Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
AltaRex Corp. | OvaRex | Anti-idiotype induction | Late-stage ovarian cancer | Filed IND for 2nd Phase IIb |
(Canada) | therapy-based vaccine; | in patients with elevated | trial (11/4) | |
consists of modified | serum CA125 levels who | |||
murine monoclonal anti- | have completed 1st-line | |||
body that binds to CA125 | treatments | |||
cancer antigen | ||||
OvaRex | Anti-idiotype induction | Recurrent ovarian cancer | Filed IND for open-label | |
therapy-based vaccine; | North American Phase II trial | |||
consists of modified | (11/5) | |||
murine monoclonal anti- | ||||
body that binds to CA125 | ||||
cancer antigen | ||||
Anesta Corp. and | Actiq | Oral transmucosal | Break-through cancer pain | Approved for marketing (11/5) |
Abbott Labora- | fentanyl citrate | in patients who are already | ||
tories (NYSE:ABT) | receiving and are tolerant | |||
to opioid therapy | ||||
DepoTech Corp. | DepoCyt | Injectable, sustained- | Neoplastic meningitis | FDA's Oncologic Drugs |
and Chiron Corp. | release formulation of | arising from lymphomas | Advisory Committee voted | |
chemotherapeutic agent | 6 to 1 to recommend accelera- | |||
cytarabine (uses Depo- | ted approval (11/16) | |||
Foam lipid-based drug | ||||
delivery system) | ||||
Ligand | Panretin | Alitretinoin 0.1% (topical); | Treatment of dermal lesions | FDA's Oncologic Drugs |
Pharmaceuticals | Gel | chemically synthesized | in AIDS-related Kaposi's | Advisory Committee recom- |
Inc. | version of 9-cis-retinoic | sarcoma | mended approval (8 to 1 vote) | |
acid (derived from | (11/16) | |||
vitamin A) | ||||
Vysis Inc. | PathVysion | Assay based on fluores- | To detect and quantify | FDA's Hematology and Path- |
HER2 DNA | cent in situ hybridization | HER2 gene in patients | ology Devices Panel voted | |
Probe Kit | technology (FISH); uses | with breast cancer | unanimously to recommend | |
locus-specific, direct- | approval (11/9) | |||
label DNA probe that | ||||
binds to HER2 gene in | ||||
tissue biopsy | ||||
CARDIOVASCULAR | ||||
Avigen Inc. | Gene therapy; use of | Hemophilia B | Filed IND for Phase I trial | |
adeno-associated viral | (11/10) | |||
(AAV) vector to deliver | ||||
gene for Factor IX to | ||||
muscle | ||||
BioTime Inc. | Hextend | Blood plasma volume | Replacement of blood | FDA completed its review of |
expander | volume during surgery | NDA and sent company an | ||
in which substantial | action letter requesting several | |||
amounts of blood are lost | clarifications (11/20) | |||
DIABETES | ||||
Ergo Science | Ergoset | Low-dose, oral formu- | Type II diabetes (mono- | FDA sent company a not |
Corp. | Tablets | lation of bromocriptine | therapy as adjunct to diet | approvable letter, citing |
(ergot alkaloid; generic | to improve glycemic | unfavorable risk/benefit ratio | ||
dopamine agonist) | control in diabetics) | (11/23) | ||
INFECTION | ||||
Glaxo Wellcome | Ziagen | Abacavir; nucleoside | HIV infection and AIDS | FDA's Antiviral Drugs |
plc (NYSE:GLX; | analogue reverse trans- | in children and adults | Advisory Committee voted | |
U.K.) | criptase inhibitor (oral; | (combination therapy with | 7 to 2 to recommend expedited, | |
tablet and liquid; twice- | AZT [Retrovir] and 3TC | accelerated approval (11/2) | ||
daily dosing) | [Epivir]) | |||
Nabi | H-BIG | Reformulated hepatitis | Prevention of reinfection | Filed expanded access IND |
B immune globulin | of transplanted livers in | (11/16) | ||
(human) | patients with chronic | |||
hepatitis B virus infection | ||||
OraVax Inc. (OTC | Colitis | Clostridium difficile | Prevention and treatment | Filed IND for Phase I trial |
Bulletin Board: | vaccine | toxoid vaccine (pre- | of C. difficile colitis | (11/24) |
ORVX) | pared from inactivated | |||
bacterial toxins) | ||||
MISCELLANEOUS | ||||
Celgene Corp. | CDC 801 | Selective cytokine | Crohn's disease | Filed IND for Phase II trials |
inhibitory drug; inhibits | (11/24) | |||
overproduction of tumor | ||||
necrosis factor (oral) | ||||
GelTex Pharma- | RenaGel | Non-absorbed polymer- | Control of elevated | Approved for marketing (11/2) |
ceuticals Inc. and | Capsules | based compound that | phosphorus levels in | |
Genzyme Corp. | binds to and eliminates | patients with end-stage | ||
target substances from | renal disease | |||
the intestinal tract | ||||
Immunex Corp. | Enbrel | Recombinant, soluble | Moderate-to-severe | Approved for marketing (11/2) |
and Wyeth-Ayerst | p75 tumor necrosis factor | active rheumatoid arthritis; | ||
Laboratories (unit | receptor (TNFr) linked | for use as monotherpay in | ||
of American Home | to the Fc portion of | patients who have failed | ||
Products Corp.; | human IgG1 | other therapies; also for use | ||
NYSE:AHP) | in combination with | |||
methotrexate | ||||
Immunex Corp. | Enbrel | Recombinant, soluble | Moderate-to-severe | Submitted supplemental BLA |
and Wyeth-Ayerst | p75 tumor necrosis factor | active rheumatoid arthritis | (11/25) | |
Laboratories (unit | receptor (TNFr) linked | in juveniles (ages 4-17) | ||
of American Home | to the Fc portion of | |||
Products Corp.; | human IgG1 | |||
NYSE:AHP) | ||||
SangStat | SangCya | Cyclosporine (oral formu- | Prevention of rejection in | Cleared for marketing (11/3) |
Medical Corp. | (formerly | lation; buioequivalent to | solid organ transplant | |
Sang-35) | Neoral oral solution) | recipients | ||
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. 9-10. |