Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

ImClone Systems Inc. (IMCL)

IMC-C225

Anti-epidermal growth factor receptor mono-clonal antibody

Refractory colorectal carcinoma

FDA granted fast-track status to IMC-C225 (2/1)

Lorus Therapeutics Inc. (Canada; LORFF; TSE:LOR)

Virulizin

Non-toxic immunotherapy that recruits monocytes and macrophages to attack tumor cells

Prostate cancer

FDA granted orphan status for Virulizin (2/20)

Millennium Pharmaceuticals Inc. (MLNM) and Ilex Oncology Inc. (ILEX)

Campath

Humanized monoclonal antibody; alemtuzumab

Chronic lymphocytic leukemia

FDA issued a Class I complete response letter concerning the BLA filed for Campath (2/21)

CENTRAL NERVOUS SYSTEM

Human Genome Sciences Inc. (HGSI)

BLyS

B lymphocyte stimulator that stimulates B cells to mature into plasma B cells, which produce antibodies

Common variable immunodeficiency

FDA granted orphan drug status (2/27)

DIABETES

Advanced Tissue Sciences Inc. (ATIS)

Dermagraft

Human tissue engineered replacement for dermal layer of skin (viable human dermal fibroblasts, derived from foreskins cultured on bioresorbable scaffold)

Diabetic foot ulcers

FDA completed its initial review of the premarket approval application and said it requires additional information (2/21)

INFECTION

Antigenics Inc. (AGEN)

AG-701

Immunotherapeutic using heat shock protein technology

Herpes simplex virus type 2

FDA gave approval for clinical testing of AG-701 (2/5)

Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE:SGP)

PEG-Intron (FDA-approved)

Peginterferon alfa-2b powder for injection

Chronic hepatitis C

Schering-Plough submitted a supplemental BLA to use the powder in combination therapy with Rebetol (ribavirin) capsules (2/6)

MISCELLANEOUS

CollaGenex Pharmaceuticals Inc. (CGPI)

Periostat

Orally administered, systemically delivered drug

Adult periodontitis

FDA granted marketing approval for a new tablet formulation of Periostat (2/5)

InKine Pharmaceutical Co. (INKP)

Colirest

Oral steroid molecule; Fc receptor technology

Crohn's disease

FDA agreed to allow the company to proceed with a pivotal study (2/27)

Nabi (NABI)

StaphVAX

Staphylococcus aureus conjugate vaccine

End-stage renal disease

Company decided to conduct an additional Phase III trial, but plans to appeal the FDA's requirement for another study (2/2)

OraPharma Inc. (OPHM)

Arestin

Adjunct treatment for periodontitis; minocycline HCl using microsphere technology

Periodontitis

FDA approved Arestin as an adjunct treatment following scaling and root planning (2/20)

Ortec International Inc. (ORTC)

Composite cultured skin

Tissue-engineered dressing consisting of two layers of human-derived skin cells (dermal and epidermal) supported with a porous collagen matrix

Recessive dystrophic epidermolysis bullosa

FDA approved the product for use in patients with recessive dystrophic epidermolysis bullosa undergoing hand reconstruction surgery (2/22)

Oxford GlycoSciences plc (UK; OGSI; LSE:OGS)

Vevesca

Oral capsule formulation of a glucosyltransferase inhibitor

Type 1 Gaucher disease

Company said it will submit an NDA by the middle of 2001 (2/12)

QLT Inc. (QLTI)

Visudyne

Injected intravenously into a patient's arm; a non-thermal laser light is shined into the patient's eye to activate the drug

Predominately classic subfoveal choroidal neovascularization caused by pathologic myopia and ocular histoplasmosis syndrome

Company received an approvable letter from the FDA (2/6)

Notes:

* Privately held; ** Denotes the date the item ran in BioWorld International

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

LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application