Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Active Biotech |
Laquinimod (SAIK-MS) |
Immunomodulatory substance |
Multiple sclerosis |
Phase II trial in 22 patients showed the drug was well tolerated at higher doses (9/27) |
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Celera |
CRA-028129 |
Cathepsin S inhibitor |
Psoriasis |
Began Phase I trial in New Zealand that will evaluate the drug in 70 healthy volunteers (9/20) |
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Isotechnika |
ISA247 |
Immunosuppressive agent |
Plaque psoriasis |
Phase III SPIRIT trial in 453 patients in Canada met all primary and secondary endpoints (9/21) |
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CANCER | ||||
Active Biotech |
TTS CD2 |
A TTS, or tumor-targeted superantigen |
Renal cancer |
Median survival at two years in Phase II trial in 43 advanced patients was 19.7 months, with 13 patients still alive (9/29) |
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Aegera |
AEG35156 |
Second-generation XIAP antisense agent |
Solid tumors |
Began Phase I trial in Canada to evaluate dosing in combination with docetaxel (9/21) |
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AEterna |
Perifosine |
Oral signal transduction inhibitor |
Advanced non- small-cell lung cancer |
Began Phase II trial in Europe to evaluate efficacy and safety with radiotherapy in 160 patients with inoperable Stage III disease (9/22) |
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Altachem |
ACP-SL017 |
Photodynamic therapy compound |
Actinic keratosis |
Starting Phase I trial in Canada to evaluate toxicity with and without photoactivation, and therapeutic effects (9/1) |
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Avantogen |
RP101 |
Antiviral drug marketed in Europe that down- regulates the STAT3 and APEX genes |
Pancreatic cancer |
Presented updated survival data in 13 patients showing continued benefit of adding drug to chemotherapy (9/20) |
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Bioenvision |
Modrenal |
Drug designed to increase estrogen binding to ER beta and decrease binding to ER alpha |
Advanced breast cancer |
Began Phase IV trial in the UK to evaluate efficacy in up to 54 post-menopausal women who failed therapy with new- generation aromatase inhibitors (9/21) |
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Gentium SpA |
Defibrotide |
Single-stranded DNA designed to protect vascular endothelial cells |
Advanced multiple myeloma |
Began Phase I/II trial in Italy to evaluate the drug as part of a chemotherapy regimen in salvage therapy (9/21) |
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ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Metastatic colorectal cancer |
The product was approved in Canada for use in combination with irinotecan for treating EGFR-expressing, metastatic, refractory disease (9/15) |
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Immunomedics |
Labetuzumab |
I-131-labeled humanized monoclonal antibody targeting a specific site on carcinoembryonic antigen |
Colorectal cancer |
Five-year trial in Germany in 23 patients found those treated with drug after surgery survived twice as long as various controls (9/21) |
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Onyx |
Sorafenib (BAY 43-9006) |
RAF kinase and VEGF inhibitor |
Advanced kidney cancer |
They filed an MAA seeking approval of the product in Europe (9/12) |
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OSI |
Tarceva (FDA-approved) |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor |
Advanced non- small-cell lung cancer |
Partner F. Hoffmann-La Roche Ltd. gained approval of the drug in Europe for use after failure of at least one chemotherapy regimen (9/21) |
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Neutec |
Mycograb |
Recombinant antibody that binds to heat-shock protein 90 |
Breast cancer |
Began Phase Ib trial to evaluate safety and efficacy with docetaxel in 20 patients in Serbia and Poland (9/19) |
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Novagali |
Nova12005 |
Oral formulation of paclitaxel |
Cancers |
Phase I trial in the Netherlands in patients with advanced cancers showed drug was safe and well tolerated (9/19) |
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PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Cancers |
Began Phase I/II trial with DTIC in malignant melanoma and began Phase I trial with carboplatin in advanced solid and hematological cancers (9/15) |
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Praecis |
Plenaxis (FDA-approved) |
Abarelix for injection, depot formulation; gonadotropin- releasing hormone antagonist |
Prostate cancer |
