Company** Product Description Indication Type Action (Date)
CANCER
Cel-Sci Corp. Multikine Natural mixture of Treatment of head and Announced preliminary
human cytokines, neck cancer prior to results of small trial con-
including interleukin-2 surgery or radiation ducted in Israel (5/6)
therapy
Matritech Inc. NMP22 Diagnostic blood test Aid in monitoring and Approved for marketing
Test Kit that detects a nuclear testing for high-risk, in Japan (5/27)
matrix protein present previously undiagnosed
at elevated levels in bladder cancer
cancer cells
Progen PI-88 Retailored polysac- Combination with Initiated Phase I trials in
Industries Ltd. charide with a sulfate chemotherapy for Australia and U.K. (5/21)
(Australia) chain attached; thought treating various cancers
to stop action of hep-
arinase (tumor cell
enzyme that allows
penetration of blood
vessels)
QLT PhotoThera- Photofrin Photosensitive drug Treatment of certain Presented results of Phase
peutics Inc. (FDA- (porfimer sodium; types of early- and late- III trials conducted in
(Canada) approved) produces toxic oxygen stage non-small cell North America and
compound when lung cancers Europe at 34th annual
light-activated) meeting of the American
Society of Clinical Onco-
logy (ASCO) in Los
Angeles (5/19)
Medarex Inc. MDX-210 Bispecific antibody Late-stage prostate Presented interim results
that targets HER2 and kidney cancer of Phase II U.K. trial at
receptor on certain (patients pre-treated ASCO meeting (5/19)
cancer cells with granulocyte
macrophage-colony
stimulating factor)
Rhone-Poulenc Taxotere Docetaxel; semisyn- Metastatic breast cancer Results of Phase III trial
Rorer Inc. thetic agent derived in patients who have conducted in Canada and
(subsidiary of from needles of the progressed or relapsed 16 other countries presen-
Rhone-Poulenc SA; European yew tree; after chemotherapy with ted at ASCO meeting
NYSE:RP; France) inhibits cancer cell anthracycline (5/18)
division by prevent-
ing assembly and
blocking disassembly
of microtubules
Xenova Group XR9576 Product derived from Various cancers Initiated Phase I trial in
plc (U.K.) naturally occurring U.K. (5/12)
compound; blocks P-
glycoprotein pump
(expels chemothera-
peutic drugs from
cancer cells) (injection)
CARDIOVASCULAR
Cypros Cordox Cardioprotective drug; Treatment of both European regulatory
Pharmaceutical (CPC-111) small molecule com- donor heart and authorities approved pro-
Corp. pound designed to reduce transplant recipient tocol for Phase II trial in
accumulation of lactate; in heart transplants U.K. (5/27)
facilitates anaerobic
glycolysis
Genetics Institute ReFacto Recombinant Factor Hemophilia A European Medicines
Inc. and Wyeth- VIII; albumin-free Evaluation Agency
Ayerst Pharma- formulated product accepted marketing auth-
ceuticals (both orization application for
subsidiaries of Amer- review (5/17)
ican Home Products
Corp.;NYSE:AHP)
Molecular Optison 2nd-generation ultra- Imaging agent for use Approved for marketing
Biosystems Inc. sound contrast imaging in patients with known in all 15 member states of
and Mallinckrodt agent; contains perflu- or suspected cardio- the European Union
Inc. (NYSE:MKG) orocarbon vascular disease (5/19)
Northfield PolyHeme Chemically modified Blood substitute; Companies intend to get
Laboratories Inc. hemoglobin derived direct replacement of regulatory approvals for
and Pharmacia & from outdated human blood in large volumes Phase III trials in U.K.,
Upjohn AB (U.K.) donor blood in trauma setting Germany and Sweden
(5/12)
CENTRAL NERVOUS SYSTEM
The Ares-Serono Rebif Recombinant interferon Multiple sclerosis Approved for marketing
Group (Switzerland) beta-1a (relapsing-remitting; in European Union (5/98)
also transitional)
Cephalon Inc. Provigil Modafinil; oral formu- Narcolepsy (sleep Approved for marketing
lation of synthetic com- disorder) in Republic of Ireland
pound that is thought to (5/15)
affect alpha-adrenergic
receptors in the brain
Neuroscience DHEA Dehydroepiandro- Alzheimer's disease Announced early comple-
