Company* |
Product | Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Pediatric Crohn's disease |
The FDA approved the drug for use in pediatric patients with moderately to severely active disease who have inadequately responded to conventional therapy (5/19) |
CANCER | ||||
Accentia Bio- |
BiovaxID |
Personalized vaccine; tumor antigen conjugated to KLH administered with GM-CSF |
Follicular non- Hodgkin'slymphoma |
Accentia's majority-owned sub- sidiary, Biovest International Inc., was granted fast-track status for the product by the FDA (5/11) |
Adventrx |
CoFactor |
Form of folic acid designed to enhance the effects of 5-FU |
Metastatic colorectal cancer |
Reached agreement on SPA with FDA for Phase III trial to compare drug to leucovorin as part of first- line regimens (5/22) |
Bioniche Life |
Urocidin |
Mycobacterial cell wall- DNA complex |
Bladder cancer |
The FDA granted fast-track designation to the product for treating non-muscle invasive bladder cancer in BCG-refractory patients (5/4) |
Celgene |
Thalomid (FDA-approved) |
Thalidomide |
Multiple myeloma |
The FDA granted accelerated approval to sNDA for use with dex- amethasone for treating newly diagnosed MM (5/25) |
Cell Genesys |
GVAX |
Vaccine comprising non- patient-specific tumor cells modified to secrete GM-CSF; an immunotherapy |
Prostate cancer |
The FDA granted fast-track designation in that indication, for which Phase III trials are ongoing (5/10) |
Genentech |
Avastin |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Advanced breast cancer |
Submitted supplemental BLA with FDA seeking approval for use with taxane chemotherapy in first-line metastatic disease (5/25) |
Hana |
Talotrexin (PT-523) |
Non-classical antifolate; analogue of aminopterin |
Acute lymphoblastic leukemia |
The FDA granted orphan designation to the product in that indication (5/22) |
Marshall |
Phenoxodiol |
Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP |
Advanced ovarian cancer |
Reached agreement with FDA on pivotal Phase III OVATURE trial that will assess restoration of sensitivity to carboplatin (5/16) |
MGI Pharma |
Dacogen |
Decitabine for injection; a hypomethylating agent |
Myelodysplastic syndromes |
The FDA approved the product and gave it a broad label for treating MDS; MGI will market the drug (5/3) |
Novelos |
NOV-002 |
Oxidized glutathione- based compound; chemo- protectant and immuno-modulator |
Advanced non-small- cell lung cancer |
Reached agreement with FDA on SPA for pivotal Phase III trial to evaluate drug in first-line chemo- therapy regimen (5/30) |
Oxford |
TroVax |
Vaccine that delivers an antigen (5T4) using a poxvirus vector |
Renal cell carcinoma |
Reached agreement on SPA with FDA for Phase III TRIST trial, which will evaluate vaccine with first-line standard therapy (5/12) |
OxiGene Inc. |
Combrestatin A4 Prodrug |
Vascular-targeting agent designed to block the flow of blood to a tumor |
Ovarian cancer |
The FDA granted orphan designation to the product in that indication (5/15) |
CARDIOVASCULAR | ||||
Cardiome |
RSD1235 |
Intravenous formulation of drug designed to selectively block ion channels in the heart |
Atrial fibrillation |
The FDA issued a refusal to file response to NDA that was filed in March by Cardiome partner Astellas Pharma US Inc. (5/31) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon |
Nuvigil |
Armodafinil; single-isomer formulation of the active ingredient in Provigil (modafinil) |
Excessive sleepiness |
FDA issued approvable letter for treating sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder; approval is contigent only on product labeling (5/1) |
Neurocrine |
Indiplon |
Capsule formulation of a non-enzodiazepine agent that targets the GABA-A receptor |
Insomnia |
The FDA said the 5-mg and 10-mg capsule formulations of the drug were approvable; a re-analysis of data was requested (5/16) |
Neurocrine |
Indiplon |
Extended-release tablet formulation of a non- enzodiazepine agent that targets the GABA-A receptor |
Insomnia |
The FDA said the agent was not approvable; it asked for a re-analysis of certain safety and efficacy data, likely requiring additional clinical data (5/16) |
NeuroHealing |
NH001 |
Dopaminergic agonist |
Brain injury |
The FDA granted orphan designation to the product for treating patients in a vegetative or minimally conscious state (5/25) |
INFECTION | ||||
Caprion |
Shigamabs |
Intravenous agent consisting of the monoclonal antibodies caStx1 and caStx2 |
Shigatoxin- producing bacterial infections |
The FDA granted fast-track designation to the product in that indication, for which a pivotal trial is being planned (5/10) |
Coley |
Actilon (CPG 10101) |
Agent designed to target and stimulate Toll-like receptor 9 |
Hepatitis C |
The FDA granted fast-track status to the product for treating refractory patients chronically infected with HCV (5/17) |
Cubist |
Cubicin (FDA-approved) |
Daptomycin for injection; a bactericidal antibiotic |
S. aureus bacteremia and endocarditis |
The FDA approved supplemental application for the new indication of treating bloodstream infections (5/25) |
Nektar |
ABIP |
Amphotericin B inhalation powder |
Pulmonary fungal infections |
The FDA granted fast-track status to the product for prevention of funal infections in patients at risk for aspergillosis (5/22) |
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg |
Alvimopan capsules; mu opioid antagonist |
Post-operative ileus |
The FDA accepted as complete the response to the July 2005 NDA approvable letter; the PDUFA date is Nov. 9(5/31) |
Aradigm |
-- |
Aerosolized, liposomal formulation of ciprofloxacin |
Cystic fibrosis |
The FDA granted orphan designation to the product in that indication (5/9) |
CollaGenex |
Oracea |
Capsule formulation of doxycycline |
Rosacea |
The FDA approved the drug for treating inflammatory lesions of rosacea in adult patients (5/30) |
Dyax Corp. |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
The FDA said more clinical data would be needed than was planned, likely setting back the development timeline (5/15) |
NPS |
Preos |
Recombinant human parathyroid hormone |
Osteoporosis |
The FDA said NPS should conduct another clinical trial to address the hypercalcemia issue raised in March 2006 approvable letter (5/2) |
Regeneron |
IL-1 Trap |
Agent designed to attach to and neutralize interleukin-1 |
CIAS1-associated periodic syndromes |
The FDA granted fast-track designation to the product for treating chronic inflammation in patients with CAPS, a spectrum of rare genetic disorders (5/31) |
Threshold |
TH-070 |
lonidamine; an indazole-3-carboxylic acid |
Benign prostatic hyperplasia |
The FDA placed a hold on Phase II program due to abnormalities seen in liver enzyme levels; the company must provide additional information to the FDA (5/11) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. |