Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Abbott
Laboratories

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Psoriatic arthritis and rheumatoid arthritis

The product was approved in Europe for treating PA and early RA (8/15)

BioMS
Medical Corp.
(Canada; TSE:MS)

MBP8298

Synthetic peptide

Multiple sclerosis

Monitors in pivotal Phase II/III trial in the UK and Canada said the study should continue (8/18); trial was extended to Sweden (8/23)

Cytochroma
Inc.*
(Canada)

CTA018

Vitamin D analogue

Plaque psoriasis

Phase Ib trial in 28 patients showed the drug was safe and unlikely to produce adverse reactions (8/3)

Isotechnika
Inc.
(Canada;
TSE:ISA)

ISA247

Immunosuppressive agent

Plaque psoriasis

Blinded data from Canadian Phase III SPIRIT trial in 453 patients indicated positive safety and efficacy results (8/3)

CANCER

Cel-Sci Corp.
(AMEX:CVM)

Multikine

Mixture of human cytokines designed to stimulate an immune response

Advanced head and neck cancer

Started the Canadian arm of a Phase III trial expected to enroll 500 patients (8/23)

MediGene AG
(Germany; FSE:
MDG)

EndoTAG-1

Carrier system designed to target paclitaxel to newly formed blood vessels

Advanced pancreatic cancer

Began Phase II trial in Europe to evaluate safety, tolerability and efficacy trends in combination with gemcitabine in 200 patients (8/24)

Oxford
BioMedica plc
(UK; LSE:OXB)

MetXia

Engineered retrovirus that delivers the P450 gene to tumor cells

Pancreatic cancer

First stage of Phase II trial in the UK demonstrated safety and tolerability in combination with cyclosphosphamide (8/1)

Progen
Industries Ltd.
(Australia; ASX:PGL)

PI-88

Anti-angiogenesis drug also designed to inhibit tumor- romoting factors

Prostate cancer

Began Phase II trial in Australia to test drug with Taxotere in 82 patients with androgen-independent disease (8/9)

Provectus
Pharmaceuticals
Inc.
(OTC BB:PVCT)

Provecta
(PV-10)

Agent designed to be retained in tumor cells while leaving normal tissue unharmed

Stage III metastatic melanoma

Initial dose in Phase I trial in Australia was well tolerated; the higher dose now will be tested (8/17)

TopoTarget
A/S
(Denmark;
CSE:TOPO)

Savene

Dexrazoxane; inhibitor of topoisomerase II

Antidote to anthracyline extravasation

The company filed for approval of the product in Europe (8/18)

YM
BioSciences Inc.
(Canada; TSE:YM) )

TheraCIM

Nimotuzumab; humanized anti-epidermal growth factor receptor monoclonal antibody

Non-small-cell lung cancer

Began Phase I/II trial in Canada to test drug with radiation vs. radiation alone in patients with Stage IIB and III disease (8/17)

CARDIOVASCULAR

Encysive
Pharmaceuticals
Inc.
(ENCY)

Thelin

Sitaxsentan; small molecule designed to block endothelin

Pulmonary arterial hypertension

The EMEA accepted for review the marketing approval application, which was filed in July (8/17)

Trigen
Holdings AG*
(Germany)

TGN 255

Intravenous direct thrombin inhibitor

For use as an anticoagulant

Phase II trial in 28 patients under- going hemodialysis in Europe suggested the agent was effective with no increase in bleeding risk (8/9)

United
Therapeutics
Corp.
(UTHR)

Remodulin (FDA-approved)

Treprostinil sodium injection

Pulmonary hypertension

Approval in 22 additional coun- tries in Europe was gained upon completion of the Mutual Recog- nition Procedure for treating NYHA Class III primary disease (8/10)

CENTRAL NERVOUS SYSTEM

Cephalon Inc.
(CEPH)

Vigil (FDA-approved)

Provigil; modafinil

Shift-work sleep disorder

The product was approved in Germany for treating the disorder in in patients working night shifts (8/30)

Neuren
Pharmaceuticals
Ltd.
(Australia;
ASX:NEU)

Glypromate

Nanturally occurring peptide fragment found in brain with protective qualities

Neurocognitive disturbance

Began Phase II trial in Australia and New Zealand in 30 patients to test safety and pharmacokinetics (8/30)

NeuroSearch
A/S
(Denmark;
CSE:NEUS)

NS2330

Agent designed to inhibit re- ptake of serotonin, noradrenaline and dopamine

Alzheimer's and Parkinson's diseases

Partner Boehringer Ingelheim GmbH decided not to move into Phase III trials after reviewing Phase II results in each indication (8/10)

Vernalis plc
(UK; VNLS)

V1003 (IX-1003)

Intranasal formulation of buprenorphine

Pain

Began Phase II trial to test efficacy in 360 patients (8/22)

WEX
Pharmaceuticals
Inc.
(Canada;
TSE:WXI)

Tetrodin

Tetrodotoxin; non-narcotic agent

Opioid withdrawal

Phase IIa trial in 14 methadone- maintained subjects showed drug failed to alleviate the withdrawal symptoms (8/18)

YM BioSciences
Inc.
(Canada;
TSE:YM)

AeroLEF

Aerosolized liposome- encapsulated fentanyl

Pain

YM subsidiary Delex Therapeutics Inc. is starting a Phase IIb trial in Canada in 120 post-surgical patients following orthopedic surgeries (8/30)

INFECTION

Acambis plc
(UK; ACAM)

ChimeriVax-JE

Vaccine against Japanese encephalitis

Japanese encephalitis

Succesfully completed bridging studies following manufacturing scale-up; also reported positive data from Phase II trials (8/23)

Immtech
International
Inc.
(AMEX:IMM)

DB289

Oral, dicationic antiviral agent

African
sleeping
sickness

Began pivotal Phase III trial in the Republic of the Congo that will compare drug to pentamididine in 250 patients (8/25)

Migenix Inc.
(Canada;
TSE:MGI)

MX-3253

Celgosivir; inhibitor of the mammalian cell enzyme alpha-glucosidase I

Hepatitis C

Began Phase IIb combination trial in up to 20 patients with peginterferon alfa-2b and ribavirin (8/11)

MISCELLANEOUS

Allergy
Therapeutics
plc
(UK: AIM:AGY)

--

Vaccine that incorporates MPL, a TLR-4 agonist

Ragweed allergy

Began pivotal Phase II trial in Canada that will evaluate efficacy vs. placebo (8/30)

Orthogen AG*
(Germany)

Orthokine

IL-1Ra protein obtained
from the patient's blood

Osteoarthritis

Trial in Germany in 400 patients

showed superiority to hyaluronic

acid therapy and placebo (8/10)

Pharmaxis Ltd.
(Australia; ASX:PXS)

Bronchitol

Mannitol formulation delivered via an inhalation device

Cystic fibrosis

Phase II trial in 49 patients in Australia and New Zealand showed statistically significantly improved lung function vs. placebo (8/31)

Protherics plc
(UK; LSE:PTI)

Voraxaze

Product containing the recombinant enzyme glucarpidase

Toxicity from methotrexate

The company submitted an MAA seeking approval of the product in Europe (7/28)@

Threshold
Pharmaceuticals
Inc.
(THLD)

TH-070

lonidamine; an indazole- 3-carboxylic acid

Benign prostatic hyperplasia

Began Phase III trial in Europe to measure efficacy vs. placebo in 480 patients (8/8)


Notes:

* Privately held.

MAA = Marketing authorization application; EMEA = European Medicines Agency.

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

@ = New occurred in July but was not included in previous chart.

AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.

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