Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Abbott Laboratories

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Rheumatoid arthritis

Presented new data from ReAct trial in Europe that reaffirmed safety and efficacy data seen in pivotal trials (6/10)

Biogen Idec Inc. (BIIB)

Amevive (FDA-approved)

Alefacept; targets the CD45RO+ subset of T cells

Plaque psoriasis

Gained approval in Australia for treating moderate to severe disease (6/17)

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

Antegren (natalizumab)

Humanized monoclonal antibody; alpha-4 antagon- ist in the selective adhesion molecule inhibitor class

Multiple sclerosis

Filed for approval with the European Medicines Agency with one- year data from ongoing Phase III trials; BLA filing was in May (6/4)

Centocor Inc. (unit of J& J) and Schering- Plough Corp.

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Rheumatoid arthritis

Approved in European Union as first-line treatment of early RA in combination with methotrexate (6/21)

Genelabs Technologies Inc. (GNLB)

Anastar (Prestara in the U.S.)

Prasterone; synthetic equivalent of dehydro- epiandrosterone

Lupus

Withdrew marketing application in Europe following word from regulators that drug was not approvable (6/7)

GW Pharmaceuticals plc* (UK; OTC BB: GWPRF)

Sativex

Spray formulation of cannabis extract

Spasticity in multiple sclerosis

Phase III trial showed a statistically significant improvement in spasticity; patients took drug with existing medications (6/21)

Serono SA (Switzerland; NYSE:SRA)

Raptiva (FDA- approved)

Efalizumab; humanized antibody designed to block T cells implicated in psoriasis

Psoriasis

European committee recommended approval in patients who failed other therapies; the drug is sold in the U.S. by Genentech Inc. (6/24)

CANCER

Allos Therapeutics Inc. (ALTH)

RSR13 (efaproxiral)

Small molecule designed to sensitize hypoxic areas of tumors prior to radiation

Brain metastases

Filed for approval with the European Medicines Agency as an adjunct to whole-brain radiation in metastases from breast cancer (6/4)

Aphton Corp. (APHT)

G17DT

Immunotherapy vaccine designed to induce antibodies to both gastrin 17 and glygastrin 17

Advanced pancreatic cancer

Began regulatory submission in Switzerland as a monotherapy in patients who can't or won't take chemotherapy (6/10)

Ark Therapeutics Group plc (UK; LSE:AKT)

Cerepro

Adenoviral-mediated gene medicine designed to induce thymidine kinase expression

Advanced gliomas

Study 903 in 36 patients demonstrated a statistically significant mean survival benefit (6/7)

Atrix Laboratories Inc. (ATRX)

Eligard (FDA-approved)

Leuprolide acetate for injectable suspension

Prostate cancer

Atrix licensee Tecnofarma International Ltd. gained marketing authorization in Mexico for two formulations of the drug (6/1)

CuraGen Corp. (CRGN) and TopoTarget A/S* (Denmark)

PXD101

Histone deacetylase inhibitor

Hematological cancers

Began Phase I trial in Denmark to evaluate safety and potential activity in 15 patients (6/30)

ImClone Systems Inc. (IMCL)

Erbitux (FDA-approved)

Cetuximab; antibody that blocks the epidermal growth factor receptor

Metastatic colorectal cancer

Partner Merck KGaA gained approval in Europe to treat EGFR-expressing cancers in combination with irinotecan after an irinotecan- based treatment failure (6/30)

Mologen AG* (Germany)

MIDGE-Th1 and dSLIM

MIDGE vector with coupled peptide and immunomodulating DNA construct

Cancers

Presented data on the two DNA- based vaccine technologies that showed positive early data on safety activity (6/11)

Onyvax Ltd.* (UK)

Onyvax-P

Immunotherapy

Prostate cancer

Phase II trial showed encouraging progression-free survival in 26 men with advanced disease (6/17)

Pharmion Corp. (PHRM)

Thalidomide Pharmion

Thalidomide; modulates levels of tumor necrosis factor-alpha

Multiple myeloma

Approved in Turkey for treating refractory disease, and for treating a severe complication of leprosy (6/3)

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

TheraCIM hR3

Humanized anti-epidermal growth factor receptor monoclonal antibody

Pediatric glioma

Began Phase I/II trial that initially will include 18 patients and be expanded to 47 patients also treated with radiation, if early data are positive (6/15)

CARDIOVASCULAR

Ark Therapeutics Group plc (UK; LSE:AKT)

Trinam

VEGF gene in an adenoviral vector delivered with Ark's biodegradable collagen collar

Prevention of blood-vessel blockage

The product gained orphan desigation in Europe to prevent block- age following vascular graft access surgery (6/17)

The Medicines Co. (MDCO)

Angiox (Angiomax; FDA-approved)

Direct thrombin inhibitor

Anticoagulant

European committee recommended approval in patients under- going percutaneous coronary interventions (6/24)

CENTRAL NERVOUS SYSTEM

Neuro3d* (France)

ND1251

Orally active phosphodiesterase-4 inhibitor

Depression

Began Phase I trial to assess safety, tolerability, pharmacokinetics and activity in the brain (6/1)

Sirenade Pharmaceuticals AG* (Germany)

SRN-001

Formulation of the dopamine agonist dihydroergocryptin (DHEC)

CNS disorders

Began a Phase I trial (6/14)

INFECTION

Arrow Therapeutics* (UK)

--

Small-molecule antiviral

Respiratory syncytial virus

Phase I trial in the UK demonstrated safety, tolerability and pharmacokinetics (6/28)

Dynavax Technologies Corp. (DVAX)

--

Prophylactic vaccine based on immunostimulatory sequences

Hepatitis B

Began Phase II/III trial in Singapore comparing vaccine to Engerix B in 80 subjects (6/22)

Immtech International Inc. (AMEX:IMM)

DB289

Oral, dicationic antiviral agent

Pneumocystis carinii pneumonia

Phase II trial involving AIDS patients in Peru demonstrated safety and efficacy of 50-mg dose (6/24)

Nabi Bio- pharmaceuticals (NABI)

Nabi-HB (FDA-approved)

Hepatitis B immune globulin; intravenous solution of human antibodies

Hepatitis B

Filed for approval in Europe under the trade name Hebig for preventing hepatitis B in HBV-positive liver transplant patients (6/24)

The Immune Response Corp. (IMNR)

IR103

Combination of HIV-1 Immunogen and Amplivax, an immunostimulatory oligonucleotide adjuvant

HIV

Began trial in Canada that will be followed by sites in the UK; they are the first human studies of the product (6/15)

Tripep AB (Sweden; SSE:TPEP)

MetaboliteX (alphaHGA)

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

HIV

Began microdosing study in the UK on non-infected volunteers (6/2)

MISCELLANEOUS

Bioniche Life Sciences Inc. (Canada; TSE:BNC)

Suplasyn

Sodium hyaluronate solution

Osteoarthritis of the knee

Pharmacoeconomic study in 310 patients in France demonstrated a significant reduction in pain (6/14)

NicOx SA (France; Nouveau Marche:NICOX)

HCT 3012 (formerly AZD3582)

Nitric oxide-releasing compound from company's CINOD class

Osteoarthritis

Data from Phase II OASIS trial showed pain relief equivalent to rofecoxib at six weeks (6/10)

Zonagen Inc.* (ZONA)

Progenta

Agent designed to block progesterone without blocking adrenal hormones

Uterine fibroids

Began Phase I/II trial in Poland to test the product in 30 women with uterine fibroids (6/29)


Notes:

* Privately held.

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

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange.

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