Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Abbott
Laboratories

Humira
(FDA-approved)

Adalimumab; fullyhuman antibody designed to block TNF-alpha

Psoriatic arthritis and rheumatoid arthritis

The EMEA recommended approval of the product for treating PA and as a first-line treatment for moderate to severe early RA (6/27)

Chelsea
Therapeutics
Inc.
(OTC BB:IVRC)

CH-1504

Orally available inert antifolate

Various diseases

Began a Phase I trial in the UK to evaluate safety and tolerability in healthy volunteers (6/9)

Cytochroma
Inc.*
(Canada)

CTA018

Vitamin D analogue

Plaque psoriasis

Phase Ia trial in Canada in 17 patients demonstrated safety and efficacy (6/2)

Isotechnika
Inc.
(Canada;
TSE:ISA)

ISA247

Immunosuppressive agent

Psoriasis

Phase II trial in Canada met its primary endpoint of a two-point reduction in global assessment, and met secondary endpoints (6/30)

CANCER

American
Pharmaceutical
Partners Inc.
(APPX)

Abraxane (FDA-approved)

Paclitaxel protein-bound particles for injection;albumin-bound

Metastatic breast cancer

The company filed for approval of the product in Canada (6/15)

Antigenics Inc.
(AGEN)

Oncophage

Personalized cancer vaccine based on heat-shock protein technology

Renal-cell carcinoma

The product was granted orphan status in Europe in that indication (6/7)

Antisoma plc
(UK; LSE:ASM)

AS1404

Vascular-disrupting agent

Recurrent ovarian cancer

Began Phase II trial to test the drug with other agents in about 70 patients in Europe, Australia and New Zealand (6/7)

Bioenvision
Inc.
(BIVN)

Clofarabine (FDA-approved)

Second-generation purine nucleoside analogue

Leukemias

Encouraging data from various trials in various indications were presented (6/6)

Bioenvision
Inc.
(BIVN)

Clofarabine
(FDA-
approved)

Second-generation purine nucleoside analogue

Acute myeloid leukemia

Phase II trial in the UK in older patients demonstrated an overall response rate of 67% (6/3)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Metastatic melanoma

Filed letter of intent seeking app- roval of the product in Europe for use with dacarbazine (6/30)

GPC Biotech
AG
(Germany;
GPCB)

1D09C3

Anti-major histocompatibility complex Class II monoclonal antibody

Hodgkin's lymphoma

The product was granted orphan designation in Europe in that indication by the EMEA (6/2)

Favrille Inc.*

FavId

Vaccine designed to stimulate immune responses

Indolent B-cell non-Hodgkin's lymphoma

Began a Phase II trial in Europe that will evaluate activity in several disease subtypes (6/6)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

Virulizin

Immunotherapy agent designed to stimulate the immune system

Pancreatic cancer

The product was granted orphan status in Europe in that indication (6/7)

Onyvax
Ltd.*
(UK)

Onyvax-P

Cell vaccine; an immunotherapy

Metastatic, hormone- resistant prostate cancer

Published data confirmed results from the first cohort in a Phase II trial showing drug may delay dis- ease progression (6/17)

OSI
Pharmaceuticals
Inc.
(OSIP) and
Genentech
Inc.
(NYSE:DNA)

Tarceva (FDA-approved)

Erlotinib HCl; small- molecule HER1/EGFR inhibitor

Advanced non- small-cell lung cancer

European regulators recommended approval for use after failure of at least one regimen; partner F. Hoffmann-La Roche Ltd. made the filing (6/27)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Tarvacin

Chimeric monoclonal antibody that binds to the phospholipid phosphatidylserine

Refractory solid tumors

Began Phase I trial to evaluate safety, tolerability, pharmaco- kinetics and dosing in up to 28 patients (6/10)

pSivida Ltd.
(Australia;
ASX:PSD)

BrachySil

Micron-sized particle in which the isotope 32 phosphorus is immobilized

Advanced liver cancer

Phase IIa trial in eight patients in Singapore showed safety and tolerability, as well as reductions in tumor size (6/21)

TopoTarget
A/S
(Denmark;
CSE:TOPO)

Savene

Dexrazoxane; inhibitor of topoisomerasde II poisons

For use in cancer treatments

Phase II/III trial in 35 patients demonstrated a 97% success rate in treating accidental extravasation of anthracycline chemotherapeutics and avoidance of surgical interventions (6/28)

Viragen Inc.
(AMEX:VRA)

