Company*
(Symbol)

Product

Description

Indication

Status (Date)


CANCER

Amgen Inc.
(AMGN)

Neulasta

Pegfilgrastim;
second generation of Neupogen

Cancer

FDA granted approval for Neulasta, which is injected once per chemotherapy cycle (2/1)

Antigenics
Inc.
(AGEN)

Oncophage

Cancer vaccine; uses heat shock proteins to activate cellular immune responses

Metastatic
melanoma

Company said the FDA granted fast-track designation for Oncophage (2/5)

Corixa Corp.
(CRXA)

Melacine

Vaccine consisting of lysed cells from two human melanoma cell lines combined with Corixa's Detox adjuvant

Melanoma

An FDA panel approved a proposed design for a second Phase III trial for the melanoma vaccine; company expects to include 700 patients in the trial (2/28)

EntreMed
Inc.
(ENMD)

Endostatin

Naturally occurring angiogenesis inhibitor

Malignant
metastatic melanoma

Endostatin received orphan drug status from the FDA (2/28)

IDEC Pharma-
ceuticals
Corp. (IDPH)

Zevalin

Monoclonal antibody linked to the radio- isotope Yttrium-90 that targets the CD20 antigen on the surface of mature B cells and B-cell tumors

Non-Hodgkin's lymphoma

FDA approved Zevalin (2/20)

ImClone
Systems Inc.
(IMCL)

Erbitux

Monoclonal antibody designed to target and block the epidermal growth factor receptor

Cancer

Company said the FDA might accept the Erbitux BLA with no new trials; the company plans to provide the agency with data from an ongoing European trial and reanalyzed data from U.S. Phase II trials (2/27)

NeoPharm Inc.
(NEOL)

SS1-PE38

Antimesothelin monoclonal antibody
toxin

Mesothelioma and ovarian cancer

Company was granted orphan drug status by the FDA (2/14)

CARDIOVASCULAR

United
Therapeutics
Corp. (UTHR)

Remodulin

Treprostinil sodium; subcutaneous
treatment

Pulmonary arterial hypertension

FDA issued an approvable letter (2/11)

DIABETES

Ortec International
Inc.
(ORTC)

OrCel

Cryopreserved
version of OrCel

Diabetic foot
ulcers

FDA approved a pivotal trial (2/6)

INFECTION

Gen-Probe
Inc.*

Procleix HIV-1/HCV Assay and the Procleix Semi-Automated System

A nucleic acid test system that detects viral genes rather than antibodies for screening donors

To detect viral genes for screening donors

FDA approved the HIV, HCV nucleic acid tests (2/28)

INFLAMMATION AND PAIN

Centocor Inc.
(unit of Johnson
and Johnson)

Remicade (FDA-approved)

Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood

Rheumatoid
arthritis

FDA approved Remicade, in combination with methotrexate, to improve physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate alone (2/28)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-CD4

Monoclonal antibody

Rheumatoid
arthritis

FDA designated HuMax-CD4 a fast-track product (2/21)

MISCELLANEOUS

Biosonix Ltd.
(subsidiary of Neoprobe Corp.; OTC BB:NEOP)

FlowGuard

Diagnostic product that employs the Angle- independent Doppler Blood Flow technology

To determine blood flow in noninvasive diagnostic and intraoperative applications

FDA approved the product (2/28)


Notes:

* Privately held

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

CSE = Copenhagen Stock Exchange; OTC BB = Over the Counter Bulletin Board

BLA = Biologics License Application; NDA = New Drug Application