Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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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) | | 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 |
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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 |
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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 |
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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 |
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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 |
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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: |
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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; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SBI=Stockholm Borsinformation; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange |