Company** | Product | Description | Indication | Type Action/Date |
CANCER | ||||
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 | ||||
(3/30) | ||||
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) | ||||
CARDIOVASCULAR | ||||
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- | ||||
istration) | ||||
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) | ||
DIABETES | ||||
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 | ||||
INFECTION | ||||
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) | |||
bacteria | ||||
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 | |||
(immunomodulator) | ||||
MISCELLANEOUS | ||||
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; | ||||
Switzerland) | ||||
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 | ||||
time | ||||
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) | ||
NOTES: | ||||
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. |