The drug was approved in Ger- many to initiate hormonal castration in patients with advanced, hormone-dependent disease, if androgen suppression is appropriate (9/28) |
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Procyon |
PCK3145 |
Synthetic peptide analogue of prostate secretory protein |
Metastatic prostate cancer |
Results from amended Phase IIa trial in the UK further confirmed safety and tolerability (9/28) |
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SGX |
Troxatyl |
Troxacitabine; nucleoside analogue |
Acute myelogenous leukemia |
The product was granted orphan drug status in Europe in that indication (9/27) |
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Solbec |
Coramsine (SBP002) |
Combination of two glycoalkaloids isolated from the fruit of Solanum linnaeanum |
Advanced solid tumors |
Phase I trial demonstrated safety and tolerability and showed potential therapeutic benefit (9/5) |
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Spectrum |
EOquin |
Synthetic prodrug activated by enzymes prevalent in hypoxic cancer cells |
High-risk superficial bladder cancer |
Began Phase II trial to test the drug in 50 patients in the Netherlands (9/6) |
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YM |
TheraCIM |
Nimotuzumab; humanized anti-epidermal growth factor receptor monoclonal antibody |
Advanced high-grade gliomas |
Updated data on 27 children in Phase II monotherapy trial showed antitumor activity without toxicities (9/27) |
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CARDIOVASCULAR | ||||
Affymax Inc.* |
Hematide |
Synthetic, peptide-based erythropoiesis-stimulating agent |
Anemia |
Began a third Phase II trial, a study in Europe to evaluate safety and pharmacokinetics of repeat injections (9/21) |
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AVI |
Resten-MP |
Intravenous delivery of AVI-4126, an antisense drug targeting the c-myc transcription factor |
Cardiovascular restenosis |
Began Phase II APPRAISAL trial in Germany to test the drug with the placement of one or more bare-metal stents (9/20) |
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GTC |
ATryn |
Recombinant form of human antithrombin |
Hereditary antithrombin deficiency |
The EMEA extended its timeline for reviewing the MAA, pushing an expected decision back to February 2006 (9/16) |
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Medicure Inc. |
MC-4232 |
A combination of MC-1 and an ACE inhibitor |
Hypertension |
Phase II MATCHED trial in co- existing diabetes and hypertension met primary blood pressure and metabolic endpoints (9/14) |
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Novogen Ltd. |
Trans-NV-04 |
Antioxidant that inhibits smooth muscle cell growth in blood vessels; an isoflavonoid compound |
Cardiovascular disease |
Phase Ib trial in Australia showed significant improvement in blood pressure and arterial stiffness in 25 at-risk patients (9/13) |
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Protein Design |
Ularitide |
Synthetic version of urodilatin, a natriuretic peptide produced in the kidney |
Acute decompensated heart failure |
Phase II SIRIUS II European trial in 221 patients showed significant improvements in dyspnea and decreased pulmonary pressure (9/4) |
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Speedel |
SPP100 (Aliskiren) |
Oral renin inhibitor |
Hypertension |
Novartis released positive data from Phase III trials using the drug as a monotherapy and in combination treatment (9/20) |
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CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. |
Risperdal |
Risperidone formulated in Alkermes' long-acting Medisorb technology |
Schizophrenia |
The product was approved in Italy; it has approval in more than 70 countries (9/15) |
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CeNeS |
M6G |
Morphine-6-glucuronide peptide vector |
Post-operative pain |
Began pivotal Phase III trial in Europe to compare drug to morphine following surgery in 428 patients (9/29) |
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Genmab A/S |
HuMax-CD20 |
Human antibody that binds to the CD20 antigen |
Relapsed chronic lymphocytic leukemia |
12 of 23 patients taking highest dose in Phase I/II trial achieved a clinical response; 5 had a complete response (9/15) |
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GW |
Sativex |
Spray formulation of cannabis extract |
Pain and sleep disturbance in multiple sclerosis |
66-patient trial in the UK showed statistical significance vs. placebo (9/27) |
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Labopharm |
-- |
Once-daily formulation of the analgesic tramadol |
Pain |
Received regulatory approval under the MRP process, paving the way for approval in 22 countries in Europe(9/6) |
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Neurochem |
