Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

AEterna Laboratories (Canada; AELA; TSE:AEL)

Neovastat/AE-941

Angiogenesis inhibitor; orally bioavailable naturally occurring product that blocks VEGF and MMPs

Multiple myeloma

Company submitted applications to the FDA to begin a clinical trial; application also was submitted with the Health Protection Branch in Canada (10/25)

Cell Therapeutics Inc. (CTIC)

CT-2103

PG-TXL; links the cancer drug Taxol to the company's polyglutamate polymer

Lung, ovarian, breast and colon cancers

FDA granted approval for the company to start a clinical study (10/30)

Coulter Pharmaceutical Inc. (CLTR) and SmithKline Beecham (NYSE:SBH)

Bexxar

Tositumomab, I-131 tositumomab

Relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma

FDA assigned priority review status to Bexxar (10/5)

Ilex Oncology Inc. (ILXO) and Millennium Pharmaceuticals Inc. (MLNM)

Campath

Alemtuzumab; humanized monoclonal antibody that specifically targets and binds to CD52 cell surface antigen on lymphocytes

B-cell lymphocytic leukemia

FDA will review Campath at the panel's Dec. 13-14 meeting; BLA was submitted in December 1999 (10/26)

Intracel Corp.*

Keyhole Limpet Hemocyanin

Immune stimulator

Bladder cancer

FDA gave Intracel permission to begin a Phase III trial (10/24)

MacroMed Inc.*

OncoGel

Formulation of paclitaxel using ReGel, MacroMed's drug delivery system; intralesionaly administered chemotherapeutic

Cancer lesions

Company received FDA clearance to initiate clinical trials in cancer patients with lesions or for those who are not candidates for aggressive surgical intervention (10/16)

Repligen Corp. (RGEN)

CTLA4-lg

T-cell regulatory protein

Leukemia

FDA granted the company approval to initiate a Phase II trial to determine if CTLA4-lg, in combination with T-cell depletion, can reduce the incidence or severity of graft-vs.-host disease (10/23)

CARDIOVASCULAR

Actelion Ltd. (Switzerland; SWX:ATLN)

Bosentan

Orally active endothelin receptor antagonist

Pulmonary hypertension

Actelion gained FDA orphan status for bosentan (10/18**)

Endovasc Ltd. Inc. (OTC BB:ENDV)

Liprostin

Liposomal encapsulated prostaglandin E-1 drug

Critical limb ischemia

Company submitted an IND to test the drug in patients who have lost cirulation in their lower limbs and are in danger of requiring amputation (10/3)

United Therapeutics Corp. (UTHR)

Uniprost (formerly UT-15)

Prostacyclin; molecule produced within the body naturally

Pulmonary hypertension

Company filed an NDA (10/16); FDA granted priority review status (10/19)

CENTRAL NERVOUS SYSTEM

Immunex Corp. (IMNX)

Novantrone (FDA-approved)

Mitoxantrone for injection concentrate

Secondary progressive multiple sclerosis

FDA approved Novantrone for reducing neurological disability and/or the frequency of clinical relapses in patients with secondary progressive, progressive relapsing or worsening relapsing-remitting MS (10/13)

Orphan Medical Inc. (ORPH)

Xyrem

Sodium oxybate; oral formulation

Narcolepsy

Company submitted an NDA for Xyrem to treat the symptoms of narcolepsy (10/2)

Pharmacia Corp. (NYSE:PHA)

Parecoxib sodium

Injectable COX-2 specific inhibitor, which can be administered intramuscularly or intravenously

Acute pain

Company submitted an NDA (10/30)

INFECTION

Aviron (AVIR) and American Home Products Corp. (NYSE:AHP)

FluMist

Intranasal vaccine

Influenza

Companies filed a BLA with the FDA for FluMist to prevent influenza in children and adults (10/31)

Human Genome Sciences Inc. (HGSI)

Albuferon

A protein created by fusing the gene for the human protein interferon alpha to the gene of another human protein, albumin

Hepatitis C

Company submitted an IND application to the FDA to initiate Phase I trials of Albuferon (10/18)

Protherics plc (UK; LSE:PTI)

