Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Acorda
Therapeutics
Inc.
(ACOR)

Fampridine-SR

Selective neuronal potassium channel blocker

Multiple sclerosis

Phase III trial run under FDA SPA demonstrated statistical significance on all three efficacy criteria, which related to walking capabilities (9/25)

Alba
Therapeutics
Corp.*

AT-1001

Oral zonulin receptor antagonist

Celiac disease

Began Phase II trial to evaluate safety, tolerability and efficacy in 79 patients during gluten challenge (9/21)

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

Phase III AFFIRM trial demonstrated monotherapy treatment significantly reduced the proportion of patients with worsening cognitive function (9/28)

Genzyme
Corp.
(GENZ)

Campath (FDA-approved)

Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces

Multiple sclerosis

Interim two-year data from Phase II trial showed favorable results vs. Rebif; Campath treatment in the study remained on hold while adverse events were investigated (9/14)

Immunomedics
Inc.
(IMMU)

Epratuzumab

Humanized anti-CD20 monoclonal antibody

Lupus

Partner UCB SA suspended dosing in Phase II trial due to a concern in the manufacturing process; the FDA placed a clinical hold on the study (9/26)

Opexa
Therapeutics
Inc.
(OPXA)

Tovaxin

Trivalent formulation of attenuated myelin-peptide reactive T cells

Multiple sclerosis

Phase I/II trial showed a relapse rate reduction of more than 90% after 12 months; is starting Phase IIb trial in 150 patients (9/18)

Rigel
Pharmaceuticals
Inc.
(RIGL)

R788

Oral syk kinase inhibitor

Rheumatoid arthritis

Began Phase II trial to evaluate responses in 180 patients who have active disease despite taking methotrexate (9/6)

Trubion
Pharmaceuticals
Inc.*

TRU-015

Immunotherapeutic agent

Rheumatoid arthritis

Began Phase IIb trial to evaluate safety and efficacy of a single infusion in 280 patients (9/27)

CANCER

AmpliMed
Corp.*

Amplimexon

Imexon injection; a cyanoaziridine compound

Advanced malignant melanoma

Data from 27 patients in Phase I/II trial of drug with dacarbazine showed five partial responses and seven patients with stable disease (9/14)

Antisoma plc
(UK; LSE:ASM)

AS1404

Small molecule derived from xanthenone acetic acid; vascular disrupting agent

Hormone- refractory prostate cancer

Data from 64 patients in Phase II trial showed a PSA response rate of 57% for drug plus docetaxel vs. 35% for docetaxel alone; also, disease progression by PSA was 17% in drug group vs. 29% with docetaxel alone (9/18)

Biothera*

Imprime PGG

Injectable beta 1,3/1,6 glucan derived from yeast; immunotherapy

Cancers

Phase I trial in healthy volunteers demonstrated safety and tolerability over three doses (9/25)

ChemGenex
Pharmaceuticals
Ltd.
(Australia;
CXSP)

Ceflatonin

sHHT; homoharringtonine; apoptosis inducer

Chronic myeloid leukemia

Began Phase II/III trial to evaluate response rates in up to 81 patients who have the T315I bcr-abl point mutation (9/20)

Cytogen
Corp.
(CYTO)

Quadramet (FDA-approved)

Samarium-153 bound to a small-molecule, bone- seeking phosphonate

Bone metastases from prostate cancer

Study in 13 patients demonstrated improved pain intensity on movement (9/19)

EntreMed
Inc.
(ENMD)

MKC-1

Small-molecule cell-cycle inhibitor

Advanced leukemias

Began a Phase I trial in that indication (9/26)

EntreMed
Inc.
(ENMD)

Panzem NCD

2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen

Hormone-
refractory
prostate cancer

Began Phase II trial to evaluate antitumor activity, safety and pharmacokinetics in patients (9/12)

Gemin X
Biotechnologies
Inc.*
(Canada)

GX15-070

Small-molecule inhibitor of bcl-2 proteins

Hodgkin's lymphoma

Began single-agent Phase II trial to evaluate efficacy, safety and pharmacokinetics in 10 to 29 patients (9/14)

