Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Aronex Pharmaceuticals (ARNX)

Atragen

Liposomal formulation of tretinoin (all-transretinoic acid)

Acute promyelocytic leukemia

Company said it had met with FDA following the agency's 9/99 advisement of deficiencies in the NDA; Aronex is preparing an amendment based on more than 100 patients vs. 56 in the original filing (5/16)

Biomira Inc. (Canada; BIOM)

Theratope vaccine

Synthetic carbohydrate-based vaccine; mimic of cancer antigen sialyl-Tn plus carrier molecule KLH

Metastatic breast cancer

Granted fast-track status (5/8)

Cell Therapeutics Inc. (CTIC)

­

Arsenic trioxide

Multiple myeloma

Granted orphan drug status (5/8); received priority review status (5/16)

Celltech Group (UK; NYSE:CLL) and American Home Products Corp. (NYSE: AHP)

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

Treatment of patients 60 years and older in first relapse with CD33+ acute myeloid leukemia

Cleared for marketing (5/18)

Genentech Inc. (NYSE:DNA)

Herceptin (FDA-approved)

Trastuzumab; humanized monoclonal antibody to HER2 growth factor receptor

Advanced metastatic breast cancer

Genentech sent a "Dear Doctor" letter advising of a reaction that has been linked to 6 deaths per 10,000 patients (5/4)

NeoPharm Inc. (NEOL)

SS1(dsFV)-PE38

Single-chain monoclonal antibody that targets mesothelin and delivers PE38, a cytotoxin

Solid tumors

Filed IND (5/1)

Nexell Therapeutics Inc. (NEXL)

Isolex 300i Magnetic Cell Selection System (enhanced version)

Magnetic cell selection system for the separation of hematopoietic stem cells and the removal of tumor cells from autologous peripheral blood

Ex vivo autologous selection of hematopoietic stem cells for use in reconstituting immune system after high-dose chemotherapy

Marketing clearance granted for product upgrade (5/15)

CARDIOVASCULAR

Endovasc Ltd. (OTC BB:ENDV)

Liprostin

Prostaglandin E1; liposomal formulation of naturally occurring vasodilating hormone

Critical limb ischemia

Endovasc's contract manufacturer, Collaborative BioAlliance, completed certified Chemistry, Manufacturing and Controls, which completed Endovasc's IND application requirements (5/22)

GelTex Pharmaceuticals Inc. (GELX) and Sankyo Parke Davis (Japan)

Welchol

Colesevelam hydrochloride; non-absorbed, lipid-lowering drug designed to bind bile acids in the intestine

Reduction of elevated LDL (low-density cholesterol)

Cleared for marketing as a single agent or in combination with an HMG-CoA reductase inhibitor (statin) (5/30)

Genzyme Transgenics Corp. (GZTC) and Genzyme General (GENZ)

­

Recombinant human antithrombin III (rhATIII)

Heparin-resistant patients requiring anticoagulation

Granted orphan drug status (5/9)

Layton BioScience Inc.*

Inversine

Mecamylamine hydrochloride; nicotine receptor antagonist originally launched in the 1950s

Neurological disorders, including Tourette's syndrome

Cleared for reintroduction to the U.S. market (5/15)

The Medicines Company*

Angiomax (formerly Hirulog)

Bivalirudin; synthetic thrombin inhibitor based on hirudin (natural anticoagulant secreted by leeches)

Anticoagulation in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty

Received approvable letter (5/16)

United Therapeutics Corp. (UTHR)

Uniprost

Subcutaneous prostacyclin therapy; stable structural analogue of prostacyclin

Pulmonary hypertension

Filed with the FDA to commence a clinical study to investigate the safety of transitioning pulmonary hypertension patients from Flolan (marketed by Glaxo Wellcome) to Uniprost (5/8)

Vascular Genetics Inc.*

­

Gene therapy using the vascular endothelial growth factor-2 gene

Coronary artery disease and critical limb ischemia

FDA sent a warning letter dated 4/28 to investigator (Jeffrey Isner at St. Elizabeth's Medical Center in Boston) documenting deficiencies in gene therapy studies (5/03)

CENTRAL NERVOUS SYSTEM

Boston Life Sciences Inc. (BLSI)

Fluoratec

Technetium-based imaging agent

Parkinson's disease and attention deficit hyperactivity disorder

Filed IND (5/12)

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

Concerta

Extended-release tablet formulation of methylphenidate hydrochloride

Attention deficit disorder/attention deficit hyperactivity disorder

Received approvable letter (5/18)

