| Company | Product | Description | Indication | Status/Date |
| Access Pharmaceuticals Inc. (OTC BB:AXCS) | OraDisc | Polymer disc formulation for improved delivery of amlexanox | Canker sores | UK Medicines Control Agency cleared clinical trial program (1/19) |
| Advanced Viral Research Corp. (OTC BB:ADVR) | Substance R | Nontoxic peptide nucleic acid immunomodulator | Viral infection | Received approval for Phase I trials in Argentina (2/18) |
| Alizyme plc (UK; LSE:AZM) | ATL-962 | Lipase inhibitor that prevents the breakdown of fat in the gut | Obesity | Company received approval to start a Phase Ib trial in Germany (10/18) |
| Amrad Corp. (Australia; ASX:AML) | AM336 | Analgesic; synthetic form of a naturally occurring compound originally identified in the venom of a fisheating marine cone snail collected from the Great Barrier Reef | Severe pain | Company received approval to begin Phase I trials in Australia (3/6) |
| Amrad Corp. (Australia; ASX:AML) | AM365 | ND | Hepatitis B infection | Company received clearance to begin Phase I trials in Australia (3/6) |
| Aphton Corp. (APHT) | Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17 | Metastatic pancreatic cancer | UK s Medicines Control Agency cleared Phase III trial of combination therapy with gemcitabine vs. gemcitabine alone (4/11) | |
| Atrix Laboratories Inc. (ATRX) and Block Drug Co. Inc. (BLOCA) | Atridox (FDA-approved) | Doxycycline 8.8% product applied as a gel to affected area, where it conforms to the shape of the periodontal pocket and solidifies, releasing doxycyline over a period of about 7 days | Periodontal disease | Approved for marketing in 11 European countries (1/4); approved in Canada (7/6) |
| AuRx Inc. | AuRx HSV-2 | Vaccine using recombinant strain of herpes in which an oncogene has been deleted | Prevention of recurrence of genital herpes | Received authorization from the Mexican Ministry of Health to conduct Phase I/II trial (4/30) |
| AVAX Technologies Inc. (AVXT) | M-Vax | Haptenized autologous cell vaccine | Metastatic melanoma | Vaccine cleared for marketing and commercially available in Australia (7/18) |
| Axcan Pharma Inc. (Canada; TSE:AXP) | Photofrin (FDA-approved) | Photosensitive drug (porfimer sodium; produces toxic oxygen compound when light-activated) | Palliative treatment of advanced lung and esophageal cancer | Product was approved in Sweden, Italy and Ireland (7/18) |
| BioChem Pharma Inc. (Canada; BCHE) and Glaxo Wellcome plc (UK; NYSE:GLX) | Trizivir | Triple combination tablet; incorporates Biochem s 3TC/Epivir, plus abacavir sulphate and zidovudine | HIV infection | European Union s Committee for Proprietary Medicinal Products recommended approval (7/18) |
| Biota Holdings Ltd. (Australia; ASX:BTA) and Glaxo Wellcome plc (UK; NYSE:GLX) | Relenza | Zanamavir for inhalation; neuraminidase inhibitor (designed and synthesized based on crystal structure of surface proteins of influenza virus); inhaled in powder form | Influenza | Cleared for marketing in Japan (1/5) |
| Bio-Technology General Corp. (BTGC) | Bio-Hep-B | Recombinant hepatitis B vaccine that integrates the S, pre-S1 and pre-S2 surface proteins of the virus | Prevention of hepatitis B infection | Cleared for marketing in Israel (2/14) |
| Bio-Technology General Corp. (BTGC) | BioHy | Injectable formulation of high-molecular-weight sodium hyaluronate | Osteoarthritis | Company received marketing approval in Europe (11/14) |
| Cell Therapeutics Inc. (CTIC) | Trisenox | Arsenic trioxide injection | Acute promyelocytic leukemia | Trisenox has been granted orphan medicinal product status by the European Commission (10/25) |
| Cel-Sci Corp. (AMEX:CVM) | Multikine | Natural mixture of human cytokines, including interleukin-2 | Breast cancer | Israeli Health Authorities granted permission to start a clinical trial (5/23); company received permission to begin a Phase II trial in Canada (6/28); Polish health authorities granted permission for Phase II trials (7/26) |
