| FDA Submissions, Approvals And Other Actions: | ||||
| October 1998 | ||||
| Company** | Product | Description | Indication | Type Action (Date) |
| CANCER | ||||
| AltaRex Corp. | BrevaRex | Anti-idiotype induction | Metastatic cancers that | Filed IND for Phase I trial |
| (Canada) | therapy; murine monoclon- | express MUC1 antigen | (10/13) | |
| al antibody that is devel- | ||||
| oped from, and specifically | ||||
| binds to, MUC1 tumor- | ||||
| associated antigen | ||||
| DepoTech Corp. | DepoCyt | Injectable, sustained- | Neoplastic meningitis | DepoTech initiated submis- |
| and Chiron Corp. | release formulation of | arising from lymphomas | sion of NDA (10/9) | |
| chemotherapeutic agent | ||||
| cytarabine (uses Depo- | ||||
| Foam lipid-based drug | ||||
| delivery system) | ||||
| CARDIOVASCULAR | ||||
| The Medicines Co.* | Hirulog | Synthetic thrombin | Anticoagulant for use in | FDA's Cardiovascular and |
| inhibitor based on | patients with unstable | Renal Drugs Advisory Com- | ||
| hirudin (natural anti- | angina undergoing per- | mittee voted 4-3 not to | ||
| coagulant secreted by | cutaneous transluminal | recommend approval (10/23) | ||
| leeches) | coronary angioplasty | |||
| DIABETES | ||||
| Advanced Tissue | Dermagraft | Human tissue-engi- | Wound healing in | FDA approved treatment |
| Sciences Inc. and | neered replacement for | diabetic foot ulcers | investigational device exemp- | |
| Smith & Nephew | dermal layer of skin | tion (IDE) (10/12) | ||
| plc (U.K.) | (viable human dermal | |||
| fibroblasts, derived from | ||||
| foreskins, cultured on | ||||
| bioresorbable scaffold) | ||||
| Generex Biotech- | Oralgen | Oral insulin (liquid; | Types I and II diabetes | Filed IND for Phase II and |
| nology Corp. | administered with metered | III trials (10/19) | ||
| (OTC Bulletin Board: | dose aerosol applicator) | |||
| GNBT; Canada) | ||||
| INFECTION | ||||
| BioChem Pharma | Epivir-HBV | Nucleoside analogue | Chronic hepatitis B | FDA's Antiviral Drugs |
| Inc. (Canada) and | (a.k.a. | (oral dosage) | virus infection in | Advisory Committee recom- |
| Glaxo Wellcome plc | lamivudine) | adults | mended approval (unani- | |
| (NYSE:GLX; U.K.) | mous vote) (10/6) | |||
| Biota Holdings Ltd. | Relenza | Zanamivir; neuraminidase | Treatment and prevention | Glaxo submitted NDA (10/27) |
| (ASX:BTA; Australia) | inhibitor (designed and | of influenza A and B | ||
| and Glaxo Wellcome | synthesized based on | |||
| plc (NYSE:GLX; U.K.) | crystal structure of surface | |||
| proteins of influenza virus); | ||||
| inhaled in powder form | ||||
| SunPharm Corp. | DEHOP | Diethylhomospermine; | AIDS-related diarrhea | FDA told company that it |
| analogue of naturally occur- | needs to conduct another | |||
| ring essential intracellular | Phase II trial before moving on | |||
| polyamine compound | to pivotal trials (10/26) | |||
| Vertex Pharma- | Agenerase | Amprenavir; 2nd-genera- | Combination therapy | Glaxo submitted NDA (10/16) |
| ceuticals Inc. and | tion HIV protease inhibitor; | with antiretroviral drugs | ||
| Glaxo Wellcome plc | twice-daily dosage | for HIV and AIDS | ||
| (NYSE:GLX; U.K.) | ||||
| MISCELLANEOUS | ||||
| Anika Thera- | Orthovisc | High-molecular weight | Osteoarthritis of the | FDA sent company a letter |
| peutics Inc. and | naturally derived form | knee | stating that PMA is not | |
| Zimmer Inc. (sub- | of hyaluronic acid | approvable; additional clin- | ||
| sidiary of Bristol- | ical data required to show | |||
| Myers Squibb Co.; | effectiveness (10/19) | |||
| NYSE:BMY) | ||||
| CollaGenex | Periostat | Orally administered | Adjunct to scaling and | Approved for marketing |
| Pharmaceuticals | drug consisting of | root planing for treating | (10/1) | |
| Inc. | subantibiotic dose of | moderate to severe | ||
| doxycycline (inhibits pro- | periodontitis in adults | |||
| duction of collagenase) | ||||
| Cypress | Prosorba | Disposable filter that | Moderate-to-severe | FDA's Gastroenterology and |
| Bioscience Inc. | Column | uses Protein A to | rheumatoid arthritis in | Urology Device Advisory |
| (FDA- | remove circulating | patients who have failed | Panel recommended approval | |
| approved) | immune complexes | 2nd-line therapy | (10 to 1 vote), with post-mar- | |
| from patient's blood | keting study required (10/29) | |||
| Discovery | Surfaxin | Sinapultide; lung sur- | Acute respiratory | FDA granted product fast- |
| Laboratories Inc. | factant containing the | distress syndrome from | track status (10/15) | |
| peptide KL4 (a 21- | direct causes (i.e., non- | |||
| amino-acid peptide | sepsis causes such as | |||
| modeled after the SP-B | pneumonia) | |||
| protein in the human | ||||
| surfactant system) | ||||
| Surfaxin | Sinapultide; lung sur- | Meconium aspiration | FDA granted product fast- | |
| factant containing the | syndrome (severe | track status (10/21) | ||
| peptide KL4 (a 21- | respiratory disease | |||
| amino-acid peptide | in infants) | |||
| modeled after the SP-B | ||||
| protein in the human | ||||
| surfactant system) | ||||
| 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. | ||||
| ASX = Australian Stock Exchange | ||||
| * 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. 13-14. | ||||
