Company** |
Product |
Description |
Indication | Type Action (Date) |
CANCER | ||||
AltaRex Corp. (Canada) | OvaRex | Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to CA125 cancer antigen |
To delay time to disease recurrence in advanced ovarian cancer |
FDA granted product fasttrack status (12/21) |
Aronex Pharmaceuticals Inc. |
Atragen |
Liposomal formulation of all-trans retinoic acid; induces tumor cells to differentiate into mature normal cells (injection) |
Acute promyelocytic leukemia in patients unable to take oral formulation of tretinoin |
Submitted NDA (12/7) |
Cell Pathways Inc. |
CP461 | Compound that triggers selective apoptosis in neoplastic cells by inhibiting enzyme cyclic GMP phosphodiesterase | Cancer | Filed IND for Phase I trial (12/29) |
Coulter Pharmaceutical Inc. |
Bexxar | Iodine I-131 tositumomab; murine monoclonal antibody against CD20 antigen on B cells, labeled with I-131 | Non-Hodgkin's lymphoma in patients refractory to chemotherapy |
FDA granted product fast-track status (12/7) |
Diatide Inc. |
NeoTect | Small-molecule synthetic peptide labeled with technetium-99m; peptide designed to adhere to somatostatin receptor | In vivo imaging agent for suspected malignant tumors of the lung |
FDA sent company an approvable letter (12/17) |
Genzyme Corp. |
Thyrogen | Thyrotropin alfa for injection; recombinant hormone |
For use in diagnostic procedures (with or without radio-iodine whole-body thyroid stimulating scanning) used to monitor patients for recurrence of thyroid cancer |
Approved for marketing (12/1) |
The Liposome Co. Inc. | Evacet |
Liposomal formulation of doxorubicin |
Metastatic breast cancer (combination therapy with cyclophosphamide) |
Submitted NDA (12/15) |
Sugen Inc. | SU 6668 | Small-molecule compound with anti-angio-genic and cytostatic properties; targets Flk-1/KDR, platelet-derived growth factor and fibroblast growth factor receptors |
Advanced solid tumors (especially for chronic therapy) |
Filed IND (12/23) |
Vysis Inc. | PathVysion HER2 DNA Probe Kit |
Assay based on fluorescent in situ hybridization technology (FISH); uses locus-specific, direct-label DNA probe that binds to HER-2 gene in tissue biopsy |
To detect and quantify HER-2 gene in patients with breast cancer | Cleared for marketing (12/14) |
CARDIOVASCULAR | ||||
Cypros Pharmaceutical Corp. | Cordox |
Cardioprotective drug; small-molecule compound designed to reduce accumulation of lactate; facilitates anaerobic glycolysis |
Sickle cell anemia crisis |
FDA granted drug expedited development status (12/14) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. |
Provigil Tablets | Modafinil; oral formulation of synthetic compound that is thought to affect alpha-adrenergic receptors in the brain |
Narcolepsy (excessive daytime sleepiness); 1st-line therapy | Approved for marketing (12/28) |
INFECTION | ||||
Avanir Pharmaceuticals | | N-docosanol 10% cream; long-chain fatty acid that interferes with viral entry into cells |
Treatment of oral-facial | FDA sent company an action letter stating that NDA is not approvable (additional clinical evidence needed to substantiate efficacy) (12/23) |
BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (NYSE:GLX; U.K.) | Epivir-HBV (lamivudine) |
Nucleoside analogue (once-daily oral dosage) |
Chronic hepatitis B virus infection in adults |
Approved for marketing (12/9) |
Biota Holdings Ltd. (ASX:BTA; Australia) and BioStar Inc.* | FLU OAI |
Optical immunoassay; rapid point-of-care influenza diagnostic |
Assay for early detection of influenza virus strains A and B | Cleared for marketing (12/2) |
Glaxo Wellcome plc (NYSE:GLX; U.K.) |
Ziagen | Abacavir; nucleoside analogue reverse trans-criptase inhibitor (oral; tablet and liquid; twice-daily dosing) |
HIV infection and AIDS in children and adults (combination therapy with AZT [Retrovir] and 3TC [Epivir]) |
Approved for marketing (accelerated approval) (12/18) |
MedImmune Inc. |
CytoGam (FDA-approved) |
Intravenous immune globulin (human) enriched in antibodies to cytomegalovirus (CMV) | Prophylaxis of CMV disease associated with organ transplantation (combination therapy with ganciclovir) |
Approved for marketing (expanded indication) (12/9) |
Schering-Plough Corp. (NYSE:SGP) | Rebetron (FDA-approved) |
Combination of Intron A (recombinant human interferon alfa-2b; injection) and Rebetol (riba-virin; synthetic nucleo-side with antiviral activity; oral) |
Combination therapy for treating chronic hepatitis C virus infection in patients with compensated liver disease who have not received prior alpha-inter-feron therapy (treatment-naive) |
Approved for marketing (2nd indication) (12/9) |
SmithKline Beecham plc (NYSE:SBH; U.K.) | LYMErix |
Recombinant OspA vaccine (outer surface protein A; antigen from tick-borne bacterium Borrelia burgdorferi, which causes the infection) | Prevention of Lyme disease (both definitive disease and asymptomatic infection) |
Approved for marketing (12/21) |
MISCELLANEOUS | ||||
Cygnus Inc. and Wyeth-Ayerst (division of American Home Products |
E2111 |
7-day estrogen transdermal patch |
Hormone replacement therapy |
Wyeth-Ayerst submitted NDA (12/1) |
Hyal Pharmaceutical Corp. (TSE:HPC; Canada) |
Solarase | 3% diclofenac gel (topical) | Actinic keratosis (pre-cancerous skin lesions caused by exposure to sun) |
FDA accepted NDA for review (12/22) |
SangStat Medical Corp. |
Thymoglobulin |
Anti-thymocyte globulin; polyclonal antibody produced in rabbits |
Reversal of acute organ rejection in kidney transplant recipients |
Approved for marketing (12/30) |
G.D. Searle & Co. Inc. (unit of Monsanto Co.; NYSE:MTC) |
Celebrex |
Celecoxib; compound inhibits COX-2 enzyme (cyclooxygenase; plays role in pain and inflammation) but not COX-1 (helps maintain normal stomach lining) |
Osteoarthritis and adult rheumatoid arthritis |
Approved for marketing (12/31) |
Transkaryotic Therapies Inc. | Alpha-Gal A |
Alpha-galactosidase A | Protein replacement for Fabry's disease (lysosomal storage disease) | FDA granted product fasttrack status (12/14) |
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; TSE = Toronto 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. 14-15. | ||||
