Company* (Country)

Product

Description

Indication

Type Action (Date)

I. CANCER

AltaRex Corp.

OvaRex MAb

Anti-idiotype induction therapy-based vaccine;consists of modified murine monoclonal antibody that binds to CA125 cancer antigen

Ovarian cancer

Company reported that 12 of 14 patients have been enrolled in Canadian Phase II trial (4/1)

U.S. Bioscience and Schering-Plough Corp. (NYSE:SGP)

Ethyol (FDA-approved)

Amifostine; selective cyto-protective agent GABA-A receptor subtype

Prevention of acute and late xerostomia in head-and-neck cancer

Cleared for marketing in Europe (4/29)

II. CENTRAL NERVOUS SYSTEM

NeurocrineBiosciences Inc.

NBI-34060

GABA-A receptor subtype agonist; next-generation non-benzodiazepine sedative hypnotic with receptor subtype selectivity

Insomnia

Completed Phase Ib trial in Germany (4/8)

II. INFECTION

Atrix Laboratories Inc.

Atridox (FDA-approved)

Biodegradable polymer incorporating 10% doxycy-cline

Periodontal disease

Approved for marketing in the U.K. (4/28)

BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (NYSE:GLX; U.K.)

Zeffix (lamivudine; FDA-approved)

Nucleoside analogue (oral dosage)

Chronic hepatitis B

European Union's Committee for Proprietary Medicinal Products recommended approval (4/26)

Corixa Corp.

LeIF (Leishmaniaelongation Initiation factor)

Recombinant version of Leishmania protein with significant T cell stimulatory activity

Drug-resistant mucosal leishmaniasis

Presented interim results from Brazilian trial at the World Health Organization's “Novel Adjuvants Currently in Clinical Testing“ meeting in Annecy, France (4/6)

Digene Corp.

Hybrid Capture II test for chlamydia and gonorrhea Hybrid Capture II test for human papillomavirus

Assay that detects genetic material from Chlamydia trachomatis andNeisseria gonorrhea Assay that detects DNA from 18 different human papillomavirus types

Detection of chlamydia and/or gonorrhea infection Detection of human papillomavirus infection

Cleared for marketing in Brazil and Argentina (4/29) Cleared for marketing in Brazil and Argentina (4/29)

D-Pharm Ltd.* (Israel)

DP-VPA

Derivative of valproic acid

Epilepsy

Cleared to initiate Phase I study in the U.K. (4/19)

Genzyme General (division of Genzyme Corp.)

Seprafilm Bioresorbable Membrane

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

Prevention of postoperative adhesions Diseases of the Colon

Data from Genzyme-sponsored retrospective study published in and Rectum (4/30)

OXO Chemie Inc. (subsidiary of OXO Chemie AG; Switzerland)

WF10

Chemically stabilized chlorite matrix called tetrachloro-decaoxygen

Late-stage HIV/AIDS

Canada's Health Protection Branch approved addition of Canadian sites to U.S. Phase III trial (4/8)

Pathogenesis Corp.

TOBI (FDA-approved)

Tobramycin for inhalation

Treatment of cystic fibrosis patients infected with Pseudomonas aeruginosa infection

Initiated enrollment in open-label randomized trial in Ireland and the U.K. (4/15)

II. MISCELLANEOUS

Phytopharm plc (U.K.)

P54

Extract of two plants that down-regulates cyclo-oxygenase 2 (COX-2); nonsteroidal anti-inflammatory agent

Osteoarthritis

Product failed to beat placebo in Phase IIa trial in the U.K. (4/20)

Protein Design Labs Inc.

SMART Anti-CD3 (humanized antibody)

Humanized antibody that binds to the CD3 antigen on T lymphocytes

Psoriasis

Initiated Phase I/II trial (4/28)

Sheffield Pharmaceuticals Inc. and Zambon Group SpA (Italy)

-

Albuterol sulfate delivered via Metered Solution inhaler

Asthma

Zambon initiated human testing in Europe (4/19)

* Privately held company.
** Unless otherwise noted, the stock symbols for public companies are listed on pp.10-11.