Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: October 2003
Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE | ||||
Centocor Inc. (unit of Johnson & Johnson) | Remicade | Infliximab; anti-TNF antibody | Fistulizing Crohn's disease | Partner Schering-Plough Corp. received approval to market pro- duct in Europe for sustaining clinical response (10/23) |
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Millennium Pharmaceuticals Inc. (MLNM) | MLN1202 | Humanized monoclonal antibody designed to block MCP-1/CCR2 chemokine pathway | Rheumatoid arthritis | Company began a Phase II trial that will include about 30 patients; trial to be conducted in Europe and Australia (10/14) |
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ProMetic Life Sciences Inc. (Canada; TSE:PLI) and Arriva Pharmaceuticals Inc.* | rAAT topical gel | Recombinant alpha-1 antitrypsin | Atopic dermatitis | Companies' joint venture opened a Phase II proof-of-concept trial in Canada (10/9) |
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Revotar Biophar- maceuticals Inc.* (Germany; majority-owned subsidiary of Encysive Pharmaceuticals Inc.; ENCY) | Bimosiamose | Topical formulation of small-molecule selecting antagonist | Psoriasis and atopic dermatitis | Company started controlled Phase IIa trial in each indication (10/9) |
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CANCER | ||||
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Aphton Corp. (APHT) | G17DT | Anti-gastrin targeted immunotherapy | Pancreatic cancer | Results of Phase III trial in 154 patients in Europe showed increased survival in advanced patients for monotherapy arm vs. placebo (10/30) |
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Eximias Pharmaceutical Corp.* | Thymitaq | Thymidylate synthase inhibitor | Hepatocellular carcinoma | Eximias gained orphan designation for the product in Europe (10/9) |
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TopoTarget Prolifix A/S* (Denmark) | PXD101 | Histone deacetylase Inhibitor | Advanced cancers | TopoTarget started a Phase I trial in 24 to 36 patients at sites in the UK (10/13) |
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CARDIOVASCULAR | ||||
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Endovasc Inc. (OTC BB:EVSC) | Liprostin | Liposome formulation of prostaglandin E1 | Critical limb ischemia and intermittent claudication | Endovasc got approval in Republic of Georgia to begin clinical trials; other sites are in Brazil, Mexico and Eastern Europe (10/8) |
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CENTRAL NERVOUS SYSTEM | ||||
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Alkermes Inc. (ALKS) | Risperdal Consta | Long-acting injectable form of risperidone | Schizophrenia | Alkermes partner Janssen-Cilag SA gained approval in France (10/9) |
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Cephalon Inc. (CEPH) | Vigil; Provigil | Modafinil tablets | Excessive daytime sleepiness | Cephalon gained approval in Ger- many and Ireland (10/9) |
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Debiopharm SA* (Switzerland) | ZT-1 | Cholinesterase inhibitor | Alzheimer's disease | Company said it would start a Phase II trial in Europe in 180 patients with mild to moderate AD (10/20) |
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INFECTION | ||||
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Gilead Sciences Inc. (GILD) | Emtriva (FDA-approved) | Emtricitabine; nucleoside reverse transcriptase inhibitor | HIV | The European Union granted marketing approval in all 15 member states of the EU (10/28) |
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ID Biomedical Corp.* (Canada; IDBE) | FluINsure | Trivalent influenza vaccine for intranasal administration | Influenza | Company received approval in Canada for field trial in 1,320 healthy adults (10/16) |
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Ipsat Therapies Oy* (Finland) | P1A | Oral formulation designed to inactivate betalactam antibiotics | Antibiotic-induced problems | Company presented Phase I data showing successful removal of harmful antibiotic residue (10/13) |
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MedImmune Inc. (MEDI) and Abbott Laboratories | Synagis (FDA-approved) | Palivizumab; humanized monoclonal antibody | Congenital heart disease | Abbott gained approval in Europe to market drug for infants born with hemodynamically significant congenital heart disease (10/30) |
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MISCELLANEOUS | ||||
Abiogen Pharma SpA* (Italy) | OGP | Small sequence of osteogenic growth peptide | Chronic idiopathic myelofibrosis | EMEA granted orphan designation to the product (10/6) |
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Labopharm Inc.* (Canada) | Tramadol | Once-daily formulation of the analgesic | Pain associated with osteoarthritis | Data presented from European Phase III trial showed product provided equivalent efficacy to extended-release, twice-daily formulation (10/15) |
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Cangene Corp. (Canada; TSE:CNJ) | Leucotropin | GM-CSF protein | To enhance white blood cells in those with Hodgkin's disease or non- Hodgkin's lymphoma after stem cell transplantation | Cangene filed for approval in Canada (10/7) |
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Xcellentis (subsidiary of Innogentics NV; Belgium) | LymphoDerm | Agent in proprietary topical formulation | Hard-to-treat venous leg ulcers | Preliminary Phase II results in 195 patients studied in four countries showed a clear trend toward improvement vs. standard of care (10/28) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||