Alzhemed |
Small molecule designed to interfere with association between glycosamino- glycans and A-beta protein |
Alzheimer's disease |
Began European Phase III trial to evaluate safety and efficacy in 930 patients with mild to moderate AD (9/13) |
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DIABETES | ||||
Develogen |
DiaPep277 |
Peptide derived from heat-shock protein 60 |
Type I diabetes |
Phase II trials demonstrated a treatment benefit by preserving beta cell function (9/14) |
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Generex |
Orallyn |
Oral insulin buccal spray formulation |
Type I and II diabetes |
Presented positive data from Phase I and II trials (9/14) |
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INFECTION | ||||
Bioenvision |
Virostat (BIVN-401 ) |
Antiviral agent |
Hepatitis C |
Phase II trial in 25 refractory patients showed a reduction in viral load of greater than 70% in 22 of the patients (9/28) |
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Flamel |
IFN-alpha-XL |
Long-acting formulation of interferon alpha |
Hepatitis C |
Phase I/II trial in 53 patients demonstrated safety, tolerability, long-acting activity and positive effects on viral load (9/23) |
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Helix |
-- |
Topical interferon alpha-2b |
Ano-genital warts |
Began Phase II trial in Sweden to test safety and efficacy in patients who are positive for human papillomavirus infection (9/12) |
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Migenix Inc. |
Celgosivir (MX-3253 |
Oral a-glucosidase I inhibitor |
Hepatitis C |
Phase IIa monotherapy trial in 43 patients in Canada demonstrated tolerability and some evidence of antiviral activity (9/27) |
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The Immune |
IR103 |
Combination of HIV-1 Immunogen and Amplivax, an immunostimulatory oligonucleotide adjuvant |
HIV |
Began Phase I/II trial in Italy to evaluate safety and bioactivity in up to 100 patients for 52 weeks (9/27) |
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MISCELLANEOUS | ||||
Antares |
Anturol (AP-1034) |
Transdermal delivery formulation of oxybutynin |
Overactive bladder syndrome |
Began Phase II trial in Germany to study dosing in 48 volunteers (9/7) |
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BioMarin |
Naglazyme (FDA-approved) |
Galsulfase; an enzyme- replacement therapy |
Mucopoly- saccharidosis-VI |
A European advisory panel issued a positive recommendation on the MAA filing (9/15) |
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Dynogen |
DDP733 |
Oral serotonin type 3 receptor (5-HT3) partial agonist |
Irritable bowel syndrome |
Began Phase II trial in Canada to assess safety and pharmacodynamics as well as symptom-based endpoints (9/28) |
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Evolutec |
rEV131 |
Histamine-binding protein |
Allergic rhinitis |
Phase II trial in 112 patients demonstrated statistical significance in symptom scores 15 minutes after an allergen challenge (9/20) |
| ||||
Eyetech |
Macugen (FDA- approved) |
Pegaptanib sodium injection; pegylated anti-VEGF aptamer |
Wet age-related macular degeneration |
An advisory panel in Europe recommended approval of the drug (9/16) |
| ||||
Genaera |
Lomucin |
Talniflumate; anti- inflammatory drug with activity against the hCLCA1 chloride channel |
Cystic fibrosis |
Began pivotal Phase II trial in Ireland that will evaluate safety and efficacy on pulmonary function in 200 patients (9/21) |
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Karo Bio AB |
KB2115 |
Compound that stimulates the thyroid hormone receptor |
Obesity and dyslipidemia |
Phase Ia portion of study was completed with no adverse findings; positive effects on blood lipids were seen (9/19) |
| ||||
LAB |
LAB CGRP |
Calcitonin gene-related peptide |
Asthma |
Phase I trial in healthy volunteers showed the product was well tolerated (9/22) |
| ||||
Manhattan |
Oleoylestrone |
Oral agent designed to lower appetite settings in the brain's ponderostat |
Obesity |
Phase Ia study in 36 obese volunteers demonstrated safety, with no serious adverse events (9/7) |
| ||||
Mesoblast |
-- |
Adult stem cell technology |
Non-union of long bone fractures |
Began a trial in up to 10 patients in Australia (9/22) |
| ||||
Osteologix |
NBS-101 |
Tablet formulation of strontium, a product approved in Europe |
Osteoporosis |
Phase I trial in Denmark showed bioequivalence to strontium ranelate at lower dose and positive effects on bone (9/28) |
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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. | ||||
AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
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