Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

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

Tysabri (FDA-approved)

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

Multiple sclerosis

The product was approved in Canada for treating relapsing-remitting MS (10/4)

ImmuPharma
plc
(UK; LSE:IMM)

IPP-201101

Agent designed to modify CD4+ T cells

Lupus

Phase II trial in Europe met its primary endpoints related to surrogate biomarkers (10/17); additional data showed clinical improvements (10/30)

Isotechnika
Inc.
(Canada;
TSX:ISA)

ISA247

Immunosuppressive agent

Psoriasis

Final, 60-week data from Phase III SPIRIT trial in Canada demonstrated safety and efficacy (10/5)

Isotechnika
Inc.
(Canada;
TSX:ISA)

ISA247

Immunosuppressive agent

Psoriasis

Began pivotal Phase III ESSENSE trial in Germany, Poland and Canada to evaluate drug vs. placebo and cyclosporine in 500 patients (10/2)

La Jolla
Pharmaceutical
Co.
(LJPC)

Riquent

Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA

Lupus

Withdrew MAA filing, following word from the EMEA that additional clinical data would be needed prior to approval (10/12)

CANCER

Adherex
Technologies
Inc.
(AMEX:ADH)

ADH-1

Cadherin antagonist; small peptide, tumor/ vascular-targeting agent

Solid tumors

Began Phase I trial to evaluate drug in separate combinations, in up to 55 patients (10/3)

Algeta ASA*
(Norway)

Alpharadin

Radiopharmaceutical based on the alpha particle emitter radium-223

Hormone- refractory prostate cancer

Phase II trial in Europe showed statistically significant effects on biomarkers of bone turnover; PSA levels also were reduced (10/23)

EpiCept
Corp.
(EPCT)

Ceplene

Histamine dihydrochloride in combination with interleukin-2

Acute myeloid leukemia

Filed MAA with EMEA, seeking approval in Europe for use with interleukin-2 for maintenance of first remission in AML patients (10/3)

Gendux AB*
(Sweden) and
Introgen
Therapeutics
Inc.
(INGN)

Advexin

Adenoviral vector containing the p53 tumor- suppressor gene

Li-Fraumeni syndrome

Reached agreement with the EMEA on plan to file for approval under exceptional circumstances provisions (10/31)

Genta Inc.(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Stage IV malignant melanoma

The product was granted orphan designation in Australia in that indication (10/17)

Micromet
Inc.
(MITI) and
Serono AS
(Switzerland;
NYSE:SRA)

MT201

Adecatumumab; fully human antibody targeting the epithelial adhesion molecule Ep-AM

Relapsed prostate cancer

Phase II trial in 84 patients in Europe showed a beneficial trend but failed to meet primary endpoint related to PSA levels (10/2)

Micromet
Inc.
(MITI) and
Serono SA
(Switzerland;
NYSE:SRA)

MT201

Adecatumumab; fully human antibody targeting the epithelial adhesion molecule Ep-CAM

Metastatic breast cancer

Phase II trial in 109 patients in Europe failed to show a clinical benefit rate of 25%; a benefit was seen in time to progression, a secondary endpoint (10/2)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Cotara

Chimeric tumor-necrosis therapy antibody attached to iodine-131

Glioblastoma multiforme

Began trial in India to evaluate safety and efficacy in up to 40 patients who have experienced their first relapse (10/12)

Wilex AG*
(Germany)

Rencarex (WX-250)

Chimeric monoclonal IgG1 antibody that binds to the MN cell-surface antigen

Metastatic renal cell cancer

Phase II study with low-dose interferon alpha-2a showed a median survival of 30 months and a two-year survival rate of 57% (10/16)

CARDIOVASCULAR

Speedel
Group AG
(Switzerland;
SWX:SPPN)

SPP635

Next-generation renin inhibitor

Hypertension

Began Phase IIa trial in Europe to evaluate safety and efficacy in 35 patients with mild to moderate hypertension (10/31)

ThromboGenics
NV
(Belgium;
Euronext:THR)

--

Intraocular injection of recombinant microplasmin

Back-of-the-eye diseases

Phase IIa MIVI-I trial demonstrated tolerability and encouraging proof of concept (10/20)

CENTRAL NERVOUS SYSTEM

Anesiva Inc.
(ANSV)

1207

Anesthetic that binds to fast sodium channel on both A and C nerve fiber

Pain

Began Phase I trial in Australia to evaluate safety and effects in 24 healthy male volunteers (10/25)

Cortex
Pharmaceuticals
Inc.
(AMEX:COR)

CX717

Ampakine analogue; designed to improve brain cell signaling

Attention deficit hyperactivity disorder

The FDA lifted clinical hold it had placed on trial, but mandated dosing limits that would preclude development in ADHD (10/24 and 10/29)

CytRx Corp.
(CYTR)

Arimoclomol

Small molecule designed to protect cells by activating molecular chaperone proteins

