Company*
(Symbol)

Product

Description

Indication

Status
(Date)


CANCER

EntreMed
Inc.
(ENMD)

Endostatin

A protein drug candidate

Neuroendocrine tumors

Endostatin received orphan drug status from the FDA (8/15)

EntreMed
Inc.
(ENMD)

Panzem

An orally available small-molecule drug candidate

Multiple myeloma

Panzem received orphan drug status from the FDA (8/15)

Inex
Pharmaceu-
ticals
Corp.
(Canada;
INEX)

Onco TCS

Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology

Non-Hodgkin's lymphoma

An independent data safety monitoring board reviewed safety data for about 35 patients in the pivotal Phase II/III trial and recommended that Inex continue the trial (8/13)

KS Biomedix
Holdings plc
(UK;LSE:KSB)

TransMID-
107R

Based on the transferrin- mediated delivery of a diphtheria toxin, which is capable of selectively killing cancer cells

Glioma

FDA granted the product fast-track status (8/6)

Vysis Inc.
(VYSI)

UroVysion

Test for monitoring recurrence of bladder cancer, which is based on the detection of genetic changes in bladder cells using the company's fluorescence DNA probe technology

Bladder cancer

FDA gave clearance to market the test (8/2)

CARDIOVASCULAR

Actelion Ltd.
(Switzerland;
SWX:ATLN)
and Genentech
Inc.
(NYSE:
DNA)

Tracleer

Bosentan; endothelin receptor antagonist

Pulmonary arterial hypertension

The Cardiovascular and Renal Drugs Advisory Committee recommended approval (8/10)

Hemosol Inc.
(Canada; HMSL;
TSE:HML)

Hemolink

A red-blood cell substitute; a purified, human-derived hemoglobin replacement product

Patients undergoing coronary artery bypass surgery

The FDA asked for changes in the Phase III trial protocol, delaying the trial; the changes are related to the dosing schedule of the product (8/13)

Scios Inc.
(SCIO)

Natrecor

Nesiritide; intravenous treatment; recombinant of B-type natriuretic peptide

Acute congestive heart failure

FDA granted marketing approval (8/13)

United
Therapeutics
Corp.
(UTHR)

Remodulin (formerly UT-15 and Uniprost)

Subcutaneous treatment; treprostinol sodium

Pulmonary arterial hypertension

The Cardiovascular and Renal Drugs Advisory Committee recommended approval (8/9)

CENTRAL NERVOUS SYSTEM

Amgen Inc.
(AMGN)

Kineret

Anakinra; interleukin-1 receptor antagonist

Rheumatoid arthritis

The FDA's Arthritis Advisory Committee recommended approval of Kineret in patients 18 and older (8/16)

INFECTION

Enzon Inc.
(ENZN)
and Schering-
Plough Corp.

Peg-Intron Powder

Injection; longer-acting form of Intron A Injection that uses Enzon's PEG technology

Chronic hepatitis C in patients with compensated liver disease

FDA approved Peg-Intron Powder used in combination therapy with Rebetol Capsules (8/8)

Gilead
Sciences
Inc.
(GILD)

Viread

Tenofovir disoproxil fumarate

HIV infection

The Antiviral Advisory Committee of the FDA will review the treatment on Oct. 3 (8/22)

MISCELLANEOUS

Biogen Inc.
(BGEN)

Amevive

Novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells

Chronic plaque psoriasis

Company completed registration filings in the U.S. and Europe seeking approval to market Amevive (8/6)

Celgene Corp.
(CELG) and
Novartis
Pharmaceu-
ticals Corp.

Dexmethyl-
phenidate HCl

A refined formulation of Ritalin (dl-methylphenidate)

Attention deficit hyperactivity disorder

FDA provided the companies with an approvable letter (8/22)

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 bloodletting

To treat life-threatening blood loss

Company submitted a BLA (8/28)

Orphan
Medical
Inc.
(ORPH)

Xyrem

Sodium oxybate oral solution

Narcolepsy

Company said the FDA accepted its plan for a response to the FDA's approvable letter dated July 2 (8/28)

Oxford Glyco-
Sciences plc
(UK; OGSI;
LSE:OGS)

Vevesca

Oral treatment; capsule formulation of a glucosyl-transferase inhibitor

Type I Gaucher disease

Company filed an NDA (8/21)

QLT Inc.
(Canada;
QLTI)

Visudyne

Verteporfin for injection

Class subfoveal choroidal neo- vascularization

FDA grants additional approval to market the product in people age 30 and older (8/23)


Notes:

* Privately held; ** Denotes the date the item ran in BioWorld International

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

LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application

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