Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
Bristol-Myers Squibb | Taxol | Paclitaxel; semi-syn- | Combination therapy | FDA's Oncologic Drugs |
Co. (NYSE:BMY) | (FDA- | thetic taxane; inhibits | with cisplatin as 1st- | Advisory Committee |
approved) | cancer cell division by | line treatment of ad- | recommended approval | |
blocking microtubule | vanced ovarian cancer | (3/20) | ||
assembly/disassembly; | ||||
derived from needles | ||||
and twigs of yew tree | ||||
Taxol | Paclitaxel; semi-syn- | Combination therapy | FDA's Oncologic Drugs | |
(FDA- | thetic taxane; inhibits | with cisplatin for treat- | Advisory Committee | |
approved) | cancer cell division by | ing non-small cell lung | recommended approval | |
blocking microtubule | cancer in patients who | (3/20) | ||
assembly/disassembly; | are not candidates for | |||
derived from needles | radiation therapy | |||
and twigs of yew tree | ||||
CellPro Inc. | Ceprate SC | Stem cell concentration | Expanded label to | FDA's Biological |
System | device; separates stem | include device's ability | Response Modifiers | |
(FDA- | cells from other cells of | to concentrate stem cells | Advisory Committee | |
approved) | bone marrow or peri- | from peripheral blood | voted unanimously that | |
pheral blood using an | as a support for myelo- | benefits outweigh risks | ||
avidin/biotin immuno- | ablative therapy; to | (3/24) | ||
affinity selection system | reduce number of tumor | |||
cells present in autograft | ||||
DepoTech Corp. | DepoCyt | Injectable, sustained- | Neoplastic meningitis | DepoTech will submit |
and Chiron Corp. | release formulation of | arising from solid | amendment to NDA that | |
chemotherapeutic agent | tumors | includes additional clin- | ||
cytarabine (uses Depo- | ical trial data; extends | |||
Foam lipid-based drug | FDA's review period to | |||
delivery) | 7/28/98 (3/6) | |||
Genentech Inc. | Herceptin | Trastuzumab; human- | Treatment of HER2- | FDA designated Hercep- |
ized monoclonal anti- | overexpressing meta- | tin as fast-track product | ||
body to HER2 growth | static breast cancer | (3/31) | ||
factor receptor | ||||
Nexell Therapeutics | Isolex 300 | Stem cell selection | To support enrichment | Submitted supplement to |
Inc. (majority-owned | and | systems; devices that | of CD34+ cells and | BLA requesting simulta- |
subsidiary of Vimrx | Isolex 300i | separate CD34+ stem | reduction of non-target | neous review of both |
Pharmaceuticals Inc.) | cells from peripheral | cells (including tumor | devices (3/17) | |
blood (Isolex 300 is | cells) in autologous | |||
semi-automated; Isolex | transplants in breast | |||
300i is fully automated) | cancer, non-Hodgkin's | |||
lymphoma and other | ||||
B cell malignancies | ||||
Pacific | BOPP | Boronated porphyrin | Malignant brain tumors | Filed IND for clinical |
Pharmaceuticals Inc. | compound (light-activated | trial (to be conducted | ||
drug for photodynamic | in Australia) (3/3) | |||
therapy) | ||||
CARDIOVASCULAR | ||||
BioTime Inc. | Hextend | Blood plasma volume | Replacement of blood | Completed submission of |
expander | volume during surgery | NDA (3/31) | ||
in which substantial | ||||
amounts of blood are lost | ||||
LXR Biotechnology | CP-Cardiosol | Cardioplegia solution | To reduce long-term | Filed IND for open-label |
Inc. | (intended to suppress | heart damage in connec- | Phase I/II trial (3/17) | |
pathways that initiate | tion with coronary artery | |||
apoptosis) | bypass graft surgery | |||
CENTRAL NERVOUS SYSTEM | ||||
The Ares-Serono | Rebif | Recombinant interferon | Multiple sclerosis | Submitted BLA (2/27)# |
Group (Switzerland) | beta-1a | (relapsing-remitting; | ||
also transitional) | ||||
Elan Corp. plc | Zonegran | Zonisamide capsules; | Adjunctive therapy for | FDA sent company an |
(Ireland) | blocks voltage-sensitive | treating partial seizures | approvable letter (3/24) | |
sodium and calcium | in adults with epilepsy | |||
channels | ||||
INFECTION | ||||
Genentech Inc. | Pulmozyme | Dornase alfa; | Reduction of incidence | FDA approved change in |
(FDA- | recombinant human | of respiratory tract | label (to include patients | |