| Centaur Pharmaceuticals Inc. and AstraZeneca Inc. (UK; NYSE:AZN) | NXY-059 | Small-molecule, intravenously delivered modifier of the cellular response to stress agents that damage and kill cells | Stroke | Companies received Japanese regulatory approval to begin a Phase I trial (11/29) |
| Centocor Inc. and Schering-Plough Corp. (NYSE:SGP) | Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha | Rheumatoid arthritis that has inadequately responded to diseasemodifying drugs; combination therapy with methotrexate | Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products recommended approval (2/23); combination therapy with methotrexate cleared for marketing (6/28) |
| Cephalon Inc. (CEPH) | Provigil | Modafinil; oral formulation of synthetic compound that is thought to affect alpha adrenergic receptors in the brain | Narcolepsy | Provigil was cleared for marketing in Italy (6/6); company launched Provigil in Switzerland (9/20) |
| Cerus Corp. (CERS) | Intercept | Pathogen inactivation system that targets and inactivates blood-borne pathogens, while leaving the therapeutic properties of platelets intact; process uses light-activated psoralen compound, S-59, which disables nucleic acid | Platelets intended for transfusion | Independent Data and Safety Monitoring Board recommended continuing Phase III European trial (4/27) |
| Chiron Corp. (CHIR) | Fluad | Vaccine containing MF59 adjuvant | Prevention of influenza infection in the elderly | Cleared for marketing in 12 European countries (5/24) |
| Chiron Corp. (CHIR) | Menjugate | Conjugate vaccine against Neisseria meningitidis serogroup C | Prevention of meningococcal C disease | Cleared for marketing in the UK (3/1); cleared for marketing in Ireland (8/8); UK health authorities and the Irish Medicines Board approved Menjugate for immunizing infants aged 2 months and older (10/17) |
| Cypress Bioscience Inc. (CYPB), Meduxus Inc. (Canada) and Fresenius HemoCare GmbH (Germany) | Prosorba | Disposable filter that uses Protein A to remove circulating immune complexes from patient s blood | Rheumatoid arthritis | Cleared for marketing in Canada (3/8); cleared for marketing in Europe (3/9) |
| D-Pharm Ltd. (Israel) | DP-b99 | Membrane-activated chelator designed to control apoptotic processes by regulating intracellular homeostasis of divalent metal ions; intravenously delivered | Stroke, traumatic brain injury and prophylaxis against neurological damage during openheart surgery | Company received approval to begin Phase I testing in Germany (3/6) |
| Enzo Biochem Inc. (NYSE:ENZ) | ND | Immune regulation medicine; stems from the company s work in EHT899 | Hepatitis C or associated hepatocellular carcinoma | Company received approval from Israel s Ministry of Health to begin a Phase I trial (11/30) |
| Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE:SGP) | Peg-Intron | Long-acting dosage form of Schering s Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol | Hepatitis C infection in adults | European Agency for the Evaluation of Medicinal Products issued recommended approval (2/22); cleared for marketing in the European Union (5/30); the European Agency recommended approval of Peg-Intron and Rebetol (ICN Pharmaceuticals Inc.) as a combination therapy (12/20) |
| Genzyme General (GENZ) | Fabrazyme | Agalsidase beta; enzyme replacement therapy | Fabry disease | European Agency for the Evaluation of Medicinal Products validated marketing authorization; product received orphan drug designation in Europe (7/1) |
| Genzyme General (GENZ) and Biobras SA (Brazil) | Thyrogen (FDA-approved) | Recombinant human thyroid stimulating hormone | Follow-up screening for patients who have been treated for thyroid cancer | Cleared for marketing in Brazil (2/2) |
