Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


CANCER

Alphapharm Pty. Ltd. (Australian subsidiary of Merck KGaA)

Erbitux

Cetuximab; antibody designed to block EGFR

Metastatic colorectal cancer

The Merck unit filed for approval of ImClone Systems Inc.'s product in Australia (11/3)

Atrix Laboratories Inc. (ATRX)

Eligard 7.5mg and 22.5mg

Leuprolide acetate for injection; sustained- release formulations

Prostate cancer

Atrix licensee Sanofi-Synthelabo Canada gained marketing approval in Canada (11/7)

Cyclacel Ltd.* (UK)

CYC202

Small-molecule cyclin- dependent kinase inhibitor

Cancers

Phase I trials by French researchers with 49 patients showed the drug was well tolerated and produced clinical benefit (11/20)

Igeneon AG* (Austria)

IGN101

Vaccine designed to trigger an immune response to epithelial cell-adhesion molecule

Metastatic colorectal cancer/adjuvant breast cancer

Igeneon said it was starting pivotal trials in both indications; the colorectal trial will test 700 patients at 24 centers in Europe; the breast study will be in 600 patients in Austria (11/11)

ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co.

Erbitux

Cetuximab; antibody designed to block EGFR

Metastatic colorectal cancer

Companies filed for approval in Canada to use drug in combination with irinotecan; the filing was given priority review status (11/24)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene

Histamine dihydrochloride in combination with interleukin-2

Advanced malignant melanoma

Maxim filed for approval in Europe (11/7)

ML Laboratories plc (UK;LSE:MLB)

--

Gene therapy containing virus with gene for nitroreductase

Prostate cancer

ML began a Phase II trial designed to assess safety and efficacy (11/12)**

Phoenix Pharmacologics Inc.*

ADI

Argine deaminase, a mycoplasma protein formulated with poly-ethylene glycol

Primary liver cancer

Company initiated a Phase III open-label trial in Italy expected to include 80 patients (11/17)

Spectrum Pharmaceuticals Inc. (SPPI)

EOquin

Anticancer agent

Superficial bladder cancer

Company initiated a Phase II study expected to include 10 European hospitals (11/17)

CARDIOVASCULAR

Endovasc Inc. (OTC BB:EVSC)

Liprostin

Lisposomal formulation of prostaglandin E1

Peripheral vascular disease

Sites In Mexico began screening patients for 120-patient Phase II trial; sites in Brazil and Russia are preparing for studies (11/20)

Genzyme Corp. (GENZ)

Cholestagel

Colesevelam hydrocholoride; nonabsorbed cholesterol-lowering agent

Primary hypercholesterolemia

The Committee for Proprietary Medicine of the EU issued a positive option on the market application; a decision is expected in Q1:04 (11/21)

Inflazyme Pharmaceuticals Inc. (Canada; TSE:IZB)

GH9001

Formulation of medium- molecular-weight heparin and low-molecular-weight dermatan sulfate

Prevention of blood clotting

Company began a Phase Ib trial in the UK to measure safety and tolerability, as well as surrogate markers of activity (11/3)

CENTRAL NERVOUS SYSTEM

Durect Corp. (DRRX)

--

Sustained-release injectable product using Saber delivery system and local anesthetic

Post-operative pain

The first trial of the drug, in 12 volunteers in Europe, showed appropriate absorption (11/6)

Newron Pharmaceuticals SpA* (Italy)

Safinamide

Molecule with multiple mechanisms of action

Epilepsy

Phase II trial in Italy and Germany showed no tolerability problems and a reduction in seizure frequency (11/18)

Phytopharm plc (UK; LSE:PYM)

PYM50028

Orally active synthetic neuroprotective and neuroregenerative agent

Alzheimer's and Parkinson's disease

Phase Ib trial in healthy subjects older than 50 showed favorable tolerability and pharmacokinetic properties (11/3)

SkyePharma plc (UK; SKYE)

DepoMorphine

Sustained-release injectable formulation of morphine

Post-operative pain

Company filed for approval of the product in the UK (11/20)

DIABETES

Biotech Holdings Ltd. (Canada; OTC BB:BIOHF)

Sucanon

Insulin-sensitizing drug

Type II diabetes

Biotech Holdings gained approval of the product in Mexico (11/3)

INFECTION

AlphaVax Inc.*

AVX101

Vaccine using VEE alphavirus vector

To prevent HIV infection

A trial started in South Africa to assess the preventive vaccine in humans (11/3)

Chiron Corp. (CHIR)

TOBI (FDA-approved)

Tobramycin solution for inhalation

Pseudomonas aeruginosa infection in CF

Chiron started the ELITE study in up to 120 cystic fibrosis patients in Europe to delay P. aeruginosa infection (11/24)

MISCELLANEOUS

Isogalen Inc. (AMEX:ILE)

Isogalen Process

Autologous cell therapy

Tissue regeneration

Isogalen said a review of 59 patients treated in the UK showed positive results, with few adverse events (11/20)

Medgenics Inc.* (Israel)

Biopump

System for delivering erythropoietin

Anemia in chronic kidney disease

The Phase I trial in Israel will measure safety and EPO delivery in anemic renal failure patients (11/6)


Notes:

* Privately held.

** Denotes date item ran in BioWorld International.

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

AMEX = American Stock Exchange; LSE = London Stock Exchange; OTC BB: Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.

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