Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

BioCryst
Pharmaceuticals
Inc.
(BCRX)

BCX-4208

Second-generation, transition-state analogue inhibitor of purine nucleoside phosphorylase

Psoriasis

Began Phase Ib trial to evaluate safety, tolerability and pharmaco- kinetics in healthy volunteers (8/9)

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

Tysabri

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

Multiple sclerosis

Safety evaluation in MS patients revealed no new confirmed cases of progressive multifocal leukoencephalopathy (8/9)

Genelabs
Technologies
Inc.
(GNLB)

Prestara

Prasterone; synthetic equivalent of dehydro-epiandrosterone

Lupus

Open-label Study GL03-01 met its primary objective of maintaining the bone mineral density of women with lupus receiving glucocorticoids (8/18)

Genmab A/S
(Denmark;
CSE:GEN)

HuMax-CD20

Human antibody that binds to the CD20 antigen

Rheumatoid arthritis

Expanded Phase I/II trial into Phase II trial that will include 200 additional patients who have failed previous treatments (8/16)

Salix
Pharmaceuticals
Ltd.
(SLXP)

Xifaxan (FDA-approved)

Rifaximin tablets; gut-selective oral antibiotic

Crohn's disease

Open-label trial in 29 patients showed a 70% improvement in disease activity in 78% of patients and 59% achieved clinical remission (8/11)

CANCER

Array
BioPharma
Inc.
(ARRY)

ARRY-334543

Small-molecule inhibitor of ErbB-2 and EGFR

Cancers

Got FDA OK to start Phase I trials to evaluate tolerability, pharmacokinetics and activity in patients with advanced disease (8/8)

BioCryst
Pharmaceuticals
Inc.
(BCRX)

Fodosine

Forodesine hydrochloride; transition-state purine nucleoside phosphorylase inhibitor

Advanced chronic lymphocytic leukemia

Began Phase II trial to evaluate efficacy and safety in up to 30 patients with fludarabine-refractory disease (8/31)

BioCryst
Pharmaceuticals
Inc.
(BCRX)

Fodosine

Forodesine hydrochloride; transition-state purine nucleoside phosphorylase inhibitor

T cell-mediated cancers

Began Phase I pharmacokinetic
trial to evaluate the bioavailability and effect of food on oral vs. intravenous formulations in healthy volunteers (8/9)

Eximias
Pharmaceutical
Corp.*

Thymitaq

Nolatrexed; antifolate that inhibits thymidylate synthase

Hepatocellular carcinoma

Phase III trial in 446 patients with unresectable disease failed to achieve its primary endpoint, a survival benefit vs. doxorubicin (8/3)

OncoGenex
Technologies
Inc.*
(Canada)
and Isis
Pharmaceuticals
Inc.
(ISIS)

OGX-011

Second-generation anti- sense drug designed to inhibit the production of clusterin, a cell- survival protein

Advanced non- small-cell lung cancer

Began Phase II trial in combination with gemcitabine and cisplatin in up to 70 chemotherapy-naive patients (8/9)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Cotara

Chimeric tumor-necrosis therapy antibody attached to iodine-131

Glioblastoma multiforme

Began open-label trial to evaluate dosing, safety and efficacy in up to 28 patients (8/29)

SGX
Pharamceuticals
Inc.*

Troxatyl

Troxacitabine; nucleoside analogue

Acute myelogenous leukemia

Began Phase II/III trial to test safety and efficacy in 211 patients with relpased or refractory AML (8/16)

CARDIOVASCULAR

Cardiome
Pharma Corp.
(Canada; CRME)

RSD1235

Oral formulation of drug designed to selectively block ion channels in the heart

Atrial fibrillation

Phase I trial in 55 healthy volunteers showed the drug was safe and well tolerated at all doses (8/31)

Cardiome
Pharma Corp.
(Canada; CRME)

Oxypurinol

Xanthine oxidase inhibitor that is the active metabolite of allopurinol

Congestive heart failure

Phase II trial in 405 patients failed to demonstrate statistical significance vs. placebo in the primary composite endpoint (8/15)