Elan Corp. plc (Ireland; NYSE:ELN) and Vernalis Group (UK; LSE:VER; formerly Vanguard Medica Group)

Frovatriptan

5HT 1B/1D agonist

Acute treatment of migraine

Received approvable letter (5/2)

DIABETES

Amylin Pharmaceuticals Inc. (AMLN)

Symlin

Pramlintide acetate; synthetic analogue of human pancreatic hormone amylin

Type I diabetes and Type II insulin-using diabetes

Completed detailed workplan for NDA, which now will include supporting data for three bulk drug suppliers, two suppliers of finished dosage products and one supplier of injector pens (5/15)

INFECTION

Cubist Pharmaceuticals Inc. (CBST)

Cidecin

Daptomycin for injection; lipopeptide antibiotic

Gram-positive infections refractory or resistant to, or contraindicated for, other medications

Filed to expand protocol of companion study to include patients with endocarditis (5/22)

Gilead Sciences Inc. (GILD) and Roche Group (Switzerland)

Tamiflu (FDA-approved)

Oseltamivir; oral neuraminidase inhibitor

Prevention of influenza in individuals 13 and older

Roche submitted application for new indication; product is approved for flu treatment (5/23)

Shearwater Polymers Inc.* and Hoffmann-La Roche (Switzerland)

Pegasys

Peginterferon alfa-2a; once-weekly injection of pegylated version of interferon alfa-2a

Chronic hepatitis C in patients with compensated liver disease

Submitted BLA (5/22)

MISCELLANEOUS

Celgene Corp. (CELG)

Thalomid (FDA-approved)

Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

Erythema nodosum leprosum

FDA sent a letter alleging the company was promoting the drug for unapproved off-label indications, such as cancer; agency demanded the company cease such activities (4/21)

Connetics Corp. (CNCT)

Olux

Clobetasol proprionate foam 0.05%; super-high potency corticosteroid

Short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp

Cleared for marketing (5/31)

Genelabs Technologies Inc. (GNLB)

GL701

Dehydroepiandosterone (DHEA), a naturally occurring hormone produced by the adrenal glands

Systemic lupus erythematosus

Began submission of NDA using rolling process in accordance with fast-track designation (5/31)

Human Genome Sciences Inc. (HGSI)

Repifermin

Recombinant keratinocyte growth factor-2 therapeutic protein (genomics derived); KGF-2 is activated in the event of an epithelial tissue wound

Active ulcerative colitis

FDA cleared IND to begin testing in third indication (5/23)

La Jolla Pharmaceutical Co. (LJPC)

LJP 394

Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA

Lupus

After a positive meeting with the FDA, the company said it plans to conduct a Phase III trial later this year (5/2)

Organogenesis Inc. (AMEX: ORG) and Novartis AG (Switzerland: NYSE:NVS)

Apligraf (FDA-approved)

Living human skin equivalent, composed of living human keratinocytes and fibroblasts

Diabetic foot ulcers of greater than two weeks duration

The FDA's General and Plastic Surgery Devices Panel recommended approval of new indication (5/8)

SangStat Medical Corp. (SANG)

Thymoglobulin (FDA-approved)

Anti-thymocyte globulin; polyclonal antibody produced in rabbits

Myelodysplastic syndrome

IND for new indication accepted for filing (5/9)

SangStat Medical Corp. (SANG) and Abbott Laboratories (NYSE: ABT)

Gengraf capsules

Oral cyclosporine; bioequivalent to Neoral (Novartis AG [Switzerland])

Prevention of organ transplant rejection

Cleared for marketing (5/5)

Sonus Pharmaceuticals Inc. (SNUS)

Echogen

Perflenapent injectable emulsion; fluorocarbon-based ultrasound contrast agent

Improved assessment of the left ventricle during echocardiograph

Company responded to issues raised in FDA's 3/00 request for re-analysis of certain data (5/23)

Zonagen Inc. (ZONA) and Schering-Plough Corp. (NYSE: SGP)

Vasomax

Immediate-release, oral formulation of phentolamine mesylate

Erectile dysfunction

FDA said an additional animal study would be required before the agency could consider approval; FDA recommended two-year rodent study due to concerns about brown fat proliferations observed in earlier rat study; Zonagen is appealing (5/16)

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

IND = Investigational new drug application

ND = Not disclosed

NDA = New drug application

PMA = Premarket approval application