like viruses NIAID R-Biopharm AG RIDASCREEN® Norwalk-like Virus ELISA graphic bar indicating product status = Market
Research reagent NCI BD Biosciences - BD PharMingen Interleukin-8 protein and antibodies graphic bar indicating product status = Market
Research reagent NIAID R&D Systems Interleukin-8 receptor graphic bar indicating product status = Market
Research reagent NIDDK GTC Biotherapeutics Transgenic milk expression kit graphic bar indicating product status = Market


PRODUCT DEVELOPMENT » CONSUMER PRODUCTS

Indication IC Licensee Product Development Market
Macular degeneration NEI Bausch & Lomb PreserVision® graphic bar indicating product status = Market


PRODUCT DEVELOPMENT » VETERINARY PRODUCTS

Indication IC Licensee Product Development Market
Equine West Nile virus vaccine NIAID Sanofi Pasteur Biologics PreveNile® 1D graphic bar indicating product status = Market
Equine West Nile virus vaccine NIAID Merial RECOMBITEK® graphic bar indicating product status = Market
Feline leukemia virus vaccine NIAID Merial PUREVAX® graphic bar indicating product status = Market
Rabies virus vaccine (oral) for wildlife NIAID Merial RABORAL V-RG® graphic bar indicating product status = Market
 
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