Company** Product Description Indication Type Action (Date)
Dako A/S HercepTest Immunohistochemical To identify breast Joint committee of FDA's
(Denmark) assay; polyclonal anti- cancer patients whose Hematology and Pathology
body-based test to tumors overexpress Devices Panel and Immunol-
detect HER2 protein HER2 protein (for ogy Devices Panel recommend-
potential treatment ed approval (unanimous) (9/4);
with Herceptin) approved for marketing (9/25)
Genentech Inc. Herceptin Trastuzumab; human- Treatment of HER2- FDA's Oncologic Drugs Advis-
ized monoclonal anti- overexpressing meta- ory Committee recommended
body to HER2 growth static breast cancer; use approval (unanimous) (9/2);
factor receptor as single agent in 2nd- approved for marketing (9/25)
and 3rd-line therapy and
in combination with
paclitaxel as 1st-line
Genzyme Corp. Thyrogen Recombinant human For use in diagnostic FDA sent company approvable
thyroid stimulating procedures (radio-iodine letter (9/16)
hormone whole-body scanning)
used to monitor patients
for recurrence of
thyroid cancer
Ribozyme Angiozyme Chemically synthesized Various cancers Submitted IND (9/22)
Pharmaceuticals ribozyme; specifically
Inc. inhibits formation of vas-
cular endothelial growth
factor receptor (VEGFr)
Techniclone TNT Tumor necrosis therapy; Malignant glioma Submitted Phase II trial pro-
Corp. chimeric monoclonal (brain tumor; inter- tocol to FDA (9/14)
antibody that targets stitial delivery system)
DNA-associated histone
antigens, labeled with
I-131 (targets necrotic
center of tumor)
Diatide Inc. and AcuTect Small-molecule synthetic In vivo imaging agent for Approved for marketing (9/15)
Nycomed peptide designed to acute deep vein thrombosis
Amersham plc adhere to GPIIb/IIIa
(U.K.) receptors on activated
platelets, labeled with
Neurogen Corp. NGD 96-1 Small molecule that Insomnia Pfizer filed IND (9/16)
and Pfizer Inc. modulates specific
(NYSE:PFE) gamma amino butyric
acid (GABA) neuro-
transmitter subtypes
DuPont Sustiva Efavirenz; non-nucleoside Combination therapy Approved for marketing (9/18)
Pharmaceuticals reverse transcriptase with antiretroviral drugs
Inc. inhibibitor (once-daily for treating HIV infect-
dosage) ion and AIDS in adults
and children
Magainin Pexiganan Pexiganan acetate; topi- Infection in diabetic FDA accepted NDA for
Pharmaceuticals (formerly cal (1% cream); broad- foot ulcers filing (9/23)
Inc. Cytolex) spectrum anti-infective;
synthetic magainin (nat-
ural host-defense peptide
isolated from frogs)
Nabi H-BIG Reformulated hepatitis Prevention of hepatitis FDA granted priority review
B immune globulin B virus infection status to PLA/ELA (9/17)
Atrix Labora- Atridox Biodegradable polymer Periodontal disease Approved for marketing (9/8)
tories Inc. and incorporating 10%
Block Drug Corp. doxycycline
Celltech Group CDP 571 Human monoclonal anti- Crohn's disease FDA granted product fast-
plc (U.K.) body that binds to and track status (9/2)
neutralizes tumor
necrosis factor
Immunex Corp. Enbrel Etanercept; recombi- Active rheumatoid FDA's Arthritis Advisory
nant, soluble p75 arthritis; for use as mono- Committee recommended
tumor necrosis factor therapy in patients who approval (unanimous) (9/16)
receptor (TNFr) linked have failed other therapies;
to the Fc portion of also for use in combination
human IgG1 with methotrexate
Not all the companies represented in this chart are biotechnology firms. Large pharmaceutical companies are included from time to time when the products they are developing address overwhelmingly important diseases such as AIDS and cancer, and where biotech companies are developing competing products.
** 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.