Company* (Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Avidex Ltd.* (UK)

RhuDex

Small-molecule, T-cell co-stimulation modulator

Rheumatoid arthritis

Successfully completed two Phase I trials studying safety, tolerability and pharmacokinetics in healthy volunteers (3/9)

BioMS Medical Corp. (Canada; TSE:MS)

MBP8298

Synthetic peptide

Multiple sclerosis

Follow-up data from Phase II trial showed drug delayed disease progression for five years in patients with HLA-DR2 or HLA-DR4 immune response genes (3/7)

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

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Rheumatoid arthritis and psoriatic arthritis

Australian officials revised the label to include treating early RA and approved a new indication for psoriatic arthritis (3/23)

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

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Ulcerative colitis

The product was approved in Europe for treating moderately to severely active UC in patients who inadequately respond to conventional therapy (3/9)

Enzo Biochem Inc. (NYSE:ENZ)

EGS21

Beta-D-glucosylceramide compound that acts on immune regulatory cells

Crohn's disease

Began a Phase II trial in Israel to evaluate the agent in Crohn's disease (3/14)

Isotechnika Inc. (Canada; TSE:ISA)

ISA247

Immunosuppressive agent

Psoriasis

48-week data from extension of Canadian Phase III SPIRIT trial showed drug continued to provide benefit (3/20)

Novogen Ltd. (Australia; NVGN)

NV-52

Synthetic analogue based on the phenolic structure of naturally occurring isoflavones

Inflammatory bowel disease

Phase I trial in six volunteers in Australia demonstrated the bio-availability of the agent (3/2)

TeGenero AG* (Germany)

TGN1412

Immunomodulatory, humanized agonistic anti-CD28 monoclonal antibody

Inflammatory diseases and cancers

Six volunteers in Phase I trial in the UK were hospitalized due to adverse events; testing was discontinued (3/15)

CANCER

Alizyme plc (UK; LSE:AZM)

ATL-104

Plant protein designed to stimulate the growth of cells that line the gastro-intestinal tract

Mucositis in cancer patients

Phase IIa trial in 64 patients in the UK demonstrated proof of concept (3/2)

EpiCept Corp. (EPCT)

Ceplene

Histamine dihydrochloride in combination with interleukin-2

Acute myeloid leukemia

Phase III trial in 320 patients met its primary endpoint of increased leukemia-free survival among AML patients in remission (3/31)

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

TheraCIM

Nimotuzumab; humanized anti-epidermal growth factor receptor monoclonal antibody

Brain stem glioma in children

Began Phase III trial in Germany to test drug with radiation therapy in 40 children with inoperable pontine glioma (3/28)

Onyx Pharmaceuticals Inc. (ONXX) and Bayer Pharmaceuticals Corp.

Nexavar (FDA-approved)

Sorafenib; RAF kinase and VEGF inhibitor

Advanced kidney cancer

The product was approved in Switzerland for use after nepherectomy and prior palliative or adjuvant therapy with cytokines (3/30)

CENTRAL NERVOUS SYSTEM

Corgentech Inc. (CGTK)

ALGRX 3268

Non-opioid, long-acting VR1 agonist

Pain

Phase II trial In Denmark in 41 patients who had undergone hernia surgery failed to show a significant difference vs. placebo (3/24)

D-Pharm Ltd.* (Israel)

DP-b99

Neuroprotective agent based on modulation of calcium, zinc, copper and iron homeostasis

Acute stroke

Monitors for Phase II trial in Germany and Israel recommended for the second time continuation of the study (3/7)

GW Pharmaceuticals plc (UK; LSE:GWP)

Sativex

Spray formulation of cannabis extract

Spasticity in multiple sclerosis patients

Phase III trial in 335 patients did not demonstrate statistical significance in all patients, but did for those who complied with the study protocol (3/17)

Inflazyme Pharmaceuticals Ltd. (Canada; TSE:IZP) and Helicon Therapeutics Inc.*

IPL455,903(HT-0712)

Phosphodiesterase 4 inhibitor

Memory impairment

Began Phase IIa trial in Europe to evaluate efficacy, safety and tolerability in 75 subjects aged 50 or older (3/20)

Neuren Pharmaceuticals Ltd. (Australia; ASX:NEU)

NNZ-2566

Small-molecule analogue of Neuren's Glypromate, which is derived from insulin-like growth factor

Traumatic brain injury

Began Phase I trial in Australia to evaluate safety in 35 healthy volunteers (3/6)

Vernalis plc (UK; LSE:VER)

V1003

Intranasal formulation of buprenorphine

Post-operative pain

Phase IIa trial in 360 patients undergoing a bunionectomy achieved the primary endpoint of pain relief vs. Vicodin and placebo (3/16)

DIABETES

Generex Biotechnology Corp. (Canada; GNBT)

Oral-lyn

Oral insulin buccal spray formulation

Type I diabetes

Positive preliminary data were seen in a trial in Ecuador (3/8); additional preliminary data showed the variations of glycosylated hemoglobin (3/15)

INFECTION

Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN)

Ceftobiprole (BAL5788)

Anti-MRSA broad-spectrum cephalosporin

S. aureus infections

Phase III trial in 774 patients demonstrated statistical noninferiority to vancomycin (3/2)

Chiron Corp. (CHIR)

Morupar

Measles, mumps and rubella vaccine

Measles, mumps and rubella

Pulled vaccine from market after potential adverse events were seen; the vaccine was provided to Italy and certain developing countries (3/16)

Crucell NV (the Netherlands; CRXL) and Chiron Corp. (CHIR)

Quinvaxem

Fully liquid pentavalent vaccine

Diphtheria, tetanus, pertussis, hepatitis B and H. influenzae

The vaccine was approved in South Korea (3/27)

Depomed Inc. (DEPO) and Madaus Srl (Italy)

Proquin XR

Once-daily, extended-release formulation of ciprofloxacin hydrochloride

Uncomplicated urinary tract infections

MAA filed earlier in 2006 was accepted for review by regulatory officials in Sweden (3/29)

FIT Biotech plc* (Finland)

--

HIV vaccine based on company's gene delivery technology

HIV

Began Phase II trial in South Africa to evaluate the immunogenicity and safety, as well as efficacy, of the therapeutic vaccine (3/28)

Idenix Pharmaceuticals Inc. (IDIX)

Telbivudine

Oral, once-daily nucleoside analogue

Hepatitis B

Phase III trial in 332 patients in China demonstrated significantly greater antiviral and clinical efficacy than lamivudine (3/27)

OctoPlus BV* (the Netherlands)

OP-145

Peptide agent designed to neutralize bacterial toxins

Chronic otitis media

Phase I trial demonstrated safety and tolerability; began Phase II trial in the Netherlands to test safety and efficacy in 52 patients (3/7)

MISCELLANEOUS

Allergy Therapeutics plc (UK; AIM:AGY)

Pollinex Quattro

Short-course vaccine with TLR4-agonist adjuvant

Ragweed allergies

R204 study in 177 patients exposed to ragweed demonstrated significantly reduced symptoms vs. placebo (3/24)

Allergy Therapeutics plc (UK; AIM:AGY)

Pollinex Quattro

Short-course vaccine with TLR4-agonist adjuvant

Grass pollen allergies

Phase II G203 trial demonstrated safety and tolerability and increased antibody levels vs. placebo (3/6)

7TM Pharma A/S* (Denmark)

TM30338

Peptide Y2 and Y4 receptor agonist

Obesity

Phase I/II trial in obese subjects demonstrated safety, tolerability and inhibition of food intake (3/20)

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.

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