approved) | DNase (aerosolized | infections in patients | under the age of 5) (3/2) | |
inhalation solution) | with cystic fibrosis | |||
Isis Pharmaceuticals | Fomivirsen | Antisense inhibitor of | Newly diagnosed and | Isis submitted chemistry, |
Inc. and Ciba Vision | (ISIS 2922) | cytomegalovirus (CMV) | advanced CMV retinitis | manufacturing and con- |
Corp. (unit of Novartis | replication | in AIDS patients | trols section of NDA | |
AG; Switzerland) | (3/25) | |||
Lidak | Lidakol | Long-chain fatty | Recurrent outbreaks of | FDA accepted NDA for |
Pharmaceuticals | (n-docosanol) | alcohol believed to | oral herpes (cold sores | review (2/26)# |
work by interfering | or fever blisters caused | |||
with viral entry into | by herpes simplex virus) | |||
cells (topical) | ||||
Merck & Co. Inc. | Crixivan | Indinavir sulfate; HIV | Treatment of HIV infec- | Received traditional mar- |
(NYSE:MRK) | protease inhibitor | tion, either as monother- | keting approval (initially | |
apy or in combination | approved under accelerated | |||
with nucleoside ana- | review 3/96) (3/5) | |||
logues | ||||
Unimed | NTZ | Nitazoxanide: a nitro- | Cryptosporidiosis in | FDA assigned priority |
Pharmaceuticals Inc. | thiazole compound with | AIDS patients (caused | review status to NDA | |
(NASDAQ:UMED) | activity against many | by Cryptosporidium | (3/5) | |
protozoan and helmin- | parvum) | |||
thic pathogens | ||||
MISCELLANEOUS | ||||
Anergen Inc. and | AnergiX | Product that incorporates | Rheumatoid arthritis | Filed IND (3/17) |
NV Organon | an Organon peptide de- | |||
(the Netherlands) | rived from human carti- | |||
lage-derived glycoprotein; | ||||
intended to selectively | ||||
inactivate T cells that | ||||
cause specific inflamma- | ||||
tory autoimmune response | ||||
CollaGenex | Periostat | Orally administered | Adjunct to scaling and | CollaGenex will submit |
Pharmaceuticals Inc. | drug consisting of | root planing for treating | amendment to NDA con- | |
subantibiotic dose of | moderate to severe | taining results of scaling/ | ||
doxycycline (inhibits | periodontitis in adults | root planing trial (3/16); | ||
production of | completed submission | |||
collagenase) | of amendment (3/31) | |||
Immunex Corp. | Enbrel | Recombinant, soluble | Severe rheumatoid | FDA designated Enbrel as |
p75 tumor necrosis | arthritis | fast-track product (3/17) | ||
factor receptor (TNFr) | ||||
linked to the Fc portion | ||||
of human IgG1 | ||||
Immunomedics Inc. | ImmuSTRIP- | Immunoassay to detect | Detection and semi- | Cleared for marketing |
HAMA | human anti-mouse anti- | quantitation of HAMA | (3/20) | |
bodies (HAMA) in blood | in patients receiving | |||
injections of mouse | ||||
antibodies for diagnostic | ||||
and/or therapeutic uses | ||||
Ligand Pharma- | TSE-424 | Tissue-selective | Postmenopausal | Wyeth-Ayerst filed IND |
ceuticals Inc. and | estrogen | osteoporosis | (3/26) | |
Wyeth-Ayerst Lab- | ||||
oratories (division of | ||||
American Home Pro- | ||||
ducts Corp.; NYSE:AHP) | ||||
Ostex International | Osteomark | Assay that measures | To determine probabil- | FDA approved expanded |
Inc. | Assay | cross-linked N-telopep- | ity of reduction in bone | indication (3/26) |
(FDA- | tides of type I collagen | mineral density in post- | ||
approved) | excreted in urine | menopausal women not | ||
taking hormonal anti- | ||||
resorptive therapy | ||||
Pharmos Corp. and | Alrex | Loteprednol etabonate | Treatment of ophthal- | Approved for marketing |
Bausch & Lomb | ophthalmic suspension | mic allergies (especially | (3/10) | |
Pharmaceuticals Inc. | 0.2% (topical steroid) | seasonal allergic conjunc- | ||
(NYSE:BOL) | tivitis) | |||
Lotemax | Loteprednol etabonate | Treatment of ophthalmic | Approved for marketing | |
ophthalmic suspension | inflammation (especially | (3/10) | ||
0.5% (topical steroid) | postoperative) | |||
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 when biotech companies are developing competing products. | ||||
# Those items identified with a hatch mark concern events that occurred in 2/98, although they were not announced until 3/98. | ||||
** 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. 10-11. |