Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)

AUTOIMMUNE

Abbott
Laboratories
(NYSE:ABT)

Humira
(FDA-
approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Crohn's disease

The EMEA's CMPH recommended approval (4/27)

Allos
Therapeutics
Inc. (ALTH)

PDX

Antifolate pralatrexate; a small-molecule chemo- therapeutic agent designed to inhibit dihydrofolate reducatase

Peripheral T-cell lymphoma

European Commission granted orphan drug designation to PDX (4/19)

Genta Inc. (GNTA)

Genasense

Oblimersen sodium injection

Advanced melanoma

Company is requesting a review of a negative opinion for market-ing authorization in Europe of its application for Genasense plus dacarbazine (4/27)

Hybrigenics
SA* (France)

Inecalcitol

A synthetic vitamin D analogue

Prostate cancer

Phase I data showed no adverse side effects at the initial dose (4/18)**

Northwest
Biotherapeutics
Inc. (OTC BB:NWBT)

DCVax-Brain

A personalized dendritic cell vaccine

Malignant brain cancers

Filed for authorization in Switzerland (4/17)

Alexion
Pharmaceuticals
Inc. (ALXN)

Soliris (FDA-approved)

Eculizumab; monoclonal antibody designed to selectively block terminal complement activation

Paroxysmal nocturnal hemoglobinuria

European regulators recommended approval, calling for a broad label(4/27)

Encysive
Pharmaceuticals
Inc. (ENCY)

Thelin

Sitaxentan sodium 100 mg tablets; selective endothelin A receptor antagonist

Pulmonary arterial hypertension

Launched Thelin in Ireland (4/2)

Proteo Biotech
AG (Germany;
OTC BB:PTEO)

Elafin

Recombinant human protein

Pulmonary arterial hypertension

Received orphan drug status from the European Commission (4/4)

Alkermes Inc.
(ALKS)

Vivitrol (FDA-approved)

Naltrexone for extended-release injectable suspension

Alcohol dependence

Submitted marketing authorization in the UK and Germany for once- monthly treatment (4/2)

SkyePharma plc
(UK; SKYE; LSE:SKP)

Requip

Ropinirole; prolonged-release tablets

Parkinson's disease

French officials approved the product (4/23)

INFECTION

Crucell NV
(the Netherlands;
CRXL)

Rabies monoclonal antibody

Rabies

Began a Phase I study in India (4/4)

Idenix
Pharmaceuticals
Inc. (IDIX) and
Novartis AG
(Switzerland)

Sebivo

Telbivudine; once-a-day tablet

Hepatitis B virus

European Commission approved Sebivo (4/30)

MediGene AG
(Germany;
FSE:MDG)

Polyphenon E Ointment

A concentrate of catechines

Genital warts

Regulatory authorities in Germany, Austria and Spain have accepted the MAA for review (4/18)

Schering-Plough
Corp.

Pegintron (FDA-approved for hepatitis C)

Peginterferon alfa-2b

Chronic hepatitis B virus

It was approved in China (4/5)

MISCELLANEOUS

Clinuvel
Pharmaceuticals
Ltd. (Australia;
ASX:CUV)

CUV1647

Agent designed to stimulate production of eumelanin

Erythropoietic protoporphyria

Received Swiss regulatory clearance to begin a Phase III trial (4/11)

Pharmaxis Ltd.
(Australia; PXSL)

Bronchitol

Inhalable dry powder formulation of mannitol delivered twice daily

Cystic fibrosis

Began a Phase III trial in Australia, the UK and Ireland to support eventual approval in the EU, Australia and elsewhere (4/11)

QLT Inc.
(Canada; QLTI)

Visudyne (FDA- approved)

Light-activated therapy

Occult subfoveal choroidal neo- vascularization secondary to age-related macular degeneration

The CMPH recommended deletion of the indication due to missed primary endpoints in a confirmatory trial (4/25)

Notes:

* Privately held. ** Denotes the date the item ran in BioWorld International.

CMPH = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

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

ASX = Australian Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board.