Company** | Product | Description | Indication | Type Action/Date |
CANCER | ||||
Amgen Inc. | Stemgen | Ancestim; r-metHuSCF; | Combination therapy | FDA's Biological |
recombinant human | with granulocyte- | Response Modifiers Ad- | ||
stem cell factor | colony stimulating | visory Committee recom- | ||
factor to increase pro- | mended approval in nar- | |||
genitor blood cells (stem | row indication (10-1 vote) | |||
cells) for autologous stem | but not for broader use to | |||
cell transplants in cancer | reduce the number of pro- | |||
patients undergoing | cedures for collecting | |||
high-dose chemotherapy | blood cells (apheresis) (7/30) | |||
Cell Pathways | FGN-1 | Exisulind; orally active | Adenomatous poly- | FDA granted product |
Inc.* | drug designed to induce | posis coli in children | fast-track status (7/9) | |
apoptosis in precan- | (precancerous colonic | |||
cerous cells | polyps) | |||
CellPro Inc. | Ceprate SC | Stem cell concentration | Expanded label to include | Cleared for marketing |
System | device; separates stem | device's ability to concen- | (7/28) | |
(FDA- | cells from other cells of | trate stem cells from peri- | ||
approved) | bone marrow or peri- | pheral blood as a support | ||
pheral blood using an | for myeloablative therapy; | |||
avidin/biotin immuno- | to reduce number of tumor | |||
affinity selection system | cells present in autograft | |||
(tumor purging) | ||||
Ceprate SC | 2nd-generation cell- | Stem cell concentration | FDA sent company an | |
Instrument II | separation device | device (see above) | approvable letter (7/13) | |
Ligand | Panretin Gel | Alitretinoin; 0.1% gel; | Treatment of dermal | FDA accepted NDA for |
Pharmaceuticals | chemically synthesized | lesions in AIDS- | priority review (7/13) | |
Inc. | version of 9-cis-retinoic | related Kaposi's | ||
acid (derived from | sarcoma | |||
vitamin A) | ||||
Nexell | Isolex 300 | Stem cell selection | To support enrichment | FDA notified company |
Therapeutics Inc. | and | systems; devices that | of CD34+ cells and | that it needs additional |
(majority-owned | Isolex 300i | separate CD34+ stem | reduction of non-target | data and clarification of |
subsidiary of Vimrx | cells from peripheral | cells (including tumor | information submitted in | |
Pharmaceuticals Inc.) | blood (Isolex 300 is | cells) in autologous | support of PMA applica- | |
semi-automated; Isolex | transplants in breast | tion (7/7) | ||
300i is fully automated) | cancer, non-Hodgkin's | |||
lymphoma and other | ||||
B cell malignancies | ||||
CARDIOVASCULAR | ||||
Cypros | Ceresine | Small molecule; acts | Closed head injury | FDA granted product |
Pharmaceutical | during and after ischemia | expedited review status | ||
Corp. | by maintaining cellular | (7/7) | ||
ATP levels or accelera- | ||||
ting their restoration | ||||
CENTRAL NERVOUS SYSTEM | ||||
Neurogen Corp. | ADC1 | Mild NMDA receptor | Epilepsy | Wyeth-Ayerst filed IND |
and Wyeth-Ayerst | antagonist and use- | for Phase II trials (6/24)# | ||
Laboratories | dependent blocker of | |||
(division of American | voltage-gated sodium | |||
Home Products Corp.; | channels | |||
NYSE:AHP) | ||||
INFECTION | ||||
Aviron | FluMist | Nasal spray formu- | Prevention of influenza | Submitted PLA/ELA |
lation of influenza | infection in children and | (7/1) | ||
vaccine; attenuated, | adults, as well as in high- | |||
cold-adapted live | risk adults (when co- | |||
virus vaccine | administered with inact- | |||
ivated vaccine) | ||||
Isis Pharma- | Vitravene | Fomivirsen; anti- | Newly diagnosed and | FDA's Dermatologic and |
ceuticals Inc. and | sense inhibitor of | advanced CMV retinitis | Ophthalmic Drugs Advis- | |
Ciba Vision Corp. | cytomegalovirus | in AIDS patients | ory Committee recom- | |
(unit of Novartis AG; | (CMV) replication | mended approval (5-2 | ||
Switzerland) | (intravitreal injection) | vote) (7/22) | ||
Magainin | Pexiganan | Pexiganan acetate; | Infection in diabetic | Submitted NDA (7/27) |
Pharmaceuticals | (formerly | topical (1% cream); | foot ulcers | |
Inc. | Cytolex) | broad-spectrum anti- | ||
infective; synthetic | ||||
magainin (natural host- | ||||
defense peptide isolated | ||||
from frogs) | ||||
North American | Certiva | Combined diphtheria, | Active immunization in | Approved for marketing |
Vaccine Inc. | tetanus and acellular | infants and children 6 | (7/30) | |
pertussis (DTaP; detox- | weeks to 7 years of age | |||
ified pertussis toxin) | against diphtheria, tet- | |||
vaccine | anus and pertussis | |||
(whooping cough) | ||||
MISCELLANEOUS | ||||
Bio-Technology | BioLon | 1% solution of sodium | Surgical aid to protect | Approved for marketing |
General Corp. | hylauronate (high mole- | corneal endothelium | (7/20) | |
cular weight viscoelastic | during various ophthal- | |||
lubricant) | mic surgical procedures | |||
Boston Life | Therafectin | Synthetic carbohydrate- | Rheumatoid arthritis | Submitted amendment to |
Sciences Inc. | based drug (oral form- | pending NDA (contains | ||
ulation) | results of Phase III trial and | |||
manufacturing data) (7/1) | ||||
Celgene Corp. | Thalomid | Thalidomide; thought | Erythema nodosum | Approved for marketing |
to act by modulating | leprosum, a severe | (7/16) | ||
levels of tumor necrosis | condition associated | |||
factor-alpha | with leprosy | |||
Creative | OP-1 | Device that combines | Bone graft; to induce | Stryker initiated modular |
Bio-Molecules Inc. | Device | genetically engineered | normal bone regenera- | PMA submission in 4/98# |
and Stryker Corp. | bone morphogenic pro- | tion in tibial non-union | ||
(NYSE:SYK) | tein (OP-1) with resorb- | fractures | ||
able collagen scaffold | ||||
that is surgically | ||||
implanted in bone | ||||
fractures and defects | ||||
Cypress | Prosorba | Disposable filter that | Severe rheumatoid | Completed submission |
Bioscience Inc. | Column | uses Protein A to | arthritis | of PMAs (7/21) |
(FDA- | remove circulating | |||
approved) | immune complexes | |||
from patient's blood | ||||
NeXstar | NX 1838 | Small molecule inhib- | Age-related macular | Submitted IND (7/22) |
Pharmaceuticals | itor of vascular endo- | degeneration | ||
Inc. | thelial growth factor, | |||
developed via NeXstar's | ||||
SELEX combinatorial | ||||
chemistry process | ||||
Therapeutic | CroTAb | Polyclonal antibody | Anti-venom product | FDA accepted PLA and |
Antibodies Inc. | (produced in sheep) | for treating snake bites | ELA for review (7/13) | |
designed to neutralize | ||||
poisonous effect of | ||||
bites from North | ||||
American pit vipers | ||||
NOTES: | ||||
# Those items indicated with a hatch mark occurred prior to 7/98. | ||||
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. | ||||
* 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. 8-9. |