Company** Product Description Indication Type Action/Date
Genzyme Corp. Thyrogen Recombinant human For use in diagnostic European marketing
thyroid stimulating procedures (radio-iodine authorization application
hormone whole-body scanning) accepted for review (2/18)
used to monitor patients
for recurrence of
thyroid cancer
Rhone-Poulenc Taxotere Docetaxel; semisyn- Treatment of advanced Approved for marketing
Rorer Inc. (subsidiary thetic agent derived metastatic breast cancer in People's Republic of
of Rhone-Poulenc from needles of the and non-small cell lung China (2/26)
SA; NYSE:RP; France) European yew tree; cancer
inhibits cancer cell
division by prevent-
ing assembly and
blocking disassembly
of microtubules
Scotia Holdings Amelorad Combination of gamma Reduction of radiation After European Medi-
plc (Scotland) linolenic acid and therapy-induced side cines Evaluation Agency
eicosapentaenoic acid effects in breast cancer said that additional clin-
patients ical trials were necessary
to prove clinical benefit,
company withdrew product
license application (2/24)
Flamel Technologies Asacard Controlled-release form- Use as preventive mea- Approved for marketing
SA (France) and G.D. ulation of cardiovas- sure against heart attack in U.K. (2/2)
Searle & Co. (subsid- cular aspirin (inhibits and stroke
iary of Monsanto Co.; platelet clumping)
Anesta Corp. ACTIQ Oral transmucosal Treatment of break- Submitted clinical trial
fentanyl citrate through pain in cancer exemption application
patients (similar to IND) in U.K. (2/19)
The Ares-Serono Rebif Recombinant interferon Multiple sclerosis Approved for marketing
Group (Switzerland) beta-1a (relapsing-remitting) in Canada (2/18)
T Cell Sciences Inc. ATM027 Humanized mono- Multiple sclerosis Reported interim results
and Astra AB (Sweden) clonal antibody that tar- of Phase I trial being con-
gets specific antigen ducted by Astra in Swe-
receptors for disease- den (2/23)
causing T cells
Biota Holdings Ltd. Relenza Zanamivir; neura- Treatment and prevent- Glaxo Wellcome initiated
(ASE:BTA; Australia) minidase inhibitor ion of viral influenza Phase III trials in Canada
and Glaxo Wellcome (designed and synthe- (inhaled in powder form) and U.S. (2/13)
plc (NYSE:GLX; U.K.) sized based on crystal
structure of surface
proteins of influenza
The Immune Remune Envelope-depleted, HIV infection and AIDS Data from open-label
Response Corp. inactivated AIDS virus trial being conducted in
(emulsified with Thailand published in
adjuvant) No. 2/3 1998 issue of
Virology; data also pre-
sented at HIV Vaccines
Trials In Thailand - Current
Progress 1998 conference
held in Bangkok (2/12)
Procept Inc. PRO 2000 Intravaginal small Prevention of HIV Presented results of 2nd
Gel molecule microbicide infection and other Phase I trial (conducted in
that binds to CD4 T sexually transmitted U.K.) at 5th Conference
cell receptor diseases (in women) on Retroviruses and
Opportunistic Infections
in Chicago (2/2)
SciClone Pharma- Zadaxin Synthetic version of Hepatitis B virus Approved for marketing
ceuticals Inc. (thymosin naturally occurring pep- infection (Peru); as in Peru and Argentina
alpha 1) tide hormone thymosin influenza vaccine (2/25)
(immunomodulator) adjuvant (Argentina)
Aeterna Psovascar Shark cartilage extract Moderate-to-severe Initiated Phase I/II trial
Laboratories Inc. with anti-angiogenic psoriasis in Canada (2/5)
(TSE:AEL; Canada) and anti-inflammatory
British Biotech plc Zacutex Platelet-activating Acute pancreatitis European Medicines
(U.K.) (formerly factor antagonist (syn- Evaluation Agency said
Lexipafant) thesized small mole- it has deferred decision on
cule drug) marketing authorization
application until the
results of an ongoing 2nd
pivotal trial are available
(necessary to provide de-
finitive proof of efficacy)
Cortecs Inter- Macritonin Oral formulation of To inhibit breakdown Reported interim analysis
national Ltd. (U.K.) salmon calcitonin (a of bone in post-meno- (6-month data) from on-
peptide hormone that pausal osteoporosis going Phase III European
inhibits bone resorption) trial (2/4)
Integra Integra Product consists of Wound healing in burns Approved for marketing
LifeSciences Corp. Artifical Skin bovine tendon-derived in South Korea (2/23)
implantable matrix with
an outer layer of a
silicone-based substi-
tute for epidermis
ProCyte Corp. Iamin Gel Prezatide copper Wound healing in Completed Phase II trial
0.5% acetate (topical gel) venous leg ulcers in U.K. (2/4)
Protein Design Zenapax Daclizumab; human- Combination therapy Results of Phase II Euro-
Labs Inc. and ized monoclonal anti- with other anti-rejection pean trial presented at
Hoffmann-La body (SMART Anti- drugs (cyclosporine and 3rd International Confer-
Roche Inc. TAC) that binds to the corticosteroids) for ence on New Trends in
interleukin-2 receptor reducing incidence of Clinical and Experiment-
on activated T cells acute rejection episodes al Immunosuppression in
in liver transplantation Geneva, Switzerland
SangStat Medical Cyclo- Cyclosporine generic Prevention of graft Submitted marketing
Corp. sporine drug (immunosuppres- rejection in organ authorization application
sive) transplantation in Europe (2/12)
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 February 1998. It does not cover ongoing clinical trials for which no news was issued in that month.
ASE = 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. 14-15.