Company* (Country; Symbol) | Product |
Description | Indication |
Status (Date) |
| ||||
AUTOIMMUNE | ||||
Abbott Laboratories |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Rheumatoid arthritis |
Presented new data from ReAct trial in Europe that reaffirmed safety and efficacy data seen in pivotal trials (6/10) |
Biogen Idec Inc. (BIIB) |
Amevive (FDA-approved) |
Alefacept; targets the CD45RO+ subset of T cells |
Plaque psoriasis |
Gained approval in Australia for treating moderate to severe disease (6/17) |
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland) |
Antegren (natalizumab) |
Humanized monoclonal antibody; alpha-4 antagon- ist in the selective adhesion molecule inhibitor class |
Multiple sclerosis |
Filed for approval with the European Medicines Agency with one- year data from ongoing Phase III trials; BLA filing was in May (6/4) |
Centocor Inc. (unit of J& J) and Schering- Plough Corp. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Rheumatoid arthritis |
Approved in European Union as first-line treatment of early RA in combination with methotrexate (6/21) |
Genelabs Technologies Inc. (GNLB) |
Anastar (Prestara in the U.S.) |
Prasterone; synthetic equivalent of dehydro- epiandrosterone |
Lupus |
Withdrew marketing application in Europe following word from regulators that drug was not approvable (6/7) |
GW Pharmaceuticals plc* (UK; OTC BB: GWPRF) |
Sativex |
Spray formulation of cannabis extract |
Spasticity in multiple sclerosis |
Phase III trial showed a statistically significant improvement in spasticity; patients took drug with existing medications (6/21) |
Serono SA (Switzerland; NYSE:SRA) |
Raptiva (FDA- approved) |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis |
Psoriasis |
European committee recommended approval in patients who failed other therapies; the drug is sold in the U.S. by Genentech Inc. (6/24) |
CANCER | ||||
Allos Therapeutics Inc. (ALTH) |
RSR13 (efaproxiral) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
Filed for approval with the European Medicines Agency as an adjunct to whole-brain radiation in metastases from breast cancer (6/4) |
Aphton Corp. (APHT) |
G17DT |
Immunotherapy vaccine designed to induce antibodies to both gastrin 17 and glygastrin 17 |
Advanced pancreatic cancer |
Began regulatory submission in Switzerland as a monotherapy in patients who can't or won't take chemotherapy (6/10) |
Ark Therapeutics Group plc (UK; LSE:AKT) |
Cerepro |
Adenoviral-mediated gene medicine designed to induce thymidine kinase expression |
Advanced gliomas |
Study 903 in 36 patients demonstrated a statistically significant mean survival benefit (6/7) |
Atrix Laboratories Inc. (ATRX) |
Eligard (FDA-approved) |
Leuprolide acetate for injectable suspension |
Prostate cancer |
Atrix licensee Tecnofarma International Ltd. gained marketing authorization in Mexico for two formulations of the drug (6/1) |
CuraGen Corp. (CRGN) and TopoTarget A/S* (Denmark) |
PXD101 |
Histone deacetylase inhibitor |
Hematological cancers |
Began Phase I trial in Denmark to evaluate safety and potential activity in 15 patients (6/30) |
ImClone Systems Inc. (IMCL) |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Metastatic colorectal cancer |
Partner Merck KGaA gained approval in Europe to treat EGFR-expressing cancers in combination with irinotecan after an irinotecan- based treatment failure (6/30) |
Mologen AG* (Germany) |
MIDGE-Th1 and dSLIM |
MIDGE vector with coupled peptide and immunomodulating DNA construct |
Cancers |
Presented data on the two DNA- based vaccine technologies that showed positive early data on safety activity (6/11) |
Onyvax Ltd.* (UK) |
Onyvax-P |
Immunotherapy |
Prostate cancer |
