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. | ||||