Gemin X
Biotechnologies
Inc.*
(Canada)

GX15-070

Small-molecule inhibitor of bcl-2 proteins

Myelofibrosis with myeloid metaplasia

Began single-agent Phase II trial to evaluate efficacy, safety and pharmacokinetics in 19 to 55 patients (9/14)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced melanoma

Long-term follow-up data from Phase III trial in 771 patients showed benefit of drug with dacarbazine in all endpoints vs. dacarbazine alone (9/15)

Genzyme
Corp.
(GENZ)

Clolar (FDA-approved)

Clofarabine; second- generation purine nucleoside analogue

Acute myelogenous leukemia

Began pivotal Phase III trial to evaluate safety and efficacy with cytarabine in up to 376 patients 60 years old and older (9/6)

Gloucester
Pharmaceuticals
Inc.*

Depsipeptide (FK228)

Romidepsin; histone deacetylase inhibitor

Pancreatic cancer and other tumors

Began open-label Phase I/II trial to evaluate dosing with gemcitabine in 30 patients (9/12)

GPC Biotech
AG
(Germany;
GPCB), Pharmion
Corp.
(PHRM)
and Spectrum
Pharmaceuticals
Inc.
(SPPI)

Satraplatin

Oral platinum compound

Hormone- refractory prostatecancer

Pivotal Phase III SPARC trial in 950 second-line patients demonstrated statistical significance vs. placebo on progression-free survival; agent and placebo were tested with prednisone (9/24)

GTx Inc.
(GTXI)

Acapodene

Toremifene citrate; small- molecule non-steroidal selective estrogen receptor modulator

Prostate cancer

Monitors reviewing safety data recommended two pivotal Phase III trials continue as planned (9/5)

Innovive
Pharmaceuticals
Inc.*

INNO-105

Naturally occurring peptide that interacts with the OGFr receptor

Advanced solid tumors

Discontinued development after Phase I trial showed drug did not achieve desired plasma levels without producing adverse side effects (9/29)

Maxygen Inc.
(MAXY)

Maxy-G34

Pegylated form of granulocyte-colony stimulating factor

Chemotherapy-
induced neutropenia

Began Phase I trial to evaluate safety, tolerability and pharmaco- kinetics in healthy volunteers (9/5)

MethylGene
Inc.
(Canada;
TSX:MYG) and
Pharmion

Corp.
(PHRM)

MGCD0103

Histone deacetylase inhibitor

Advanced B-cell lymphomas

Began Phase II single-agent trial to evaluate efficacy and other endpoints in up to 82 patients (9/15)

Myriad
Genetics Inc.
(MYGN) and
EpiCept Corp.
(EPCT)

Azixa

Inducer of apoptosis

Cancer that metastasized to the brain

Phase I trial established the maximum tolerated dose; evidence of activity also was seen (9/25)

NeoPharm
Inc.
(NEOL)

IL13-PE38QQR

Cintredekin besudotox; agent designed to deliver bacterial cytotoxic PE38

Recurrent glioblastoma multiforme

Follow-up data from Phase I/II trial continued to show evidence of prolonged overall survival (9/18)

Northwest
Biotherapeutics
Inc.
(OTC BB:NWBT)

DCVax-LB

Personalized vaccine made from a patient's dendritic cells

Non-small-cell lung cancer

Began Phase I trial to evaluate progression- ree and overall survival (9/7)

OSI
Pharmaceuticals
Inc.
(OSIP) and
Genentech
Inc.
(NYSE:DNA)

Tarceva (FDA-approved)

Erlotinib; small-molecule
HER1/EGFR inhibitor

Non-small-cell lung cancer

Began a Phase III trial to evaluate the drug as an adjuvant therapy after surgery in 945 patients, to assess effect on disease-free survival (9/21)

Oxford
BioMedica plc
(UK; LSE:OXB)

TroVax

Immunotherapy vaccine that delivers an antigen (5T4) using a poxvirus vector

Advanced breast cancer

Is starting a Phase II open-label trial that will evaluate responses and survival in 160 patients (9/5)

