Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
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 | ||||
therapy | ||||
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) | ||||
CARDIOVASCULAR | ||||
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 | ||||
technetium-99m | ||||
CENTRAL NERVOUS SYSTEM | ||||
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 | ||||
INFECTION | ||||
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) | ||
(human) | ||||
MISCELLANEOUS | ||||
Atrix Labora- | Atridox | Biodegradable polymer | Periodontal disease | Approved for marketing (9/8) |
tories Inc. and | incorporating 10% | |||
Block Drug Corp. | doxycycline | |||
(NASDAQ:BLOCA) | ||||
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 | |||
NOTES: | ||||
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. |