Company*
(Symbol)

Product

Description

Indication

Status (Date)


CANCER

Amgen Inc.
(AMGN)

Aranesp

Darbepoetin alfa

Anemia associated with certain types of chemotherapy

Company submitted a BLA (9/20)

Atrix Lab-
oratories
Inc.
(ATRX)

Leuprogel Three-Month Depot

Atrigel formulation containing leuprolide acetate; injected subcutaneously

Prostate cancer

Company submitted an NDA (9/26)

Avax
Tech-
nologies
Inc.

(AVXT)

M-Vax and
O-Vax

Cancer vaccines that work by using the patient's own cells, which are modified with a hapten molecule so that the tumor cells appear foreign to the body

Melanoma and ovarian cancer

FDA has requested more information before releasing a clinical hold (9/21)

Corixa Corp.
(CRXA)

Bexxar

Radioimmunotherapy antibody conjugated to iodine-131

Relapsed or refractory low-grade or transformed low-grade non-Hodgkin's lymphoma

Companies submitted the final responses to information requested by the FDA in its complete review letter received March 16 (9/7)

Genta Inc.
(GNTA)

Genasense

Antisense compound geared toward blocking the production of Bcl-2

Multiple myeloma, acute myelocytic leukemia and chronic lymphocytic leukemia

FDA granted Genasense orphan drug status (9/4); FDA gave it fast-track designation (9/20)

IDEC
Pharma-
ceuticals
Corp.
(IDPH)

Zevalin

Radioimmunotherapy; mouse monoclonal antibody targeted against the CD20 antigen and conjugated to a yttrium-90 radioisotope; administered with Rituxan

Non-Hodgkin's lymphoma

The Oncologic Drugs Advisory Committee recommended approval of Zevalin (9/11)

Matrix
Pharma-
ceutical
Inc.
(MATX)

IntraDose Injectable
Gel

Biodegradable gel containing cisplatin and epinephrine

Head and neck cancer

FDA medical reviewers recommended rejection of the product (9/7); the Oncologic Drugs Advisory Committee said the data failed to prove enough evidence that the gel is safe and effective; it recommended against approval (9/10)

CARDIOVASCULAR

Actelion
Ltd.
(Switz-
erland; SWX:
ATLN)

Tracleer

Bosentan; endothelin receptor antagonist

Pulmonary arterial hypertension

FDA issued an approvable letter for Tracleer (9/18)

Avant Immuno-
therapeutics
Inc.
(AVAN)

TP10

Complement inhibitor

Infants undergoing cardiac surgery

FDA removed the hold on clinical trials; company expects to resume enrollment (9/28)

Genentech
Inc.
(NYSE:
DNA)

Cathflo
Activase

Activates plasminogen, which dissolves the blood-clotting material or fibrin to break down the thrombus and restore flow through the central venous catheter

To break down clots in central venous catheters

FDA approved the agent (9/5)

Vasogen
Inc.
(Canada;
AMEX:
MEW;
TSE:VAS)

?

Immune modulation therapy

Peripheral arterial disease

FDA granted approval for the company to begin a pivotal clinical trial (9/5)

CENTRAL NERVOUS SYSTEM

Repligen
Corp.
(RGEN)

Secretin

Human synthetic secretin

Pediatric autism

FDA granted fast-track designation for secretin (9/5)

DIABETES

Keryx Biopharm-
aceuticals
Inc.
(Israel;
KERX)

KRX-101

Sulodexide

Diabetic nephropathy

FDA designated the compound a fast-track product (9/6)

INFECTION

Aviron
Inc.

(AVIR)

FluMist

Intranasal vaccine

Influenza

FDA issued a complete response letter related to the BLA, requiring additional information and clarification regarding clinical and manufacturing data (9/4)

Cangene
Corp.
(Canada;
TSE:CNJ)

?

Hyperimmune product

Hepatitis B

Company filed a BLA (9/25)

Visible
Genetics
Inc.
(VCIN)

TruGene HIV-1 Genotyping Kit and Open- Gene DNA Sequencing System

Designed to genetically decode the highly mutagenic HIV-1 from patient serum, identify mutations and indicate a treatment regimen

AIDS

FDA gave the company clearance to market the three-part kit (9/27)

MISCELLANEOUS

Amgen
Inc.
(AMGN)

Aranesp

Darbepoetin alfa; recombinant erythropoietic protein that stimulates production of oxygen-carrying red blood cells

Anemia associated with chronic renal failure

FDA granted approval (9/18)

Immunex
Corp.
(IMNX)

Enbrel

Tumor necrosis factor- inhibiting drug

Psoriatic arthritis

FDA granted priority review status for the supplemental BLA (9/17)

Ortec Inter-
national
Inc.
(ORTC)

OrCel

Bilayered cellular matrix

Donor site wounds in burn victims

FDA aproved the product (9/4)

PhotoCure
ASA
(Norway;
OSE:PHO)

Metvix

Photodynamic therapy involving a cream that is activated by light

Actinic keratosis

Company submitted an NDA for Metvix in combination with the CureLight lamp in photodynamic therapy (9/27)

Protherics
plc
(UK;
LSE:PTI)

DigiFab

Consists of ovine antibody fragments that bind digoxin, preventing it from reaching the heart

Digoxin toxicity

FDA approved the product (9/4)


Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OSE = Oslo Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application