Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
Aphton Corp. and | Gastrim- | Vaccine for treating | Pancreatic cancer | Initiated Phase III trials in |
Pasteur Merieux | mune | cancers driven by hor- | Canada (11/19) | |
Connaught Canada | mone gastrin; consists | |||
(unit of Rhone-Poulenc | of synthetic peptides | |||
SA; NYSE: RP; France) | bound to carrier | |||
Diatide Inc. and | NeoTect | Small molecule synthetic | In vivo imaging agent for | Nycomed submitted market- |
Nycomed | peptide labeled with | suspected malignant tumors | ing application to European | |
Amersham plc | technetium-99m; peptide | of the lung | Medicines Evaluation Agency | |
(U.K.) | designed to adhere to | (11/23) | ||
somatostatin receptor | ||||
Genta Inc. | G 3139 | Anticode (antisense) | Hormone-refractory, | Initiated new Phase I/IIa |
compound; synthetic | metastatic prostate cancer | trial in Canada (11/17) | ||
DNA strands that bind | (combination therapy with | |||
to mRNA for bcl2 gene | mitoxantrone) | |||
(proto-oncogene) | ||||
GlycoDesign Inc.* | GD 0039 | Orally active small | Renal cell carcinoma | Health Canada approved |
(Canada) | molecule compound | (cancer resistant to 1st-line | expansion of Phase II trial to | |
that inhibits key carbo- | chemotherapy) | include patients with colo- | ||
hydrate processing | rectal cancer (11/25) | |||
enzymes in tumor cells | ||||
Maxim Pharma- | Maxamine | Maxamine (H2 receptor | Advanced renal cell | Initiated Phase II trial in |
ceuticals Inc. and | Therapy | agonist) combined with | carcinoma | Sweden, Denmark and U.K. |
BioNative AB* | BioNative's natural cyto- | (11/30) | ||
(Sweden) | kine Interferon Alfanative | |||
and interleukin-2 | ||||
Novopharm | NovoMAb- | Recombinant, pan-car- | Recurrent non-Hodgkin's | Completed patient enrollment |
Biotech Inc. (TSE: | G2 scFv | cinoma-specific human | B-cell lymphoma | in Phase I Canadian trial |
NVO; Canada) | monoclonal antibody | (11/17) | ||
(2nd generation) | ||||
Progen Industries | PI-88 | Retailored polysaccharide | Various cancers | Initiated Phase I trial in U.K. |
Ltd. (NASDAQ: | with a sulfate chain at- | (11/5) | ||
PGLAF; Australia) | tached; thought to stop | |||
action of heparinase | ||||
(tumor cell enzyme | ||||
that allows penetration | ||||
of blood vessels) | ||||
Ribi ImmunoChem | Melacine | Therapeutic cancer | Stage IV melanoma | Company withdrew European |
Research Inc. | vaccine made of lysed | marketing application, after | ||
cells from 2 human mela- | European Agency For Evalu- | |||
noma cell lines with a | ation of Medicinal Products | |||
broad array of melanoma | said that company would have | |||
antigens, combined with | to conduct additional Phase III | |||
Detox adjuvant | studies before it would | |||
continue review of application | ||||
(11/2) | ||||
CARDIOVASCULAR | ||||
Hemosol Inc. | Hemolink | Highly purified hemo- | Blood substitute in | Completed patient recruitment |
(TSE:HML; Canada) | globin extracted from | renal dialysis patients | in North American Phase II | |
outdated human donor | (co-administered with | trial (11/30) | ||
blood, then cross-linked | erythropoietin) | |||
to form stable hemo- | ||||
globin molecule | ||||
CENTRAL NERVOUS SYSTEM | ||||
Neurobiological | Memantine | Orally administered | Severe dementia in the | Reported results of Phase III |
Technologies Inc. | N-methyl-D-aspartate | elderly, including | trial conducted by Merz in | |
and Merz + Co. | receptor antagonist | Alzheimer's disease | Germany; results show statis- | |
GmbH & Co. | (prevents over-activation | tically significant improvement | ||
(Germany) | of the receptor) | in functional independence (11/12) | ||
INFECTION | ||||
BioChem Pharma | Zeffix | Nucleoside analogue | Chronic hepatitis B | Presented combined data from |
