Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Aronex Pharmaceuticals Inc. (ARNX)

Atragen

Liposomal formulation of tretinoin (all trans- retinoic acid)

Acute promyelocytic leukemia

FDA accepted for review the company's amendment to its NDA (8/21)

Direct Therapeutics Inc.*

DTI-015

Contains the chemother- apeutic drug carmustine dissolved in absolute ethanol

Glioblastoma multiforme

FDA granted orphan drug designation (8/8)

Genta Inc. (GNTA)

Genasense

Antisense compound; synthetic DNA strands that bind to mRNA for the bc12 gene (proto-oncogene)

Advanced malignant melanoma

FDA granted orphan drug designation (8/7)

Ilex Oncology Inc. (ILXO), Millennium Pharmaceuticals Inc. (MLNM) and Schering AG (Germany)

Campath

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

B-cell lymphocytic leukemia

Companies submitted response in answer to FDA's 6/23 complete response letter, which addressed the 12/99 BLA for the product (8/21)

Inex Pharmaceuticals Corp. (Canada; INEX)

Onco TCS

Therapeutic consisting of vincristine encapsulated in the transmembrane carrier systems drug delivery technology developed by Inex

Relapsed aggressive non-Hodgkin's lymphoma

FDA granted fast-track designation (8/17)

Zarix Inc.*

Thymitaq

Nolatrexed dihydrochloride; a novel thymidylate synthase inhibitor

Liver cancer

FDA approved the design of the pivotal Phase III trial; the study will be conducted in the U.S., Canada, Europe and South Africa (8/9)

CARDIOVASCULAR

Alliance Pharmaceutical Corp. (ALLP) and Schering AG (Germany)

Imagent

Ultrasound contrast agent; aqueous dispersion of microbubbles containing mixture of perfluorochem- ical vapor and a physiologi- cal gas

To improve ultrasound images of the walls of the heart

FDA sent an approvable letter to the company for the marketing of Imagent (8/21)

United Therapeutics Corp. (UTHR)

Uniprost

Subcutaneous prostacyclin therapy; stable structural analogue of prostacyclin

Pulmonary hypertension

Submitted initial sections of NDA (8/14)

CENTRAL NERVOUS SYSTEM

Avanir Pharmaceuticals (AMEX:AVN)

AVP-923

A new formulation of dextromethorphan; also comprised of an enzyme inhibitor that slows the metabolism of dextro- methorphan

Neurodegenerative diseases

FDA accepted an IND to begin Phase II/III studies to assess emotional lability in patients with multiple sclerosis, Lou Gehrig's disease, Alzheimer's disease and stroke (8/9)

Crescendo Pharmaceuticals Corp. (CNDO) and Alza Corp. (NYSE:AZA)

Concerta

Extended-release tablet formulation of methylphenidate hydrochloride

Attention deficit hyperactivity disorder

FDA approved the drug for marketing; Alza licensed it from Crescendo Pharmaceuticals Corp. (8/3)

EpiCept Corp.*

--

Oral spray pain killer

Oral mucositis

Filed IND (8/14)

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

Demonstrated statistical significance in the primary endpoint of complete wound closure by 12 weeks; company submitted a a pre-market approval application to the FDA (8/25)

INFECTION

Amarillo Biosciences Inc. (OTCBB:AMAR)

Veldona

Low dose oral alpha interferon (natural)

Papillomavirus warts

FDA granted orphan drug designation to treat the warts in the oral cavity of HIV-positive patients (8/22)

Calypte Biomedical Corp. (CALY)

­

HIV-1 antibody urine test

Detection of HIV

Cleared for distribution in China (8/24)

Cerus Corp. (CERS) and Baxter Healthcare Corp. (BAX)

Intercept Platelet System

Pathogen inactivation system that targets and inactivates bloodborne pathogens, while leaving the therapeutic properties of platelets intact; process uses light-activated psoralen compound, S-59, which disables nucleic acid

To protect against the transmission of disease through blood transfusions

Company received clearance from a Data and Safety Monitoring Board to continue a Phase III trial; the DSMB reviewed data from the first 200 patients in the 600-patient study (8/17)

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

E. coli infection

FDA authorized the company to provide the Children's Hospital of Wisconsin in Milwaukee with emergency doses due to an outbreak (8/3)

MISCELLANEOUS

Gliatech Inc. (GLIA)

Adcon-L (FDA-approved)

Anti-adhesion barrier gel (semisynthetic carbohydrate polymer)

Inhibition of post- surgical scarring and adhesions following back surgery

Company commented on FDA's Form 483 report on irregularities in clinical trial used to support PMA; Gliatech launched a task force of executives and researchers not involved in the trial to investigate; the company also said it would respond to the items cited in the Form 483 within 15 days (8/29)

NeuroSearch A/S (Denmark)

NS2359

Synthetic small-molecule compound that acts as mixed monoamine reuptake inhibitor

Cocaine addiction

FDA granted approval for the first Phase II study in cocaine abusers (8/28)

NPS Pharmaceuticals Inc. (NPSP)

ALX-0600

Analogue of naturally occurring peptide GLP2; enhances rate of growth of epithelium of small intestine

Short bowel syndrome

FDA designated it as an orphan drug (8/1)

Pharmacia Corp. (NYSE:PHA)

Azulfidine En-tabs

Sulfasalazine delayed- release tablets

Juvenile rheumatoid Arthritis (RA)

FDA approved the new indication in children with RA involving five or more diseased joints who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (8/22)

QLT Photo- Therapeutics (QLTI) and CIBA Vision Corp. (CIBA)

Visudyne (FDA- approved)

Photodynamic therapy activated by specially designed laser that produces low-level non-thermal 689 nm light

Ocular conditions characterized by - choroidal neovas- cularization

Companies filed a supplemental NDA for Visudyne to treat eye diseases beyond age-related macular degeneration (8/14); granted priority review status (8/29)

Transkaryotic Therapies Inc. and Aventis Pharma AG (unit of Avents SA [France; NYSE:AVE])

Dynepo (formerly GA-EPO)

Gene-activated erythro- poietin; gene in human cells is activated in situ to pro- duce EPO

Anemia in patients with chronic renal failure

Aventis filed in the U.S. and Europe for marketing approval (8/3)

Notes:

* Privately held

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

BLA = Biologics License Application

NDA = New Drug Application

ND = Not disclosed

PMA = Pre-market Approval Application

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