Company** Product Description Indication Type Action (Date)
Biomira Inc. Tru-Scint AD Technetium-99m- In vivo imaging agent Canadian regulatory
(Canada) labeled monoclonal for detecting recurrent agency informed com-
antibody that reacts breast cancer and pri- pany that the data in its
with most adeno- mary residual or recur- new drug application (NDA)
carcinomas rent ovarian cancer (filed 5/96, seeking expe-
dited approval) were insuf-
ficient for determining sta-
tistical significance; com-
pany will not resubmit NDA
Cel-Sci Corp. Multikine Natural mixture of Head and neck cancer Expanded clinical trials
human cytokines, treatment prior to sur- in Canada (12/3)
including interleukin-2 gery or radiation therapy
Immuno-Designed MAK Cell Macrophage-activated Single therapy (or com- Initiated Phase II trials in
Molecules SA* Therapy killer cell therapy (uses bination therapy with France (12/10)
(France) point-of-care cell bispecific antibodies) for
processor to isolate ovarian and bladder
mononuclear cells from cancer
patient's blood; cells
activated ex vivo)
Novopharm NOVOMAb- Recombinant, pan- Progressive non-Hodg- Initiated Phase I trial in
Biotech Inc. G2 scFv carcinoma-specific kin's B cell lymphoma Canada (12/17)
(TSE:NVO; Canada) human monoclonal
(2nd generation)
Maxim Maxamine H2 receptor agonist that Combination therapy Results of ongoing clini-
Pharmaceuticals blocks phagocyte signal with interleukin-2 for cal trial (being conducted
Inc. that leads to death of improving relapse- in Sweden) published in
natural killer T cells remission in acute 12/97 issue of Leukemia
myelogenous leukemia and Lymphoma (12/2)
BioTime Inc. Hextend Blood plasma volume Replacement of blood Completed Phase III
expander volume during surgery trials in U.K. (12/8)
in which substantial
amounts of blood are lost
Hemosol Inc. Hemolink Highly purified hemo- For use in orthopedic Expanded sites for Phase
(TSE:HML; Canada) globin extracted from surgery (primary hip and II Canadian trials to in-
outdated human donor primary knee replace- clude the Maritimes
blood, then cross-linked ments) (12/22)
to form stable hemo-
globin molecule (red
blood cell substitute)
Hemosol Inc. Hemolink Highly purified hemo- To enhance effective- Canadian health author-
(TSE:HML; Canada) globin extracted from ness of erythropoietin ities approved protocol
outdated human donor therapy in patients for additional Phase II
blood, then cross-linked with chronic anemia trial (12/18)
to form stable hemo- associated with kidney
globin molecule (red failure
blood cell substitute)
Chiroscience Chirocaine Levobupivacaine; chiral Broad usage in local, Submitted European mar-
Group plc (U.K.) version of approved drug regional or spinal keting authorization
bupivacaine anesthesia application (in Sweden)
Cortecs Macrulin Oral capsule formulation Type II diabetes Reported data from Phase
International Ltd. of porcine insulin (insulin II trial on 6 patients in
(U.K.) peptide coated with an the Netherlands (12/10)
amphipathic molecule)
Scotia Holdings plc Tarabetic Gamma-linolenic acid Diabetic neuropathy U.K.'s Medicines Control
(Scotland) (based on evening Agency rejected marketing
primrose oil) application (for the 2nd
time) based on wide var-
iation in results from 12
clinical trial centers;
company will not conduct
more trials (12/19)
Aquila Malaria Vaccine containing the Malaria Initiated Phase I trial in
Biopharmaceuticals vaccine synthetic peptide SPf66 Colombia (cosponsored
Inc. (hybrid molecule contain- by the Colombian govern-
ing antigenic domains ment and the World
from 2 life cycle stages Health Organization) (12/1)
of malaria parasite), plus
the Stimulon adjuvant
Aronex Pharma- Nyotran Liposomal formulation Systemic fungal Filed marketing author-
ceuticals Inc. and of the antifungal agent infections ization application
Grupo Ferrer Inter- Nystatin in Spain (12/19)
nacional SA (Spain)
Aviron and Smith- -- Vaccine based on Vaccine for infectious Initiated Phase I trial in
Kline Beecham single surface antigen mononucleosis (caused Belgium (12/3)
Biologicals responsible for most of by EBV)
(Belgium; unit of the neutralizing antibodies
SmithKline Beecham plc; stimulated by Epstein-
NYSE:SBH; U.K.) Barr virus (EBV) infection,
together with SmithKline's
adjuvant technology
The Liposome Abelcet Amphotericin B lipid Severe, invasive fungal Approved for marketing
Co. Inc. complex (injection) infections (2nd-line in Norway (12/29)
Novopharm GPI-2A Antisense therapy; HIV infection and Initiated Phase I trial in
Biotech Inc. use of antisense oligo- AIDS Canada (12/9)
(TSE:NVO; Canada) nucleotide that blocks
HIV replication,
delivered via cationic
Synsorb Biotech Synsorb Pk Orally delivered carbo- Prevention of serious Received approval to
Inc. (Canada) hydrate attached to inert, complications from begin Phase III trials in
insoluble support; binds E. coli infections, Argentina (12/2)
to toxins secreted by including hemolytic
bacteria in the gastro- uremic syndrome
intestinal tract
Aeterna Psovascar Shark cartilage extract Moderate-to-severe Health Canada approved
Laboratories Inc. with anti-angiogenic psoriasis protocol for Phase I/II
(TSE:AEL; Canada) and anti-inflammatory trial (12/17)
Biomatrix Inc. Hylaform Hylan B gel tissue Correction of facial Approved for marketing
augmentation product wrinkles and depressed in Canada and Israel
scars (12/31)
Hyal Pharma- Hyanalgese-D Diclofenac 3% gel Pain relief in osteo- Announced that product
ceutical Corp. (formulated in drug arthritis did not achieve statistic-
(TSE:HPC; Canada) delivery system) ally significant results in
Phase III Canadian trial;
company will discontinue
product development
Integra Integra Product consists of Wound healing in burns; Approved for marketing
LifeSciences Corp. Artificial Skin bovine tendon-derived also, use in plastic and in People's Republic of
implantable matrix with reconstructive surgery China (12/8)
an outer layer of a
silicone-based substitute
for epidermis
Life Medical Piliel Serum-free combina- Topical gel for hair Company terminated the
Sciences Inc. tion of nutrients and regrowth and reduction European clinical trials on
(NASDAQ:CHAI) hormones applied in of hair loss in men this product, saying it had
situ; thought to stimulate sufficient information that
cell growth, form blood the product would not
vessels and improve yield the desired benefit
blood flow (12/17)
NPS Pharma- KRN-568 Orally active small Primary Kirin initiated Phase II
ceuticals Inc. and (R-568) molecule drug that acts hyperparathyroidism trial in Japan (12/11)
Kirin Pharma- at calcium receptors on
ceuticals (division of surface of parathyroid
Kirin Brewery; Japan) cells
Oxford OGT 918 Orally active small Gaucher's disease U.K.'s Medicines Control
GlycoSciences plc* molecule that inhibits (lysosomal storage Agency approved clinical
(U.K.) glycolipid formation disease) trial protocol (12/31)
SangStat Medical Bulk cyclo- Ingredient in SangStat's Immunosuppressive Approved for manufactur-
Corp. and Gensia sporine cyclosporine generic drug; used to prevent ing in European Union
Sicor Inc. substance drug graft rejection in (12/11)
organ transplantation
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 12/97. It does not cover ongoing clinical trials for which no news was issued that month.
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. 10-11.