Company** | Product | Description | Indication | Type Action/Date |
Name | ||||
CANCER | ||||
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) | ||||
CARDIOVASCULAR | ||||
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) | |||
NYSE:MTC) | ||||
CENTRAL NERVOUS SYSTEM | ||||
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 | ||||
INFECTION | ||||
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 | ||||
virus) | ||||
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) | |||
MISCELLANEOUS | ||||
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 | |||
properties | ||||
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) | ||||
(2/5) | ||||
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 | |||
(2/17) | ||||
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) | ||
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 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. |