Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Biogen Idec
Inc.
(BIIB) and
Elan Corp. plc
(Ireland)

Tysabri

Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells

Multiple sclerosis

EMEA committee recommended approval of the drug for treating relapsing-remitting MS to delay the progression of disability and reduce the frequency of relapses (4/28)

Serono SA
(Switzerland;
NYSE:SRA)

Rebif (FDA-approved)

Interferon beta-1a

Multiple sclerosis

Submitted variation of MAA that seeks European approval of a new formulation of Rebif (4/4)

CANCER

Bioenvision
Inc.
(BIVN)

Evoltra (FDA-approved)

Clofarabine; second- generation purine nucleoside analogue

Acute myeloid leukemia

Phase I/II trial in 30 patients older than 60 showed an overall response rate of 92%; drug was given with danorubicin (4/5)

Celgene
Corp.
(CELG)

Revlimid

Lenalidomide; derivative of Thalomid (thalidomide)

Advanced multiple myeloma

The EMEA accepted for review the MAA filing that seeks approval of the drug in Europe (4/7)

Genentech
Inc.
(NYSE:DNA)

Herceptin (FDA-approved)

Trastuzumab; monoclonal antibody against the HER2/neu protein

Early stage breast cancer

EMEA committee recommended approval for use as an adjuvant treatment; the filing was made by F. Hoffmann-La Roche Ltd. (4/28)

ImClone
Systems
Inc.
(IMCL)

Erbitux (FDA-approved)

Cetuximab; antibody that blocks the epidermal growth factor receptor

Advanced head and neck cancer

Partner Merck KGaA got approval in Europe to expand the label to include use with radiotherapy in advanced head and neck cancer (4/3)

Onyx Pharmaceuticals
Inc.
(ONXX) and
Bayer Pharma-
ceuticals Corp.

Nexavar (FDA-approved)

Sorafenib; RAF kinase and VEGF inhibitor

Advanced kidney cancer

European regulators issued a positive opinion on marketing application; separately, the drug was approved in Mexico in that indication (4/28)

Onyx
Pharmaceuticals
Inc.
(ONXX) and
Bayer Pharma-
ceuticals Corp.

Nexavar (FDA-approved)

Sorafenib; RAF kinase and VEGF inhibitor

Liver cancer

The product was granted orphan designation in Europe for treating hepatocellular carcinoma, or liver cancer (4/18)

OSI
Pharmaceuticals
Inc.
(OSIP)

Tarceva (FDA-approved)

Erlotinib; small-molecule HER1/EGFR inhibitor

Advanced non-small-cell lung cancer

OSI partner Chugai Pharmaceutical Co. Ltd. filed for approval of the product in Japan (4/17)

Pharmexa
A/S
(Denmark;
CSE:PHARMX)

GV1001

Peptide vaccine that targets telomerase

Pancreatic cancer

Began Phase III PrimoVax trial to evaluate drug with gemcitabine in 520 patients in Europe and Australia (4/26)

CARDIOVASCULAR

Fibrex Medical
Inc.*
(Austria)

FX06

Anti-inflammatory peptide

Myocardial infarction

Phase I trial in 30 healthy volunteers in Austria demonstrated safety and tolerability (4/6)

CENTRAL NERVOUS SYSTEM

BioLineRx
Ltd.*
(Israel)

BL-1020

Small-molecule neuro-transmission modulator

Schizophrenia

Began Phase I trial in Israel to evaluate safety and pharmacokinetics (4/10)

CardioVascular
BioTherapeutics
Inc.
(OTC BB:CVBT)

--

Agent containing Cardio Vascu-Grow, a stimulator of angiogenesis

Chronic back pain

Began proof-of-concept studies in patients in Russia and Eastern Europe (4/26)

Debiopharm Pharmaceuticals
SA*
(Switzerland)

ZT-1

Hup A derivative; acetylcholinesterase inhibitor

Alzheimer's disease

Phase I monthly sustained-release implant study demonstrated safety and tolerability; Phase II oral study demonstrated efficacy and safety (4/25)

Faust
SA*
(France)

FP001

Glutamate release inhibitor

Amyotrophic lateral sclerosis

Phase IIa trial in 24 patients in France demonstrated safety and tolerability, and that it could be administered with riluzole (4/26)

Neuren
Pharmaceuticals
Ltd.
(Australia;
ASX:NEU)

Glypromate

Naturally occurring peptide fragment with protective qualities found in brain

Brain protection in CAPG surgery

Successfully completed Phase II safety trial in Australia and New Zealand in 33 patients undergoing coronary artery bypass surgery (4/27)

Neuropharma
(unit of Zeltia
Group; Spain;
MSE:ZEL)

NP031112

Inhibitor of glycogen synthase kinase 3

Alzheimer's disease

Began Phase I trial in Germany to evaluate safety and dosing (4/24)

SkyePharma
plc
(UK; SKYE)

DepoDur (FDA-approved)

Sustained-release, injectable liposomal formulation of morphine

Postsurgical pain

The product was approved in the UK; additional approvals in Europe are anticipated (4/28)

INFECTION

Biolex
Therapeutics
Inc.*
and
OctoPlus Tech-
nologies NV*
(the Netherlands)

