Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Biogen Inc. (BGEN)

Amevive

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

Chronic plaque psoriasis

FDA issued a complete response letter and requested additional information and clarification, but no new trials are needed (6/14)

CANCER

Corixa Corp. (CRXA)

Bexxar

Tositumomab and
iodine-131 tositumomab;
an investigational radioimmunotherapy

Non-Hodgkin's lymphoma

Company won an appeal against an FDA decision requiring additional clinical trials; Corixa now has the opportunity to present its case before the FDA's Oncologic Drugs Advisory Committee (6/27)

Lorus Therapeutics Inc. (Canada; OTC BB:LORFF)

Virulizin

Immunotherapeutic drug
that leads to stimulation of macrophages, monocytes and natural killer cells to attack tumor cells

Pancreatic cancer

FDA granted fast-track status for Virulizin (6/4)

Millennium Pharmaceu-
ticals Inc.
(MLNM)

MLN341 and MLN518

Designed to inhibit the proteasome; and a small molecule designed to inhibit the Fit-3 receptor tyrosine kinase

Multiple myeloma; acute myeloid leukemia

FDA granted fast-track designation for both products (6/5)

Trans-
Molecular
Inc.*

131I-
TM-601

A radiopharmaceutical cancer drug containing a synthetic version of a substance derived from scorpions, called chlorotoxin

Glioma

Company received orphan drug status for 131I-TM-601 from the FDA (6/27)

INFECTION

ViroPharma Inc. (VPHM)

Picovir

Works by inhibiting the ongoing viral replication of picornavirus capsid, a protective shell of the virus that is necessary for infection and transmission

Common cold

FDA issued a "not approvable" letter saying there was insufficient data in the NDA on the interaction between Picovir and other drugs (6/5)

MISCELLANEOUS

Alliance Pharmaceutical Corp. (ALLP)

Imagent

Ultrasound imaging agent

For patients with suboptimal echocardiograms to opacify the left ventricle

FDA granted approval (6/3)

Cellegy Pharmaceuticals Inc. (CLGY)

Tostrex

Testosterone gel; a non- staining gel designed to be administered to an area on the thighs once daily

Male hypogonadism

Company submitted an NDA (6/3)

Oxford GlycoSciences plc (UK; OGSI; LSE:OGS)

Vevesca

Oral capsule formulation of a glucosyltransferase inhibitor

Gaucher's disease

FDA said Vevesca is not approvable due to lack of evidence of safety and efficacy (6/24)

Notes:

* Privately held

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

LSE = London Stock Exchange; OTC BB = Over the Counter Bulletin Board

NDA = New Drug Application