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 theclinical and regulatory status of biotech and biotech-related productsin development in countries other than the U.S., whether those productsare 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 publicbiotechnology companies can be found by referring to the BioWorld StockReport For Public Biotechnology Companies on pp. 9-10.