Company**

Product

Description

Indication

Type Action (Date)

CANCER

Aronex Pharmaceuticals Inc.

Atragen

Liposomal formulation of all-trans retinoic acid; induces tumor cells to differentiate into mature normal cells (injection)

Acute promyelocytic leukemia in patients unable to take oral formulation of tretinoin

NDA accepted for review (2/4)

Cerus Corp. (NASDAQ:CERS)

ACIT (allogeneic cellular immune therapy)

Based on light-activated psoralen compound, S-59, developed to target and prevent replication of DNA and RNA

Reduction of serious adverse immune responses related to bone marrow transplantation procedures

Received FDA approval to start clinical trials (2/23)

GlycoDesign Inc.* (Canada)

GD 0039

Orally active small- molecule compound that inhibits key carbohydrate processing enzymes in tumor cells

Chemoprotective agent in advanced breast cancer patients receiving combination therapy of 5-FU, doxorubicin and cyclophosphamide

Received FDA approval to start Phase I/II study in the spring of 1999 (2/18)

IGT Pharma* (Canada)

Anhydrovinblastine

Analog of vinblastine (vinca alkaloid)

Advanced solid tumors, including non-small-cell lung cancer

Initiated Phase I trial (2/24)

Matrix Pharmaceutical Inc.

FMdC

Nucleoside analogue believed to inhibit DNA synthesis directly by incorporation into DNA strands and indirectly by blocking the action of ribonucleotide reductase, an enzyme important to nucleotide formation; structure and action similar to gemcitabine

Non-small-cell lung cancer

Initiated Phase II trial (2/25)

Ligand Pharmaceuticals Inc.

Ontak (denileukin difitox, DAB389IL-2)

Fusion protein consisting of a fragment of diphtheria toxin genetically fused to interleukin-2; targets IL-2 receptors on the surface of malignant cells and some normal lymphocytes, leading to the death of those cells

Persistent or recurrent cutaneous T-cell lymphoma whose cells express the CD25 component of the IL-2 receptor

Cleared for marketing (2/5)

Panretin Gel

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

Cleared for marketing (2/3)

The Liposome Co. Inc.

Evacet

Liposomal formulation of doxorubicin

Metastatic breast cancer (combination therapy with cyclophosphamide)

NDA accepted for filing (2/18)

Magainin Pharmaceuticals Inc.

Squalamine

Synthetically produced version of a compound found in the dogfish shark; anti-angiogenic compound combines a steroid and a polymine

Advanced cancer

Reported interim Phase I data (2/22)

SuperGen Inc.

Nipent (FDA-approved)

Pentostatin for injection; chemotherapeutic drug that inhibits adenosine deaminase (blocks DNA synthesis)

Treatment of various mature T-cell lymphomas, particularly cutaneous T-cell lymphoma and peripheral T-cell lymphoma

Filed supplemental NDA for new indications (2/26)

U.S. Bioscience Inc. andAlza Corp.

Ethyol (FDA-approved)

Amifostine; selective cytoprotective agent

To reduce incidence and severity of radiation- induced xerostomia (dry mouth) in patients with head and neck cancer

Supplemental NDA accepted for filing and granted priority review status (2/23)

CARDIOVASCULAR

CytRx Corp.

Flocor

Purified poloxamer 188; surfactant molecule that alters the way cells and molecules interact with water

Acute sickle cell crisis

Reached half-way point (112 patients) in enrollment for Phase III trial

Emisphere Technologies Inc. and Elan Corp. plc (Ireland)

-­-

Oral formulation of heparin (anticoagulant)

Prevention of deep vein thrombosis in patients undergoing surgery for hip replacement

Phase III study launch delayed due to FDA's request for additional data, prinicipally from studies using final process material (2/25)

CENTRAL NERVOUS SYSTEM

Vanguard Medica Group plc (U.K.) and Elan Corp. plc (Ireland)

Miguard (frovatriptan) tablets

5HT1B/1D agonist

Acute treatment of migraine

Vanguard submitted NDA (2/1)

DIABETES

Biocontrol Technology Inc.