Rigel
Pharmaceuticals
Inc.
(RIGL) and
Serono SA
(Switzerland;
NYSE:SRA)

R763

Orally available, multi-Aurora kinase inhibitor

Refractory solid tumors

Serono began a Phase I trial in patients to evaluate safety and tolerability (9/19)

SciClone
Pharmaceuticals
Inc.
(SCLN)

Zadaxin

Synthetic preparation of thymosin alpha-1

Malignant melanoma

Interim trial data showed drug with dacarbazine doubled the overall tumor response vs. the control group (9/18)

Sonus
Pharmaceuticals
Inc.
(SNUS)

Tocosol Camptothecin

Camptothecin-based agent formulated with vitamin E-based technology

Advanced solid tumors

Began Phase I trial to evaluate safety and antitumor effects in up to 61 patients (9/28)

Synta
Pharmaceuticals
Corp.*

STA-4783

Heat shock protein 70
inducer

Metastatic melanoma

Phase IIb trial in 81 patients doubled progression-free survival vs. paclitaxel alone (9/11)

VioQuest
Pharmaceuticals
Inc.
(OTC BB:VQPH)

VQD-001

Sodium stibogluconate; inhibitor of protein tyrosine phosphatases

Advanced solid tumors

Began Phase I/II trial to evaluate safety, tolerability and pharmaco-kinetics with interferon alpha-2b in patients (9/26)

VioQuest
Pharmaceuticals
Inc.
(OTC BB:VQPH)

VQD-002

Triciribine-phosphate; targeted tricyclic nucleoside

Leukemia

Began Phase I/IIa trial of the product in that indication (9/12)

CARDIOVASCULAR

Affymax Inc.*

Hematide

Synthetic, peptide-based erythropoiesis-stimulating agent

Anemia

Phase I trial showed increases in circulating reticulocytes and statistically significant increases in red blood cells (9/15)

Alexion
Pharmaceuticals
Inc.
(ALXN)

Soliris (eculizumab)

Humanized monoclonal antibody designed to block complement protein C5

Paroxysmal nocturnal hemoglobinuria

Phase III TRIUMPH trial in 87 patients demonstrated significantly reduced symptoms vs. placebo (9/20)

Arena
Pharmaceuticals
Inc.
(ARNA) and
Merck & Co. Inc.

MK-0354

Niacin receptor agonist; designed to regulate plasma lipid levels

Atherosclerosis

Merck ended development in that indication following Phase II trial in patients with dyslipidemia (9/25)

Cardiome
Pharma Corp.
(Canada; CRME)

RSD1235

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

Atrial fibrillation

61% of drug patients in Phase IIa trial completed the study in normal heart rhythm vs. 43% for the placebo; it was statistically significant for one of the two doses (9/13)

Cerus Corp.
(CERS)

Intercept Blood System

Pathogen-inactivation system for red blood cells that uses the compound S-303

For use in blood transfusions

Began Phase I trial to evaluate red blood cell recovery post-transfusion vs. untreated cells in 28 patients (9/12)

Critical
Therapeutics
Inc.
(CRTX)

CTI-01

Ethyl pyruvate; small molecule believed to inhibit release of cytokines

Complications of cardiac surgery

Phase II data from 102 patients treated before trial was stopped due to a manufacturing issue showed no positive trends in efficacy vs. placebo (9/15)

Cytokinetics
Inc.
(CYTK)

CK-1827452

Cardiac myosin activator; intravenous formulation

Heart failure

Phase I trial in healthy volunteers established a maximum dose and showed improvements in heart function (9/13)

EPIX
Pharmaceuticals
Inc.
(EPIX)

PRX-00023

Long-acting 5-HT1A agonist

Generalized anxiety disorder

Phase III trial failed to demonstrate statistically significant improvement vs. placebo in the primary endpoint; it did show benefit in secondary endpoint related to depression (9/21)

Genmab A/S
(Denmark;
CSE:GEN)

HuMax-EGFr

Zalutumumab; human antibody that targets the epidermal growth factor receptor

Refractory head and neck cancer

Began pivotal Phase III trial to evaluate efficacy with best supportive care against that care alone in up to 273 patients (9/14)