CroFab

Antivenom; consists of antibody fragments, derived by injecting rattlesnake venom into sheep and harvesting the antibodies, which will bind to the toxins of the rattlesnake's venom

Rattlenake bites

Company won FDA approval for CroFab as a treatment for rattlesnake bites (10/11**)

MISCELLANEOUS

Allergan Inc. (NYSE:AGN) and Acadia Pharmaceuticals*

AGN 195795

Gene-specific adrenergic agonist

Glaucoma

Allergan filed an IND application with the FDA (10/31)

Alexion Pharmaceuticals Inc. (ALXN)

5G1.1

Monoclonal antibody that inhibits the fifth component of the complement cascade

Dermatomyositis

FDA granted orphan drug status (10/6)

Genelabs Technologies Inc. (CNLB)

Aslera (FDA-approved)

GL701 or prasterone

Systemic lupus erythematosus

FDA granted priority review status to the Aslera NDA (10/25)

Genentech Inc. (NYSE:DNA)

Alteplase

Recombinant, a bioengineered version of the naturally occurring tissue plasminogen activator

To open occluded central venous access devices

Company submitted a supplemental BLA to restore function of devices necessary to withdraw or infuse vital fluids to ill patients (10/2)

Gliatech Inc. (GLIA)

ADCON-L

Anti-adhesion barrier gel (semisynthetic carbohydrate polymer)

Post-surgical scarring and adhesions

Gliatech withdrew its PMA supplement in response to the FDA's concerns and has proposed re-evaluating the MRI data (10/16)

Inspire Pharmaceuticals Inc. (ISPH)

INS37217 Respiratory

Second-generation P2Y(2) agonist designed to enhance the lung's innate mucosal hydration and mucociliary clearance mechanisms

Cystic fibrosis

Company filed IND to begin clinical trials (10/3)

Neurochem Inc. (Canada; TSE:NRM)

Fibrillex

Orally active antifibrillary agent

Secondary amyloidosis

Neurochem received IND status from the FDA, allowing it to begin Phase II/III trials (10/11)

Novazyme Pharmaceuticals Inc. *

NZ-1001

Highly phosphorylated enzyme replacement therapy

Pompe disease

FDA granted orphan drug status (10/5)

Orphan Medical Inc. (ORPH)

Xyrem

Sodium oxybate; oral solution

Narcolepsy

FDA granted priority review status (10/17)

Ortec International Inc. (ORTC)

Composite Cultured Skin

Cryopreserved (frozen) version of CCS

Venous statis skin ulcers

Company received FDA permission to begin a pivotal trial; trial expected to include up to 200patients (10/18)

Q-Med AB* (Sweden)

DEFLUX

Copolymer between non-animal stabilized hyaluronic acid and dextranomer

Vesicoureteral reflux

An FDA advisory board recommended the approval of DEFLUX to treat vesicoureteral reflux in children (10/23)

Serono Inc. (U.S. affiliate of Serono SA, Switzerland; NYSE:SRA)

Ovidrel

Choriogonadotropin alfa for injection

Infertility

FDA granted marketing approval (10/2)

SkyePharma plc (UK; SKYE)

Solaraze

Uses Hyaluronan Induced Targeting transdermal delivery technology

Acute keratosis

FDA granted marketing approval (10/20)

V.I. Technologies Inc. (VITX)

PEN110

Inactine product

To inactivate pathogens in red blood cells

Company received FDA clearance to begin a Phase II trial (10/2)

Vivus Inc. (VVUS)

Alibra

Urethral microsuppository of alprostadil and prazosin hydrocholoride

Erectile dysfunction

Company withdrew its NDA and plans to meet with the FDA to determine the additional data needed; company also plans to meet with the European Agency for the Evaluation of Medicinal Products concerning the pending European application (10/20)

Notes:

* Privately held; ** Denotes the date the item ran in BioWorld International.

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; SWE = Switzerland Stock Exchange; TSE = Toronto Stock Exchange; VSE = Vancouver Stock Exchange

BLA = Biologics License Application

IND = Investigational New Drug

NDA = New Drug Application

ND = Not disclosed

PMA = Premarket Approval Application

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