Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Amgen Inc.
(AMGN)

Enbrel (FDA-
approved)

Etanercept; tumor
necrosis factor inhibitor

Ankylosing
spondylitis

Amgen filed a supplemental BLA (1/22)

Biogen Inc.
(BGEN)

Amevive

Alefacept; novel immunomodulatory
agent that selectively targets the CD45RO+ subset of T cells

Chronic plaque
psoriasis

FDA approved Amevive (1/31)

Cambridge
Antibody
Tech-
nology
Group plc (UK; CATG; LSE:CAT) and Abbott Laboratories

Humira (FDA-
approved)

Adalimumab; human monoclonal antibody that blocks tumor necrosis factor alpha

Rheumatoid
arthritis

Humira received FDA approval to reduce the signs and symptoms and to inhibit the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (1/2)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade
(FDA-
approved)

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

Crohn's
disease

FDA designated Remicade for priority review for use in maintaining fistula closure in patients with fistulizing Crohn's disease (1/7)

CANCER

American Pharmaceutical Partners Inc. (APPX)

ABI-007

A cremophor-free
nanoparticle paclitaxel

Metastatic
breast cancer

The company received FDA fast-track designation for ABI-007 (1/17)

CancerVax
Corp.*

Canvaxin

Therapeutic cancer
vaccine; allogeneic, whole-cell vaccine that expresses more than 20 antigens

For the
post-surgical treatment of patients with metastatic melanoma

The FDA granted fast-track designation to Canvaxin (1/27)

Eximias
Pharmaceutical
Corp.*

Thymitaq

Nolatrexed
dihydrochloride

Hepatocellular
cancer

An independent Data Safety Monitoring Board unanimously recommended the continuation of the Phase III trial (1/16)

Genta Inc.
(GNTA)

Ganite (FDA-
approved)

Gallium nitrate
injection

Cancer-related
hypercalcemia

The FDA reactivated the NDA for Genta to market the approved drug; the company initiated a Phase IIb study in patients with non-Hodgkin's lymphoma who have low blood counts and who failed prior chemotherapy and rituximab (1/3)

Millennium
Pharmaceuticals
Inc. (MLNM)

Velcade

A proteasome
inhibitor; bortezomib

Multiple
myeloma

Millennium filed an NDA for Velcade (1/22)

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin
gadolinium injection

Lung cancer
with brain
metastases

The FDA completed a special protocol assessment for the Phase III trial, which is now under way and will enroll about 550 patients (1/7)

CARDIOVASCULAR

Alpha
Therapeutic Corp.
(ANIK) and Baxter Healthcare Corp.

Aralast

Alpha-1 proteinase
inhibitor

Congenital
deficiency
of alpha-1 proteinase inhibitor and clinically evident emphysema

FDA approved Aralast (1/9)

CENTRAL NERVOUS SYSTEM

Forest
Laboratories
Inc. (NYSE:FRX)

Memantine

A moderate-affinity,
uncompetitive N-
methyl D-aspartate receptor antagonist that modulates glutamate levels

Alzheimer's
disease

FDA accepted the NDA (1/30)

INFECTION

MedImmune
Inc.
(MEDI)

FluMist

Live influenza virus
vaccine; nasally delivered

Influenza

The FDA issued a complete response letter and did not request additional clinical trials (1/30)

Nabi Bio-
pharma-

ceuticals

(NABI)

Nabi-HB (FDA-
approved)

Intravenous immune
globulin

Hepatitis B

The FDA accepted for priority review the company's BLA for Nabi-HB to prevent hepatitis B infection in transplanted livers (1/23)

MISCELLANEOUS

Corgentech
Inc.*

CGT021

E25 Decoy, an oligo-
nucleotide that binds to
and inactivates the pivotal
cell-cycle transcription
factor E2F, administered
in Corgentech's drug-
delivery device

To prevent
arteriovenous
graft failure in
end-stage renal disease patients requiring hemo- dialysis

The FDA granted fast-track designation for CGT021, which will enter a Phase I/II trial (1/23)

Genzyme
General
(GENZ) and BioMarin Pharmaceutical Inc. (BMRN)

Aldurazyme

Enzyme replacement
therapy; laronidase

Mucopolysac-
charidosis-1

An FDA panel recommended the approval of Aldurazyme (1/15); the FDA issued a complete response letter without requesting additional clinical data for final approval (1/29)

Genzyme
General
(GENZ)

Fabrazyme

Agalsidase beta
enzyme replacement
therapy

Fabry's
disease

An FDA panel voted 14-1 in favor when asked if Genzyme's study showing “near-normalization“ of renal capillary endothelium was reasonably likely to predict a clinically meaningful effect (1/13)

ISTA Pharma-
ceuticals Inc.
(ISTA) and Senju Pharmaceuticals Co. Ltd. (Japan)

Istalol

Formulation
of timolol

Glaucoma

FDA accepted the NDA for filing (1/7)

Miravant
Medical
Tech-
nologies
Inc.
(OTC BB:MRVT)

PhotoPoint
SnET2

Photodynamic
therapy

Wet age-
related macular degeneration

Company plans to file an NDA (1/30)

Northfield
Laboratories
Inc.
(NFLD)

PolyHeme

Alternative to blood
transfusions for patients
with acute blood loss;
carries oxygen, restores blood volume and is designed to treat hemorrhagic shock resulting from extensive blood-letting

To treat
severely
injured
trauma
patients

Company submitted its response to questions and comments from the FDA regarding the proposed Phase III trial (1/31)

Regeneron
Pharmaceuticals
Inc.
(REGN)

Axokine

Genetically re-
engineered version of a naturally occurring human protein known as ciliary neurotrophic factor

Obesity

FDA granted fast-track designation covering treatment of severely obese people who are unresponsive to, intolerant of or unsuitable candidates for certain FDA-approved medicines for long-term treatment (1/7)

Transkaryotic
Therapies Inc.
(TKTX)

Replagal

Agalsidase alfa;
enzyme replacement
therapy

Fabry's
disease

An FDA panel agreed that TKT failed to provide substantial evidence of efficacy (1/14)


Notes:

* Privately held company.

BLA = Biologics License Application; NDA = New Drug Application

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

NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board