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Company** Product Description Indication Type Action (Date)
CANCER
Bristol-Myers Squibb Taxol Paclitaxel; semi-syn- Combination therapy FDA's Oncologic Drugs
Co. (NYSE:BMY) (FDA- thetic taxane; inhibits with cisplatin as 1st- Advisory Committee
approved) cancer cell division by line treatment of ad- recommended approval
blocking microtubule vanced ovarian cancer (3/20)
assembly/disassembly;
derived from needles
and twigs of yew tree
Taxol Paclitaxel; semi-syn- Combination therapy FDA's Oncologic Drugs
(FDA- thetic taxane; inhibits with cisplatin for treat- Advisory Committee
approved) cancer cell division by ing non-small cell lung recommended approval
blocking microtubule cancer in patients who (3/20)
assembly/disassembly; are not candidates for
derived from needles radiation therapy
and twigs of yew tree
CellPro Inc. Ceprate SC Stem cell concentration Expanded label to FDA's Biological
System device; separates stem include device's ability Response Modifiers
(FDA- cells from other cells of to concentrate stem cells Advisory Committee
approved) bone marrow or peri- from peripheral blood voted unanimously that
pheral blood using an as a support for myelo- benefits outweigh risks
avidin/biotin immuno- ablative therapy; to (3/24)
affinity selection system reduce number of tumor
cells present in autograft
DepoTech Corp. DepoCyt Injectable, sustained- Neoplastic meningitis DepoTech will submit
and Chiron Corp. release formulation of arising from solid amendment to NDA that
chemotherapeutic agent tumors includes additional clin-
cytarabine (uses Depo- ical trial data; extends
Foam lipid-based drug FDA's review period to
delivery) 7/28/98 (3/6)
Genentech Inc. Herceptin Trastuzumab; human- Treatment of HER2- FDA designated Hercep-
ized monoclonal anti- overexpressing meta- tin as fast-track product
body to HER2 growth static breast cancer (3/31)
factor receptor
Nexell Therapeutics Isolex 300 Stem cell selection To support enrichment Submitted supplement to
Inc. (majority-owned and systems; devices that of CD34+ cells and BLA requesting simulta-
subsidiary of Vimrx Isolex 300i separate CD34+ stem reduction of non-target neous review of both
Pharmaceuticals Inc.) cells from peripheral cells (including tumor devices (3/17)
blood (Isolex 300 is cells) in autologous
semi-automated; Isolex transplants in breast
300i is fully automated) cancer, non-Hodgkin's
lymphoma and other
B cell malignancies
Pacific BOPP Boronated porphyrin Malignant brain tumors Filed IND for clinical
Pharmaceuticals Inc. compound (light-activated trial (to be conducted
drug for photodynamic in Australia) (3/3)
therapy)
CARDIOVASCULAR
BioTime Inc. Hextend Blood plasma volume Replacement of blood Completed submission of
expander volume during surgery NDA (3/31)
in which substantial
amounts of blood are lost
LXR Biotechnology CP-Cardiosol Cardioplegia solution To reduce long-term Filed IND for open-label
Inc. (intended to suppress heart damage in connec- Phase I/II trial (3/17)
pathways that initiate tion with coronary artery
apoptosis) bypass graft surgery
CENTRAL NERVOUS SYSTEM
The Ares-Serono Rebif Recombinant interferon Multiple sclerosis Submitted BLA (2/27)#
Group (Switzerland) beta-1a (relapsing-remitting;
also transitional)
Elan Corp. plc Zonegran Zonisamide capsules; Adjunctive therapy for FDA sent company an
(Ireland) blocks voltage-sensitive treating partial seizures approvable letter (3/24)
sodium and calcium in adults with epilepsy
channels
INFECTION
Genentech Inc. Pulmozyme Dornase alfa; Reduction of incidence FDA approved change in
(FDA- recombinant human of respiratory tract label (to include patients
