BGCOLOR="#FFFFFF"> Company** Product Description Indication Type Action (Date)

CANCER

Amgen Inc. Neupogen Filgrastim; recombinant Acute myelogenous Approved for marketing

(FDA- human granulocyte leukemia (adjunct to (5th indication) (4/7)

approved) colony-stimulating factor chemotherapy)

(stimulates production

of neutrophils)

CellPro Inc. Ceprate SC Stem cell concentration Expanded label to FDA sent company an

System device; separates stem include device's ability approvable letter (4/9)

(FDA- cells from other cells of to concentrate stem cells

approved) bone marrow or peri- from peripheral blood

pheral blood using an as a support for myelo-

avidin/biotin immuno- ablative therapy; to

affinity selection system reduce number of tumor

cells present in autograft

(tumor purging)

DepoTech Corp. DepoCyt Injectable, sustained- Neoplastic meningitis DepoTech submitted

and Chiron Corp. release formulation of arising from solid amendment to NDA

chemotherapeutic agent tumors (includes interim data

cytarabine (uses Depo- from Phase IV trial)

Foam lipid-based drug (4/24)

delivery)

Schering-Plough Intron A Recombinant human Combination therapy Submitted supplement to

Corp. (NYSE:SGP) (FDA- interferon alfa-2b with Ara-C (cytarabine PLA and requested prior-

approved) (injection) arabinoside) for initial ity review status (4/13)

treatment of chronic

myelogenous leukemia

CARDIOVASCULAR

Cor Therapeutics Integrilin Eptifibatide; small To reduce death, heart FDA sent company an

Inc. and Schering- molecule synthetic com- attack and other compli- approvable letter for

Plough Corp. pound (derived from cations of percutaneous broad indications (4/2)

(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)

Interneuron CerAxon Citicholine sodium; Reduction of infarct FDA granted product

Pharmaceuticals organic molecule that size and improvement fast-track status (4/3);

Inc. consists of cytidine and in neurological function company withdrew NDA

choline (components in patients with ischemic due to results of Phase III

of brain cell membranes) stroke trial, which showed that

product did not outper-

form placebo (4/20)

LXR CP-Cardiosol Cardioplegia solution To reduce long-term Product put on clinical

Biotechnology Inc. (intended to suppress heart damage in connect- hold; FDA wants addi-

pathways that initiate ion with coronary artery tional preclinical data,

apoptosis; heart pro- bypass graft surgery especially for potential

tectant solution) delayed adverse effects

(4/14)

Merck & Co. Inc. Aggrastat Tirofiban HCl; non- Treatment of acute FDA's Cardiovascular

(NYSE:MRK) peptide inhibitor of coronary syndromes and Renal Drugs Advis-

platelet aggregation (unstable angina and ory Committee recom-

based on component of non-Q-wave myocardial mended approval (9-1

venom of saw-scaled infarction) vote) (4/10)

viper snake; blocks

GPIIb/IIIa platelet

receptor

Scios Inc. Natrecor Nesiritide; human B- Acute congestive heart Submitted NDA (4/27)

type natriuretic peptide failure

(BNP; naturally occur-

ring hormone produced

in heart)

CENTRAL NERVOUS SYSTEM

Cephalon Inc. and Myotrophin Mecasermin; recombi- Amyotrophic lateral FDA cancelled the Peri-

Chiron Corp. nant human insulin- sclerosis pheral and Central Ner-

like growth factor vous System Drugs Adv-

(injection) isory Committee meeting

scheduled for 4/9 to allow

the agency to continue

its review of the NDA

(4/6)

Chiroscience Chirocaine Levobupivacaine; chiral Broad usage in local, Submitted NDA (4/29)

Group plc (U.K.) version of approved drug regional or spinal

bupivacaine anesthesia

INFECTION

AMDL Inc. PyloriProbe Direct enzyme immuno- Diagnostic test for Filed 510(k) (4/30)

(OTC Bulletin Board: assay (EIA) that detects H. pylori infection

AMDD) presence of Helicobacter

pylori antibodies in blood

Digene Corp. Hybrid Assays detect DNA Diagnostic assays for Filed 3 510(k)s: one for

Capture II from Chlamydia sexually transmitted each test individually and

CT and GC trachomatis (CT) and diseases one for simultaneous

DNA Tests Neisseria gonorrhea testing (4/30)

(GC)

Interferon Alferon N Highly purified, multi- HIV infection FDA advised company

Sciences Inc. Injection species, natural-source that results of Phase III

(FDA- human alpha interferon trial were insufficient to

approved) file for approval and that

additional trial will be

necessary to evaluate pro-

duct's efficacy (4/2)

Isis Pharmaceuti- Fomivirsen Antisense inhibitor of Newly diagnosed and Isis completed submission

cals Inc. and (ISIS 2922) cytomegalovirus (CMV) advanced CMV retinitis of NDA (4/8)

Ciba Vision Corp. replication in AIDS patients

(unit of Novartis AG;

Switzerland)

Novopharm GPI-2A Antisense therapy; HIV infection and AIDS Filed IND for Phase Ib/II

Biotech Inc. use of antisense oligo- in patients who have trials (4/21)

(TSE:NVO; Canada) nucleotide that blocks failed or are resistant to

HIV replication, available HIV therapies

delivered via cationic

liposomes (intravenous

and subcutaneous)

MISCELLANEOUS

Atrix Atridox Biodegradable polymer Chronic adult perio- FDA sent company an

Laboratories Inc. incorporating 8.5% dontitis approvable letter (4/8)

doxycycline

Gliatech Inc. Adcon-L Anti-adhesion barrier To inhibit postopera- FDA sent company an

gel (semisynthetic tive adhesions involving approvable letter (4/9)

carbohydrate polymer) spinal cord and nerve

roots and to improve

patient outcome follow-

ing lumbar disc surgery

ProCyte Corp. OsmoCyte Hydropolymer dressing Wound dressing for Cleared for marketing

PCA Pillow containing copper acute and chronic (4/7)

Wound peptide gel wounds

Dressing

Therapeutic CroTAb Polyclonal antibody Anti-venom product Submitted PLA and ELA

Antibodies Inc. (produced in sheep) for treating snake bites (4/27)

designed to neutralize

poisonous effect of

bites from North Amer-

ican pit vipers

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.

TSE = Toronto Stock Exchange

** 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.

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