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.