Company** |
Product |
Description |
Indication |
Action/Date |
CANCER | ||||
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. |
INXC-6295 |
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) |
CARDIOVASCULAR | ||||
CytRx Corp. |
Flocor |
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) |
Flocor |
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. |
CP-Cardiosol |
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) |
Fragmin |
Dalteparin sodium injection; low molecular weight heparin |
Unstable angina and non-Q-wave myocardial infarction |
Cleared for marketing (5/26) |
CENTRAL NERVOUS SYSTEM | ||||
Merck & Co. Inc. (NYSE:MRK) |
Vioxx |
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) |
Exelon |
Rivastigmine tartrate capsules |
Mild to moderate Alzheimer's disease |
Received approvable letter (5/13) |
DIABETES | ||||
Alteon Inc. |
Pimagedine |
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) |
NovoRapid |
Insulin aspart; rapid acting, self-injected insulin analogue |
Diabetes mellitus |
European Union's Committee for Proprietary Medicinal Products recommended approval (5/25) |
INFECTION | ||||
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) |
LeuTech |
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. |
T-1249 |
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) |
MISCELLANEOUS | ||||
Gliatech Inc. |
ADCON-A |
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. |
OP2000 |
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) |
Vasomax |
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. |