Amyotrophic lateral sclerosis

The product was granted orphan designation in Europe (10/31)

GW
Pharmaceuticals
plc
(UK;LSE:GWP)

Sativex

Spray formulation of cannabis extract

Pain in those with advanced cancers

Filed for approval in Canada for treating pain not adequately relieved by opioids (10/19)

KeyNeurotek
AG*
(Germany)

KN 38-7271

Cannabiniod receptor agonist

Traumatic brain injury

Began Phase II trial in Europe to evaluate efficacy and tolerability in more than 100 patients (10/17)

Prana
Biotechnology
Ltd.
(Australia;
PRAN)

PBT2

Small molecule that binds metal ions

Alzheimer's disease

Is starting Phase IIa trial in Sweden to evaluate safety, tolerability and signs of efficacy in patients with early AD (10/5)

DIABETES

Karo Bio
AB
(Sweden;
SSE:KARO)

KB3305

Agent designed to antagonize glucocorticoid action in the liver

Type II diabetes

Is starting a Phase I trial in Sweden to evaluate the product in healthy volunteers (10/25)

INFECTION

AB-Pharma
BV*
(the
Netherlands)

Verum

Alkaline phosphatase agent

Severe sepsis

Pilot study in 36 patients demonstrated tolerability; also, survival rates were increased (10/20)

Acambis plc
(UK; ACAM)

ChimeriVax-JE

Single-dose vaccine against Japanese encephalitis virus

Japanese encephalitis virus

Pivotal Phase III safety trial showed comparable adverse events to placebo; early Phase III data on efficacy were positive (10/30)

Bavarian
Nordic A/S
(Denmark; CSE:
BAVA)

MVA-BN polytope

MVA-BN virus expressing 21 epitopes from killer T cells and 18 epitopes from helper T cells

HIV

Began Phase I and II trials in Europe to evaluate immunogenicity and safety in both healthy and HIV- infected subjects (10/23)

BioAlliancePharma
SA
(France;
Euronext:BIO)

Loramyc (miconazole Lauriad)

Bioadhesive buccal tablet containing the antifungal agent miconazole

Oropharyngeal candidiasis

The product was approved in France for treating OC in immuno-depressed patients (10/13)

Gilead
Sciences Inc.
(GILD) and
Bristol-Myers
Squibb Co.

Atripla
(FDA-approved)
(Viread and Emtriva)

Once-daily, single tablet containing BMS' Sustiva and Gilead's Truvada

HIV

Submitted MAA with EMEA, seeking approval of the triple-combination drug (10/9)

MISCELLANEOUS

Allergy
Therapeutics
plc
(UK;
AIM:AGY)

Pollinex Quattro

Short-course vaccine with TLR4-agonist adjuvant

Ragweed allergies

Dose-ranging trial demonstrated the product was immunogenic (10/13)

BioMarin
Pharmaceutical
Inc.
(BMRN) and
Genzyme
Corp.
(GENZ)

Aldurazyme (FDA-approved)

Laronidase; enzyme replacement therapy

Mucopoly- saccharidosis I

The product was approved in Japan in that indication (10/31)

Biovitrum AB
(Sweden; SSE:BVT)

BVT.28949

5-HT2A antagonist

Glaucoma

Began Phase II trial in Sweden and Ukraine to evaluate the product in 150 patients with elevated intraocular pressure (10/16)

DUSA
Pharmaceuticals
Inc.
(DUSA)

Levulan (FDA-approved)

Aminolevulinic acid HCl; photodynamic therapy; used with light source

Dermatology indications

Partner Stiefel Laboratories Inc. gained approval of the product in Brazil (10/17)

Genzyme
Corp.
(GENZ)

Synvisc (FDA-approved)

Hylan G-F20; an elastoviscous hylan therapeutic

Osteoarthritis

Received additional approval in Europe to include treatment of pain due to osteoarthritis of the ankle and shoulder (10/2)

Renovo Group
plc
(UK; LSE:
RNVO)

Juvista

Therapeutic application of human recombinant TGF-beta3

Scarring

Phase II trial showed statistically significant reductions in scarring in split-thickness skin-graft donor sites vs. placebo (10/24)

Repros
Therapeutics
Inc.
(RPRX)

Proellex (Progenta)

Agent designed to block progesterone without blocking adrenal hormones

Endometriosis

Three-month data from Phase II study in Europe showed a reduction of pain vs. Lupron (10/24)

Spectrum
Pharmaceuticals
Inc.
(SPPI) and
AEterna
Zentaris Inc.
(Canada; AEZS)

Ozarelix

Fourth-generation luteinizing hormone- releasing hormone

Benign prostatic hyperplasia

Phase II trial in 144 patients in Europe met its primary endpoint of improving clinical symptoms vs. placebo(10/3)


Notes:

* Privately held.

CHMP = 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.

AMEX = American Stock Exchange; AIM = Alternative Investment Market; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.