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: |
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* Privately held |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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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 |
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BLA = Biologics license application |
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IND = Investigational new drug application |
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NDA = New drug application |
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ND = Not disclosed |
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PMA = Premarket approval application |