Icagen Inc.
(ICGN)

ICA-17043

Small-molecule ion channel inhibitor

Sickle cell disease

Monitors recommended continuation of Phase III ASSERT trial for patients on concurrent hydroxyurea therapy; they earlier said treatment should stop in those not on hydroxyurea (9/12)

Myogen Inc.
(MYOG)

Ambrisentan

Ora lendothelin receptor antagonist

Pulmonary hypertension

Began open-label Phase III ARIES-3 trial to evaluate effect on exercise capacity in 200 patients from a range of PH subgroups (9/7)

NitroMed Inc.
(NTMD)

BiDil (FDA-approved)

Nitric oxide-enhancing oral agent; combination of isosorbide dinitrate and hydralazine

Heart failure in African-Americans

Presented various positive data on efficacy, safety, tolerability, compliance and survival (9/11)

Nuvelo Inc.
(NUVO)

rNAPc2

Recombinant nematode anticoagulant protein

Acute coronary syndromes

Phase II trial showed higher dose reduced ischemia by more than 50% (9/6)

Pervasis
Therapeutics
Inc.*

Vascugel

Cell therapy product that enables implantation of allogeneic endothelial cells

Vascular injury

Began Phase I trials to evaluate safety and feasibility in maintenance of vascular patency after creation of arteriovenous (AV) access graft and AV fistula (9/27)

QuatRx
Pharmaceuticals
Co.*

QRX-431

Selective thyroid beta agonist

High cholesterol/ obesity

Began Phase I trial to evaluate the drug candidate (9/28)

Vasogen Inc.
(Canada; VSGN)

Celacade

Immune-modulation therapy; delivers oxidative stress to a patient's cells

Advanced chronic heart failure

New data from Phase III ACCLAIM trial showed statistical significance was reached in a large patient subset; overall, efficacy was not reached (9/5); new data showed a reduction in hospitalization days (9/13)

ZymoGenetics
Inc.
(ZGEN)

rhThrombin

Recombinant human thrombin

Controlling blood loss during surgery

Phase III trial vs. bovine thrombin met its primary endpoint of comparable hemostasis; also, antibody formation was lower in drug group (9/5)

CENTRAL NERVOUS SYSTEM

Alexza
Pharmaceuticals
Inc.
(ALXA)

AZ-004

Inhalation formulation of the antipsychotic drug loxapine

Agitation in schizophrenic patients

Began Phase IIa trial to evaluate safety and efficacy vs. placebo in 120 patients (9/22)

Corcept
Therapeutics
Inc.
(CORT)

Corlux

Mifepristone; oral GR-II antagonist with potential mitigating effects on cortisol

Psychotic major depression

Study 09, the second of three Phase III trials in treating the psychotic features of PMD, showed no meaningful improvement vs. placebo; secondary endpoints also were not met (9/29)

CytRx Corp.
(CYTR)

Arimoclomol

Small molecule designed to provide cellular protection by activating molecular chaperone proteins

Amyotrophic lateral sclerosis

Phase IIa trial in 84 patients demonstrated safety and tolerability; no improvement was seen on disease progression (9/26)

Evotec AG
(Germany;
FSE:EVT)

EVT 201

Partial positive allosteric modulator of the GABA-A receptor complex

Insomnia

Began Phase II trial to evaluate efficacy vs. placebo in 66 patients (9/21)

Evotec AG
(Germany;
FSE:EVT)

EVT 301

Oral, selective and reversible inhibitor of monoamine oxidase B

Alzheimer's disease

Development was ended when abnormal liver data were seen in healthy volunteers participating in a safety study (9/13)

Javelin
Pharmaceuticals
Inc.
(AMEX:JAV)

Dyloject

Diclofenac injection; nonsteroidal anti- inflammatory agent

Pain

Final Phase IIb data showed drug met primary endpoint of pain relief over six hours; all five doses showed statistical significance vs. placebo (9/14)

Jazz
Pharmaceuticals
Inc.*

Xyrem (FDA-approved)

