Avigen Inc.

Coagulin B

Adeno-associated virus used to deliver Factor IX clotting gene

Hemophilia B

FDA approved IND (5/24)

Crescendo Pharmaceuticals Corp. and Alza Corp.

Viadur (a.k.a. DUROS leuprolide)

Leuprolide acetate implant; drug-filled, miniature titanium implant that continuously delivers leuprolide for a full year

Palliative treatment of advanced prostate cancer

Submitted NDA (5/26)

INEX Pharmaceuticals Corp.


Lipid-encapsulated c-myc oligonucleotide

Cancer (in combination with cisplatin)

Filed IND (4/22)

Matrix Pharmaceutical Inc.

IntraDose Injectable Gel

Biodegradable gel combining cisplatin and epinephrine (intratumoralinjection)

Head and neck cancer

Received fast-track designation (5/12)


CytRx Corp.


Purified poloxamer 188; intravenously delivered surfactant moleculethat alters the way cells and molecules interact with water

Sickle cell vasoocclusive crisis

Received fast-track designation (5/17)


Purified poloxamer 188; intravenously delivered surfactant molecule that alters the way cells and molecules interact with water

Sickle cell vasoocclusive crisis

Received 2nd and final installment of $400,000 grant from FDA's Division of Orphan Drug Product Development (5/25)

LXR Biotechnology Inc.


Cardioplegia solution (intended to suppress pathways that initiate apoptosis)

Protection of cardiac tissue during cardiopulmonary bypass surgery

FDA cleared IND (5/18)

Pharmacia & Upjohn (NYSE: PNU)


Dalteparin sodium injection; low molecular weight heparin

Unstable angina and non-Q-wave myocardial infarction

Cleared for marketing (5/26)


Merck & Co. Inc. (NYSE:MRK)


Rofecoxib; specific inhibitor of cyclooxygenase-2

Relief of signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain

Cleared for marketing (5/21)

Novartis AG (Switzerland)


Rivastigmine tartrate capsules

Mild to moderate Alzheimer's disease

Received approvable letter (5/13)


Alteon Inc.


Compound designed to block abnormal glucose/protein complexes (advanced glycosylation end products)

Kidney disease in Type I diabetics

After meeting with FDA, company decided to seek new corporate development partner and will explore the possibility of a Phase III pivotal trial program with proteinuria as a primary endpoint (5/24)

Novo Nordisk A/S (Denmark)


Insulin aspart; rapid acting, self-injected insulin analogue

Diabetes mellitus

European Union's Committee for Proprietary Medicinal Products recommended approval (5/25)


Cerus Corp. and Fenwal division of Baxter International (NYSE:BAX)

Cerus FFP pathogen inactivation system

Inactivates pathogens in fresh frozen plasma using light-activated drug, S-59, a synthetic small molecule from a class known as psoralens; when illuminated, S-59 undergoes specific and irreversible chemical reaction with nucleic acid

Inactivation of pathogens in fresh frozen plasma

Received clearance to proceed with Phase III trial (5/12)

Digene Corp.

Hybrid Capture test for cytomegalovirus

Signal amplification test for cytomegalovirus DNA and

Detection of cytomegalovirus infection

Microbiology Devices Panel voted to allow identification of product as signal amplification assay, which allows for higher reimbursement (5/21)

ID Biomedical Corp. (Canada)

GAS (Group A streptococcus) vaccine

Protein-based (or subunit) vaccine designed to produce an immune response against multiple strains

Prevention of Group A streptococcus infection

National Institute of Allergy and Infectious Disease filed IND (5/11)

Palatin Technologies Inc. (NASDAQ:PLTN)


Antibody-based infection imaging agent

Diagnosis of equivocal appendicitis

Following successful meeting with FDA, company will proceed with Biologics License Application (5/26)

Trimeris Inc.


Synthetically designed peptide that blocks fusion of HIV with host cells; active against T-20 resistant isolates

HIV infection

Received fast-track designation (5/13)


Gliatech Inc.


Resorbable, carbohydrate polymer liquid which achieves broad coverage of the upper peritoneal cavity following application

Inhibition of postsurgical adhesions following certain abdominal and colorectal surgeries

Filed investigational device exemption to initiate pilot trial (5/5)

Immunex Corp. and Wyeth-Ayerst Laboratories division of American Home Products Corp. (NYSE:AHP)

Enbrel (FDA-approved)

Etanercept; recombinant, soluble p75 tumor necrosis factor (TNFr) linked to the Fc portion of human IgG1

Severely active polyarticular-course juvenile rheumatoid arthritis

Companies updated label to advise doctors not to start the drug in patients with severe infections (5/10)

Enbrel (FDA-approved)

Etanercept; recombinant, soluble p75 tumor necrosis factor (TNFr) linked to the Fc portion of human IgG1

Severely active polyarticular-course juvenile rheumatoid arthritis

Cleared for marketing in additional indication (5/28)

Intercardia Inc.


Ultra low molecular weight heparin; oligosaccharide product derived from heparin with antithrombotic and anti-inflammatory properties

Inflammatory bowel disease

IND cleared the FDA's 30-day review period without comment (5/12)

Interferon Sciences Inc. (OTC BB: IFSC)

Alferon N Injection (FDA-approved)

Highly purified, multi-species, natural source human alpha interferon

Treatment-naive hepatitis C infection

Company met with FDA to discuss Phase III trial; agency said an additional study would be required prior to filing for approval (5/25)

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


Immediate-release, oral formulation of phentolamine mesylate

Erectile dysfunction

Companies opted to forgo June advisory panel review of NDA until results of additional studies can be submitted; non-approvable letter expected (5/10)

** Unless otherwise noted, the stock symbols for public companies are listed on pp. 8 and 9.