| Genzyme General (GENZ) and GelTex Pharmaceuticals Inc. (GELX) | Renagel Capsules (FDA-approved) | Non-absorbed polymer-based compound that binds to and eliminates target substances from the intestinal tract | Hyperphosphatemia | Cleared for marketing in the 15 member states of the European Union (2/3) |
| Gilead Sciences Inc. (GILD) | Adefovir dipivoxil | Reverse transcriptase inhibitor | Chronic hepatitis B virus | Company received approval in China to begin a Phase I trial (12/11) |
| Gilead Sciences Inc. (GILD) and Fujisawa Healthcare Inc. (Japan) | AmBisome | Liposomal formulation of amphotericin B for | Systemic or disseminated infections due to Candida Aspergillus or Cryptococcus | Fujisawa received marketing approval in Canada (3/20) |
| Gilead Sciences Inc. (GILD) and F. Hoffmann-La Roche Ltd. | Tamiflu (FDA-approved) | Oseltamivir phosphate; neuraminidase inhibitor | Influenza A and B | Companies received regulatory approval in Japan (12/12) |
| Gliatech Inc. (GLIA) | ADCON-L (FDA-approved) | Anti-adhesion barrier gel (semisynthetic carbohydrate polymer) | Inhibition of postsurgical scarring and adhesions following back surgery | The European Economic Area approved ADCON-L for distribution (9/20) |
| Hemosol Inc. (Canada; TSE:HML) | HML-115 | Autologous gamma-delta T-cell infusion | Chronic myeloid leukemia | Company received approval to begin a Phase I trial in Canada (10/17) |
| Immtech International Inc. (IMMT) | DB289 | Oral anti-infective | Pneumocystis carini pneumonia | Company received approval to begin a Phase I trial in 72 volunteers in Berlin (10/13) |
| Immunex Corp. (IMNX) and WyethAyerst Pharmaceuticals (unit of American Home Products Corp.; NYSE:AHP) | Enbrel | Etanercept; recombinant, soluble T75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgG1 | Adult rheumatoid arthritis that inadequately responds to diseasemodifying drugs | Cleared for marketing in 15 European Union countries by the European Medicines Evaluation Agency (2/7); Enbrel was approved for for marketing in Canada (12/8) |
| Inflazyme Pharmaceuticals Ltd. (Canada; TSE:IZP) | IPL576,092 | Oral therapy | Asthma | Company received approval to begin Phase II trials in the UK (12/22) |
| InSite Vision Inc. (AMEX:ISV), Global Damon Pharm (Korea) and Kukje Pharma Ind. Co. Ltd. (Korea) | AquaSite | Dry eye treatment that uses dulcents and DuraSite (crosslinked carboxyl-containing polymer) for sustained delivery | Dry eye syndrome | Cleared for marketing in Korea (5/17) |
| International Wex Technologies Inc. (Canada; CDNX:WXI) | Tetrodin | Non-narcotic pharmaceutical developed from a naturally occurring organic substance | Opiate addictions | Company received permission to begin a Phase Ia trial in Canada (12/7) |
| Karo Bio AB (Sweden) | Ointment containing a substance that activates the thyroid hormone receptor | Skin atrophy caused by repeated steroid treatment of skin diseases | Swedish Medical Products Agency approved application to start Phase II trials (4/18) | |
| Ligand Pharmaceuticals Inc. (LGND) | Panretin Gel (FDA-approved) | Alitretinoin 0.1% (topical); chemically synthesized version of 9-cis-retinoic acid (derived from vitamin A) | Cutaneous lesions in Kaposi s sarcoma patients | European Committee for Proprietary Medicinal Products recommended approval for marketing (7/17); European Commission granted marketing authorization (10/17) |
| Ligand Pharmaceuticals Inc. (LGND) | Targretin | Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors | Advanced-stage cutaneous T-cell lymphoma | The Committee for Proprietary Medicinal Products recommended approval in Europe for Targretin to treat skin manifestations of lymphoma patients refractory to at least one systemic treatment (11/21) |