Sodium oxybate oral solution

Fibromyalgia syndrome

Began a Phase III trial to evaluate safety and efficacy vs. placebo (9/7)

MAP
Pharmaceuticals
Inc.*

MAP0004

Formulation of dihydro- ergotamine mesylate delivered with MAP's inhaler

Migraine

Began Phase II trial to evaluate pain relief and other endpoints in 100 patients (9/5)

Medivation
Inc.
(AMEX:MDV)

Dimebon

Neuroprotectant agent that's been on the market in Russia since 1983

Huntington's disease

Is starting a Phase I/IIa trial to evaluate safety, tolerability and preliminary efficacy (9/28)

Memory
Pharmaceuticals
Corp.
(MEMY)

MEM 1003

Neuronal L-type calcium channel modulator

Acute mania in bipolar disorder

Began Phase IIa trial to evaluate safety and efficacy vs. placebo in 60 patients (9/5)

NeurogesX
Inc.*

Transacin (NGX-4010)

High-concentration trans- capsaicin dermal patch

HIV-associated neuropathy

Open-label extension study showed reductions in pain over the entire 52-week study period (9/6)

NovaDel
Pharma Inc.
(AMEX:NVD)

--

Spray formulation of sumatriptan

Migraine

Pilot study demonstrated a statistically significant faster rate of absorption than Imitrex tablets (9/28)

Pozen Inc.
(POZN) and
GlaxoSmithKline
plc (UK)

Trexima

Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen

Migraine

Presented various positive data from several studies, including consistent efficacy over multiple migraine attacks (9/20)

DIABETES

Amylin
Pharmaceuticals
Inc.
(AMLN)

Symlin
(FDA-approved)

Pramlintide acetate; an
analogue of human amylin

Type II diabetes

211-patient trial showed benefit of adding drug to basal insulin regimen in those failing to meet glucose targets (9/7)

MannKind
Corp.
(MNKD)

Technosphere Insulin

Dry-powder formulation of insulin delivered by company's inhaler

Type II diabetes

Phase III trial showed comparable improvements in glycemic control when compared to injected insulin aspart (NovoLog) (9/18)

Nastech
Pharmaceutical
Co. Inc.
(NSTK)

--

Rapidly acting intranasal insulin formulation

Diabetes

Began a Phase I trial to evaluate safety, bioavailability and glucose response vs. approved agents (9/19)

INFECTION

Acambis plc
(UK; ACAM)

ChimeriVax- West Nile

Vaccine against West Nile virus

West Nile virus

First part of Phase II trial showed a seroconversion rate of 97% in the 112 healthy adults participating (9/12)

Advanced Life
Sciences
Holdings Inc.
(ADLS)

Cethromycin

Second-generation ketolide antibiotic agent

Infections

Presented positive efficacy and safety data from Phase II and III trials in community- acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and anthrax infection (9/29)

AlphaVax
Inc.*

AVX101

Vaccine incorporating the HIV gag gene

Prevention of HIV infection

Preliminary Phase I data showed antibody responses to the HIV gag antigen in all those receiving the highest dose; vaccine was safe and well tolerated (9/6)

BioCryst
Pharmaceuticals
Inc.
(BCRX)

Peramivir

Influenza neuraminidase inhibitor

Influenza

Phase I trials in 79 healthy volunteers demonstrated tolerability, and safety at high doses (9/29)

Bioenvision
Inc.
(BIVN)

Suvus

Agent designed to prevent replication of DNA and RNA in pathogens

Hepatitis C

Phase II trial in chronic patients with HCV genotype 4a infection demonstrated reductions in viral load (9/8)

Caprion
Pharmaceuticals
Inc.*
(Canada)

Shigamabs

Intravenous agent consisting of the monoclonal antibodies caStx1 and caStx2

Shigatoxin- producing E. coli infections

Phase I trial in 40 healthy volunteers demonstrated safety and tolerability (9/19)

Elusys
Therapeutics
Inc.*

Anthim (ETI-204)

Monoclonal antibody that targets the protective antigen component of anthrax

Anthrax infection

Phase I trial demonstrated safety and tolerability, and a mean half-life of 16 days (9/28)