Inc. (Canada) and | (a.k.a. | (oral dosage) | virus infection in adults | 4 Phase III trials in Asia (in |
Glaxo Wellcome | lamivudine) | (monotherapy) | patients with variant viral | |
plc (NYSE:GLX; U.K.) | strains) at the American | |||
Association for the Study of | ||||
Liver Diseases (AASLD) | ||||
meeting in Chicago (11/9) | ||||
BioChem Pharma | Heptovir | Nucleoside analogue | Chronic hepatitis B | Approved for marketing in |
Inc. (Canada) and | (a.k.a. | (oral dosage) | virus infection in adults | Canada (11/30) |
Glaxo Wellcome | lamivudine) | |||
plc (NYSE:GLX; U.K.) | ||||
Chiron Corp. | MenC | Conjugate vaccine | Meningococcus C infection | Results of Phase II Canadian |
vaccine | against Meningococcus; | in children (infants and | trial published in 11/18/98 | |
links polysaccharide | toddlers) | issue of the Journal of the | ||
antigen of MenC strain to | American Medical Association | |||
a diphtheria antigen | (11/17) | |||
The Liposome | Abelcet | Amphotericin B lipid | Invasive fungal infections | Approved for marketing in |
Co. Inc. | complex (injection) | (2nd-line therapy) | Singapore (11/6) | |
SciClone Pharma- | Zadaxin | Synthetic version of | Chronic hepatitis B virus | Presented results of Phase II trial |
ceuticals Inc. | (thymosin | naturally occurring pep- | infection (combination | (conducted in Hong Kong in im- |
alpha 1) | tide hormone thymosin | therapy with nucleoside | mune-tolerant Chinese patients) | |
(immunomodulator) | analogue famciclovir) | at the AASLD meeting (11/4) | ||
SciClone Pharma- | Zadaxin | Synthetic version of | Chronic hepatitis B virus | Presented results of Phase II |
ceuticals Inc. | (thymosin | naturally occurring pep- | infection (combination | trial conducted in Hong Kong |
alpha 1) | tide hormone thymosin | therapy with nucleoside | at AASLD meeting (11/5) | |
(immunomodulator) | analogues famciclovir | |||
and lamivudine) | ||||
Synsorb Biotech | Synsorb Pk | Orally delivered carbo- | Treatment of pediatric | Presented results of open- |
Inc. (Canada) and | hydrate attached to inert, | enterohemorrhagic | label study conducted in | |
Takeda Chemical | insoluble support; binds | E. coli infections, including | Japan at 28th Eastern Regional | |
Industries Ltd. | to toxins secreted by | hemolytic uremic syn- | Meeting of the Japanese Soc- | |
(Japan) | bacteria in the gastro- | drome (co-administered | iety of Nephrology in Tokyo | |
intestinal tract | with antibiotics) | (11/23) | ||
Vertex Pharma- | Agenerase | Amprenavir; 2nd-genera- | Combination therapy | Glaxo submitted application |
ceuticals Inc. and | tion HIV protease inhib- | with Retrovir (AZT) and | for marketing approval in | |
Glaxo Wellcome | itor; twice-daily dosage | Epivir (3TC) for HIV | European Union (11/2) | |
plc (NYSE:GLX; U.K.) | infection and AIDS in | |||
adults and children | ||||
MISCELLANEOUS | ||||
Pharming Group | Recombinant human | Pompe's disease (lyso- | Initiated Phase II trial in the | |
NV (EASDAQ:PHAR; | alpha-glucosidase | somal storage disroder) | Netherlands (11/9) | |
the Netherlands) | (produced in milk of | |||
transgenic rabbits) | ||||
Protein Design | Zenapax | Daclizumab; human- | Prevention of acute organ | Committee For Proprietary |
Labs Inc. and | ized monoclonal anti- | rejection in kidney trans- | Medicinal Products recom- | |
Hoffmann- | body (SMART Anti- | plant patients | mended approval in European | |
La Roche Inc. | TAC) that binds to the | Union (11/30) | ||
interleukin-2 receptor | ||||
on activated T cells | ||||
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. | ||||
TSE = Toronto Stock Exchange | ||||
* Private companies are indicated with an asterisk. | ||||
** 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. 9-10. |