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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