Pharma Inc. sterone; neurosteroid tion of patient enrollment
(Canada; unit of in 1st of 2 pivotal multi-
Neurocrine national Phase III trials
Biosciences Inc.) (5/4)
INFECTION
Advanced Viral Reticulose Peptide-nucleic acid Hiv infection and Reported results of Phase
Research Corp. compound; stimulates AIDS in treatment- III trials conducted in
(NASDAQ:ADVR) cytocidal arm of naive patients Barbados (5/21)
immune system and
activates production
of cytokines
BioChem Pharma Lamivudine Nucleoside analogue Chronic hepatitis B Glaxo Wellcome present-
Inc. and Glaxo (oral dosage) virus infection ed results of 2 internat-
Wellcome plc ional trials (including
(NYSE:GLX; U.K.) in Asia) at Digestive Dis-
ease Week (DDW) annual
meeting in New Orleans;
results show drug's effi-
cacy can be sustained for
2 years (5/17)
Cantab Pharma- DISC HSV Genetically disabled Vaccine for treating Presented data from Phase
ceuticals plc and herpes simplex virus and preventing genital I U.K. trials at 8th Inter-
Glaxo Wellcome (replication-deficient herpes national Congress on
plc (NYSE:GLX; both live virus) Infectious Diseases in
U.K.) Boston (5/18)
Isis Pharma- Fomivirsen Antisense inhibitor of Newly diagnosed and Filed marketing authori-
ceuticals Inc. and cytomegalovirus (CMV) advanced CMV retinitis zation application with
Ciba Vision Corp. replication in AIDS patients European Agency for the
(unit of Novartis AG; Evaluation of Medicinal
Switzerland) Products (5/5)
North American — Polysaccharide Group C meningo- Presented preliminary
Vaccine Inc. conjugate vaccine coccal infection in results of 2 trials conduct-
infants, children and in U.K. (one of which is
young adults a Phase II trial in infants)
at the meeting of the
European Society of Pedi-
atric Infectious Diseases
(5/27)
SciClone Zadaxin Synthetic version of Chronic hepatitis B Results of Phase III trial
Pharmaceuticals (thymosin naturally occurring pep- virus infection conducted in Taiwan
Inc. alpha 1) tide hormone thymosin published in 5/98 issue of
(immunomodulator) Hepatology (5/29)
SciClone Pharma- Zadaxin Synthetic version of Chronic hepatitis B Schering-Plough K.K.
ceuticals Inc. and (thymosin naturally occurring pep- virus infection initiated pivotal Phase
Schering-Plough alpha 1) tide hormone thymosin III trial in Japan (5/12)
K.K. (Japan; sub- (immunomodulator)
sidiary of Schering-
Plough Corp.; NYSE:
SGP)
MISCELLANEOUS
Centocor Inc. Infliximab Chimeric monoclonal Moderate-to-severe Submitted marketing
(formerly antibody to tumor Crohn's disease, includ- authorization application
Avakine) necrosis factor-alpha ing fistulizing Crohn's to European Agency for
disease Evaluation of Medicinal
Products (3/6)#
Hyal Pharma- Solarase 3% diclofenac gel Actinic keratosis Approved for marketing
ceutical Corp. (topical) (precancerous skin in Canada (5/20)
(TSE:HPC; Canada) lesions caused by
exposure to sun)
Icos Corp. ICM3 Monoclonal antibody Psoriasis Initiated Phase I/II trial in
to ICAM-3 (molecule Europe (5/20)
found on T cells and
antigen-presenting
cells); prevents T-cell
activation
Pharming Holding — Transgenic human Pompe's disease (a.k.a. Initiated Phase I trial in
NV (the Netherlands) alpha-glucosidase; glycogen storage dis- the Netherlands (4/15)#
produced in milk of order Type II)
transgenic rabbits
Phytopharm plc P54 Botanical pharma- Osteoarthritis Initiated Phase II trial in
(U.K.) ceutical derived from U.K. (5/6)
medicinal plant; active
components down-
regulate production of
COX-2 (cyclo-oxygenase)
Zonagen Inc. and Z-MAX Immediate-release oral Male erectile Approved for marketing
Schering-Plough (a.k.a. formulation of phentol- dysfunction in Mexico (5/29)
Corp. (NYSE:SGP) Vasomax) amine mesylate
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 May 1998, with the exception of items marked with #.
It does not cover ongoing clinical trials for which no news was issued in that month.
** 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. 19-20.