Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Amgen Inc.
(AMGN) and
Wyeth

Enbrel (FDA- approved)

Etanercept; anti-tumor necrosis factor-alpha antibody

Plaque psoriasis

The product was approved in Europe for treating adults with moderate to severe disease who failed to respond to other therapies (9/30)

Serono SA
(Switzerland;
NYSE:SRA)

Raptiva (FDA-approved)

Efalizumab; humanized antibody designed to block T cells implicated in psoriasis

Chronic plaque psoriasis

Gained marketing approval in the European Union for treating moderate to severe disease when other treatments were ineffective or inappropriate (9/23)

CANCER

Amgen Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa, a recombinant erythropoietic protein

Anemia from chemotherapy

European regulators approved extended dosing regimens for the drug (9/20)

Austrianova*
(Austria)

NovaCaps

Retroviral vector-based delivery system

Inoperable pancreatic cancer

European regulators issued a positive opinion on company's proposed pivotal trial in 200 patients (9/8)

Clavis
Pharma A/S*
(Norway)

CP-4055

Fatty-acid derivative
of cytarabine

Advanced solid tumors

Phase I trial in 24 patients confirmed safety and showed some signs of efficacy (9/24)

Guilford
Pharmaceuticals
Inc.
(GLFD)

Gliadel Wafer (FDA-approved)

Wafer comprised of a biodegradable polymer incorporating carmustine

Malignant glioma

Extended marketing authorization was granted in Europe to include use in newly diagnosed patients with high-grade glioma as an adjunct to surgery and radiation (9/14)

Medarex Inc.
(MEDX) and
Cell Genesys
Inc.
(CEGE)

MDX-010 and GVAX

Fully human anti-CTLA-4 antibody; whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF

Advanced prostrate cancer

Companies began a Phase I trial of the combination of the products in 45 patients in the Netherlands to test safety, dosing and efficacy endpoints (9/13)

MethylGene
Inc.
(Canada;
TSE:MYG)

MG98

Second-generation antisense compound designed to inhibit the expression of DNA methyltransferase

Solid tumors

Data from seven patients in Phase I trial in the UK showed reduction of DNMT1 mRNA by 52% after one cycle and 65% after two (9/30)

Oxford
BioMedica
plc
(UK; LSE:OXB)

TroVax

Vaccine that delivers an antigen (5T4) using a poxvirus vector

Colorectal cancer

Interim analysis of Phase II trial in 13 Stage IV patients showed safety with chemotherapy and specific immune responses to the 5T4 antigen (9/1)

OxiGene Inc.
(OXGN)

Combrestatin A4 Prodrug

Vascular-targeting agent designed to block flow of blood to a tumor

Cervical cancer

Began Phase I trial in combination with cisplatin in 18 patients in Denmark with advanced or recurrent disease (9/14)

Pharmion
Corp.
(PHRM)

Vidaza (FDA-approved)

Azacitidine for injectable suspension; believed to have demethylation and cytotoxic actions

Myelodysplastic syndromes

European regulators accepted for review the marketing authorization application (9/21)

Salmedix Inc.*

SDX-101

Single component of the anti- inflammatory drug etodolac

Chronic lymphocytic leukemia

Began Phase II trial in Europe to evaluate responses of drug and chlorambucil in 80 patients (9/30)

ViRexx
Medical Corp.
(Canada; TSE:VIR)

Occlusin Injection

Embolotherapeutic agent; designed to lead to clot formation

Liver cancer

Began Phase I trial in 12 patients in Canada to test safety when used as an embolizing agent as part of transcatheter arterial chemoembolization (9/23)

CARDIOVASCULAR

Sangart Inc.*

Hemospan

Hemoglobin-based oxygen carrier

Blood substitute

Began Phase II trial to test the product in 90 Swedish patients undergoing elective orthopedic surgeries (9/8)

The Medicines
Co.
(MDCO)

Angiox (Angiomax; FDA-approved)

Bivalirudin; direct thrombin inhibitor

Anticoagulant

The product was approved in the European Union for use as an anticoagulant in patients under- going percutaneous coronary interventions (9/22)

CENTRAL NERVOUS SYSTEM

Acadia
Pharmaceuticals
Inc.
(ACAD)

ACP-103

5-HT2A inverse agonist

Schizophrenia

Trial in 18 healthy volunteers in Sweden showed the drug reduced the motor disturbances and hyperprolactinemia caused by haloperidol treatment (9/15)

CeNeS
Pharmaceuticals
plc
(UK; LSE:CEN)

M6G

Morphine metabolite

Postoperative pain

Phase III trial in 167 patients who had knee-replacement surgery demonstrated statistically significant analgesia (9/20)

