Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
| | ||||
CANCER | ||||
Alphapharm Pty. Ltd. (Australian subsidiary of Merck KGaA) |
Erbitux |
Cetuximab; antibody designed to block EGFR |
Metastatic colorectal cancer |
The Merck unit filed for approval of ImClone Systems Inc.'s product in Australia (11/3) |
Atrix Laboratories Inc. (ATRX) |
Eligard 7.5mg and 22.5mg |
Leuprolide acetate for injection; sustained- release formulations |
Prostate cancer |
Atrix licensee Sanofi-Synthelabo Canada gained marketing approval in Canada (11/7) |
Cyclacel Ltd.* (UK) |
CYC202 |
Small-molecule cyclin- dependent kinase inhibitor |
Cancers |
Phase I trials by French researchers with 49 patients showed the drug was well tolerated and produced clinical benefit (11/20) |
Igeneon AG* (Austria) |
IGN101 |
Vaccine designed to trigger an immune response to epithelial cell-adhesion molecule |
Metastatic colorectal cancer/adjuvant breast cancer |
Igeneon said it was starting pivotal trials in both indications; the colorectal trial will test 700 patients at 24 centers in Europe; the breast study will be in 600 patients in Austria (11/11) |
ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co. |
Erbitux |
Cetuximab; antibody designed to block EGFR |
Metastatic colorectal cancer |
Companies filed for approval in Canada to use drug in combination with irinotecan; the filing was given priority review status (11/24) |
Maxim Pharmaceuticals Inc. (MAXM) |
Ceplene |
Histamine dihydrochloride in combination with interleukin-2 |
Advanced malignant melanoma |
Maxim filed for approval in Europe (11/7) |
ML Laboratories plc (UK;LSE:MLB) |
-- |
Gene therapy containing virus with gene for nitroreductase |
Prostate cancer |
ML began a Phase II trial designed to assess safety and efficacy (11/12)** |
Phoenix Pharmacologics Inc.* |
ADI |
Argine deaminase, a mycoplasma protein formulated with poly-ethylene glycol |
Primary liver cancer |
Company initiated a Phase III open-label trial in Italy expected to include 80 patients (11/17) |
Spectrum Pharmaceuticals Inc. (SPPI) |
EOquin |
Anticancer agent |
Superficial bladder cancer |
Company initiated a Phase II study expected to include 10 European hospitals (11/17) |
CARDIOVASCULAR | ||||
Endovasc Inc. (OTC BB:EVSC) |
Liprostin |
Lisposomal formulation of prostaglandin E1 |
Peripheral vascular disease |
Sites In Mexico began screening patients for 120-patient Phase II trial; sites in Brazil and Russia are preparing for studies (11/20) |
Genzyme Corp. (GENZ) |
Cholestagel |
Colesevelam hydrocholoride; nonabsorbed cholesterol-lowering agent |
Primary hypercholesterolemia |
The Committee for Proprietary Medicine of the EU issued a positive option on the market application; a decision is expected in Q1:04 (11/21) |
Inflazyme Pharmaceuticals Inc. (Canada; TSE:IZB) |
GH9001 |
Formulation of medium- molecular-weight heparin and low-molecular-weight dermatan sulfate |
Prevention of blood clotting |
Company began a Phase Ib trial in the UK to measure safety and tolerability, as well as surrogate markers of activity (11/3) |
CENTRAL NERVOUS SYSTEM | ||||
Durect Corp. (DRRX) |
-- |
Sustained-release injectable product using Saber delivery system and local anesthetic |
Post-operative pain |
The first trial of the drug, in 12 volunteers in Europe, showed appropriate absorption (11/6) |
Newron Pharmaceuticals SpA* (Italy) |
Safinamide |
Molecule with multiple mechanisms of action |
Epilepsy |
Phase II trial in Italy and Germany showed no tolerability problems and a reduction in seizure frequency (11/18) |
Phytopharm plc (UK; LSE:PYM) |
PYM50028 |
Orally active synthetic neuroprotective and neuroregenerative agent |
Alzheimer's and Parkinson's disease |
Phase Ib trial in healthy subjects older than 50 showed favorable tolerability and pharmacokinetic properties (11/3) |
SkyePharma plc (UK; SKYE) |
DepoMorphine |
Sustained-release injectable formulation of morphine |
Post-operative pain |
Company filed for approval of the product in the UK (11/20) |
DIABETES | ||||
Biotech Holdings Ltd. (Canada; OTC BB:BIOHF) |
Sucanon |
Insulin-sensitizing drug |
Type II diabetes |
Biotech Holdings gained approval of the product in Mexico (11/3) |
INFECTION | ||||
AlphaVax Inc.* |
AVX101 |
Vaccine using VEE alphavirus vector |
To prevent HIV infection |
A trial started in South Africa to assess the preventive vaccine in humans (11/3) |
Chiron Corp. (CHIR) |
TOBI (FDA-approved) |
Tobramycin solution for inhalation |
Pseudomonas aeruginosa infection in CF |
Chiron started the ELITE study in up to 120 cystic fibrosis patients in Europe to delay P. aeruginosa infection (11/24) |
MISCELLANEOUS | ||||
Isogalen Inc. (AMEX:ILE) |
Isogalen Process |
Autologous cell therapy |
Tissue regeneration |
Isogalen said a review of 59 patients treated in the UK showed positive results, with few adverse events (11/20) |
Medgenics Inc.* (Israel) |
Biopump |
System for delivering erythropoietin |
Anemia in chronic kidney disease |
The Phase I trial in Israel will measure safety and EPO delivery in anemic renal failure patients (11/6) |
| | ||||
Notes: | ||||
* Privately held. | ||||
** Denotes date item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; OTC BB: Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
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