Company** Product Description Indication Type Action/Date
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
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
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
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)
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
# 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.