Diasensor 1000 Non invasive Blood Glucose Monitor

Individually calibrated, spectrophotometer-based system for meas-uring glucose levels

Monitoring of blood glucose levels

Submitted PMA Shell (2/24)

Celtrix Pharmaceuticals Inc.

SomatoKine

IGF-BP3 complex; recombinant version of complex formed by insulin-like growth factor-1 and its major binding protein

Type 1 diabetes

Reported results of Phase IIa trial (2/25)

Magainin Pharmaceuticals Inc.

Locilex Cream (formerly Cytolex)

Pexiganan acetate; topical (1% cream); broad-spectrum anti-infective; synthetic magainin (natural host-defense peptide isolated from frogs)

Infection in diabetic foot ulcers

Scheduled to go before FDA's Anti-Infective Drugs Advisory Committee meeting 3/4 (2/24)

INFECTION

Avanir Pharmaceuticals

­--

N-docosanol 10% cream; long-chain fatty acid that interferes with viral entry into cells

Treatment of oral-facial herpes infections

Meeting with FDA set for third week of March to discuss NDA and additional evidence submitted following 12/22 not approvable letter (2/8)

Biota Holdings Ltd. (ASX:BTA; Australia) and Glaxo Wellcome plc (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

FDA's antiviral drugs advisory committee voted against recommending approval (2/24)

Chembio Diagnostic Systems*

PreVue B. burgdorferi Antibody Detection Assay

Point-of-care testfor Lyme disease bacteria (B. burgdorferi) using recombinant antigenic proteins

Initial test for Lyme disease, to be used in conjunction with confirmatory Western Blot test

Cleared for marketing (2/16)

Chiron Corp. and Ortho-Clinical Diagnostics Inc. (unit of Johnson & Johnson; NYSE:J&J)

RIBA HCV 3.0 Strip Immuno-blot Assay

3-step test uses 5 proteins that react to hepatitis C antibodies in the blood; previous version of test used 4 proteins

Confirmatory test for hepatitis C viral infection

Cleared for marketing (2/12)

Medeva plc (NYSE:MDV; U.K.)

Hepagene

3rd-generation recombinant vaccine that incor-porates all 3 hepatitis B virus surface antigens (pre-S1, pre-S2 and S)

Vaccine for hepatitis B virus infection

Submitted BLA (2/10)

Trimeris Inc.

T-20

Antiviral fusion- inhibiting compound (delivered by continuous subcutaneous infusion via pump)

HIV infection (combination therapy with 3 other antiretroviral drugs)

Received fast-track designation (2/4)

MISCELLANEOUS

Anika Therapeutics Inc. and Zimmer Inc. (subsidiary of Bristol Myers Squibb Co.; NYSE:BMY)

Orthovisc

High-molecular weight naturally derived form of hyaluronic acid

Osteoarthritis of the knee

Filed investigational device exemption for Phase III trial; FDA sent not-approv-able letter 10/98 (2/24)

InKine Pharmaceutical Co. Inc.

INKP-100

Sodium phosphate tablets

Purgative agent for adults undergoing colonoscopic examination

Scheduled pre-NDA meeting for early April with FDA officials (2/25)

Merck & Co. Inc. (NYSE:MRK)

Vioxx (rofecoxib)

COX-2 specific inhibitor

Osteoarthritis and pain

FDA's Arthritis Advisory Committee to consider NDA on 4/20 (2/25)

Ostex International Inc.

Osteomark NTx Serum Test

Quantitative measure of cross-linked N-telopeptides of type 1 collagen (NTx) in serum as an indicator of human bone collagen breakdown (resorption)

Prediction of skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following therap

Cleared for marketing (2/8)


NOTES:

Not all the companies represented in this chart are biotechnology firms. Large pharmaceutical companies are included from time to time when the products they are developing address overwhelmingly important diseases such as AIDS and cancer, and where biotech companies are developing competing products.

ASX = Australian Stock Exchange; TSE = Toronto Stock Exchange

* Private companies are indicated with an asterisk.

** 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.

No Comments