Company** Product Description Indication Type Action (Date)
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
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
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)
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)
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)
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
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
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
Not all the companies represented in this chart are biotechnologyfirms. Large pharmaceutical companies are included from time to time whenthe products they are developing address overwhelmingly important diseasessuch as AIDS and cancer, and where biotech companies are developing competingproducts.
* Private companies are indicated with an asterisk.
** Unless otherwise noted, the trading symbols for publicbiotechnology companies can be found by referring to the BioWorld StockReport For Public Biotechnology Companies on pp. 9-10.