Human Genome
Sciences Inc.
(HGSI)

HGS004

Fully human monoclonal antibody that binds the chemokine receptor CCR5

HIV

Phase I trial demonstrated tolerability, as well as antiviral activity, in patients (9/29)

Iomai Corp.
(IOMI)

--

Needle-free, patch-based influenza vaccine

Influenza

Is starting a Phase I trial that will compare the product to the traditional vaccine in 300 patients (9/11)

Medarex Inc.
(MEDX)

CDA-1 (MDX-066) and MDX-1388

Fully human monoclonal antibodies against C. difficile Toxin A and Toxin B, respectively

C. difficile- associated diarrhea

Began Phase II trial to evaluate the efficacy of the combination vs. placebo in up to 200 patients (9/6)

Novelos
Therapeutics
Inc.
(OTC BB:NVLT)

NOV-205

Hepatoprotective agent with immunomodulating and anti-inflammatory properties

Hepatitis C

Began Phase Ib monotherapy trial in 30 chronic patients who have failed treatment with pegylated interferon plus ribavirin (9/28)

Nventa Bio-
pharmaceuticals
Corp.
(TSX:NVN)

HspE7

Therapeutic vaccine against the human papillomavirus

HPV-related diseases

81% of 27 patients with genital warts in Phase II trial had complete or partial responses (9/7)

Protherics plc
(UK; LSE:PTI)

CytoFab

Anti-TNF-alpha polyclonal antibody fragment

Sepsis

Full data from Phase IIb trial in 81 patients showed TNF-a neutralization and efficacy trends (9/5)

SciClone
Pharmaceuticals
Inc.
(SCLN)

SCV-07

Oral form of synthetic dipeptide; immuno- modulatory agent

Viral infections

Phase I trial demonstrated oral availability (9/15)

Sequella Inc.*

SQ109

Orally active diamine antibiotic

Tuberculosis

Began Phase I trial to evaluate safety and pharmacokinetics in 48 healthy volunteers (9/12)

Vertex
Pharmaceuticals
Inc.
(VRTX) and
plc (UK)

Lexiva (FDA-approved)

Telzir; fosamprenavir calcium; protease inhibitor

HIV

48-week trial in treatment-naive patients demonstrated low rates of virologic failure and drug GlaxoSmithKline resistance (9/28)

ViroPharma
Inc.
(VPHM)

Maribavir

Benzimidazole compound; oral inhibitor of cytomegalovirus

Prevention of CMV infection in transplant patients

Began Phase III trial to evaluate prophylactic benefit in 500 patients who have undergone allogeneic stem cell transplantation (9/28)

MISCELLANEOUS

Aastrom
Biosciences
Inc.
(ASTM)

Tissue Repair Cells

Autologous bone marrow- derived adult stem and progenitor cells

Long bone non-union fractures

One-year data from 12 patients in Phase I/II trial showed 10 of them had bone bridging at the fracture site (9/15)

Acuity
Pharmaceuticals
Inc.*

Bevasiranib (Cand5)

Small interfering RNA therapeutic designed to shut down VEGF

Wet age-related macular degeneration

Phase II CARE trial in 129 patients demonstrated safety, tolerability and biological effects (9/11)

Adolor Corp.
(ADLR) and
GlaxoSmithKline
plc (UK)

Entereg/Entrareg

Alvimopan capsules; muopioid antagonist

Opioid-induced bowel dysfunction

One Phase III trial met its primary endpoints, while another Phase III trial, as well as a Phase II trial, failed to demonstrate statistical significance (9/5)

Amgen Inc.
(AMGN)

Denosumab (AMG 162)

Fully human antibody targeting RANK Ligand, a mediator of osteoclasts

Bone loss

Post-hoc analysis of Phase II trial showed improvements in bone mineral density and in parameters of hip structural analysis (9/19)

Arena
Pharmaceuticals
Inc.
(ARNA)

Lorcaserin hydrochloride

Oral, selective stimulator of the 5-HT2C serotonin receptor

Obesity

Began first of three planned Phase III trials; the BLOOM study will evaluate safety and efficacy in 300 patients (9/12)

