Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Alza Corp. (NYSE:AZA) and Schering-Plough Corp. (NYSE:SGP)

Caelyx

Pegylated liposomal formulation of doxorubicin

Second-line treatment for advanced ovarian cancer

European Union's Committee for Proprietary Medicinal Products recommended approval (6/30)

Ariad Pharmaceuticals Inc. (ARIA)

Argent GvHD

Genetically engineered donor T lymphocytes containing a gene encoding an inactive apoptosis protein that is activated upon administration of an oral drug called AP1903

Treatment of graft-vs.-host disease in patients who undergo bone marrow transplants

Presented data from Phase I trial in Italy at the 3rd annual meeting of the American Society of Gene Therapy in Denver; received permission to begin a Phase II trial at the same site (6/2)

Bavarian Nordic Research Institute AS (Denmark; CSE:BAVA)

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Immunotherapy based on MVA-F6 vector, which overproduces human tyrosinase (a key enzyme in melanin production and a melanoma tumor antigen)

Metastatic malignant melanoma

Initiated Phase I/II trial in Italy (6/27)

Cel-Sci Corp. (AMEX:CVM)

Multikine

Natural mixture of human cytokines, including interleukin-2

Head and neck cancer

Permission granted for Phase II trial in Canada (6/28)

Cytogen Corp. (CYTO)

ProstaScint (FDA-approved)

Monoclonal antibody that targets prostate-specific membrane antigen, conjugated with indium-111

Imaging of metastatic prostate cancer

Submitted marketing application to the European Agency for the Evaluation of Medicinal Products (6/26)

CARDIOVASCULAR

Hemosol Inc. (Canada; TSE:HML)

Hemolink

Hemoglobin replacement product derived from red blood cells

Avoidance of transfusion of donor red blood cells in coronary artery bypass surgery

Preliminary results of Phase III trial in Canada and the UK showed a high rate of transfusion avoidance in the control group, and the company said additional analysis was needed (6/12); after further analysis, company reported positive results and announced plans to submit a marketing application in Canada (6/26)

CENTRAL NERVOUS SYSTEM

Cephalon Inc. (CEPH) and Dompe SpA (Italy)

Provigil (FDA-approved)

Modafinil; oral formulation of synthetic compound that is thought to affect alpha adrenergic receptors in the brain

Excessive daytime sleepiness associated with narcolepsy

Cleared for marketing in Italy (6/6)

DIABETES

Aventis Pharma (unit of Aventis SA [France; NYSE:AVE])

Lantus (FDA-approved)

Insulin glargine injection; recombinant human insulin analogue; long-acting

Types I and II diabetes

Cleared for marketing in the European Union (6/14)

INFECTION

Cantab Pharmaceuticals plc (UK; LSE:CTB)

TA-CIN

Vaccine based on a genetically engineered fusion protein derived from human papilloma virus

Cervical dysplasia associated with human papilloma virus 16

Initiated Phase I trial in the Netherlands (6/15)

The Immune Response Corp. (IMNR) and Agouron Pharmaceuticals Inc. (subsidiary of Pfizer Inc. [NYSE:PFE])

Remune

Envelope-depleted, inactivated AIDS virus (emulsified with adjuvant); therapeutic vaccine

HIV infection

Presented interim results from trial in Spain at the 5th European Conference on Experimental AIDS Research (6/21)

PathoGenesis Corp. (PGNS)

TOBI (FDA-approved)

Tobramycin solution for inhalation

Management of chronic pulmonary infection due to Pseudomonas aeruginosa infections in cystic fibrosis patients

Reported one-month data from UK trial at the 13th International Cystic Fibrosis Congress in Stockholm (6/6)

Vertex Pharmaceuticals Inc. (VRTX) and Glaxo Wellcome plc (NYSE:GLX)

Agenerase (FDA-approved)

Amprenavir; 2nd-generation HIV protease inhibitor

HIV infection

European Union's Committee for Proprietary Medicinal Products recommended approval (6/30)

MISCELLANEOUS

Alza Corp. (NYSE:AZA) and Sanofi-Synthelabo (France)

Ditropan XL (FDA-approved)

Oxybutynin chloride extended-release tablets (via OROS osmotic drug-delivery technology); tablet formulation

Urinary urge incontinence

Three dosages cleared for marketing in UK, which will serve as reference member state for mutual recognition procedure in European Union (6/19)

Centocor Inc. (subsidiary of Johnson & Johnson [NYSE:JNJ]) and Schering-PloughCorp. (NYSE:SGP)

Remicade (FDA-approved)

Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha

Reduction of the signs and symptoms of rheumatoid arthritis in patients with active disease when the response to disease-modify-ing drugs has been inadequate

Combination therapy with methotrexate cleared for marketing (6/28)

QLT Photo-Therapeutics and Ciba Vision (eye care unit of Novartis AG [Switzerland])

Visudyne (FDA-approved)

Verteporfin for injection; photodynamic therapy activated by specially designed laser that produces low-level, non-thermal 689 nm light

Wet form of age-related macular degeneration

Cleared for marketing in Canada (6/1)

Teva Pharmaceutical Industries Ltd. (Israel; TEVA)

Copaxone (FDA-approved)

Glatiramer acetate for injection; four-amino-acid peptide derived from myelin basic protein

Relapsing-remitting multiple sclerosis

Cleared for marketing in the UK (6/2)

Notes:

* Privately held.

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