Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Alfacell Corp. (OTC BB:ACEL) | Onconase | Cytotoxic ribonuclease; member of the superfamily of pancreatic ribonucleases | Malignant mesothelioma | Onconase received orphan medicinal product designation in Europe (2/21) |
Cell Therapeutics Inc. (CTIC) | Trisenox | Arsenic trioxide injection | Relapsed acute promyelocytic leukemia | European Agency for the Evaluation of Medicinal Products validated the marketing authorization application filed in November for Trisenox (2/2) |
Cyclacel Ltd. (Scotland)* | CYC202 | A cell cycle drug of the cyclin dependent kinase inhibitor class | Cancer | Company entered Phase I trials with CYC202 in the UK (2/20) |
YM Biosciences Inc. (Canada)* | Tesmilifene | Intracellular histamine antagonist being developed as a chemopotentiator | Hormone-refractory prostate cancer | Company is recommencing Phase II trials (2/20) |
Zarix Inc.* | Thymitaq | Thymidylate synthase | Cancer | Company initiated pivotal Phase III trials in Canada for Thymitaq to treat several different cancers with an initial emphasis on hepatocellular carcinoma (2/5) |
CARDIOVASCULAR |
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Actelion Ltd. (Switzerland; SWX:ATLN) | Tracleer | Bosentan; orally active endothelin receptor antagonist | Pulmonary arterial hypertension | The European Commission granted orphan medicinal product designation (2/21) |
Hemosol Inc. (Canada; TSE:HML) | Hemolink | Highly purified human-derived hemoglobin replacement product | Patients undergoing coronary artery bypass grafting surgery | Company submitted a marketing authorization application in the UK (2/27) |
United Therapeutics Corp. (UTHR) | UT-15 | Prostacyclin analogue | Pulmonary arterial hypertension | Company submitted a marketing authorization application in France (2/5) |
CENTRAL NERVOUS SYSTEM |
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Centocor Inc. (unit of Johnson & Johnson; NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP) | Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha | Rheumatoid arthritis and joint damage | Companies received marketing approval in Europe for Remicade with methotrexate to improve physical function of patients with RA and for the reduction of the rate of progression of joint damage when response to disease-modifying drugs is inadequate (2/5) |
International Wex Technologies Inc. (Canada; CDNX:WXI) | Tetrodin | Non-narcotic pharmaceutical developed from a naturally occurring organic substance | Moderate to severe pain | A study of 11 terminally ill cancer patients indicated the pain reliever Tetrodin increased quality of life (2/7) |
INFECTION |
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Achillion Pharmaceuticals Inc.* | ACH-126,443 | Orally administered antiviral agent | Hepatitis B virus and HIV | Company initiated a Phase I trial in Scotland (2/5) |
Bavarian Nordic Research Institute SA (Denmark; CSE:BAVA) | MVA-BN | Orthopox vaccine | Orthopox | Company received approval to begin a Phase I study in Germany (2/21) |
Gilead Sciences Inc. (GILD) | Tamiflu | Oseltamivir phosphate | Influenza A and B | Roche submitted Tamiflu for regulatory approval in Europe as a treatment of influenza A and B in adults and children and the prevention of influenza A and B in adolescents and adults (2/27) |
Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Designed to trigger< therapeutic synergism with marketed antivirals/TD> |
HIV | Company initiated HIV salvage treatment trials in the European Union (2/20) |
Pharming Group NV (UK; PHAR) | hLF | Recombinant human lactoferrin | Antibiotic-resistant bacteria | Company completed Phase I trials showing hLF was well tolerated, up to high doses, making it suitable to treat serious infections, such as hospital-acquired Staphylococcus aureus (2/21**) |
PowderJect Pharmaceuticals plc (UK; LSE:PJP) | Vaccine | DNA immunotherapeutic | Hepatitis B | Company initiated clinical testing (2/23) |
SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymosin alpha 1 synthetic peptide | Hepatitis B | Company received approval in India (2/5) |
MISCELLANEOUS |
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Cellegy Pharmaceuticals Inc. (CLGY) | Anogesic | Nitroglycerin ointment | Chronic anal fissures | Company said it intends to file a new drug submission in Canada requesting marketing approval for Anogesic (2/8) |
Curis Inc. (CRIS) and Stryker Corp. (NYSE:SYK) | OP-1 Implant | Osteogenic protein 1 | Orthopedic and periodontal disorders | The Australian Drug Evaluation Committee recommended the granting of marketing authorization for OP-1 Implant (2/16) |
Dyax Corp. (DYAX) and Debiopharm SA (Switzerland)* | EPI-HNE-4 | Human neutrophil elastase inhibitor | Adult cystic fibrosis | Companies initiated a Phase IIa trial in France (2/13) |
KS Biomedix Holdings plc (UK; LSE:KSB) | KSB301 | Super-high affinity monoclonal antibody | Osteoarthritis | Company moved the product into Phase IIb development in Europe (2/9) |
Millennium Pharmaceuticals Inc. (MLNM) | LDP-02 | Humanized monoclonal antibody | Ulcerative colitis and Crohn's disease | Company began a Phase II trial in Canada (2/8) |
NexMed Inc. (NEXM) | Befar | Topical treatment; alprostadil cream | Erectile dysfunction | Company received approval in China for the distribution and sale of Befar (2/2) |
Notes: |
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* Privately held; ** Denotes the date the item ran in BioWorld International |
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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; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange |
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