Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Aphton Corp. (APHT)

­

Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17

Metastatic pancreatic cancer

Received FDA clearance of Phase III trial of combination therapy with gemictabine vs. gemcitabine alone (4/11)

BioTime Inc. (AMEX:BTX)

PentaLyte

Pentastarch-based physiologically balanced blood plasma volume expander

Replacement of blood volume in a variety of surgical applications

FDA cleared Phase I trial (4/18)

Matrix Pharmaceutical Inc. (MATX)

IntraDose

Biodegradable gel containing cisplatin and epineephrine (intra-tumoral injection)

Squamous cell carcinoma

Submitted initial section of NDA (4/3); orphan drug status granted (4/13)

Neurocrine Biosciences Inc. (NBIX)

NBI-3001

Interleukin-4 Pseudomonas toxin fusion protein; chimeric protein linking inter-leukin-4 (which binds to cancer cells because they express elevated levels of the IL-4 receptor) and Pseudomonas exotoxin (a cytotoxin)

Astrocytic glioma

Granted orphan drug status (4/27)

CENTRAL NERVOUS SYSTEM

Atlantic Technology Ventures (ATLC)

CT-3

Ajulemic acid; synthetic derivative of trahydrocan-nabinol (THC-11-oic acid)

Pain relief

Filed IND (4/3)

Novartis Pharmaceuticals Corp. (unit of Novartis AG; Switzerland)

Exelon capsules

Rivastigmine tartrate; cholinesterase inhibitor

Mild to moderate Alzheimer's disease

Cleared for marketing (4/24)

INFECTION

OraPharma Inc. (OPHM)

MPTS

Minocycline periodontal therapeutic system; microsphere encapsulated formulation of the antibiotic minocycline

Periodontitis

NDA accepted for review (4/26)

Triangle Pharmaceuticals Inc. (VIRS)

Coviracil

Emtricitabine; antiviral nucleoside analogue

HIV infection

FDA issued clinical hold on FTC-302 trial, which is being conducted in South Africa under a U.S. IND; NDA may be delayed until at least 2H:00 (4/7)

Xoma Ltd. (XOMA) and Baxter Healthcare Corp. (NYSE:BAX)

Neuprex

Recombinant bactericidal/permeability increasing protein (rBPI-21)

Severe meningo-coccemia in children

FDA officials said Phase III trial results were insufficient to support BLA filing; companies are looking for additional ways to supply the data (4/25)

MISCELLANEOUS

Alexion Pharmaceuticals Inc. (ALXN)

5G1.1

Monoclonal antibody complement inhibitor

Pemphigoid

Filed IND (4/6)

Atrix Laboratories Inc. (ATRX)

Dapsone topical gel

Topical formulation of dapsone, an antibiotic and anti-inflammatory agent burn wounds

Chronic itch associated with healed and healing

Submitted IND (4/27)

Coherent Inc. (COHR)

Opal Photo-activator

Laser for use in conjunction with Visudyne, QLT's photodynamic therapy (see separate entry below)

Wet form of age-related macular degeneration

Cleared for marketing (4/13)

Gliatech Inc. (GLIA)

Adcon-P

Adhesion control barrier; resorbable carbohydrate polymer liquid

Prevention of post-surgical scarring following gynecological pelvic surgery

FDA agreed to review product under PMA modular review process and accepted first module (4/6); FDA accepted second module (4/20)

Immunex Corp. (IMNX)

Enbrel (FDA-approved)

Etanercept; recombinant, soluble T75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgG1

Delay of radiographic progression of joint damage in patients with early rheumatoid arthritis

Arthritis Advisory Committee unanimously recommended approval of additional indication (4/11)

Organogenesis Inc. (AMEX:ORG)

Apligraf

Living human skin equivalent, composed of living human keratinocytes and fibroblasts

Diabetic foot ulcers

PMA to be reviewed by the General and Plastic Surgery Devices Panel 5/8/00 (4/7)

QLT PhotoTherapeutics Inc. (Canada;QLTI)

Visudyne

Verteporfin for injection; photodynamic therapy is activated through use of specially designed laser that produces low-level, non-thermal 689 nm light

Wet form of age-related macular degeneration

Cleared for marketing (4/13)

Repligen Corp. (RGEN) and ChiRhoClin Inc.*

Secretin-Repligen

Synthetic porcine secretin

Pancreatic function diagnostic

Received approvable letter (4/28)

Zonagen Inc. (ZONA)

Vasomax and Vasofem

Phentolamine mesylate-based products

Erectile dysfunction (Vasomax) and female sexual arousal disorder (Vasofem)

Submitted final results of two-year rat study required by FDA to lift clinical hold (4/18)

Notes:

* Privately held

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

AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange

BLA = Biologics license application

IND = Investigational new drug application

NDA = New drug application

ND = Not disclosed

PMA = Premarket approval application

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