Company** |
Product | Description |
Indication |
Type Action (Date) |
CANCER | ||||
Cel-Sci Corp. |
Multikine | Natural mixture of human cytokines, including interleukin-2 | Treatment of head and neck cancer prior to surgery or radiation therapy |
Received permission to initiate Phase II trial in Poland (1/8) |
Multikine |
Natural mixture of human cytokines, including interleukin-2 |
Treatment of head and neck cancer prior to surgery or radiation therapy in patients with newly diagnosed disease |
Received permission to initiate trial in Israel (1/26) |
|
Chiron Corp. | Proleukin | Aldesleukin; recombinant interleukin-2 | Metastatic melanoma |
Approved for marketing in Canada (2nd indication) (1/8) |
Digene Corp. |
Hybrid Capture II HPV Test | Assay that detects DNA from 18 different human papillomavirus (HPV) types |
Cervical cancer screening (in conjunction with Pap smear) |
Presented preliminary results of international studies (conducted in Canada, U.K., France, South Africa, Costa Rica, Zimbabwe and the Netherlands) at 17th International Papillomavirus Conference in Charleston, S.C. (1/15) |
Genta Inc. | G 3139 | Anticode (antisense) compound; synthetic DNA strands that bind to mRNA for bcl2 gene (proto-oncogene) |
Relapsed follicular non-Hodgkin's lymphoma (combination therapy with cyclophosphamide) |
Initiated new Phase I/IIa trial in Canada (1/11) |
G 3139 | Anticode (antisense) compound; synthetic DNA strands that bind to mRNA for bcl2 gene (proto-oncogene) |
Non-Hodgkin's lymphoma resistant to initial chemotherapy (combination therapy with chemotherapy) | Initiated Phase II trial in U.K. (1/21) |
|
Immunomedics Inc. |
CEA-Scan |
Fragment of murine monoclonal antibody to tumor marker carcino-embryonic antigen (CEA), labeled with technetium-99m |
In vivo nuclear imaging agent for breast cancer (in women with abnormal mammograms) |
Submitted marketing application to European Medicines Evaluation Agency (1/26) |
Ivax Corp. (AMEX:IVX) |
Paxene |
Paclitaxel; compound extracted from needles and limb stock of ornamental yew trees | AIDS-related Kaposi's sarcoma |
European Committee for Proprietary Medicinal Products recommended approval (1/28) |
Neoprobe Corp. | NEO 2000 | Hand-held isotope detector (gamma detection system) | For use in intraoperative lymphatic mapping (surgical detection and management of cancer) |
Received CE Mark certification in European Union (1/29) |
CARDIOVASCULAR | ||||
CV Therapeutics Inc. |
Ranolazine |
Piperazine acetamide | Chronic unstable angina | Initiated pivotal Phase III trials in Canada, the Czech Republic and Poland (1/29) |
Integra Life-Sciences Corp. |
Helistat and Helitene | Hemostatic agents; Helistat is absorbable collagen hemostatic sponge designed to promote platelet aggregation; Helitene is absorbable collagen hemostatic agent in fibrillar form |
To help control bleeding in cardiovascular, neurosurgical and general surgical procedures |
Received CE Mark certification in European Union (1/27) |
CENTRAL NERVOUS SYSTEM | ||||
Chiron Corp. and Berlex Laboratories Inc. |
Betaseron |
Recombinant human interferon beta-1b |
Secondary progressive multiple sclerosis | Approved for marketing by the Commission of the European Communities (1/28) |
INFECTION | ||||
BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (NYSE:GLX; U.K.) |
Heptodin (a.k.a. lamivudine) |
Nucleoside analogue (oral dosage) |
Chronic hepatitis B virus infection | Approved for marketing in People's Republic of China (1/9) |
Icos Corp. | IC14 |
Antibody that binds to CD14 (a receptor for various bacterial toxins) and blocks endotoxin-induced cytokine cascade |
Sepsis |
Initiated Phase I trial in Europe (1/14) |
The Liposome Co. Inc. | Abelcet | Amphotericin B lipid complex (injection) | Systemic fungal infections (2nd-line therapy) |
Approved for marketing in the Netherlands (1/12) |
Neose Technologies Inc. |
NE-1539 |
Complex carbohydrate that occurs naturally in human breast milk (intranasal administration) | Prevention of middle ear infections (otitis media) in children | Initiated Phase II trial in Finland (1/26) |
SciClone Pharmeceuticals Inc. | Zadaxin (thymosin alpha 1) | Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) | Chronic hepatitis B virus infection | Filed marketing application in New Zealand (1/5) |
SciClone Pharmaceuticals Inc. |
Zadaxin (thymosin alpha 1) | Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) |
Chronic hepatitis B virus and hepatitis C virus infections | Approved for marketing in Venezuela (1/5) |
MISCELLANEOUS | ||||
Unigene Labcalcitonin (injection) |
Forcalcitonin |
Recombinant salmon calcitonin (injection) |
Paget's disease; also hypercalcemia associated with malignancy |
Approved for marketing in all 15 member states of European Union (1/19) |
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. | ||||
** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 14-15. |