BioMimetic
Therapeutics
Inc.
(BMTI)

GEM 21S

Synthetic bone matrix combined with PDGF, a tissue growth factor

Periodontal disease and gingival recession

Follow-up data from pivotal trial showed a statistically significant increase in bone fill vs. treatment with the Beta-TCP matrix alone (9/18)

Dynogen
Pharmaceuticals
Inc.*

DDP733

Oral, serotonin type 3 receptor partial agonist

Gastroesophageal reflux disease

Began Phase Ib trial to evaluate safety; efficacy also will be studied (9/13)

Indevus
Pharmaceuticals
Inc.
(IDEV)

Pagoclone

Non-benzodiazepine, selective GABA-A receptor agonist

Premature ejaculation

Phase II trial was discontinued due to insufficient efficacy (9/26)

Jerini AG
(Germany;
FSE:JI4)

Icatibant

Bradykinin B2 receptor antagonist

Hereditary angioedema

Pivotal Phase III FAST-2 trial showed a significant reduction in the time to onset of symptom relief;
pivotal Phase III FAST-1 trial, how-
ever, failed to meet the primary
endpoint (9/21)

Kalypsys
Inc.*

KD3010

Small-molecule peroxi- some proliferator-activator receptor delta agonist

Metabolic disorders/ obesity

Began Phase Ia trial to evaluate safety, tolerability and pharmaco- kinetics in healthy volunteers (9/26)

MacuSight
Inc.*

--

Company's formulation of sirolimus (rapamycin)

Diabetic macular edema

Began Phase I trial to evaluate safety and tolerability of two types of ocular injections in 30 patients (9/26)

Neurocrine
Biosciences
Inc.
(NBIX)

NBI-56418

Small-molecule gonado- tropin- releasing hormone receptor antagonist

Endometriosis

Follow-on data from Phase II trial showed favorable safety and efficacy; Phase IIb trial is planned (9/12)

Nucryst
Pharmaceuticals
Corp.
(NCST)

NPI 32101

Topical cream formulation of nanocrystalline silver

Atopic dermatitis

Phase II trial in 409 patients failed to demonstrate significant difference in disease clearance vs. placebo (9/20)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational agent for BPH

Benign prostatic hyperplasia

Phase II trial in 175 patients demonstrated statistical significance vs. placebo in symptom scores (9/19)

Orexigen
Therapeutics
Inc.*

Contrave

Agent combining bupropion with one of several doses of naltrexone

Obesity

Data from 24-week Phase III trial showed significant advantages in weight loss vs. placebo, and it outperformed either naltrexone or bupropion given alone (9/26)

Ortec
International
Inc.
(OTC BB:
ORTN)

OrCel

Collagen sponge seeded with allogeneic epidermal and dermal cells

Venous leg ulcers

Confirmatory trial demonstrated statistically significant wound closure vs. placebo; a PMA filing was planned (9/12)

Progenics
Pharmaceuticals
Inc.
(PGNX)
and Wyeth

Methyl-
naltrexone

Intravenous mu opioid receptor antagonist

Postoperative ileus

Began first of two pivotal Phase III trials, to evaluate safety and efficacy in 500 patients who have undergone segmental colectomy surgery (9/20)

Tranzyme
Pharma Inc.*

TZP-101

Selective ghrelin receptor agonist

Gastroparesis

Began Phase I trial to evaluate the agent in diabetic patients suffering from gastroparesis (9/21)

Vivus Inc.
VVUS)

Alista

Topical formulation of alprostadil

Female sexual arousal disorder

Phase IIb trial in women who have undergone a hysterectomy did not show a statistically significant increase vs. placebo in satisfactory sexual events (9/29)

Zelos
Therapeutics
Inc.*
and
Nektar
Therapeutics
Inc.
(NKTR)

Ostabolin-C

Inhaled powder formulation of Zelos' parathyroid hormone

Osteoporosis

Began Phase I trial to evaluate safety, tolerability and pharma-cokinetics in up to 56 healthy postmenopausal women (9/21)


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