Company* |
Product | Description |
Indication | Status (Date) |
AUTOIMMUNE | ||||
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Biogen Idec |
Antegren (natalizumab) |
Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class |
Multiple sclerosis |
Companies submitted an application for approval in Canada and expect to submit applications in Australia and Switzerland in 4Q:04 (8/17) |
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CANCER | ||||
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Amgen Inc. |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Anemia from chemotherapy |
European committee issued positive opinion on expanding the label to include extended dosing (8/5) |
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Aphton Corp. |
Insegia |
Immunotherapy vaccine designed to induce antibodies to both gastrin 17 and glygastrin 17 |
Advanced pancreatic cancer |
The company filed for approval of the drug in Canada for patients for whom chemotherapy is not indicated (8/26) |
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A.P. Pharma |
APF530 |
The anti-emetic granisetron in a polymer- based drug delivery system |
Chemotherapy-induced nausea and vomiting |
Initial results from Phase I trial in the UK demonstrated measurable blood levels of granisetron over a four-day period (8/12) |
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Bioenvision |
Clofarabine |
Second-generation purine nucleoside analogue |
Acute leukemias in children |
Filed for approval in Europe for treating refractory or relapsed leukemia in children (8/20) |
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Bioenvision |
Clofarabine |
Second-generation purine nucleoside analogue |
Adult acute leukemia |
Began pivotal Phase II trial in the UK that will include 65 patients and last nine months (8/10) |
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Bioenvision |
Modrenal |
Drug designed to increase estrogen binding to ER beta and decrease binding to ER alpha |
Breast cancer |
Began two trials in the UK, a Phase II in pre-menopausal women and a Phase IV in post-menopausal women (8/9) |
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Onyx |
BAY 43-9006 |
RAF kinase and VEGF inhibitor |
Renal-cell carcinoma |
The drug was granted orphan designation in Europe in that indication (8/4) |
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OSI |
Tarceva |
Erlotinib HCl; small-molecule HER1/EGFR inhibitor |
Non-small-cell lung cancer |
Partner F. Hoffmann-La Roche Ltd. submitted an application in Europe seeking approval as a mono-therapy in patients with advanced disease (8/26) |
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Viventia |
Proxinium |
Product that uses tumor-seeking antibody fragments to deliver agents to cancer cells |
Bladder cancer |
Began Phase I trial in Canada to to assess safety and tolerability in 24 patients (8/19) |
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YM BioSciences |
TheraCIM hR3 |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
Glioma |
The product was granted orphan designation in Europe (8/10) |
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ZymoGenetics |
TACI-Ig |
Soluble fusion protein linking the extracellular portion of the TACI receptor to the Fc portion of human immunoglobulin |
Rheumatoid arthritis |
Began Phase Ib study in Europe and Australia in 60 patients to evaluate safety and pharmacokinetics, while also monitoring biological effects (8/30) |
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CARDIOVASCULAR | ||||
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Protemix Corp.* |
Laszarin |
Small molecule designed to remove excess copper from the body |
Heart disease in diabetics |
Phase II trial in Type II diabetics showed increased urinary output of copper vs. treated controls (8/31) |
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CENTRAL NERVOUS SYSTEM | ||||
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Axaron |
AX200 |
Drug designed to prevent death of nerve cells and promote regeneration of damaged brain tissue |
Stroke |
Began Phase II trial in Germany (8/2) |
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DIABETES | ||||
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Depomed Inc. (DEPO) and Biovail Corp. (Canada) |
Glumetza |
Once-daily, extended-release formulation of the approved drug metformin |
Type II diabetes |
Regulators in Canada accepted for review the new drug submission on the drug (8/10) |
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Generex |
Oralin |
Oral insulin spray formulation |
Diabetes |
Filed for approval of the product in Ecuador (8/31) |
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INFECTION | ||||
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Immtech |
DB289 |
Oral, dicationic antiviral agent |
Malaria |
Began Phase I trial, designed to complement Phase II in Thailand, to evaluate pharmacokinetics in 74 healthy volunteers (8/9) |
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Viral Genetics Inc. (OTC BB:VRAL) |
VGV-1 |
Thymus nuclear protein extracted from bovine thymus gland |
HIV |
Began 80-patient trial in South Africa that will assess viral load, as well as safety and immunological function (8/3) |
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MISCELLANEOUS | ||||
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Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature neonates |
European regulators designated Surfaxin an orphan product in that indication (8/12) |
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NexMed Inc. |
Femprox |
Alprostadil cream |
Female sexual arousal disorder |
Pilot overseas study in eight patients showed a significant difference in the primary efficacy end- point vs. placebo cream (8/25) |
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Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
