Company* (Symbol) |
Product |
Description |
Indication |
Status (Date)** |
CANCER | ||||
Alza Corp. (NYSE:AZA) |
Viadur |
Leuprolide acetate implant; uses Alza's Duros implant technology to provide 12-month testosterone suppression |
Advanced prostate cancer |
Cleared for marketing (3/6) |
Aphton Corp. (APHT) |
-- |
Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17 |
Metastatic stomach cancer |
IND approved (3/16) |
Atrix Laboratories Inc. (ATRX) |
|
Slow-release (120-day) formulation of leuprolide; product is injected subcutaneously as a liquid, then solidifies and releases a predermined dose of leuprolide |
Advanced prostate cancer |
Submitted IND (3/22) |
BioChem Pharma Inc. (Canada; BCHE) and UroCor Inc. (UCOR) |
Pacis BCG, Live |
Immunotherapy that contains Armand-Frappier live, attenuated strain of Bacillus Calmette-Guerin (BCG) |
Bladder cancer |
Cleared for marketing (3/2) |
BioNumerik Pharmaceuticals Inc.* |
BNP7787 |
Small-molecule chemoprotectant |
Prevention or reduction of nerve damage associated with paclitaxel |
Granted fast-track status (3/8) |
Cell Therapeutics Inc. (CTIC) |
|
Arsenic trioxide |
Relapsed or refractory acute promyelocytic leukemia |
Granted fast-track status (3/29); filed NDA (3/29) |
Celltech Group (UK; NYSE: CLL) and American Home Products Corp. |
Mylotarg (formerly CMA-676) |
Gemtuzumab ozogamicin; humanized recombinant antibody targeting CD33+(leukemic) cells; linked to antitumor antibiotic called calicheamicin, isolated from a bacterium in caliche clay |
CD33+ relapsed acute myeloid leukemia |
Oncologic Drugs Advisory Committee recommended approval, but only for patients over 60 (3/17) |
IBC Pharmaceuticals LLC (joint venture between Immunomedics Inc. [IMMU] and Beckman Coulter Corp. [NYSE:BEC]) |
Pentacea |
Bispecific antibody delivered via injection; one arm (injected first) binds to CEA+ tumors; radiation carrier arm is subsequentl injected |
Small-cell lung cancer |
Granted orphan drug status (3/8) |
NeoPharm Inc. (AMEX:NEO) |
IL-13 PE38QQR |
Interleukin-13 combined with PE38 toxin |
Glioblastoma |
Filed IND (3/13) |
SciClone Pharmaceuticals Inc. (SCLN) |
Zadaxin |
Thymosin alpha 1; synthetic version of naturally occuring peptide hormone thymosin (immunomodulator) |
Hepatocellular carcinoma |
Granted orphan drug status (3/22) |
CARDIOVASCULAR | ||||
Avant Immunotherapeutics Inc. (AVAN) |
TP10 |
Soluble form of complement receptor 1 (CR1), designed to inhibit complement proteins |
Reperfusion injury and cardiac surgery in infants |
Granted orphan drug status (3/14) |
Genetics Institute and Wyeth-Ayerst Pharmaceuticals (both subsidiaries of American Home Products Corp.; NYSE:AHP) |
ReFacto Antihemophilic Factor |
Recombinant Factor VIII; albumin-free formulated product |
Hemophilia A |
Cleared for marketing (3/7) |
Vascular Genetics Inc.* |
|
Gene therapy using the vascular endothelial growth factor-2 gene |
Coronary artery disease and critical limb ischemia |
The company announced it would not enroll or treat additional patients due to an FDA hold on testing; during the hold period VGI will provide the agency with data from the three (out of four) clinical trials that have been completed, and will provide measurements of blood levels of VEGF-2 protein in treated patients (3/29) |
CENTRAL NERVOUS SYSTEM | ||||
Boston Life Sciences Inc. (BLSI) |
Altropane |
Radioimaging probe for dopamine neurons |
Diagnosis of attendeficit hyperactivity disorder (ADHD) |
Filed protocol for Phase II trial (3/2) |
Elan Corp. plc (Ireland; NYSE:ELN) and Dainippon Pharmaceuticals Co. Ltd. (Japan) |
Zonegran capsules |
Zonisamide; blocks voltage-sensitive sodium and calcium channels |
Focal epileptic seizures (adjunctive therapy) |
Cleared for marketing (3/28) |
Duramed Pharmaceuticals Inc. (DRMD) |
Cenestin tablets (FDA-approved) |
Plant-derived (soy and yams) synthetic conjugated estrogens |
Moderate to severe vasomotor symptoms associated with menopause |
FDA approved supplemental NDA for 1.25 mg dosage strength (3/13) |
Immunex Corp. (IMNX) |
Novantrone (FDA-approved) |
Mitoxantrone for injection concentrate |
Multiple sclerosis |
Received approvable letter (3/3) |
INFECTIOUS DISEASE | ||||
Agouron Pharmaceuticals Inc. (subsidiary of Warner-Lambert Co.; NYSE:WLA) |
Viracept |
Film-coated version (new formulation of FDA-approved drug) |
HIV infection of nelfinavir mesylate (protease inhibitor) |
FDA cleared new formulation for marketing (3/6) |
Aviron (AVIR) and Wyeth Lederle Vaccines (unit of American Home Products; NYSE:AHP) |
FluMist |
Nasal spray formulation of influenza vaccine; attenuated, cold-adapted live virus vaccine |
Prevention of influenza infection |
Company announced plans to submit BLA in the fourth quarter (3/7) |
CollaGenex Pharmaceuticals Inc. (CGPI) |
Periostat (new formulation of FDA-approved drug) |
Small, film-coated tablet containing 20mg doxycycline hyclate, which inhibits production of collagenase |
Adjunctive treatment of adult periodontitis |
Filed NDA (3/31) |
Synsorb Biotech Inc. (Canada; SYBB) |
Synsorb Pk |
Orally delivered carbohydrate attached to inert, insoluble support; binds to toxins secreted by bacteria in the gastrointestinal tract |
Prevention of hemolytic uremic syndrome associated with E. coli O157: H7 infections |
Granted fast-track status (3/13) |
MISCELLANEOUS | ||||
Collgard Biopharmaceuticals Ltd.* (Israel) |
Halofuginone |
Orally bioavailable inhibitor of the synthesis of collagen Type I and collagenase |
Scleroderma |
Granted orphan drug status (3/10) |
Genentech Inc. (NYSE: DNA) |
Pulmozyme (FDA-approved) |
Dornase alfa; recombinant human DNase (aerosolized inhalation solution) |
Cystic fibrosis |
Genentech notified the FDA and the public of a packaging defect affecting approximately one of every 1,700 ampules, potentially causing leakage (3/13) |
Notes: | ||||
* Indicates a privately held company | ||||
** The dates listed indicate the issue dates of press releases, and are not necessarily the dates on which stated events took place. | ||||
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 | ||||
ND = Not disclosed | ||||
IND = Investigational new drug application | ||||
NDA = New drug application | ||||
BLA = Biologics license application |
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