Company* (Symbol)

Product

Description

Indication

Status (Date)**

CANCER

Atrix Laboratories Inc. (ATRX)

Slow-release formulation of leuprolide acetate us-Atrix's Atrigel drug delivery technology

Prostate cancer

Submitted IND (2/1)

Cell Pathways Inc. (CLPA)

Aptosyn

Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase

Precancerous colon polyps in patients with familial adenomatous polyposis

Cell Pathways met with FDA 1/25 and affirmed that preparations for commercializing Aptosyn are proceeding as anticipated (2/22)

Chimeric Therapies Inc.*

Graft engineering technology that processes donor bone marrow in such a way as to allow only a partial transplant

Bone marrow transplant in leukemia patients

Received regulatory clearance to begin two Phase I trials (2/1)

EntreMed Inc. (ENMD)

2-methoxyestradiol (2ME2); orally active, small-molecule angiogenesis inhibitor

Advanced breast cancer

Received approval to begin clinical testing (Phase I) (2/14)

IDT Inc. (subsidiary of Biocontrol Technology Inc. (OTCBB: BICO) and HemoCleanse Inc.*

Perfusion-Induced Systemic Hyperthermia (PISH)

Uses ThermoChem technology and disposables to deliver PISH, a therapy in which core body termperature is raised to 42 degrees (107.6 degrees F)

Non-small-cell lung cancer

Received FDA and institutional permission to continue trial (2/17)

Ilex Oncology Inc. (ILXO), Millennium Pharmaceuticals Inc. (MLNM) and Berlex Laboratories (unit of Schering AG; Germany)

Campath

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

B-cell chronic lymphocytic leukemia

BLA accepted for filing (2/15)

Ligand Pharmaceuticals Inc. (LGND)

Targretin gel

Bexarotene 1%; topical therapy based on synthetic retinoid that selectively activates retinoid X receptors

Cutaneous lesions in stage IA, IB or IIA cutaneous T-cell lymphoma patients who have not tolerated other therapies or who have refractory or persistant disease

Priority review status granted (2/7)/TD>

The Liposome Company Inc.

Evacet

Liposomal formulation of doxorubicin

Metastatic breast cancer

Met with FDA officials to discuss additional analyses submitted at the end of 1999 with an eye toward resubmission of NDA; original NDA withdrawn 10/99 (2/3)

Maxim Pharmaceuticals (AMEX:MMP)

Maxamine

H2 receptor agonist

Metastatic malignant melanoma

Orphan drug status granted for Maxamine as an adjunct to cytokine therapy (2/25)

CARDIOVASCULAR

Biosite Diagnostics Inc. (BSTE) and Scios Inc. (SCIO)

Triage BNP Test

Test to measure B-type natriuretic peptide

Diagnosis of congestive heart failure

FDA advisory committee will review product 3/24 (2/9)

Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham plc (UK; NYSE: SBH)

Novastan

Synthetic small molecule (argotroban) derived from arginine; acts as direct inhibitor of thrombin

Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia

Received approvable letter (2/22)

UroGen Corp. (OTC BB: UROG)

Factor VIII gene therapy product; delivery system derived from common cold virus

Hemophilia A

IND approved, allowing Phase I trial to start (2/11)

CENTRAL NERVOUS SYSTEM

Gliatech Inc. (GLIA)

Adcon-L (FDA-approved)

Anti-adhesion barrier gel (semisynthetic carbohydrate polymer)

To inhibit post-operative adhesions involving spinal cord and nerve roots, and to improve patient outcome following lumbar disc surgery

Company resumed distribution of product to hospitals in the U.S.; based on re-inspection conducted by the FDA, the contract manufacturing firm European Medical Contract Manufacturing BV was removed from automatic detention list for the importation of Adcon-L (2/1)

DIABETES

Advanced Tissue Sciences Inc. (ATIS) and Smith & Nephew plc (NYSE:SNN)

Dermagraft

Human tissue-engineered replacement for dermal layer of skin (viable human dermal fibroblasts, derived from foreskins, cultured on bioresorbable scaffold)

Diabetic foot ulcers

FDA approved application for amendment to IDE application; amendment modifies study inclusion criteria to limit future enrollment to patients with ulcers of greater than six weeks duration (2/29)

INFECTION

BioMedicines Inc. *

Genetically engineered version of omega interferon

Hepatitis C virus infection

Filed IND (2/15)

Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE:SGP)

Peg-Intron

Long-acting dosage form of Schering's Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol

Chronic hepatitis C virus infection in adults with compensated liver disease

BLA accepted for review (2/10)

Gilead Sciences Inc. (GILD) and Fujisawa Healthcare Inc. (Japan)

AmBisome (FDA-approved)

Liposomal formulation of amphotericin B

Potentially life-threatening fungal infections in neutropenic cancer patients

Supplemental NDA approved; label includes results of trial comparing AmBisome to Abelcet (amphotericine B lipid complex; manufactured by The Liposome Company [LIPO]) (2/10)

Hemispherx Biopharma Inc. (AMEX:HEB)

Ampligen

Double-stranded synthetic RNA compound poly I:poly C12U

HIV infection that is becoming resistant to currently approved regimens

Filed for HIV emergency treatment IND and Phase II and III trials of Ampligen in combination with several Highly Active Antiretroviral Therapy (HAART) regimens (2/17)

Palatin Technologies Inc. (AMEX:PTN)

LeuTech

Radiolabeled monoclonal-antibody-based system for imaging infection (product binds specifically to white blood cells)

Diagnosis of equivocal appendicitis

BLA accepted for review (2/23)

MISCELLANEOUS

Alexion Pharmaceuticals Inc. (ALXN)

5G1.1

Anti-inflammatory of the fifth component of the complement cascade (C5)

Dermatomyositis

Filed IND (2/1)

Amarillo Biosciences Inc. (OTC BB: AMAR)

Natural human lymphoblastoid interferon-alpha

Behcet's disease

Granted orphan drug status (2/1)

ARIAD Pharmaceuticals Inc. (ARIA)

AP1903

Small-molecule dimerizer drug for use in conjunction with Ariad's ARGENT (Ariad Regulated Gene Expression Technology); in GvHD product, T cells are harvested from donor peripheral blood prior to bone marrow graft, isolated and genetically engineered to include a gene for an inactive apoptosis protein; T cells are reinfused along with the graft; if patient exhibits a GvHD response, the dimerizer drug, AP1903, is administered to activate the apoptosis protein

Acute graft-versus-host disease

Orphan drug status granted; Phase II trial scheduled to begin (2/24)

InterMune Pharmaceuticals*

Actimmune

Interferon gamma-1b Injection (FDA-approved)

Severe, malignant osteopetrosis

Cleared for marketing (2/11)

QLT Phototherapeutics Inc. (Canada; QLTI) and CIBA Vision (eye care unit of Novartis AG; Switzerland)

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

Received approvable letter (2/11)

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; 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

BLA = Biologics license application

IDE = Investigational device exemption

IND = Investigational new drug application

NDA = New drug application

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