Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
Novopharm | — | Generic paclitaxel | Breast and ovarian | Submitted ANDA in Canada |
Biotech Inc. | cancer | (9/10) | ||
(TSE:NVO; Canada) | ||||
Vysis Inc. | PathVysion | Assay based on fluores- | To detect and quantify | Submitted marketing applica- |
HER2 DNA | cent in situ hybridization | HER2 gene in patients | tion in France (9/10) | |
Probe Kit | technology (FISH); uses | with breast cancer | ||
locus-specific, direct- | ||||
label DNA probe that | ||||
binds to HER2 gene in | ||||
tissue biopsy | ||||
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. | Myotrophin | Mecasermin; recombi- | Amyotrophic lateral | Companies withdrew appli- |
and Chiron Corp. | nant human insulin- | sclerosis | cation to market product in | |
like growth factor | Europe (9/15) | |||
(injection) | ||||
NPS | NPS 1776 | Orally active small-mole- | Epilepsy | Initiated Phase I trial in U.K. |
Pharmaceuticals | cule drug with anti- | (9/29) | ||
Inc. | convulsant properties | |||
Sibia | SIB 1553A | Small molecule com- | Alzheimer's disease | Initiated 2nd Phase I trial in |
Neurosciences | pound; subtype-selective | South Africa (9/28) | ||
Inc. | nicotinic acetylcholine | |||
receptor agonist; stimu- | ||||
lates release of acetyl- | ||||
choline in brain | ||||
DIABETES | ||||
Generex Bio- | Oralin | Liquid (oral) formula- | Types I and II diabetes | Canada's Health Protection |
technology Corp. | tion of insulin, admin- | Branch approved protocol for | ||
(OTC Bulletin Board: | istered via metered dose | Phase II/III trial (9/10) | ||
GNBT; Canada) | aerosol application | |||
INFECTION | ||||
Biota Holdings Ltd. | Relenza | Zanamivir; neura- | Treatment and preven- | Glaxo filed applications for |
(ASX:BTA; Australia) | minidase inhibitor | tion of influenza A and B | regulatory approval in Canada | |
and Glaxo Wellcome | (designed and synthe- | and European Union (9/23); | ||
plc (NYSE:GLX; U.K.) | sized based on crystal | clinical data from international | ||
structure of surface pro- | trials (Australia and New Zea- | |||
teins of influenza virus); | land; also U.S.) presented at | |||
inhaled in powder form | 38th Interscience Conference | |||
on Antimicrobial Agents and | ||||
Chemotherapy (ICAAC) in | ||||
San Diego (9/27) | ||||
The Liposome Co. | Abelcet | Amphotericin B lipid | 1st-line threatment of | Approved for marketing in |
Inc. | complex (injection) | invasive fungal disease | Australia (9/11) | |
MISCELLANEOUS | ||||
Aeterna | Psovascar | Shark cartilage extract | Moderate to severe | Reported interim results of |
Laboratories Inc. | (AE-941) | with anti-angiogenic | plaque-type psoriasis | Phase I/II Canadian trial at |
(TSE:AEL; Canada) | and anti-inflammatory | 5th European Congress on | ||
properties | Psoriasis in Milan, Italy (9/8) | |||
Allelix Biophar- | ALX-0600 | Analogue of naturally | Short bowel syndrome | Initiated Phase I trial in |
maceuticals Inc. | occurring peptide GLP2; | Europe (9/8) | ||
(Canada) | enhances rate of growth | |||
of epithelium of small | ||||
intestine | ||||
Celgene Corp. | CDC 801 | Selective cytokine | Crohn's disease | Announced results of Phase I |
inhibitory drug | trial conducted in U.K. (9/10) | |||
Trega Biosciences | HP228 | Small molecule that | Management of inflam- | Completed Phase I trial in |
Inc. and Dura | acts at melanocortin | mation associated with | Northern Ireland; company | |
Pharmaceuticals | receptors to modulate | pain and with chronic | will not pursue further devel- | |
Inc. | cytokine levels; adminis- | bronchial asthma | opment without partner (9/30) | |
tered to lungs via Dura's | ||||
Spiros pulmonary drug | ||||
delivery system | ||||
Unigene | Fortical | Recombinant salmon | Paget's disease and | European Committee for Pro- |
Laboratories Inc. | Injection | calcitonin | hypercalcemia associated | prietary Medicinal Products |
with cancer | unanimously recommended | |||
approval (9/29) | ||||
NOTES: | ||||
ASX = Australian Stock Exchange; TSE = Toronto Stock Exchange | ||||
This chart is intended to provide a monthly update on the clinical and regulatory status of biotech and biotech-related products in development in countries other than the U.S., whether those products are being developed by U.S.-based or non-U.S.-based firms. | ||||
** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 14-15. |