Company*
(Symbol)

Product

Description

Indication

Status
(Date)


CANCER

AltaRex Corp.
(Canada; OTC
BB: ALRXF; TSE:AXO)

OvaRex MAb

Modified murine monoclonal antibody that binds to CA 125 cancer antigen

Ovarian cancer

Company reported positive reresults in which 56% of German patients who received the therapy survived more than one year, 34% survived more than two and 11% out of the 34% survived more than five years (7/12)

British Biotech
plc
(UK; BBIOY)

E21R

A granulocyte macrophage- colony stimulating factor antagonist

Acute myeloid leukemia

Company received approval to start a Phase II trial at University College London (7/26)

CancerVax
Corp.*

Canvaxin

Allogeneic; whole cell vaccine that expresses over 20 antigens

Melanoma

Company said it plans to prepare a new drug submission seeking marketing approval in Canada (7/25)

Cephalon
Inc.
(CEPH)

Actiq

Oral transmucosal fentanyl citrate

Cancer

Actiq was granted marketing approval in 16 European countries (7/2)

Inex
Pharma-
ceuticals
Corp. (Canada; TSE:IEX)

INX-3280

Anticancer therapeutic that targets the c-myc gene, believed to be a factor in the uncontrolled cell growth characteristic of tumors

Cancer

The final patient was enrolled in a Phase I trial of INX-3280 in combination with cisplatin (7/23)

Millennium
& ILEX Partners
LP
(joint venture between Millennium Pharmaceuticals Inc., MLNM; and ILEX Oncology Inc., ILXO)

MabCampath

Humanized monoclonal antibody; alemtuzumab

B-cell chronic lymphocytic leukemia

European Commission granted marketing authorization to the MabCampath antibody (7/12)

Oxford
BioMedica
plc
(UK)*

MetXia

Gene-activated prodrug therapy

Breast cancer

Company received approval in the UK to start a further trial (7/18**)

SciClone
Pharma-
ceuticals
Inc.
(SCLN)

Zadaxin

Immune system enhancer; synthetic immunostimulant peptide

Cancer

Zadaxin was approved in the Philippines as an adjuvant to chemotherapy to treat various cancers (7/23)

CARDIOVASCULAR

Cerus Corp.
(CERS) and
Baxter Healthcare Corp. (NYSE:BAX)

Intercept Platelet System

A system to inactivate bacteria, viruses and other pathogens and white blood cells in platelets intended for transfusion

Thrombo-
cytopenia

Results from a Phase III European trial showed the safety and efficacy was comparable to the first cycle of Intercept platelets, with comparable increases in platelet counts following transfusion (7/16)

CENTRAL NERVOUS SYSTEM

Biovail Corp.
(NYSE: BVF)
and Celgene Corp. (Canada; CELG)

d-methyl-
phenidate
(d-MPH)

Chirally pure version of dl-methylphenidate

Attention deficit disorder

Companies filed a new drug submission in Canada (7/10)

Immunex
Corp.
(IMNX)

Enbrel (FDA- approved)

Etanercept; tumor necrosis factor receptor

Psoriatic arthritis

Company filed for regulatory approval in Canada (7/17)

INFECTION

Biosearch Italia
SpA
(Italy; Nuovo
Mercato:BIO)

Ramoplanin

Naturally occurring antibiotic

Infections due to vancomycin- resistant Enterococci

Company received orphan drug status in Europe for Ramoplanin (7/12)

SciClone
Pharmaceuticals
Inc. (SCLN)

Zadaxin

Immune system enhancer; synthetic immunostimulant peptide

Hepatitis B and C

Company received expanded indications in Mexico (7/10)

Trinity Medical
Group USA Inc. (
OTC BB:TMGU) and The Immune Response Corp. (IMNR)

Remune

HIV-1 immunogen

HIV

Companies filed an NDA in Thailand (7/30)

MISCELLANEOUS

Atrix
Laboratories
Inc.
(ATRX)

Atridox

8.5% doxycycline combined with the Atrigel drug delivery system

Periodontal disease

Atrix received approval in Switzerland to market Atridox in the Atrigel drug delivery system (7/3)

AVAX
Technologies
Inc. (AVXT)

¿

Treatment consisting of introducing the normal gene into stem cells of patients through gene therapy

Severe combined immunodeficiency disease

Product gained orphan medicinal product status in Europe (7/19)

Axcan Pharma
Inc.
(Canada;
AXCA; TSE:AXP)

Photofrin (FDA-approved)

Photosensitive drug (porfimer sodium; produces toxic oxygen compound when light-activated)

High-grade dysplasia associated with Barrett's esophagus

Company filed a new drug submission in Canada (7/5)

Enzo Biochem
Inc.
(NYSE:ENZ)

¿

Immune regulation medicine

Crohn's disease

Company received approval in Israel to being a Phase I trial (7/12)

Inhale
Therapeutic
Systems Inc.
(INHL) and Aventis Behring LLC

¿

Inhalable form of alpha-1-antitrypsin

Hereditary emphysema

Aventis received orphan medicinal product designation from the European Commission (7/26)

Lilly ICOS
LLC
(joint venture
between ICOS Corp., ICOS; and Eli Lilly & Co.)

Cialis

Oral drug; a PDE5 inhibitor

Erectile dysfunction

Company filed an application in Europe for the approval of Cialis (7/12)

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

Vevesca

Oral capsule formulation of a glucosyl transferase inhibitor

Type I Gaucher disease

Company submitted a marketing authorization application to the European Medicines Evaluation Agency (7/12)

QLT Inc.
(QLTI) and
Novartis AG (Switzerland)

Visudyne

Verteporfin for injection

Predominately subfoveal choroidal neovascularization

Health Canada granted approval (7/26)


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; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange

NDA = New Drug Application

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