Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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British Biotech plc (UK; BBIOY) and BresaGen Ltd. (Australia; BSGNY; ASX:BGN) | E21R | Metalloenzyme inhibitor | Chronic myelomonocytic leukemia | BresaGen commenced patient recruitment for a Phase II study in Australia (3/6) |
Canfite Ltd. (Israel)* | AFite | Oral antitumor drug for adjunctive treatment with chemotherapy | Cancer | Company began Phase I trials in Europe and the U.S. (3/6) |
Millennium Pharmaceuticals Inc. (MLNM) and ILEX Oncology Inc. (ILXO) | Mab-Campath | Humanized monoclonal antibody; alemtuzumab | Chronic lymphocytic leukemia | Mab-Campath was recommended for approval in Europe under the condition the companies conduct a post-approval trial (3/30) |
Pharmagenesis Inc.* | PG2 | Plant-derived hematopoiesis enhancer that restores blood cells after destruction of bone marrow cells induced by chemotherapy | Cancer | Company said PG2 passed clinical trials in China (3/19) |
PhotoCure ASA (Norway; OSE:PHO) | Metvix PDT | Photodynamic therapy; the cream is activated through illumination with a red light | High-risk basal cell carcinoma and actinic keratosis | Company submitted a marketing authorization application in Australia (3/15) |
Ribozyme Pharmaceuticals Inc. (RZYM) | Herzyme | Ribozyme designed to downregulate the HER2/neu oncogene | Breast and ovarian cancer | Company submitted an IND to begin clinical trials in Canada (3/1) |
CARDIOVASCULAR |
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Actelion Ltd. (Switzerland; SWX:ATLN) | Tracleer | Oral dual endothelin receptor antagonist, bosentan | Pulmonary arterial hypertension | Company filed for European Union marketing authorization (3/1) |
Theratechnologies Inc. (Canada; TSE:TH) | ThGRF | Growth hormone-releasing factor analogue | Chronic obstructive pulmonary disease | Company began enrollment in a trial to assess safety and efficacy (3/6) |
CENTRAL NERVOUS SYSTEM |
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Genmab A/S (Denmark; CSE:GEN) | HuMax-CD4 | Fully human antibody | Rheumatoid arthritis | Phase I/II data indicate HuMax-CD4 was well tolerated, produced no serious adverse effects and no depletion of CD4-positive T cells (3/8) |
INFECTION |
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Enzon Inc. (ENZN) and Schering-Plough Corp. | Peg-Intron | Peg-Intron injection and Rebetol capsules as a combination therapy | Chronic hepatitis C | European Commission granted marketing approval (3/28) |
ID Biomedical Corp. (Canada; IDBE; TSE:IDB) | StreptAvax | A multivalent recombinant vaccine designed to protect against 26 serotypes | Group A stretococcus infection | Canadian authorities approved the start of a Phase I/II trial (3/22) |
Immtech International Inc. (IMMT) | DB289 | Oral, anti-infective | Pneumocystis carinii pneumonia and African sleeping sickness | Company completed a Phase I trial (3/7) |
Interneuron Pharmaceuticals Inc. (IPIC) | PRO 2000 | Vaginal microbicide | Sexually transmitted disease prevention | Company said PRO 2000 will be tested in a goverment-funded Phase II/III trial to begin later this year in Zimbabwe, Malawi, South Africa and India (3/1) |
MISCELLANEOUS |
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Amgen Inc. (AMGN) | Aranesp | Darbepoetin alfa; an erythropoietic protein | Anemia | The European Committee on Proprietary Medicinal Products recommended approval (3/19) |
Cellegy Pharmaceuticals Inc. (CLGY) | Rectogesic | Nitroglycerin ointment | Anal fissures | Company filed for marketing approval in South Korea (3/6) |
Genzyme General (GENZ) | Fabrazyme | Agalsidase beta enzyme replacement therapy | Fabry disease | The Committee for Proprietary Medicinal Products issued a positive opinion on the marketing authorization application for Fabrazyme (3/28) |
ICN Pharmaceuticals Inc. (NYSE:ICN) | Virazole | Intravenous ribavirin (100 mg/ml) | Hemorrhagicfever with renal syndrome | The European Commission granted orphan drug status designation (3/16) |
QLT Inc. (Canada; QLTI) and Novartis Ophthalmics (unit of Novartis AG; Switzerland) | Visudyne (FDA-approved) | Verteporfin; a nonthermal laser light is shined into the patient's eye to activate the drug | Subfoveal choroidal neovascularization secondary to pathologic myopia | Visudyne received marketing approval in Europe for the new indication (3/23) |
Trankaryotic Therapies Inc. (TKTX) | Replagal | Agalsidase alfa enzyme replacement therapy | Fabry disease | The Committee for Proprietary Medicinal Products issued a positive opinion on the marketing authorization application for Fabrazyme (3/28) |
Vasogen Inc. (Canada; TSE:VAS; AMEX:MEW) | | Immune modulation therapy | Moderate to severe psoriasis | Company received approval to proceed with a 105-patient trial in Canada (3/6) |
Notes: |
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* Privately held. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; OSE = Norwegian Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |
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IND = Investigational New Drug application |
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