Company* (Symbol) | Product | Description | Indication | Status/Date** |
CANCER | ||||
ImClone Systems Inc. (IMCL) and Merck KGaA (Germany) | C225 | Monoclonal antibody that targets and inhibits the epidermal growth factor receptor | Advanced squamous cell head and neck carcinoma | Expanded Phase III trial into Spain (12/2) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin capsules | Bexarotene; synthetic retinoid X receptors; oral formulation | Cutaneous T-cell lymphoma | Submitted marketing authorization application to the European Medicines Evaluation Agency (EMEA) (12/1) |
Transgene (France; TRGNY) | VV-MUC1-IL2 | Vaccine in which the genes for the tumor antigen MUC1 and the immune stimulant IL2 are inserted into a vaccinia virus | Metastatic breast cancer | Announced Phase II trial results (12/10) |
INFECTION | ||||
Hollis-Eden Pharmaceuticals Inc. (HEPH) | HE2000 | Compound thought to act by a mechanism of action that affects energy regulation in the host cell | HIV infection | Announced preliminary Phase I/II trial results from South African study |
PathoGenesis Corp. (PGNS) | TOBI | Tobramycin; 300 mg nebulizer solution | Chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients | UK Department of Health granted marketing authorization (12/15) |
MISCELLANEOUS | ||||
Aeterna Laboratories Inc. (Canada; TSE:AEL) | AE-941 | Antiangiogenic product, the mode of action of which includes the inhibition of matrix metalloproteinases, as well as interaction with VEGF receptor sites | Age-related macular degeneration | Presented Phase I results at The Retina Society 32nd Annual Meeting in Hawaii (12/6) |
Biopure Corp. (BPUR) | Oxyglobin | Hemoglobin glutamer - 200 oxygen therapeutic | Canine anemia | European Commission issued marketing authorization (12/2) |
Hemopure | Hemoglobin glutamer - 250 (bovine) | Red blood cell transfusion in orthopedic surgery | Health Canada's Bureau of Biologics and Radiopharmaceuticals granted clearance to expand Phase III trial into Canada (12/23) | |
Ciba Vision (a unit of Novartis AG) and QLT PhotoTherapeutics Inc. (Canada;TSE:QLTI) | Visudyne | Verteporfin; light-activated drug for photodynamic therapy | Wet form of age-related macular degeneration | Received marketing aproval from the Swiss regulatory agency Interkantonale Kontrollstelle fur Heilmittel (12/16) |
IntraBiotics Pharmaceuticals Inc.* | Protegrin IB-367 | Synthetically derived analogue of naturally occurring protegrins | Oral mucositis | Announced Phase II results of multinational trial at the American Society of Hematology Annual Meeting in New Orleans (12/6) |
Notes:
This chart is intended to provide a monthly update on the clinical and regulatory status of biotech and biotech-related products in development in countries other than the U.S., whether those products are being developed by U.S.-based or non-U.S.-based firms. It covers only those events that were announced in 12/99. It does not cover ongoing clinical trials for which no news was issued that month.
* Indicates a privately held company.
** The dates listed indicate the issue dates of press releases, and are not necessarily the dates on which stated events took place.
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