Corautus
Genetics Inc.
(VEGF)

VEGF-2

Vascular endothelial growth factor-2 in the form of naked plasmid DNA

Severe angina

Monitors in Phase IIb GENASIS trial recommended continuation following a second interim analysis in 115 patients (8/4)

CV
Therapeutics
Inc.
(CVTX)

Regadenoson

Selective A2A-adenosine receptor agonist

Myocardial perfusion imaging

Pivotal Phase III trial in 784 patients met its primary endpoint by showing comparable MPI results to Adenoscan (8/10)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 301012

Capsule formulation of second- generation anti-sense inhibitor of ApoB-100

Cholesterol management

Phase I trial showed rapid reductions in apoB-100 along with reductions in LDL levels (8/4)

Millennium
Pharmaceuticals
Inc.
(MLNM)

MLN1202

Humanized monoclonal antibody designed to block CCR2 chemokine receptors

Atherosclerotic cardiovascular disease

Began Phase II trial in up to 110 patients to assess safety and the effect on circulating C-reactive protein (8/18)

Myogen Inc.
(MYOG)

Darusentan

Type-A selective endothelin receptor antagonist and inhibitor of endothelin-induced vasoconstriction

Resistant hypertension

Phase IIb trial demonstrated statistically significant reduction in systolic blood pressure and in diastolic blood pressure vs. placebo (8/18)

Myogen Inc.
(MYOG)

Ambrisentan

Type-A selective endothelin receptor antagonist

Pulmonary arterial hypertension

Phase II data showed an increase of 36.1 meters in six-minute walk distance (p<0.0001), with similar increases for each dose group (8/11)

Nuvelo Inc.
(NUVO)

rNAPc2

Recombinant nematode anticoagulant protein c2 originally isolated from hookworms

Acute coronary syndrome

Began Phase II proof-of-concept trial evaluating drug as a replacement for heparin in 50 to 100 patients (8/22)

Nuvelo Inc.
(NUVO)

Alfimeprase

Modified fibrolase delivered via catheter; thrombolytic agent

Chronic peripheral arterial occlusion

Phase I trial in 20 patients showed drug generally was well tolerated with no bleeding complications (8/8)

Synthetic Blood
International
Inc.
(OTC BB:SYBD)

Oxycyte

Perfluorocarbon-based blood substitute and therapeutic oxygen carrier

Blood substitute

Starting eight-patient pilot Phase II trial to evaluate safety and biological effects in patients with traumatic brain injury (8/22)

Vasogen Inc.
(Canada; VSGN)

Celacade

Immune-modulation therapy

Peripheral arterial disease

Phase III SIMPADICO trial ended early after monitors said efficacy was not being demonstrated (8/30)

ZymoGenetics
Inc.
(ZGEN)

rhThrombin

Recombinant human trhombin

For control of bleeding

Aggregate data from four Phase II trials showed the agent was safe and well tolerated, with a favorable immunogenicity profile (8/10)

CENTRAL NERVOUS SYSTEM

Altea
Therapeutics
Corp.*

--

Hydromorphone transdermal patch

Pain

Positive data were seen in Phase II dose-ranging study (8/30)

Axonyx
Inc.
(AXYX)

Posiphen

Positive isomer of Phenserine , an inhibitor of acetylcholin

Alzheimer's disease

Began Phase I trial to evaluate the product in healthy volunteers (8/1)

Cephalon
Inc.
(CEPH)

Provigil (FDA-approved)

Modafinil tablets

Excessive sleepiness

Pivotal Phase III trial in patients with shift-work sleep disorder demonstrated improvements vs. placebo on several measures (8/3)

DOV
Pharmaceutical
Inc.
(DOVP)

Ocinaplon

Agent that modulates a subset of GABA-A receptors

Anxiety

Suspended further dosing in ongoing Phase III trial due to liver enzyme elevations seen in one patient in the trial (8/25)