Locteron

Controlled-release form of alpha interferon

Hepatitis C

Phase I trial in the Netherlands demonstrated the safety and tolerability in healthy volunteers and supported dosing every two weeks (4/27)

Oxxon
Therapeutics
Ltd.*
(UK)

--

Agent from Hi-8 PrimeBoost platform designed to stimulate an immune response

Hepatitis B

Phase II trial showed the vaccine was well tolerated and induced HBeAg seroconversion, followed by a viral load decrease (4/27)

Pharmasset
Inc.*
and
Bukwang
(South Korea)

Clevudine

Pyrimidine nucleoside analogue

Hepatitis B

Preliminary data from Phase III trial in Korea demonstrated significant viral suppression and bio- chemical improvement (4/27)

Oncoscience
AG*
(Germany)
and YM
BioSciences Inc.
(Canada; TSE:YM)

Nimotuzumab

Anti-EGFr monoclonal antibody

Brain stem glioma

Began Phase III trial in combination with radiation in 36 children with inoperable pontine glioma (4/27)

Targeted
Genetics Corp.
(TGEN)

tgAAC09

Preventive vaccine based on HIV subtype C; uses a recombinant adeno-associated viral vector

HIV

Began clinical trial in Zambia to evaluate safety and immuno-genicity in 16 volunteers (4/26)

Transgene SA
(France; Eurolist:
FR0005175080)

TG4001 (MVA-HPV-IL-2)

Therapeutic vaccine; MVA virus carrying and expressing HPV16 E6 and E7 genes

Cervical intraepithelial neoplasia

Phase II trial in France resulted in avoidance of surgery for 9 of 18 women (4/25)

Tripep AB
(Sweden; SSE:TPEP)

AlphaHGA

Agent designed to inhibit the spread of the virus from the infected cell

HIV

Phase I/II trial in Thailand failed to show a significant decrease of HIV levels in patients (4/4)

ViRexx
Medical Corp.
(Canada; TSE:VIR)

HepaVaxx B Vaccine

Molecule containing a hepatitis B viral antigen and a portion of a murine monoclonal antibody

Hepatitis B

Is starting a Phase I trial in 15 patients in Canada to evaluate safety (4/27)

MISCELLANEOUS

AEterna
Zentaris Inc.
(Canada; AEZS)

Cetrotide (cetrorelix; FDA-approved)

Luteinizing hormone- releasing hormone antagonist

For use in in vitro fertilization

The product was approved in Japan, where it will be made and sold by partners Nippon Kayaku Co. Ltd. and Shionogi & Co. Ltd.

(4/20)

Cellegy
Pharmaceuticals
Inc.
(OTC BB:CLGY)

Tostrex

Transdermal testosterone gel product

Hypogonadism

European licensee ProStrakan Group plc concluded the MRP, paving the way for approvals in EU countries (4/11)

Chronogen
Inc.*
(Canada)

CHGN111

Topical agent; inhibitor of the mitochondrial enzyme CLK-1

Age-related diseases

Began Phase I/II trial in Canada to prevent cutaneous phototoxicity induced by photodynamic therapy (4/26)

Clinuvel
Pharmaceuticals
Ltd.
(Australia;
ASX:CVU)

CUV1647 (formerly Melanotan or EPT1647)

Agent designed to stimulate production of eumelanin

Sun poisoning

Phase II trial in 26 patients demonstrated statistically significant reductions in the need for rescue medication vs. placebo (4/18)

Cytori
Therapeutics
Inc.
(CYTX)

--

Adult adipose-derived stem and regenerative cells

For use in breast reconstruction

Began open-label study in Japan to test safety and feasibility in 20 breast cancer patients who have had a partial mastectomy (4/20)

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYGN)

CYT005- AllQbG10

Immunodrug carrier mixed with house dust mite allergen

Dust mite allergy

Follow-up data from Phase IIa trial showed therapeutic benefit for an extended period of time (4/25)

Genzyme
Corp.
(GENZ)

Myozyme

Recombinant human acid alpha-lucosidase enzyme

Pompe disease

The product was approved in Europe for use as a long- term enzyme-replacement therapy (4/3)

LAB
International
Inc.
(Canada;
TSE:LAB)

LAB CGRP

Calcitonin gene-related peptide; vasodilative agent

Asthma

Began Phase IIa trial in 12 patients to evaluate safety and tolerability, and efficacy vs. salbutamol and placebo (4/18)

NPS
Pharmaceuticals
Inc.
(NPSP)

Preotact (Preos)

Recombinant human parathyroid hormone

Postmenopausal osteoporosis

The European Commission granted marketing authorization for the product; Nycomed Group has European marketing rights (4/26)

Nuvo
Research Inc.
(Canada; TSE:NRI)

Pennsaid

Topical non-steroidal anti-inflammatory agent

Osteoarthritis

52-week data from Phase III trial confirmed safety (4/26)

Pharmaxis
Ltd.
(Australia;
PXSL)

Bronchitol

Mannitol formulation delivered via an inhalation device

Bronchiectasis

Began Phase III trial to evaluate the product in 350 patients with the chronic obstructive lung dis- ease(4/19)


Notes:

* Privately held.

MAA = Marketing authorization application; MRP = Mutual Recognition Procedure; EMEA = European Medicines Agency.

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; MSE = Madrid 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.