Company** Product Description Indication Type Action (Date)
Biocircuits Corp. PSA Assay Point-of-care assay Aid in diagnosing and Filed 510(k) (5/11)
(NASDAQ:BIOC) for prostate-specific monitoring prostate
antigen cancer
DepoTech Corp. DepoCyt Injectable, sustained- Neoplastic meningitis FDA sent company a non-
and Chiron Corp. release formulation of arising from solid approvable letter, saying
chemotherapeutic agent tumors the product failed to
cytarabine (uses Depo- decisively prove patient
Foam lipid-based drug benefit; FDA also said
delivery) data are sufficiently
promising to support sub-
mission of treatment IND
for this indication (5/26)
Genentech Inc. Herceptin Trastuzumab; human- Treatment of HER2- Completed submission of
ized monoclonal anti- overexpressing meta- BLA (5/4)
body to HER2 growth static breast cancer
factor receptor
Genzyme Corp. Thyrogen Recombinant human For use in diagnostic FDA's Endocrinologic
thyroid stimulating procedures (radio-iodine and Metabolic Drugs
hormone whole-body scanning) Advisory Committee
used to monitor patients recommended approval
for recurrence of (5/15)
thyroid cancer
Ligand - Panretin Chemically synthesized Kaposi's sarcoma in Submitted NDA (5/27)
Pharmceuticals Topical Gel version of 9-cis-retinoic AIDS patients
Inc. acid (natural hormone
derived from vitamin A)
(topical gel formulation)
Matritech Inc. NuMA Diagnostic blood test Aid in monitoring and FDA said product does
Test Kit that detects a nuclear management of patients not meet its criteria
matrix protein present diagnosed with colon for 510(k) marketing
at elevated levels in cancer clearance (5/19)
colon cancer cells
SuperGen Inc. Mitomycin Mitomycin for Combination therapy Approved for marketing
injection with approved chemo- (5/4)
therapeutic drugs for
treating adenocarcinoma
of the stomach and
Cor Therapeutics Integrilin Eptifibatide; small To reduce death, heart Approved for marketing
Inc. and Schering- molecule synthetic com- attack and other compli- (5/18)
Plough Corp. pound (derived from cations of percutaneous
(NYSE:SGP) rattlesnake venom) that transluminal coronary
inhibits GPIIb/IIIa angioplasty as well as in
receptor that mediates acute coronary condi-
platelet aggregation tions (unstable angina
and non-Q-wave myo-
cardial infarction)
Genetics Institute ReFacto Recombinant Factor Hemophilia A FDA accepted BLA for
Inc. and Wyeth- VIII; albumin-free review (5/17)
Ayerst Pharma- formulated product
ceuticals (both sub-
sidiaries of American
Home Products Corp.;
Merck & Co. Inc. Aggrastat Tirofiban HCl; non- Treatment of acute Approved for marketing
(NYSE:MRK) peptide inhibitor of coronary syndromes (5/14)
platelet aggregation (unstable angina and
based on component of non-Q-wave myocardial
venom of saw-scaled infarction) in patients
viper snake; blocks who need drug therapy
GPIIb/IIIa platelet only as well as in those
receptor (intravenous) who are expected to
undergo angioplasty
Texas Biotech- Novastan Synthetic small mole- Anticoagulant therapy FDA sent company a
nology Corp. and cule (argatroban) deri- in patients with heparin- nonapprovable letter
SmithKline ved from arginine; acts induced thrombocyto- (drug was not studied in
Beecham plc as direct inhibitor of penia comparison to placebo)
(NYSE:SBH; U.K.) thrombin (5/11)
Anesta Corp. ACTIQ Oral transmucosal Treatment of break- Submitted amendment to
fentanyl citrate through pain in cancer NDA (in response to 11/97
patients not approvable letter) (5/5)
Cephalon Inc. Myotrophin Mecasermin; recombi- Amyotrophic lateral FDA stated product is
and Chiron Corp. nant human insulin- sclerosis potentially approvable,
like growth factor subject to submission of
(injection) additional information from
ongoing studies showing
product's effectiveness
in treating disease (5/12)
Ergo Science Ergoset Formulation of bromo- Type II diabetes (mono- FDA's Endocrinologic and
Corp. Tablets criptine (ergot alkaloid; therapy as adjunct to Metabolic Drugs Advisory
generic dopamine diet to improve glycemic Committee voted not to rec-
agonist) control in diabetics) ommend for approval (5/14)
Biota Holdings AB FLU OIA Rapid point-of-care Diagnostic test for BioStar filed 510(k)
Ltd. (ASX:BTA; optical immunoassay influenza (5/11)
