Company** Product Description Indication Type Action/Date
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)
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outdated human donor surgery (primary hip and Phase II trial (4/23)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)
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)
Generex Oralin Oral formulation of Diabetes Completed proof-of-con-
Biotechnology Corp. insulin cept trials in Ecuador
(OTC Bulletin Board: (4/30)
GNBT; Canada)
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-
NeXstar AmBisome Liposomal formulation Systemic fungal infect- Approved for marketing
Pharmaceuticals Inc. of amphotericin B ions (2nd-line therapy) in New Zealand (4/27)
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
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
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.