Company* |
Product | Description |
Indication | Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Amgen Inc. |
Enbrel (FDA-approved) |
Etanercept; anti- tumor necrosis factor-alpha antibody |
Rheumatoid arthritis |
FDA approved an indication to induce a major clinical response in RA patients (9/28) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Rheumatoid arthritis |
The FDA approved an expanded label as a first-line treatment, in combination with methotrexate, to treat moderate to severe RA (9/30) |
CANCER | ||||
Biomira Inc. |
BLP25 |
Therapeutic vaccine encapsulating a sequence of the MUC1 cancer mucin in a liposomal delivery system |
Non-small-cell lung cancer |
The FDA granted fast-track status to the product for treating late-stage NSCLC patients (9/29) |
Burzynski |
Anti-neoplastons A10 and AS2-1 |
Compounds composed of growth-inhibiting peptides, amino acid derivatives and organic acids |
Brain stem glioma |
The FDA granted orphan designation to the products in that indication (9/7) |
Corixa Corp. |
Bexxar (FDA-approved) |
Radiolabeled antibody combining tositumomab and iodine-131; targets CD20 antigen on B cells lymphoma |
Low-grade, follicular or transformed CD20-positive non-Hodgkin's lymphoma |
The FDA accepted for review the supplemental BLA, which was filed in July; the FDA also granted priority- review status to the filing (9/20) |
Guilford |
Gliadel Wafer (FDA-approved) |
Wafer comprised of a biodegradable polymer incorporating carmustine |
Malignant glioma |
FDA granted orphan designation to the product in malignant glioma patients undergoing primary surgical resection (9/27) |
OSI |
Tarceva |
Erlotinib HCl; small-molecule HER1/EGFR inhibitor |
Non-small-cell lung cancer |
The FDA accepted for review the NDA, which was filed in August for treating advanced patients for whom chemotherapy has failed (9/30) |
CARDIOVASCULAR | ||||
CoTherix Inc.* |
Ventavis |
Inhaled formulation of iloprost, a prostacyclin analogue |
Pulmonary arterial hypertension |
The FDA accepted for review the NDA, which was filed in July; the product also was granted priority review and received orphan designation; it is sold in Europe by Schering AG (9/8) |
KAI |
KAI-9803 |
Protein kinase C inhibitor; targets the delta-PKC isozyme |
Acute myocardial infarction |
The FDA granted orphan designation to the product in that indication (9/28) |
NovaDel |
-- |
Aerosol nitroglycerin lingual spray |
Angina |
The FDA acecpted for review the NDA, which seeks approval for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease (9/29) |
CENTRAL NERVOUS SYSTEM | ||||
Boston Life |
Axosine |
Small-molecule axonal growth factor |
Motor function recovery after a stroke |
The FDA placed a hold on a Phase I trial pending the submission of additional pharmacology/toxicology data (9/14) |
Prestwick |
Tetrabenazine |
Dopamine depletor that works by selectively blocking the VMAT2 transporter |
Chorea associated with Huntington's disease |
The FDA designated fast-track and orphan status to the drug, which is on the market in Europe and Canada (9/16) |
Proneuron |
ProCord |
Autologous incubated macrophage therapy |
Acute spinal cord injury |
The FDA granted orphan designation to the Phase II product for improving motor and sensory neurological outcomes (9/13) |
DIABETES | ||||
Amylin |
Exenatide |
Incretin mimetic; synthetic exendin-4 |
Type II diabetes |
The FDA accepted for review the NDA on the drug, which was filed in June (9/1) |
INFECTION | ||||
Acambis plc |
-- |
Modified vaccinia Ankara vaccine |
Smallpox infection |
The FDA granted fast-track status to the vaccine, which is being developed under a contract from the NIH (9/24) |
Acambis plc |
ACAM2000 |
Second-generation vaccine |
Smallpox |
The FDA lifted the clinical hold it had placed on Phase III trial, and agreed that the current enrollment was sufficient to complete data analysis (9/20) |
Access |
OraDisc A |
Amlexanox delivered via a mucoadhesive patch |
Canker sores |
The FDA approved the product for treating aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system (9/30) |
Depomed |
Proquin XR |
Once-daily, extended-release formulation of the antibiotic ciprofloxacin |
Uncomplicated urinary tract infections |
The FDA accepted for review the NDA, which was filed in July (9/20) |
Inhibitex |
Aurexus |
Humanized monoclonal antibody that targets the ClfA protein on the surface of S. aureus |
S. aureus infections |
The FDA designated fast-track status to the Phase II product (9/21) |
Vicuron |
Anidulafungin |
Broad-spectrum agent from the echinocandin class |
Esophageal candidiasis; invasive candidiasis/ candidemia |
Following FDA approvable letter in May, company said it expected to file NDA supplement in 2Q:05 for esophageal candidiasis; in invasive disease, filing is planned for 3Q:05 using integrated data (9/21) |
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg (alvimopan) |
Mu opioid antagonist |
Postoperative ileus |
The FDA accepted for review the NDA, which was filed in June, and designated it for standard review (9/8) |
Atrix |
Aczone (Atrisone) |
Dapsone gel formulated with Atrix's SMP technology |
Acne |
Companies submitted an NDA with the FDA (9/1) |
Altus |
TheraCLEC |
Oral enzyme-replacement |
Pancreatic |
The FDA selected the product for participation in the Continuous Marketing Application Pilot 2 pro- gram (9/10) |
Cellegy |
Cellegesic |
Nitroglycerin ointment |
Pain from anal fissures |
The FDA accepted for review the NDA on the product, which was filed in June (9/1) |
Halozyme |
Cumulase |
Ex vivo formulation of recombinant human PH20 hyaluronidase |
Treatment of oocytes |
Submitted a 510(k) application to the FDA for treating oocytes to facilitate certain in vitro fertilizations (9/14) |
ISTA |
Vitrase (FDA-approved) |
Ovine hyaluronidase formulation |
For use as a spreading agent |
The FDA granted three years of market exclusivity to the product, which was approved in May (9/21) |
Miravant |
SnET2 |
Photodynamic therapy that uses a light-activated drug to destroy abnormal blood vessels |
Age-related macular degeneration |
The FDA issued an approvable letter that calls for an additional trial before approval can be gained (9/30) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board. | ||||