Australia) and that detects influenza
BioStar Inc.* virus strains A and B in
multiple sample types
Novopharm GPI-2A Antisense therapy; HIV infection and AIDS Company voluntarily
Biotech Inc. use of antisense oligo- in patients who have withdrew its IND for
(TSE:NVO; Canada) nucleotide that blocks failed or are resistant to Phase Ib trial and will re-
HIV replication, available HIV therapies submit once supplement-
delivered via cationic ary animal data on higher
liposomes (intravenous doses intended for this
and subcutaneous) trial are available (5/11)
Schering-Plough Rebetron Combination of Combination therapy FDA's Antiviral Drugs
Corp. (NYSE:SGP) Intron A (recombi- for treating chronic Advisory Committee
and ICN Pharma- nant human interferon hepatitis C virus voted unanimously in
ceuticals Inc. alfa-2b; injection) and infection in patients favor of approval (5/4)
(NYSE:ICN) Rebotol (ribavirin; with compensated liver
synthetic nucleoside disease who have re-
with antiviral activity; lapsed following alpha-
oral) (each product interferon therapy
separately approved
by FDA for other uses)
Shaman Provir Oral formulation of Diarrhea in AIDS FDA granted product
Pharmaceuticals compound SP-303, patients fast-track status (5/7)
Inc. which is isolated from
the croton plant; it is
thought to act by
inhibiting secretion of
chloride from intestinal
SmithKline LYMErix Recombinant OspA Prevention of Lyme FDA's Vaccine and Re-
Beecham plc vaccine (outer surface disease (both definitive lated Biological Products
(NYSE:SBH; U.K.) protein A; antigen disease and asympto- Advisory Committee
from tick-borne bac- matic infection) found the product to be
terium Borrelia burg- safe and effective (5/26)
dorferi, which causes
the infection)
Unimed Cryptaz Nitazoxanide; a nitro- Cryptosporidial FDA's Antiviral Drugs
Pharmaceuticals (a.k.a. NTZ) thiazole compound diarrhea in AIDS Advisory Committee
Inc. with activity against patients (caused by requested additional
many protozoan and Cryptosporidium information before
helminthic pathogens parvum) deciding whether to
(oral dosage) recommend (drug not
compared to placebo)
Centocor Inc. Infliximab Chimeric monoclonal Moderate-to-severe FDA's Gastrointestinal
(formerly antibody to tumor Crohn's disease, includ- Drugs Advisory Commit-
Avakine) necrosis factor-alpha ing fistulizing Crohn's tee recommended appro-
disease val (unanimous) (5/28)
Cypress Prosorba Disposable filter that Severe rheumatoid FDA selected PMA sup-
Bioscience Inc. Column uses Protein A to arthritis plement for special review
(FDA- remove circulating status (expedited review)
approved) immune complexes (5/27)
from patient's blood
Gliatech Inc. Adcon-L Anti-adhesion barrier To inhibit postopera- Approved for marketing
gel (semisynthetic tive adhesions involving (5/28)
carbohydrate polymer) spinal cord and nerve
roots and to improve
patient outcome follow-
ing lumbar disc surgery
Immunex Corp. Enbrel Recombinant, soluble Active rheumatoid Completed submission
p75 tumor necrosis arthritis of BLA (5/7)
factor receptor (TNFr)
linked to the Fc portion
of human IgG1
Novartis Pharma- Simulect Basiliximab; selective Prevention of acute Approved for marketing
ceuticals Corp. high-affinity mono- rejection episodes after (5/13)
(unit of Novartis AG; clonal antibody that kidney transplantation
Switzerland) blocks receptor for
Organogenesis Apligraf Living human skin Treatment of venous Approved for marketing
Inc. and Novartis (a.k.a. equivalent, composed of leg ulcers (of greater (5/26)
Pharma AG Graftskin) living human keratino- than 1 month's duration)
(Switzerland) cytes and fibroblasts
(epidermis and dermis;
isolated from infant
foreskins) cultured in
a 3-dimensional system
Ortec Composite Bioengineered bovine Management of chronic FDA granted humanitar-
International Inc. Cultured Skin collagen matrix seeded dermal ulcers in patients ian use device designat-
with epidermal and with junctional or dystro- ion to product (5/4)
dermal cells (biologi- phic forms of Epidermo-
cally active wound lysis Bullosa
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.
ASX = Australian Stock Exchange; TSE = Toronto Stock Exchange
* 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. 19-20.