| Company** | Product | Description | Indication | Type Action/Date |
| Name | ||||
| CANCER | ||||
| Genzyme Corp. | Thyrogen | Recombinant human | For use in diagnostic proce- | FDA accepted NDA for |
| thyroid stimulating | dures (radio-iodine whole- | filing and granted it | ||
| hormone | body scanning) used to | priority review status | ||
| monitor patients for recur- | (2/18) | |||
| rence of thyroid cancer | ||||
| NeoPharm Inc. | Neomark | Broxiuridine; a radio- | Prognostic test to | Company will provide |
| sensitizer that is incor- | measure tumor cell pro- | FDA with additional | ||
| porated into DNA of | liferation in breast | information and analysis on | ||
| tumor cells | cancer | its product application (2/2) | ||
| Seragen Inc. (OTC | DAB389IL-2 | Denileukin diftitox; | Recurrent or persistent | FDA accepted BLA for |
| Bulletin Board:SRGN) | interleukin-2 (IL-2) fusion | cutaneous T cell lymph- | filing and designated | |
| protein consisting of | oma in patients who | application for priority | ||
| diphtheria toxin fragment | have received prior | review (2/4) | ||
| A-fragment B genetically | therapy | |||
| fused to human IL-2 (targets | ||||
| high-affinity IL-2 receptors | ||||
| on activated T cells) | ||||
| SuperGen Inc. | MitoExtra | Mitomycin reformulated | Various cancers | FDA accepted NDA for |
| with 'shielding' drug | filing (2/24) | |||
| delivery technology | ||||
| CARDIOVASCULAR | ||||
| Diatide Inc. | AccuTect | Small molecule syn- | In vivo imaging agent | FDA's Medical Imaging |
| thetic peptide, designed | for acute deep vein | Advisory Committee | ||
| to adhere to GPIIb/IIIa | thrombosis | recommended approval | ||
| receptors on activated | (7 to 4 vote, 1 abstension) | |||
| platelets, labeled with | (2/9); FDA sent company | |||
| technetium-99m | an approvable letter (2/23) | |||
| The Medicines | Hirulog | Synthetic thrombin | Anticoagulant for use | FDA accepted NDA for |
| Co.* | inhibitor based on | in patients with unstable | filing (2/18) | |
| hirudin (natural anti- | angina undergoing per- | |||
| coagulant secreted by | cutaneous transluminal | |||
| leeches) | coronary angioplasty | |||
| Sonus Pharma- | EchoGen | Fluorocarbon-based | Contrast radiography | FDA requested additional |
| ceuticals Inc. | Emulsion | ultrasound contrast | information in its review | |
| agent | of NDA, including a re- | |||
| analysis of some of animal | ||||
| and clinical data (2/26) | ||||
| CENTRAL NERVOUS SYSTEM | ||||
| Alexion Pharma- | Apogen MP4 | MP4 is recombinant | Multiple sclerosis | Filed IND (2/23) |
| ceuticals Inc. | molecule designed to | |||
| eliminate T cells that target | ||||
| nerves in the brain based | ||||
| (on Apogen technology) | ||||
| MISCELLANEOUS | ||||
| Anika Thera- | Orthovisc | Ultra-pure, high mole- | Osteoarthritis of the | FDA accepted PMA for |
| peutics Inc. | cular-weight naturally | knee | filing and said it will not | |
| derived hyaluronic acid | require advisory panel | |||
| (intra-articular injection) | review (2/24) | |||
| Bio-Technology | BioLon | 1% solution of sodium | For use in ophthalmic | FDA sent company an |
| General Corp. | hyaluronate (visco- | surgical procedures | approvable letter (2/3) | |
| elastic lubricant) | (i.e., cataract removal) | |||
| Centocor Inc. | Avakine | Infliximab; chimeric | Moderate-to-severe | FDA accepted BLA for |
| (formerly cA2 | monoclonal antibody | Crohn's disease, includ- | filing and designated | |
| or Cen-TNF) | to tumor necrosis | ing fistulizing Crohn's | application for priority | |
| factor-alpha | disease | review (2/25) | ||
| Connetics Corp. | Betametha- | Foam formulation of | Treatment of all steroid- | FDA accepted NDA for |
| sone mousse | corticosteroid beta- | responsive dermatoses, | filing (2/25) | |
| methasone-17-alpha | including scalp psoriasis | |||
| valerate | ||||
| Metra Biosystems | Pyrilinks-D | Urine-based assay that | Test to monitor anti- | Cleared for marketing |
| Inc. | Assay | measures excretion of | resorptive drugs | (2/3) |
| (FDA- | deoxypyridinoline cross- | (including Fosamax) | ||
| approved) | links (immunoassay; | in treatment and pre- | ||
| biochemical indicator of | vention of post-meno- | |||
| bone resorption) | pausal osteoporosis | |||
| MGI Pharma Inc. | Salagen | Pilocarpine HCl | Treatment of dry mouth | Approved for marketing |
| Tablets | caused by Sjogren's | (2/17) | ||
| syndrome (autoimmune | ||||
| disease) | ||||
| Penederm Inc. | Avita Gel | Topical formulation of | Treatment of acne | Cleared for marketing |
| retinoic acid (tretinoin); | (2/3) | |||
| employs TopiCare liquid | ||||
| polymers for drug delivery | ||||
| SangStat Medical | Sang-35 | Cyclosporine generic | Prevention of graft | FDA sent company an |
| Corp. | drug (immunosuppres- | rejection in organ | action letter, citing minor | |
| sive) | transplantation | deficiencies in AADA (2/12) | ||
| NOTES: | ||||
| Not all the companies represented in this chart are biotechnology firms. Large pharmaceutical companies are included from time to time when the products they are developing address overwhelmingly important diseases such as AIDS and cancer, and where biotech companies are developing competing products. | ||||
| * Private companies are indicated with an asterisk. | ||||
| ** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 14-15. | ||||
