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.

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