DOV
Pharmaceuticals
Inc.
(DOVP)

Bicifadine

Serotonin and norepinephrine reuptake inhibitor

Post-operative pain

Began Phase III trial to assess efficacy in 200 patients following vaginal hysterectomy (8/4)

Endo
Pharmaceuticals
Inc.
(ENDP)

Oxymorphone ER

Extended-release formulation of oxymorphone

Pain

Phase III trial to support existing NDA demonstrated statistically significant differences in pain scores vs. placebo in 205 patients with moderate to severe chronic low-back pain (8/22)

Predix
Pharmaceuticals
Inc.*

PRX-00023

5-HT1A agonist

Generalized anxiety disorder

Began pivotal Phase III trial to evaluate efficacy vs. placebo in up to 310 patients with moderate to severe GA (8/15)

Neurobiological
Technologies
Inc.
(NTII)

Xerecept

Synthetic mimic of the corticotropin- releasing factor hormone

Peritumoral brain edema

Began open-label, extended-use study open to brain cancer patients who were in the Phase III trial (8/25)

Renovis Inc.
(RNVS)

REN-1654

Oral TNF-alpha release inhibitor

Sciatica

Phase II trial showed a positive trend but did not reach statistical significance in pain relief (8/25)

TorreyPines
Therapeutics
Inc.*

NGX267

Muscarinic (M1) receptor agonist

Alzheimer's disease

Began Phase I trial to assess tolerability, safety and pharmacokinetics in 55 healthy volunteers (8/8)

XenoPort
Inc.
(XNPT)

XP13512

Transported prodrug of gabapentin (Pfizer Inc.'s Neurontin)

Restless legs syndrome

Phase IIb trial in 95 patients showed statistical significance at one dose level (8/2)

DIABETES

Amylin
Pharmaceuticals
Inc.
(AMLN) and
Alkermes Inc.
(ALKS)

Exenatide (Byetta)

Long-acting form of the FDA-approved incretin mimetic

Type II diabetes

Phase II trial in 45 patients showed drug was well tolerated after 15 weeks; improvements in hemoglobin A1C and weight were seen (8/22)

INFECTION

Anadys
Pharmaceuticals
Inc.
(ANDS)

Isatoribine (ANA245)

Agent designed to regulate innate immunity by interacting with Toll-like receptor 7

Hepatitis C

Phase Ib trial in 32 patients demonstrated a statistically significant antiviral effect with relatively few and mild side effects (8/23)

Emergent
BioSolutions
Inc.*

--

Single-dose oral typhoid vaccine

Typhoid fever

Phase II trial in 32 healthy volunteers showed new dosing regimen was well tolerated and highly immunogenic (8/30)

Gilead Sciences
Inc.
(GILD) and
Achillion
Pharmaceuticals
Inc.*

GS 9132 (ACH-806)

Small-molecule inhibitor of hepatitis C virus replication

Hepatitis C

Began Phase I trial to evaluate pharmacokinetics, tolerability and safety in 20 healthy volunteers (8/15)

Gilead
Sciences Inc.
(GILD)

Truvada and Sustiva (both FDA- approved)

Fixed-dose combination of Gilead and Bristol- Myers Squibb Inc.'s HIV drugs

HIV

Second formulation of the combination did not demonstrate bio- equivalence to the individual products dosed separately (8/9)

Migenix Inc.
(Canada;
TSE:MGI)
and Cadence
Pharmaceuticals
Inc.*

MX-226 (CPI-226)

Omiganan pentahydro-
chloride; a topical antibiotic

Catheter-related infections

Began Phase III trial under FDA SPA to evaluate efficacy vs. povidone-iodine in 1,250 hospitalized patients with central venous catheters (8/30)

Panacos
Pharmaceuticals
Inc.
(PANC)

PA-457

Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein

HIV

Phase IIa trial in 32 patients met its primary endpoint with a statistically significant decrease in viral load vs. placebo (8/22)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Tarvacin

