Company** Product Description Indication Type Action/Date
Aeterna Laboratories AE-941 Shark cartilage extract Refractory metastatic Reported results of Phase
Inc. (TSE:AEL; Canada) with anti-angiogenic lung cancer I/II North American
and anti-inflammatory trial at 89th annual meet-
properties ing of the American
Association for Cancer
Research, in New Orleans
Guilford Gliadel Biodegradable polyan- Treatment of recurrent Approved for marketing
Pharmaceuticals Inc. hydride polymer wafer malignant glioblastoma in Brazil (3/2)
and Rhone-Poulenc containing carmustine multiforme; used in
Rorer Inc. (subsidiary (implant) conjunction with surgery
of Rhone-Poulenc SA; to remove brain tumor
NYSE:RP; France)
NaPro Anzatax Paclitaxel; compound Generic equivalent to Approved for marketing
BioTherapeutics Inc. extracted from needles Bristol-Myers Squibb's in Singapore (3/12)
and F.H. Faulding & and limb stock of Taxol, which has been
Co. Ltd. (Australia) ornamental yew trees approved as a 2nd-line
therapy for breast and
ovarian cancer
Rhone-Poulenc Granocyte Lenograstim; glycosyl- Prevention of infection Approved for marketing
Rorer Inc. (subsidiary ated recombinant human and reduction of neutro- in Algeria, Cameroon,
of Rhone-Poulenc granulocyte colony- penia in chemotherapy Kazakhstan, Malaysia,
SA; NYSE:RP; France) stimulating factor patients Poland, Romania and
Slovenia (3/9)
Taxotere Docetaxel; semisyn- Treatment of advanced Approved for marketing
thetic agent derived metastatic breast cancer in Algeria, Bahrain,
from needles of the Bangladesh, Cameroon,
European yew tree; Guatemala, Iran, the Ivory
inhibits cancer cell Coast, Kenya, Lebanon,
division by prevent- Slovenia and Thailand
ing assembly and (3/9)
blocking disassembly
of microtubules
Taxotere Docetaxel; semisyn- Treatment of non-small Approved for marketing
thetic agent derived cell lung cancer in Algeria, Guatemala,
from needles of the Iran, Kenya, Slovenia,
European yew tree; South Korea and Thailand
inhibits cancer cell (3/9)
division by prevent-
ing assembly and
blocking disassembly
of microtubules
Ribi ImmunoChem Melacine Therapeutic cancer Stage IV melanoma Marketing authorization
Research Inc. and vaccine made of lysed application accepted and
Schering-Plough Corp. cells from 2 human mela- granted expedited review
(NYSE:SGP) noma cell lines with a broad by European Agency for
array of melanoma anti- Evaluation of Medicinal
gens, combined with Ribi's Products (3/30)
Detox adjuvant (contains
monophosphoryl lipid
A and mycobacterial
cell-wall skeleton)
GeneMedicine Inc. VEGF Gene Vascular endothelial Inhibition of restenosis Two physician-initiated
Medicine growth factor (VEGF) following angioplasty in Phase II trials began in
gene incorporated in 2 clinical settings: peri- Finland in 2/98 (3/19)
DOTMA cationic lipid pheral vascular disease,
gene delivery system coronary artery disease
(intravascular admin-
Sonus Pharma- EchoGen Fluorocarbon-based Contrast radiography Committee for Proprietary
ceuticals Inc. and Emulsion ultrasound contrast in patients with suspect- Medicinal Products rec-
Abbott Laboratories agent ed or established cardio- ommended approval in
(NYSE:ABT) vascular disease European Union (3/30)
Amylin Pramlintide Synthetic analogue of To improve glucose Completed patient enroll-
Pharmaceuticals Inc. human pancreatic control in patients with ment in two 6-month
hormone amylin Type I diabetes and in Phase III trials in Europe
insulin-using patients and Canada (3/19)
with Type II diabetes
Agouron Pharma- Viracept Nelfinavir mesylate; HIV infection Approved for marketing
ceuticals Inc. and HIV protease inhibitor and AIDS in Japan (3/6)
Japan Tobacco Inc. (synthetic small
(Japan) molecule)
BioChem Pharma Inc. Combivir Combination of anti- HIV infection and Approved for marketing
and Glaxo Wellcome retroviral drugs 3TC/ AIDS in European Union (3/20)
plc (NYSE:GLX; U.K.) Epivir (Lamivudine)
and AZT (Retrovir) in
single tablet
Lamivudine Nucleoside analogue Chronic hepatitis B Glaxo Wellcome filed for
(oral dosage) virus infection marketing approval in
European Union (3/25)
Biota Holdings Ltd. Relenza Zanamivir; neura- Treatment and preven- Glaxo Wellcome filed for
(ASX:BTA; Australia) minidase inhibitor tion of viral influenza marketing approval in
and Glaxo Wellcome (designed and synthe- (inhaled in powder form) Australia (3/30)
plc (NYSE:GLX; U.K.) sized based on crystal
structure of surface pro-
teins of influenza virus)
Cortecs International Pseudostat Oral (mucosal) vaccine Chronic bronchitis and Announced interim
Ltd. (U.K.) consisting of killed bronchiectasis results of Phase II U.K.