ExonHit
Therapeutics
SA*
(France)

Ikomio

Small molecule believed to have neuroprotective effects

Amyotrophic lateral sclerosis

Phase III trial in 400 patients in Europe taking drug and Rilutek failed to demonstrate a survival benefit vs. placebo (9/27)

IDEA AG*
(Germany)

IDEA-033

Analgesic product delivered by ultra-deformable carriers

Joint and musculoskeletal pain

Began open-label Phase III trial to evaluate safety, efficacy and compliance in 400 patients with osteoarthritis of the knee (9/16)

Lyfjathroun hf
Biopharmaceuticals*
(Iceland)

--

Sumatriptan nasal spray

Acute migraine

Phase Ib study in eight healthy volunteers showed the product was safe and well tolerated (9/10)

Newron
Pharmaceuticals
SpA*
(Italy)

Safinamide

Molecule believed to have multiple mechanisms of action

Parkinson's disease

Began multinational Phase III trial in 240 patients to test drug vs. placebo as an add-on therapy to a dopamine agonist (9/13)

INFECTION

ID Biomedical
Corp.
(Canada;
TSE:IDB)

Fluvira S/F

Vaccine comprised of the A/New Caledonia, A/ Wyoming and B/Jiangsu strains

Influenza

Canadian regulators cleared the vaccine for shipping and use throughout Canada (9/10)

Immtech
International
Inc.
(AMEX:IMM)

DB289

Oral, dicationic antiviral agent

African sleeping sickness

All patients evaluated from Phase IIb trial in the Congo were parasite-free in follow-on testing; the drug was well tolerated (9/28)

Micrologix
Biotech Inc.
(Canada; TSE:MBI)

MBI-3253 (celgosivir)

Oral a-glucosidase I inhibitor

Hepatitis C

Began Phase IIa trial in 60 patients
in Canada to evaluate HCV viral loads and safety (9/7)

Sinovac Biotech
Inc.
(China;
OTC BB:SNVBF)

--

Split flu vaccine

Influenza

Filed for approval of the vaccine in China (9/16)

Sinovac Biotech
Inc.
(China;
OTC BB:SNVBF)

--

Vaccine for severe acute respiratory syndrome

SARS

Phase I trial in 18 healthy volunteers in China showed no adverse reactions after two inoculations (9/7)

The Immune
Response Corp.
(IMNR)

Remune

Immune-based therapy comprised of a whole- killed virus and an adjuvant

HIV

Interim results from a Phase II trial in Italy showed HIV-specific immunity in drug-naive patients (9/14)

MISCELLANEOUS

APT Pharmaceuticals*

--

Aerosolized hydroxy- chloroquine that uses the Aradigm Corp. AERx pulmonary delivery system

Various diseases

Began Phase I trial in Australia to test safety and tolerability (9/13)

Auxilium
Pharmaceuticals
Inc.
(AUXL)

Testim

Topical 1% testosterone gel

Hypogonadism

Phase IV study in 151 hypogonadal men showed better results in sexual endpoints for Testim group than those who remained on AndroGel therapy (9/15)

BioXell SpA*
(Italy)

BXL-628

Inhibitor of growth factor phosphorylation and bcl-2

Benign prostatic hyperplasia

Phase II trial in 120 patients demonstrated a statistically significant reduction in reducing prostate volume (7.2%) vs. placebo (9/27)

Cambridge
Antibody
Technology Group
plc
(UK; LSE:CAT)

CAT-354

Human anti-IL-13 monoclonal antibody

Severe asthma

Began Phase I trial in the UK to study the safety, tolerability and pharmacokinetics of the product (9/8)

Cellegy
Pharmaceuticals
Inc.
(CLGY)

Rectogesic (Cellegesic)

Nitroglycerin ointment

Pain from anal fissures

UK authorities approved the product there and will act as a reference member state for other Europeancountries (9/13)

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYTN)

CYT003-QbG10

Virus-like particle packaged with an immunostimulatory sequence

Various diseases

Phase I trial in 35 healthy volunteers showed QbG10 was safe, well tolerated and highly immunogenic (9/16)

Eyetech
Pharmaceuticals
Inc.
(EYET)
and Pfizer Inc.

Macugen

Pegaptanib sodium injection; pegylated anti-VEGF aptamer

Age-related macular degeneration

European regulators accepted for review the approval application; companies also completed filing in Canada (9/20)

Protherics
plc
(UK; LSE:PTI)

DigiFab (FDA-approved)

Polyclonal antibody designed to neutralize digoxin

Digoxin toxicity

The company filed for approval in the UK (9/2)


Notes:

* Privately held.

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

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.

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