Phase II trial showed encouraging progression-free survival in 26 men with advanced disease (6/17) |
Pharmion Corp. (PHRM) |
Thalidomide Pharmion |
Thalidomide; modulates levels of tumor necrosis factor-alpha |
Multiple myeloma |
Approved in Turkey for treating refractory disease, and for treating a severe complication of leprosy (6/3) |
YM BioSciences Inc. (Canada; TSE:YM) and Oncoscience AG* (Germany) |
TheraCIM hR3 |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
Pediatric glioma |
Began Phase I/II trial that initially will include 18 patients and be expanded to 47 patients also treated with radiation, if early data are positive (6/15) |
CARDIOVASCULAR | ||||
Ark Therapeutics Group plc (UK; LSE:AKT) |
Trinam |
VEGF gene in an adenoviral vector delivered with Ark's biodegradable collagen collar |
Prevention of blood-vessel blockage |
The product gained orphan desigation in Europe to prevent block- age following vascular graft access surgery (6/17) |
The Medicines Co. (MDCO) |
Angiox (Angiomax; FDA-approved) |
Direct thrombin inhibitor |
Anticoagulant |
European committee recommended approval in patients under- going percutaneous coronary interventions (6/24) |
CENTRAL NERVOUS SYSTEM | ||||
Neuro3d* (France) |
ND1251 |
Orally active phosphodiesterase-4 inhibitor |
Depression |
Began Phase I trial to assess safety, tolerability, pharmacokinetics and activity in the brain (6/1) |
Sirenade Pharmaceuticals AG* (Germany) |
SRN-001 |
Formulation of the dopamine agonist dihydroergocryptin (DHEC) |
CNS disorders |
Began a Phase I trial (6/14) |
INFECTION | ||||
Arrow Therapeutics* (UK) |
-- |
Small-molecule antiviral |
Respiratory syncytial virus |
Phase I trial in the UK demonstrated safety, tolerability and pharmacokinetics (6/28) |
Dynavax Technologies Corp. (DVAX) |
-- |
Prophylactic vaccine based on immunostimulatory sequences |
Hepatitis B |
Began Phase II/III trial in Singapore comparing vaccine to Engerix B in 80 subjects (6/22) |
Immtech International Inc. (AMEX:IMM) |
DB289 |
Oral, dicationic antiviral agent |
Pneumocystis carinii pneumonia |
Phase II trial involving AIDS patients in Peru demonstrated safety and efficacy of 50-mg dose (6/24) |
Nabi Bio- pharmaceuticals (NABI) |
Nabi-HB (FDA-approved) |
Hepatitis B immune globulin; intravenous solution of human antibodies |
Hepatitis B |
Filed for approval in Europe under the trade name Hebig for preventing hepatitis B in HBV-positive liver transplant patients (6/24) |
The Immune Response Corp. (IMNR) |
IR103 |
Combination of HIV-1 Immunogen and Amplivax, an immunostimulatory oligonucleotide adjuvant |
HIV |
Began trial in Canada that will be followed by sites in the UK; they are the first human studies of the product (6/15) |
Tripep AB (Sweden; SSE:TPEP) |
MetaboliteX (alphaHGA) |
Agent designed to inhibit the spread of the virus from the infected cell |
HIV |
Began microdosing study in the UK on non-infected volunteers (6/2) |
MISCELLANEOUS | ||||
Bioniche Life Sciences Inc. (Canada; TSE:BNC) |
Suplasyn |
Sodium hyaluronate solution |
Osteoarthritis of the knee |
Pharmacoeconomic study in 310 patients in France demonstrated a significant reduction in pain (6/14) |
NicOx SA (France; Nouveau Marche:NICOX) |
HCT 3012 (formerly AZD3582) |
Nitric oxide-releasing compound from company's CINOD class |
Osteoarthritis |
Data from Phase II OASIS trial showed pain relief equivalent to rofecoxib at six weeks (6/10) |
Zonagen Inc.* (ZONA) |
Progenta |
Agent designed to block progesterone without blocking adrenal hormones |
Uterine fibroids |
Began Phase I/II trial in Poland to test the product in 30 women with uterine fibroids (6/29) |
Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
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