Pseudomonas aeruginosa trial (3/10)
The Immune Remune Envelope-depleted, Combination therapy Initiated Phase I trial in
Response Corp. inactivated AIDS virus with antiviral drugs for U.K. (sponsored by The
(emulsified with reconstituting an HIV- Wellcome Trust) (3/10)
adjuvant) specific immune response
in AIDS patients
PathoGenesis Corp. TOBI Tobramycin for Chronic lung infections Filed new drug submis-
inhalation (Pseudomonas aerugi- sion in Canada; product
nosa) in patients with granted priority review
cystic fibrosis status (3/23)
SciClone Zadaxin Synthetic version of Hepatitis B virus Approved for marketing
Pharmaceuticals Inc. (thymosin naturally occurring pep- infection in Kuwait (3/24)
alpha 1) tide hormone thymosin
Bio-Technology Oxandrin Orally active testoster- Involuntary weight loss, Approved for marketing
General Corp. one analogue (oxandro- including that associ- in Russia (3/11)
lone) ated with AIDS wasting
Celgene Corp. SelCID Small molecule inhibi- Chronic inflammatory Initiated multidose Phase
(CC801) tor of tumor necrosis diseases (including I trial in U.K. (3/10)
factor alpha overpro- rheumatoid arthritis and
duction (oral admin- inflammatory bowel
istration) disease)
Celtrix SomatoKine IGF-BP3 complex; Restoration of bone Reported interim results
Pharmaceuticals Inc. recombinant version of mineral density in of Phase II trial conducted
complex formed by patients recovering from in Belgium (3/26)
insulin-like growth surgery for hip fracture
factor-1 and its major
binding protein
Integra LifeSciences Integra Product consists of Use in reconstructive Approved for marketing
Corp. Artifical Skin bovine tendon-derived surgery and in full- in European Union (CE
implantable matrix with thickness skin injuries Mark certification) (3/20)
an outer layer of a
silicone-based substi-
tute for epidermis
Phytopharm plc Zemaphyte Botanical (plant-based Severe refractory Announced results of 2
(U.K.) pharmaceutical) eczema in children Phase III U.K. trials
and adults (3/25)
Protein Design Labs Zenapax Daclizumab; human- Combination therapy Approved for marketing
Inc. and F. Hoffmann- ized monoclonal anti- with other antirejection in Switzerland (3/3)
La Roche AG body (SMART Anti- drugs (cyclosporine and
(Switzerland) TAC) that binds to the corticosteroids) for
interleukin-2 receptor reducing incidence of
on activated T cells acute rejection episodes
in liver transplantation
QLT PhotoThera- Verteporfin Light-activated drug Treatment of various Initiated Phase IIIb trial
peutics Inc. (Canada) (BPD-MA) for photodynamic forms of macular degen- in North America and
and Ciba Vision Corp. therapy eration Europe (3/19)
(unit of Novartis AG;
Vysis Inc. AneuVysion Assay that uses fluor- Prenatal genetic test Approved for marketing
EC Assay escence in situ hybridi- for Down's syndrome in France and throughout
zation (FISH) technol- and other chromosomal Europe (registered with
ogy to measure aneu- disorders associated Agence du Medicament)
ploid nuclei in amnio- with mental retardation (3/24)
centesis specimens; and birth defects
24-hour turnaround
Zonagen Inc. and Vasomax Immediate-release oral Male erectile Schering-Plough filed
Schering-Plough Corp. formulation of phentol- dysfunction product registration appli-
(NYSE:SGP) amine mesylate cation in Mexico (3/19)
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. It covers only those events that were announced in 3/98. It does not cover ongoing clinical trials for which no news was issued in that month.
ASX = Australian Stock Exchange; TSE = Toronto Stock Exchange
** 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. 10-11.