Company** | Product | Description | Indication | Type Action/Date |
CANCER | ||||
Digene Corp. | Hybrid | Assay detects DNA | Used in conjunction | U.K.'s Imperial Cancer |
Capture II | from 18 different | with Pap smear testing | Research Fund will | |
HPV DNA | human papillomavirus | to detect HPV (cause of | direct 12,000-woman | |
Test | (HPV) types | cervical cancer) | screening study (4/9) | |
Guilford Pharma- | Gliadel | Biodegradable polyan- | Treatment of recurrent | Approved for marketing |
ceuticals Inc. and | hydride polymer wafer | malignant glioblastoma | in Argentina; filed for | |
Rhone-Poulenc Rorer | containing carmustine | multiforme; used as | marketing approval in | |
Inc. (subsidiary of | (implant) | adjunct to surgery | France and Israel (4/15) | |
Rhone-Poulenc SA; | ||||
NYSE:RP; France) | ||||
NeXstar | DaunoXome | Liposomal formulation | Advanced HIV-related | Approved for marketing |
Pharmaceuticals Inc. | of daunorubicin | Kaposi's sarcoma (1st- | in Australia (4/27) | |
line therapy) | ||||
Pacific | BOPP | Boronated porphyrin | Malignant brain tumors | Initiated Phase I trial in |
Pharmaceuticals Inc. | compound (light-activa- | Australia (4/22) | ||
ted drug for photo- | ||||
dynamic therapy) | ||||
CARDIOVASCULAR | ||||
Hemosol Inc. | Hemolink | Highly purified hemo- | Alternative to blood | U.K. regulatory agency |
(TSE:HML; Canada) | globin extracted from | transfusion in orthopedic | approved protocol for | |
outdated human donor | surgery (primary hip and | Phase II trial (4/23) | ||
blood, then cross-linked | primary knee replace- | |||
to form stable hemo- | ments) | |||
globin molecule (red | ||||
blood cell substitute) | ||||
CENTRAL NERVOUS SYSTEM | ||||
Allelix | ALX-0646 | Selective serotonin | Migraine headaches | U.K. regulatory agency |
Biopharmaceuticals | agonist; designed to act | approved protocol for | ||
Inc. (Canada) | on specific receptors in | Phase I trial (4/9); init- | ||
brain; oral dosage | iated Phase I trial (4/28) | |||
The Ares-Serono | Rebif | Recombinant interferon | Multiple sclerosis | New results from |
Group (Switzerland) | beta-1a | (relapsing-remitting; | PRISMS clinical trial | |
also transitional) | (conducted in Canada) | |||
presented at 50th annual | ||||
meeting of the American | ||||
Academy of Neurology, | ||||
in Minneapolis (4/30) | ||||
DIABETES | ||||
Generex | Oralin | Oral formulation of | Diabetes | Completed proof-of-con- |
Biotechnology Corp. | insulin | cept trials in Ecuador | ||
(OTC Bulletin Board: | (4/30) | |||
GNBT; Canada) | ||||
INFECTION | ||||
Amarillo | Veldona | Low-dose oral alpha | Hepatitis B virus | Approved for marketing |
Biosciences Inc. | interferon (natural) | infection | in Ghana (4/20) | |
BioChem Pharma Inc. | Lamivudine | Nucleoside analogue | Chronic hepatitis B | Glaxo Wellcome present- |
and Glaxo Wellcome | (oral dosage) | virus infection (mono- | ed results of 2 Phase III | |
plc (NYSE:GLX; U.K.) | therapy and combi- | trials (in Europe and Can- | ||
nation therapy with | ada) at the European | |||
Intron A) | Association for the Study | |||
of the Liver meeting, in | ||||
Lisbon, Portugal (4/16) | ||||
BioChem Vaccines | Influenza | Vaccine incorporates | Influenza | Initiated Phase I trial in |
(subsidiary of BioChem | vaccine | antigens from 3 strains | Canada (4/28) | |
Pharma Inc.; Canada) | of influenza virus in | |||
and Biovector | a supra-molecular bio- | |||
Therapeutics SA* | vector delivery tech- | |||
(France) | nology (lipid/poly- | |||
saccharide carrier) | ||||
(nasal administration) | ||||
MedImmune Inc. | CytoGam | Intravenous immune | Attenuation of primary | Approved for marketing |
globulin enriched in | cytomegalovirus | in Mexico and Poland | ||
antibodies to cyto- | infection associated | (2/9)# | ||
megalovirus | with kidney trans- | |||
plantation | ||||
NeXstar | AmBisome | Liposomal formulation | Systemic fungal infect- | Approved for marketing |
Pharmaceuticals Inc. | of amphotericin B | ions (2nd-line therapy) | in New Zealand (4/27) | |
MISCELLANEOUS | ||||
Advanced Magnetics | Feridex I.V. | Magnetic resonance | Detection of liver | Approved for marketing |
Inc. and Taejoon | imaging (MRI) contrast | lesions | in South Korea (4/6) | |
Pharmaceutical Co. | agent | |||
Ltd. (South Korea) | ||||
Axys | APC-366 | Tryptase inhibitor | Asthma | Final results of Phase IIa |
Pharmaceuticals Inc. | (synthetic small | trial conducted in U.K. | ||
molecule); administra- | presented at American | |||
tion by inhalation of | Lung Association/Amer- | |||
nebulized drug | ican Thoracic Society | |||
1998 International Con- | ||||
ference, in Chicago (4/27) | ||||
Bio-Technology | Oxandrin | Orally active testoster- | Involuntary weight loss, | Approved for marketing |
General Corp. | one analogue (oxandro- | including that assoc- | in South Korea and the | |
lone) | iated with AIDS wasting | Azerbaijan Republic (4/23) | ||
Biomatrix Inc. | Synvisc | Elastoviscous hylan bio- | Osteoarthritis of the | Reported data from post- |
polymer; chemically | knee | marketing trial (com- | ||
modified version of | paring Synvisc to diclo- | |||
natural hyaluronan | fenac) conducted in U.K. | |||
at joint annual meeting of | ||||
the British and Spanish | ||||
Societies of Rheumatol- | ||||
ogy, in Brighton, England | ||||
(4/24) | ||||
PowderJect | PowderJect | Needleless injection | Male erectile dys- | Announced results of |
Pharmaceuticals plc | Alprostadil | system for alprostadil | function (impotence) | Phase I trial in U.K. |
(U.K.) | (delivers dry powder | (4/20) | ||
formulation through | ||||
the skin) | ||||
T Cell Sciences Inc. | TP10 | Soluble complement | Lung transplantation | Results of Canadian |
receptor 1; a comple- | Phase I/II trial presented | |||
ment inhibitor designed | at 18th annual meeting of | |||
to prevent release of | the International Society | |||
inflammation-causing | for Heart and Lung Trans- | |||
factors and to minimize | plantation, in Chicago | |||
complement-mediated | (4/16) | |||
injury (I.V. infusion) | ||||
Trega Biosciences | HP228 | Small molecule that | Management of inflam- | Initiated Phase I trial in |
Inc. and Dura | acts at melanocortin | mation associated with | Europe (4/13) | |
Pharmaceuticals Inc. | receptors to modulate | pain and with chronic | ||
cytokine levels; admin- | bronchial asthma | |||
istered to lungs via | ||||
Dura's Spiros pulmo- | ||||
nary drug delivery | ||||
system | ||||
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 events that were announced in April 1998, with the exception of one item (the 2/98 approval of MedImmune Inc.'s CytoGam in Mexico and Poland). It does not cover ongoing clinical trials for which no news was issued in 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. |