Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

4SC AG
(Germany; FSE:VSC)

SC12267

New type of small-molecular active agent from the class of disease-modifying anti-rheumatic drugs; works as a selective inhibitor in the biosynthesis of pyrimidine

Rheumatoid arthritis

Started a Phase IIa study in 120 patients in Germany, Poland and Serbia (12/4)

Centocor Inc.
(unit of J&J) and
Schering-Plough
Corp.

Remicade
(FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Rheumatoid arthritis

European Commission approved a label extension allowing for a shortened infusion time (12/14)

Isotechnika Inc.
(Canada; TSX:ISA)

ISA247

Immunosuppressive drug

Psoriasis

Enrolled its first patient in a European/Canadian Phase III trial for moderate to severe patients (12/5)

CANCER

Ardana plc
(UK; LSE:ARA)

Teverelix

Gonadotropin-releasing hormone antagonist

Benign prostatic hyperplasia

Phase II data showed it induced symptomatic improvement from as early as week two and the duration of the effect appeared to last around eight weeks (12/27)**

Advanced
Magnetics Inc.
(AMAG)

Combidex

Imaging agent for use with magnetic resonance imaging

To diagnose metastatic lymph nodes

Company's European partner, Guerbet SA, submitted an MAA (12/6)

BioAlliance
Pharma SA
(France; Euronext:
BIO)

Doxorubicin
Transdrug

Nanoparticle formulation of doxorubicin

Primary liver cancer

Received the go-ahead from French authorities to start a Phase II/III trial (12/20)**

Oncolytics
Biotech Inc.
(Canada; ONCY;
TSX:ONC)

Reolysin

A formulation of the reovirus

Advanced cancer

Started patient enrollment in its UK Phase II study (12/22)

Onyvax Ltd.*
(UK)

Onyvax-P

Cell vaccine; an immuno-therapy

Prostate cancer

Phase IIb trial is under way in the UK and the Baltic States (12/13)**

OSI
Pharmaceuticals
Inc.
(OSIP)

Tarceva
(FDA-approved)

Once-daily therapy

Metastatic pancreatic cancer

European Committee for Medicinal Products for Human Use recommended approval (12/15)

QLT USA Inc.
(unit of QLT Inc.;
Canada; QLTI;
TSX:QLT)

Eligard
(FDA-approved)

45 mg, six-month formulation

Advanced prostate cancer

Approved in Germany (12/1)

SkyePharma
plc
(UK; SKYE)

Solaraze
(FDA-approved)

Diclofenac; topical gel

Actinic keratosis

Australian regulators approved Solaraze (12/6)**

CARDIOVASCULAR

Alliance
Pharmaceutical
Corp.
(OTC BB: ALLP)

Oxygent

Perfluorochemical emulsion

To prevent post- operative ileus

Received approval from French authorities (12/18)

BioTime Inc.
(OTC BB:BTIM)

Hextend

Plasma volume expander

To expand plasma volume

A Japanese Phase II trial is under way (12/7)

CV
Therapeutics
Inc.
(CVTX)

Ranexa
(FDA-approved)

Ranolazine

Chronic angina

Filed for European approval (12/21)

Northern
Therapeutics
Inc.*
(Canada)
and MaxCyte
Inc.*

Engineered cell-based therapy

Idiopathic pulmonary arterial hyper-tension

Began the first human trial, a Phase IIa study in 18 patients at two sites in Canada (12/12)

CENTRAL NERVOUS SYSTEM

Trophos*
(France)

TRO19622

Compound believed to promote the survival of a range of neurons

Amyotrophic lateral sclerosis

Completed a Phase Ib trial and plans to start a pivotal Phase II/III trial (12/13)**

DIABETES

Speedel Group
(Switzerland;
SWX:SPPN)

SPP301

Once-a-day oral endothelin A receptor antagonist

Diabetic nephropathy

Company halted a pivotal Phase III trial following the development of excessive fluid retention in patients receiving the drug (12/20)**

INFECTION

Dynavax
Technologies
Corp.
(DVAX)

Heplisav

Immunostimulatory sequence-based vaccine targeting Toll-like receptor 9

Hepatits B virus

Started a pivotal Phase III trial in Canada (12/21)

Helix
BioPharma Corp.
(Canada; TSX:HBP)

Topical interferon alpha-2b

Ano-genital warts associated with human papillomavirus infection

Started patient enrollment in a Phase II trial in Sweden (12/11)

Inovio
Biomedical
Corp.
(AMEX:INO)
and Tripep AB
(Sweden; SSE:TPEP)

ChronVac-C

DNA vaccine administered using Inovio's MedPulse DNA Delivery System

Hepatitis C virus

Filed an application for a Phase I study in healthy volunteers (12/5)

InterMune Inc.
(ITMN) and
F. Hoffmann-La
Roche Ltd.
(Switzerland)

ITMN-191

An NS3/4A protease inhibitor

Chronic hepatitis C virus

Received approval in Europe to start a Phase Ia trial (12/19)

Ipsat
Therapies Ltd.*
(Finland)

P1A

Product designed to inactivate beta-lactam antibiotics in the lower intestinal tract

Upper and lower respiratory tract infections

Recruited the first patient in a Phase IIb study of P1A in combination with Ampicillin (12/4)

Pevion
Biotech Ltd.*
(Switzerland)

Virosome-based therapeutic hepatitis C vaccine that combines PevitTER and PeviPRO

Hepatitis C

Began a Phase I trial in 30 healthy volunteers (12/20)**

SciClone
Pharmaceuticals
Inc.
(SCLN) and
Sigma-Tau SpA
(Italy)

Zadaxin

Thymalfasin or thymosin alpha 1

Hepatitis C

Completed enrollment in a Phase III trial of Zadaxin in combination with pegylated interferon alpha and ribavirin; trial conducted in Europe has enrolled 553 patients (12/28)

Tibotec
Pharmaceuticals
Ltd.*
(Ireland)

Prezista

Darunavir

HIV

Committee for Human Medicinal Products recommended conditional approval of Prezista based on a pooled analysis of two Phase II trials (12/15)

MISCELLANEOUS

Vernalis plc (UK;
VNLS)

V24343

A cannabinoid-1 antagonist

Obesity, Type II diabetes and related disorders

Started a Phase I trial (12/11)


Notes:

* Privately held; ** The date the item ran in BioWorld International. MAA = Marketing authorization application.

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

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