approved) DNase (aerosolized infections in patients under the age of 5) (3/2)
inhalation solution) with cystic fibrosis
Isis Pharmaceuticals Fomivirsen Antisense inhibitor of Newly diagnosed and Isis submitted chemistry,
Inc. and Ciba Vision (ISIS 2922) cytomegalovirus (CMV) advanced CMV retinitis manufacturing and con-
Corp. (unit of Novartis replication in AIDS patients trols section of NDA
AG; Switzerland) (3/25)
Lidak Lidakol Long-chain fatty Recurrent outbreaks of FDA accepted NDA for
Pharmaceuticals (n-docosanol) alcohol believed to oral herpes (cold sores review (2/26)#
work by interfering or fever blisters caused
with viral entry into by herpes simplex virus)
cells (topical)
Merck & Co. Inc. Crixivan Indinavir sulfate; HIV Treatment of HIV infec- Received traditional mar-
(NYSE:MRK) protease inhibitor tion, either as monother- keting approval (initially
apy or in combination approved under accelerated
with nucleoside ana- review 3/96) (3/5)
logues
Unimed NTZ Nitazoxanide: a nitro- Cryptosporidiosis in FDA assigned priority
Pharmaceuticals Inc. thiazole compound with AIDS patients (caused review status to NDA
(NASDAQ:UMED) activity against many by Cryptosporidium (3/5)
protozoan and helmin- parvum)
thic pathogens
MISCELLANEOUS
Anergen Inc. and AnergiX Product that incorporates Rheumatoid arthritis Filed IND (3/17)
NV Organon an Organon peptide de-
(the Netherlands) rived from human carti-
lage-derived glycoprotein;
intended to selectively
inactivate T cells that
cause specific inflamma-
tory autoimmune response
CollaGenex Periostat Orally administered Adjunct to scaling and CollaGenex will submit
Pharmaceuticals Inc. drug consisting of root planing for treating amendment to NDA con-
subantibiotic dose of moderate to severe taining results of scaling/
doxycycline (inhibits periodontitis in adults root planing trial (3/16);
production of completed submission
collagenase) of amendment (3/31)
Immunex Corp. Enbrel Recombinant, soluble Severe rheumatoid FDA designated Enbrel as
p75 tumor necrosis arthritis fast-track product (3/17)
factor receptor (TNFr)
linked to the Fc portion
of human IgG1
Immunomedics Inc. ImmuSTRIP- Immunoassay to detect Detection and semi- Cleared for marketing
HAMA human anti-mouse anti- quantitation of HAMA (3/20)
bodies (HAMA) in blood in patients receiving
injections of mouse
antibodies for diagnostic
and/or therapeutic uses
Ligand Pharma- TSE-424 Tissue-selective Postmenopausal Wyeth-Ayerst filed IND
ceuticals Inc. and estrogen osteoporosis (3/26)
Wyeth-Ayerst Lab-
oratories (division of
American Home Pro-
ducts Corp.; NYSE:AHP)
Ostex International Osteomark Assay that measures To determine probabil- FDA approved expanded
Inc. Assay cross-linked N-telopep- ity of reduction in bone indication (3/26)
(FDA- tides of type I collagen mineral density in post-
approved) excreted in urine menopausal women not
taking hormonal anti-
resorptive therapy
Pharmos Corp. and Alrex Loteprednol etabonate Treatment of ophthal- Approved for marketing
Bausch & Lomb ophthalmic suspension mic allergies (especially (3/10)
Pharmaceuticals Inc. 0.2% (topical steroid) seasonal allergic conjunc-
(NYSE:BOL) tivitis)
Lotemax Loteprednol etabonate Treatment of ophthalmic Approved for marketing
ophthalmic suspension inflammation (especially (3/10)
0.5% (topical steroid) postoperative)
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 when biotech companies are developing competing products.
# Those items identified with a hatch mark concern events that occurred in 2/98, although they were not announced until 3/98.
** 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. 10-11.

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