Company* | Product | Description | Indication | Status (Date) |
AUTOIMMUNE | ||||
Amgen Inc. (AMGN) | Enbrel (FDA-approved) | Etanercept; anti-tumor necrosis factor-alpha antibody | Psoriasis | The FDA approved the drug's fifth indication, for treating adults with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy (4/30) |
|
Centocor Inc. (unit of Johnson & Johnson) | Remicade (infliximab; FDA-approved) | Monoclonal antibody that targets and binds to tumor necrosis factor-alpha |
Ankylosing spondylitis | FDA accepted supplemental BLA filing, which primarily was based on the Phase III ASSERT trial (4/19) |
|
Centocor Inc. (unit of Johnson & Johnson) |
Remicade (infliximab; FDA-approved) |
Monoclonal antibody that targets and binds to tumor necrosis factor-alpha |
Rheumatoid arthritis | FDA accepted for filing supplemental BLA as first-line therapy, in combination with methotrexate, for treating early RA patients with moderately to severely active disease (4/6) |
CANCER | ||||
Genta Inc. (GNTA) and Aventis SA (France) |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced melanoma | The drug is being made available, in combination with dacarbazine, through an expanded access program (4/20) |
Maxim Pharmaceuticals Inc. (MAXM) |
Ceplene | Histamine dihydrochloride in combination with interleukin-2 | Advanced malignant melanoma | The FDA approved a treatment protocol allowing Maxim to provide expanded access of drug while the Phase II trial continues (4/14) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer Pharmaceuticals Corp. |
BAY 43-9006 |
RAF kinase and VEGF inhibitor |
Metastatic kidney cancer | The FDA granted fast-track status to the product in that indication; the product is in Phase III trials (4/5) |
|
SuperGen Inc. (SUPG) |
Dacogen |
Decitabine for injection |
Myelodysplatic syndromes | FDA granted SuperGen's request for a rolling NDA submission, which it said should be completed by the end of 3Q:04 (4/22) |
CARDIOVASCULAR | ||||
Discovery Laboratories Inc. (DSCO) |
Surfaxin | Engineered version of natural human lung surfactant | Respiratory distress syndrome in premature infants | Company filed NDA with the FDA based largely on results from two Phase II trials (4/14) |
|
ESP Pharma Inc.* |
-- |
Intravenous formulation of hydralazine |
Severe intrapartum hypertension | The FDA granted orphan designation in that indication associated with severe pre-eclampsia and eclampsia of pregnancy (4/21) |
|
Tishcon Corp.* |
Ubiquinol |
Coenzyme Q10 | Pediatric congestive heart failure | The FDA granted the product orphan designation in that indication (4/19) |
CENTRAL NERVOUS SYSTEM | ||||
|
DOV Pharmaceutical Inc. (DOVP) |
Bicifadine |
Non-narcotic analgesic | Acute pain and chronic back pain (4/1) | DOV and FDA agreed on Phase III program in both indications; trials are expected to start in 3Q:04 (4/1) |
|
Tishcon Corp.* |
Ubiquinol |
Coenzyme Q10 |
Huntington's disease | The FDA granted the product orphan designation in that indication (4/19) |
DIABETES | ||||
Depomed Inc. Biovail Corp. (Canada) |
Glumetza 500 mg and 1,000 mg | Once-daily, extended-release formulations of the approved drug metformin |
Type II diabetes | Companies submitted an NDA (DEPO) and with the FDA covering both dosage formulations (4/28) |
INFECTION | ||||
Immtech International Inc. (AMEX:IMM) | DB289 | Oral, dicationic antiviral agent | African sleeping sickness |
The FDA granted fast-track designation to the product in that indication (4/26) |
MISCELLANEOUS | ||||
|
Bone Care International Inc. (BCII) |
Hectorol (FDA-approved) | Doxercalciferol; pro-hormone vitamin D2 analogue |
Secondary hyperparathyroidism | FDA approved added indication of SHPT that develops in earlier stages of chronic kidney disease prior to dialysis (4/26) |
|
Santarus Inc. (SNTS) |
Rapinex |
Immediate-release formulation of the proton pump inhibitor omeprazole |
Gastric ulcers | FDA accepted for filing the NDA seeking approval for treating gastric ulcers and preventing upper gastrointestinal bleeding in critically ill patients (4/29) |
ThromboGenics Ltd.* (Ireland) | Microplasmin | Thrombolytic agent | Retinal disorders in children | FDA granted orphan designation for use of the drug in pediatric eye surgeries (4/1) |
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange. | ||||