Multiferon

Multisubtype, natural human alpha interferon

Various diseases

Drug was approved in Chile as a second-line treatment in cases in which recombinant interferon therapy failed (4/25)

Viventia
Biotech Inc.
(Canada; TSE:VBI)

Proxinium

Antibody fragment conjugated with a cancer-killing payload

Head and neck cancer

The product was granted orphan designation in Europe in that indication by the EMEA (6/1)

CENTRAL NERVOUS SYSTEM

CeNeS
Pharmaceuticals
plc
(UK; AIM:CEN)

CNS 5161

Selective NMDA antagonist

Neuropathic pain

Phase IIa proof-of-concept study showed agent was well tolerated and a trend toward an improvement in pain levels (6/8)

CeNeS
Pharmaceuticals
plc
(UK; AIM:CEN)

M6G

Morphine-6-glucuronide peptide vector

Post-operative pain

Presented data on oral bioavailability and its potential in that indication (6/1)

Durect Corp.
(DRRX)

SABER-Bupivacaine

Sustained-release formulation of bupivacaine delivered by SABER system

Post-operative pain

Second cohort of hernia patients in Phase II trial in Australia reported improved pain relief vs. commercial bupivacaine (6/20)

GW
Pharmaceuticals
plc
(UK; LSE:GWP)

Sativex

Spray formulation of cannabis extract

Spasticity in multiple sclerosis

UK regulators denied an appeal to allow marketing of the product without additional trials (6/10)

DIABETES

Depomed Inc.
(DEPO) and
Biovail Corp.
(Canada)

Glumetza

Once-daily, extended- release formulation of metformin hydrochloride

Type II diabetes

The product was approved in Canada; Biovail plans to launch it there in 4Q:05 (6/1)

Generex
Biotechnology
Corp.
(Canada;
GNBT)

Orallyn

Oral insulin spray formulation

Diabetes

Small study in volunteers in Israel showed a shorter time to maximum insulin concentration vs. subcutaneous insulin (6/7)

Metabolex
Inc.*

Metaglidasen

Oral insulin sensitizer

Type II diabetes

Phase II trial in 217 patients demonstrated statistically significant reduction of hemoglobin A1c and other endpoints (6/10)

TolerRx Inc.*

TRX4

Humanized monoclonal antibody that binds to the CD3 receptor on T cells

Type I diabetes

Phase II trial in 80 patients in Europe showed insulin-producing beta cells were preserved and a reduction in the amount of insulin needed to control blood glucose levels (6/23)

INFECTION

Arpida Ltd.
(Switzerland;
SWX:ARPN)

Iclaprim

Broad-spectrum antibiotic

Infections

Phase I trial in the UK showed achievement of high concentrations of drug in specific lung compartments, paving the way for a trial in pneumonia (6/22)

BioInvent
International
AB
(Sweden;
SSE:BINV)

BI-201

Human antibody that binds to the TAT protein

HIV

Began Phase I/II trial in the UK to assess safety, tolerability and pharmacokinetics, as well as viral load (6/20)

Human Genome
Sciences Inc.
(HGSI)

Albuferon

Long-acting form of interferon alpha that uses albumin fusion technology

Hepatitis C

Began Phase IIb trial with ribavirin in Europe and elsewhere to evaluate efficacy and safety in 440 patients with HCV genotype 1 (6/1)

Nabi Bio-
pharmaceuticals
(NABI)

Civacir

Antibody-based hepatitis C immune globulin

Hepatitis C

The product was granted orphan status in Europe for preventing recurrent HCV-induced liver disease in liver transplant recipients (6/22)

MISCELLANEOUS

Cambridge
Antibody
Technology
Group plc
(UK; CATG)

CAT-354

Human anti-IL-13 monoclonal antibody

Severe asthma

Preliminary data from Phase I trial in the UK demonstrated tolerability with no safety concerns identified (6/23)

Karo Bio
AB
(Sweden;
SSE:KARO)

KB2115

Compound that stimulates the thyroid hormone receptor

Obesity and dyslipidemia

Began Phase I trial in overweight subjects to evaluate tolerability, safety and pharmacokinetics as well as effects on high blood lipids and other risk factors (6/20)

Revotar Biophar-
maceuticals Inc.*
(Germany; majority-
owned by Encysive
Pharmaceuticals
Inc.; ENCY)

Bimosiamose

Topical formulation of pan-selectin antagonist

Acute lung injury

The product was granted orphan designation in Europe in that indication (6/9)


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.

AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.

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