Company* |
Product |
Description |
Indication |
Status |
AUTOIMMUNE | ||||
Novogen |
NV-52 |
Synthetic analogue based on the phenolic structure of naturally occurring isoflavones |
Inflammatory bowel disease |
Began Phase I trial in Australia to evaluate safety and inflammatory markers in 12 volunteers (8/7) |
CANCER | ||||
Epeius |
Rexin-G |
Gene therapy vector containing a gene that blocks the action of the cyclin G1 gene |
Solid tumors |
The product was granted accelerated approval in the Philippines for treating all solid tumors (8/10) |
Immutep SA* |
ImmuFact IMP321 |
T-cell immunostimulatory factor designed to amplify T- cell responses |
Metastatic breast cancer |
Began Phase I trial in France to evaluate use of the drug after paclitaxel treatment (8/3) |
Generex |
AE37 |
Synthetic peptide vaccine designed to stimulate response against tumors expressing the HER-2/neu oncogene |
Prostate cancer |
Began Phase II trial in Greece to evaluate the vaccine in 30 patients; the product comes from Generex subsidiary Antigen Express (8/8) |
MGI Pharma |
Dacogen (FDA-approved) |
Decitabine for injection; a hypomethylating agent |
Acute myeloid leukemia |
The EMEA granted orphan designation to the product in Europe in that indication (8/1) |
Pharmexa |
HER-2 Protein AutoVac |
Vaccine designed to generate an antibody response against the HER-2 protein |
Stage IV breast cancer |
Data from the first 10 patients in Phase II trial testing drug with the adjuvant QS-21 did not show efficacy; further recruitment was stopped (8/14) |
Spectrum |
Ozarelix |
Fourth-generation luteinizing hormone- releasing hormone |
Hormone- dependent prostate cancer |
Phase II trial in 64 patients in Europe showed encouraging safety and efficacy results (8/2) |
CARDIOVASCULAR | ||||
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
The company was notified that the product is being approved in Europe (8/10) |
GTC |
ATryn |
Recombinant form of human antithrombin |
Venous thrombo- embolism |
The product was approved in Europe for the prophylaxis of VT in surgery of patients with congenital antithrombin deficiency (8/2) |
CENTRAL NERVOUS SYSTEM | ||||
Addex |
ADX10059 |
Selective modulator of the metabotropic glutamate receptor |
Migraine |
Began Phase IIa trial in Europe to evaluate efficacy, safety and toler- ability (8/30) |
Evotec AG |
EVT 101 |
NR2B subtype selective NMDA receptor antagonist |
Alzheimer's disease |
Phase I trial in healthy volunteers demonstrated favorable tolerability and pharmacokinetics (8/9) |
GW |
Sativex |
Spray formulation of cannabis extract |
Central neuropathic pain |
Began Phase III trial in Europe and Canada to evaluate pain relief in 218 patients with multiple sclerosis (8/9) |
Labopharm |
-- |
Once-daily formulation of the analgesic tramadol |
Pain |
Canadian regulators accepted marketing application for review; the targeted review period is 300 days (8/28) |
Transition |
AZD-103 |
Scyllo-cyclohexanehexol; oral agent that acts on beta amyloid |
Alzheimer's disease |
Phase I trial in Canada demon- favorable safety, tolerability and pharmacokinetics (8/8) |
Vectura Group |
VR040 |
Inhaled formulation of apomorphine |
Parkinson's disease |
Phase II trial demonstrated safety, tolerability and recovery from an induced "off" episode of PD (8/8) |
DIABETES | ||||
Diamyd |
Diamyd |
Agent containing GAD65, the dominating autoantigen in autoimmune diabetes |
Type I diabetes |
Phase II trial in 70 young people in Sweden demonstrated statistically significant preservation of insulin production (8/25) |
Phosphagenics |
TPM-02/ Insulin |
Insulin delivered by transdermal carrier |
Diabetes |
Phase I trial in healthy volunteers demonstrated delivery of insulin through the skin (8/23) |
INFECTION | ||||
ACE |
ACE393 |
Injectable vaccine against Campylobacter jejuni |
Travelers' diarrhea |
Began Phase I trial in France to evaluate safety, tolerability and immunogenicity in up to 72 healthy subjects (8/31) |
Arpida Ltd. |
AR-709 |
Bactericidal antibiotic agent |
Infections |
Is starting a microdose study in healthy volunteers in the UK to evaluate pharmacokinetics (8/3) |
Biota Holdings Ltd. |
Relenza |
Zanamivir for inhalation; neuraminidase inhibitor |
Influenza |
GSK gained marketing approval of the drug in Europe for preventing flu in those 5 years old and BTA) and Glaxoolder, and for treating children who are 5 or older (8/25) |
Biota |
BTA-798 |
Agent targeting the human rhinovirus |
The common cold |
Phase Ia trial in the UK demonstrated safety and tolerability (8/2); began Phase Ib trial in the UK in 32 healthy volunteers (8/17) |
Cellegy |
Savvy |
C31G vaginal gel |
HIV prevention |
Monitors said trial in Nigeria was unlikely to provide evidence of efficacy, based on interim data; the trial was being stopped (8/28) |
Oscient |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Multiple indications |
The product was approved in Mexico for community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis (8/1) |
Sinovac |
-- |
Vaccine against H5N1 influenza virus |
Influenza |
Preliminary data from Phase I trial showed different doses induced immune responses (8/28) |
Transave Inc.* |
SLIT Amikacin |
Inhaled, sustained-release liposome formulation of amikacin |
Pseudomonas aeruginosa infections |
The product was granted orphan designation in Europe for treating P. aeruginosa lung infections in cystic fibrosis patients (8/2) |
MISCELLANEOUS | ||||
Athersys |
ATHX- 105 |
Selective agonist of the serotonin receptor 5HT2c |
Obesity |
Is starting a Phase I trial in the UK to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (8/10) |
BioBalance |
Probactrix |
Single strain of non- pathogenic E. coli M-17 |
Gastro- esophageal reflux disease |
Began open-label trial in Israel to evaluate the product in 30 GERD patients (8/16) |
IDEA AG* |
IDEA-033 |
Analgesic agent keptoprofen delivered by ultradeformable carriers |
Osteoarthritis of the knee |
Phase III trial in 866 patients in Europe demonstrated statistical significance at the highest dose levels (8/2) |
Genzyme |
Synvisc (FDA-approved) |
Hylan G-F20; an elastoviscous hylan therapeutic |
Osteoarthritis |
Filed for expanded approval in Europe to include treatment of pain due to osteoarthritis of the ankle and shoulder (8/11) |
NeuroSearch |
Tesofensine (NS2330) |
Agent designed to inhibit reuptake of serotonin, noradrenaline and dopamine |
Obesity |
Is starting Phase IIb TIPO-1 trial to evaluate the product in 200 patients (8/18) |
TopoTarget |
Savene (Totect) |
Dexrazoxane; inhibitor of topoisomerase II |
Antidote to anthracyline extravasation |
The product was approved in Europe for protecting tissue from accidental exposure to cancer agents during chemotherapy (8/2) |
Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; MRP = Mutual Recognition Procedure; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