| Medarex Inc. (MEDX), ImmunoDesigned Molecules SA and ImmunoDesigned Molecules Inc. | MDX-210 | Bispecific antibody that targets HER2 receptor | Ovarian cancer | Received European regulatory approval to initiate Phase III trial of MDX-210 in combination with IDM s Monocyte-derived Activated Killer (MAK) cell technology (2/14) |
| Medicure Inc. (CDNX:MPH) | Cardoxal | Oral therapeutic | Myocardial infarction and ischemic reperfusion injury | Canada s Therapeutic Products Directorate approved the company s IND application and the company began a clinical trial (10/25) |
| Nexell Therapeutics Inc. (NEXL) and Baxter Healthcare Corp. (NYSE:BAX) | Isolex 300i Magnetic Cell Selection System (FDA-approved) | Magnetic cell selection system for the separation of hematopoietic stem cells and the removal of tumor cells from autologous peripheral blood | Ex vivo autologous selection of hematopoietic stem cells for use in transplantation following high-dose chemotherapy | Cleared for marketing in Australia (5/18) |
| NicOx SA (France; Nouveau Marche: NICOX) | HCT-1026 | Nitro-flubiprofen; prostaglandin inhibitor | Urinary frequency and urgency, with or without urinary incontinence | UK Medicines Control Agency approved Clinical Trials Exemption (4/20) |
| Oncolytics Biotech Inc. (Canada; CDNX:ONC) | Reolysin | Reovirus (respiratory enteric orphan virus), which targets solid tumors with an activated Ras gene pathway; reovirus is a naturally occurring virus believed to cause mild infections of the upperrespiratory and gastrointestinal tracts in humans | Cancer | Company received approval in Canada to begin a Phase I trial (3/22) |
| Oxford BioMedica plc (UK) | TroVax | Vaccine; targeted at tumorassociated antigens | Colorectal cancer | Company received approval in the UK to enter Phase I/II trials (10/16) |
| Oxford GlycoSciences plc (UK; LSE:OGS) | Vevesca (OGT 918) | Oral capsule formulation of a glucosyltransferase inhibitor | Gaucher s disease | Vevesca was designated an orphan medicinal product by the European Commission (10/25) |
| PathoGenesis Corp. (PGNS) and AMRAD Pharmaceuticals Pty. Ltd. (Australia) | TOBI | Tobramycin solution for inhalation | Management of cystic fibrosis patients with Pseudomonas aeruginosa infections | Cleared for marketing in Israel (1/5); cleared for marketing in Australia (2/23) |
| Praxis Pharmaceuticals Inc. (OTC BB:PRXXE) | Carbohydrate-based compound | Acne | Company received clearance to begin a clinical trial in Australia (3/8) | |
| QLT Phototherapeutics Inc. (Canada; QLTI) and CIBA Vision (unit of Novartis AG; Switzerland; NYSE:NVS) | Visudyne (FDA-approved) | Verteporfin for injection; photodynamic therapy is activated through use of specially designed laser that produces low-level, nonthermal 689 nm light | Wet form of age-related macular degeneration | Committee for Proprietary Medicinal Products recommended approval in the European Union (4/14); cleared for marketing in Canada (6/1); European Commission granted marketing authorization (7/28) |
| QLT Phototherapeutics Inc. (Canada; QLTI) and CIBA Vision (unit of Novartis AG; Switzerland; NYSE:NVS) | Visudyne (FDA-approved) | Verteporfin for injection; photodynamic therapy is activated through use of specially designed laser that produces low-level, nonthermal 689 nm light | Choroidal neovascularization | Committee for Proprietary Medicinal Products recommended approval in the European Union (12/15) |
| SangStat Medical Corp. (SANG) | Thymoglobuline | Anti-thymocyte globulin; polyclonal antibody produced in rabbits | Prophylaxis of transplant rejection and therapy for acute kidney rejection | Cleared for marketing in Italy (8/31) |
| SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) | Influenza vaccine adjuvant for individuals with weakened immune systems | Cleared for marketing in South Korea (4/13); cleared for marketing and launched in Italy (5/23) |
| SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) | Hepatitis B and C infection | Received marketing approval in Thailand, Laos and Malta (3/17); received approval in Argentina (8/7); received expanded approval in Peru for hepatitis C (9/28) |
| Serono SA (Switzerland; NYSE:SRA) | Luveris | Recombinant human luteinizing hormone, lutropin alfa | Female infertility | The Committee for Proprietary Medicinal Products recommended approval in Europe (8/15); company received marketing approval in Europe (12/5) |
| Serono SA (Switzerland; NYSE:SRA) | Ovidrel | Recombinant chorionic gonadotropin | Anovulation | Company received a recommendation for approval from the Committee for Proprietary Medicinal Products (12/5) |
| Serono SA (Switzerland; NYSE:SRA) | Serostim | Recombinant human growth hormone product | AIDS wasting | The European Commission granted orphan medicinal product designation to Serostim (9/13) |
| Skyepharma plc (UK; LSE:SKP) and Sanofi-Synthelabo (France) | Xatral | Once-daily oral formulation of alfuzosin | Benign prostatic hyperplasia | Companies earned approvals in Denmark, France, the Netherlands and Switzerland (1/26) |
| SuperGen Inc. (SUPG) | Rubitecan; oral chemotherapy compound in the camptothecin class | Pancreatic cancer | IND approved in Canada (2/4) | |
| Teva Pharmaceutical Industries Ltd. (TEVA) | Copaxone (FDA-approved) | Glatiramer acetate for injection; 4-amino-acid peptide derived from myelin basic protein | Relapsing-remitting multiple sclerosis | Cleared for marketing in the UK, allowing Teva to file for approval throughout the European Union (8/13); company launched Copaxone in the UK (12/5) |
| The Liposome Co. Inc. (LIPO) | Abelcet | Complex of amphotericin B with two phospholipids | Invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B | Cleared for marketing in Lebanon (2/17) |
| The Liposome Co. Inc. (LIPO) | Myocet (Evacet) | Liposomal formulation of doxorubicin | Metastatic breast cancer | Committee for Proprietary Medicinal Products recommended approval in the European Union (4/14) |
| Transkaryotic Therapies Inc. (TKTX) | Replagal | Agalsidase alfa; enzyme replacement therapy | Fabry disease | European Medicines Evaluation Agency accepted marketing authorization application for review (7/19) |
| Unigene Laboratories Inc. (OTC BB:UGNE) | Forcaltonin | Injectable recombinant calcitonin | Osteoporosis, Paget s disease and hypercalcemia | Company received a preapproval letter to market the product in Switzerland (8/15) |
| Vasogen Inc. (Canada; TSE:VAS) | VAS981 | Cell processing technology that modifies donor T cells to reduce inflammatory cytokine response | Leukemia patients undergoing bone marrow transplantation | Company received approval for a clinical trial in Canada (3/22) |
| Vertex Pharmaceuticals Inc. (VRTX) and Glaxo Wellcome plc (UK; NYSE:GLX) | Agenerase (FDA-approved) | Amprenavir; 2nd-generation HIV protease inhibitor | HIV | Companies received approval to market Agenerase in the European Union in combination with other antiretroviral agents to treat HIV (10/23) |
| Virax Holdings Ltd. (Australia; ASX:VHL) | VIR201 | Recombinant avipox virus designed to co-express genes for immunogenic but highly conserved parts of the AIDS virus in conjunction with a human cytokine (interferon-gamma) | HIV/AIDS | Company received approval to conduct clinical trials in Australia to test the vaccine (8/31) |
| Visible Genetics Inc. (Canada; VGIN) | Trugene HIV-1 Genotyping Kit | Sequence-based DNA test | HIV | Company was granted approval in France (12/21) |
| Zonagen Inc. (ZONA) and Schering-Plough Corp. (NYSE:SGP) | Vasomax | Immediate-release, oral formulation of phentolamine mesylate | Erectile dysfunction | The UK s Medicines Control Agency sent ScheringPlough a letter saying the product poses no carcinogenic threat to humans, lifting the suspension of clinical testing (8/1) |
