Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
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 | ||||
pancreas | ||||
CARDIOVASCULAR | ||||
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.; | ||||
NYSE:AHP) | ||||
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) | ||
CENTRAL NERVOUS SYSTEM | ||||
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) | ||||
DIABETES | ||||
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) | ||
INFECTION | ||||
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 | ||||
cells | ||||
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) | ||||
(5/6) | ||||
MISCELLANEOUS | ||||
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 | |||
interleukin-2 | ||||
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 | |||
dressing) | ||||
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. | ||||
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. |