Chimeric monoclonal antibody that binds to the phospholipid phospha- tidylserine

Hepatitis C

Began Phase I trial to evaluate safety, pharmacokinetics and viral load in up to 32 nonresponding patients (8/8)

PharmAthene
Inc.*
and
Medarex Inc.
(MEDX)

Valortim (MDX-1303)

Fully human monoclonal antibody targeting the Bacillus anthracis protective antigen

Anthrax infection

Starting a Phase I trial to evaluate safety and pharmacokinetics in 46 healthy volunteers (8/8)

MISCELLANEOUS

Advanced
Magnetics Inc.
(AMEX:AVM)

Ferumoxytol

Intravenously administered bioavailable iron

Iron replacement in anemic chronic kidney disease

Revising trial to include more patients and redesigning the hemodialysis protocol currently under way (8/11)

Arena
Pharmaceuticals
Inc.
(ARNA)

APD356

Small-molecule, selective 5HT2C serotonin receptor agonist

Obesity

Follow-up from Phase IIa trial indicate no apparent drug effect on heart valves or pulmonary artery pressure (8/25)

Auxilium
Pharmaceuticals
Inc.
(AUXL)

--

Product using Transmucosal Film Technology to deliver testosterone

Hypogonadism

Phase II trial in 69 men showed tolerability and increased serum testosterone levels (8/1)

CollaGenex
Pharmaceuticals
Inc.
(CGPI)

COL-3

Second-generation agent from program in inhibition of multiple proteases and cytokines

Rosacea

Phase II trial in 14 patients showed reduced inflammatory lesion count vs. placebo (8/2)

Connetics
Corp.
(CNCT)

Desilux

Desonide; low-potency topical steroid in emollient foam delivery vehicle

Atopic dermatitis

Phase III trial in 581 patients demonstrated statistically significant treatment effect vs. placebo (8/15)

Intercytex
Ltd.*
(UK)

ICX-PRO

Topical product containing allogeneic, human dermal fibroblasts

Wound healing

Reported succcessful completion of Phase IIb trial and start of Phase III trial in 200 patients with venous leg ulcers who haven't responded to conventional therapy (8/8)

Isolagen Inc.
(AMEX:ILE)

Isolagen Process

Autologous cellular therapy

Contour deformities

Phase III trials in 100 patients each met three of the four primary endpoints, and together achieved statistical significance (8/1)

NPS
Pharmaceuticals
Inc.
(NPSP)

Teduglutide

Analogue of the hormone glucagon-like peptide-2

Short bowel syndrome

Phase II trial in 16 patients showed significant growth of the intestinal lining and improved dietary absorption of nutrients and fluids (8/18)

NPS
Pharmaceuticals
Inc.
(NPSP)

Preos

Recombinant human parathyroid hormone

Osteoporosis

Two-year data showed bone mineral density gains in postmenopausal women were maintained or improved with use of alendronate after PTH (8/10)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational agent for BPH

Benign prostatic hyperplasia

Interim analysis of Phase II trial revealed no serious drug side effects (8/4)

Palatin
Technologies
Inc.
(AMEX:PTN)
and King
Pharmaceuticals

PT-141

Intranasally delivered melanocortin agonist

Erectile dysfunction

Began Phase IIb trial in 560 patients to gather data for use in pivotal Phase III trials (8/3)

Progenics
Pharmaceuticals
Inc.
(PGNX)

MNTX

Methylnaltrexone; agent designed to block peripheral opioid receptors

Opioid-induced constipation

Reported additional positive data from previously reported Phase III trial; primary and secondary end- points were met (8/22)

Rigel
Pharmaceuticals
Inc.
(RIGL)

R112

Intranasal agent designed to interrupt the signal from the IgE receptor

Allergic rhinitis

Began Phase II trial comparing drug to placebo and Beconase AQ in 375 patients (8/9)


Notes:

* Privately held.

BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment.

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

AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.

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