Company **

Product

Description

Indication

Type Action (Date)

CANCER

Ligand Pharmaceuticals Inc.

Panretin Gel (FDA-approved)

Alitretinoin 0.1% (topical); chemically synthesized version of 9-cis-retinoic acid (derived from vitamin A)

Treatment of dermal lesions in AIDS-related Kaposi's sarcoma

Submitted marketing authorization application to the European Agency for the Evaluation of Medicinal Products (2/8)

ILEX Oncology Inc.

Intoplicine

Synthetic anticancer agent that inhibits topoisomerase I and II; compound induces single- and double-strand DNA breaks, which lead to cancer death

Cancer

Added Princess Margaret Hospital at the University of Toronto as a site in Phase I trial (2/1)

QLT Photo-Therapeutics Inc. (Canada)

Photofrin (FDA-approved)

Photosensitive drug (por-fimer sodium; produces toxic oxygen compound when light-activated)

Palliative treatment of advanced lung and esophogeal cancer

Cleared for marketing in Finland (2/25)

CARDIOVASCULAR

Cor Therapeutics Inc. and Schering-Plough Corp. (NYSE:SGP)

Integrilin (FDA- approved)

Eptifibatide; small-molecule synthetic compound (derived from rattlesnake venome) that inhibits GPIIb/IIIa receptor that mediates plate let aggregation

Prevention of myocardial infarction in patients presenting with unstable angina or non-Q wave myocardial infarction

European Agency for the Evaluation of Medicinal Products issued positive opinion recommending approval (2/26)

CENTRAL NERVOUS SYSTEM

Celgene Corp. and Biovail Corp. International (NYSE:BVF)

d-MPH (d-methylphenidate hydrochloride)

Chirally pure form of Ritalin

Attention deficit hyperactivity disorder

Canadian authorities approved investigational new drug application, allowing clinical trials to begin (2/16)

Hemispherx Biopharma Inc. (AMEX:HEB)

Ampligen

Double-stranded synthetic RNA compound poly I:poly C12U

Chronic fatigue syndrome (a.k.a. myalgic encephalomyelitis)

European Union marketing application cleared first stage of regulatory review (2/4)

Integra LifeSciences Corp.

DuraGen Dural Graft Matrix

Collagen matrix for the restoration of the membrane; provides a scaf-fold for the infiltration of fibroblasts and a substrate for the deposition of new collagen

Method of dural closure dural in neurological procedures

Received CE Mark Certification, permitting marketing in 18 European Union member states (2/4)

NeoTherapeutics Inc.

Neotrofin (AIT-082)

Small-molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors

Mild to moderate Alzheimer's disease

Initiated Phase IIb trial in the Republic of South Africa, with additional countries to be added, pending regulatory approval (2/16)

Neurocrine Biosciences Inc.

NBI-34060

GABA receptor agonist; next-generation non-benzo-diazepine sedative hypnotic with receptor subtype selectivity

Insomnia

Initiated Phase Ib trials in Germany (2/1)

Neurogen Corp. and Pfizer Inc. (NYSE:PFE)

NGD 97-1

GABA (gamma aminobutyric acid) receptor agonist

Memory disorders, including Alzheimer's disease

Initiated Phase I trials in Europe (2/1)

Neurogen Corp. and Wyeth-Ayerst Laboratories (subsidiary of American Home Products Corp.; (NYSE:AHP)

ADCI

Mild NMDA antagonist and use-dependent blocker of voltage-gated sodium channels

Epilepsy

Wyeth-Ayerst informed Neurogen it would not pursue further clinical testing of ADCI, which was tested in Phase Ia trials in France ( 2/1)

INFECTION

Biota Holdings (ASX:BTA; Australia) and Glaxo Wellcomeplc (NYSE:GLX; U.K.)

Relenza

Zanamivir; neuraminidase inhibitor (designed and synthesized based on crystal structure of surface proteins of influenza virus); inhaled in powder form

Treatment and prevention of influenza A and B

Australian Drug Evaluation Committee recommended approval (2/9)

Chiron Corp.

Triacelluvax

Diphtheria and tetanus toxoids and acellular pertussis vaccine

Prevention of diphtheria, tetanus and acellular per tussis

Cleared for marketing by the European Medicines Evaluation Agency; marketing allowed in 15 EMEA member states, except Germany (2/2)

La Jolla Pharmaceutical Co.

LJP 394

Molecule (toleragen) that binds to surface of B cells and shuts off production of antibodies to double-stranded DNA

Nephritis in patients with systemic lupus erythematosus

Expanded Phase II/III trial to Europe and Canada (2/25)

Pasteur Merieux Connaught (unit of Rhone-Poulenc SA; NYSE:RP; France)

ALVAC-HIV (vCP205)

Recombinant canarypox expressing the glycoprotein 120 envelope protein, Gag and protease

Prevention of HIV infection

Initiated safety trial in Africa (2/8)

PathoGenesis Corp.

TOBI (FDA-approved)

Tobramycin for inhalation

Chronic lung infection (with Pseudomonas aeruginosa) in cystic fibrosis patients

Cleared for marketing in Canada and Argentina (2/16)

North American Vaccine

DTap-IPV

Combines Certiva, a DTaP vaccine, with injectable, inactivated polio vaccine

Prevention of diphtheria, tetanus, acellular pertusis and polio

Approved for marketing in Germany (2/1)

Schering-Plough Corp. (NYSE:SGP)

Rebetron (FDA-approved)

Combination of Intron A (recombinant human interferon alfa-2b; injection) and Rebetol (ribavirin; synthetic nucleoside with antiviral activity; oral)

Combination therapy for treating chronic hepatitis C virus infection in both relapse and treatment-naive adult

Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products recommended approval (2/26)

VaxGen Inc.

AIDSVAX B/E preventive vaccine

Bivalent vaccine consisting of recombinant copies of glycoprotein 120 from the surface of 2 types of HIV

Prevention of HIV infection

Thailand's Ministry of Public Health approved the start of Phase III trial (2/9)

MISCELLANEOUS

Cortecs plc (U.K.)

Macritonin

Oral formulation of salmon calcitonin (a peptide hormone that inhibits bone resorption)

Postmenopausal osteoporosis

Completed European Phase III trial; company now in a position to collect and analyze one-year bone mineral density data and bone marker data (2/24)

Genzyme General (division of Genzyme Corp.)

Seprafilm Bioresorbable Membrane (FDA-approved)

Bioresorbable membrane that prevents fibrin, unleashed as the result of surgical insult, from building the scaffolding needed for adhesions

Reduction of incidence of adhesions following cardiac urgery

Received CE Mark approval, permitting European Union marketing (2/10)

SangStat Medical Corp.

SangCya (formerlySang-35)

Cyclosporine (oral formulation; buioequivalent to Neoral oral solution)

Prevention of rejection in solid organ transplant recipients, as well as other immunosuppressant indications

Cleared for marketing in the U.K. (2/4)

This chart is intended to provide a monthly update on the clinical and regulatory status of biotech and biotech-related products in development in countries other than the U.S., whether those products are being developed by U.S.-based or non-U.S.-based firms.

** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 16-17.