Company** Product Description Indication Type Action (Date)
Anthra Pharma- Valstar Valrubicin (injected Treatment of aggressive, FDA Advisory Commit-
ceuticals Inc. directly into bladder) recurring, spreading tee voted not to recom-
(IPO pending) bladder cancer (2nd-line mend approval (studies
therapy) not rigorous enough to
prove drug helped
patients) (6/1)
Diatide Inc. P829 Synthetic, somatostatin- In vivo imaging agent Submitted NDA (6/16);
and Nycomed- (techtide) type receptor-binding for non-small cell lung FDA granted NDA
Amersham (U.K.) peptide P829, designed to cancer priority review status
attach to targeted disease (6/22)
molecules and labeled
with technetium-99m
Genzyme Corp. Thyrogen Recombinant human For use in diagnostic FDA extended deadline
thyroid stimulating procedures (radio-iodine for taking action on NDA
hormone whole-body scanning) until 9/15/98 (FDA
used to monitor patients requested submission of
for recurrence of amendment related to
thyroid cancer chemistry and manufac-
turing section of NDA) (6/15)
Rhone-Poulenc Taxotere Docetaxel; semisyn- Metastatic breast cancer FDA's Oncologic Drugs
Rorer Inc. (sub- (FDA- thetic agent derived in patients who have Advisory Committee
sidiary of Rhone- approved) from needles of the failed any previous recommended approval
Poulenc SA; European yew tree; chemotherapy (7-1 vote) (6/1); approved
NYSE:RP; France) inhibits cancer cell for marketing (6/23)
division by prevent-
ing assembly and
blocking disassembly
of microtubules
Seragen Inc. Ontak Denileukin diftitox; Recurrent or persistent FDA's Oncologic Drugs
(OTC Bulletin Board: (DAB389IL-2) interleukin-2 (IL-2) cutaneous T cell lymph- Advisory Committee
SRGN) and Ligand fusion protein consist- oma in adult patients voted unanimously that
Pharmaceuticals ing of diphtheria toxin who have received product has clinical bene-
Inc. fragment A-fragment B prior therapy fit (6/2); FDA issued
genetically fused to "complete review" letter
human IL-2 (targets high- but requested additional
affinity IL-2 receptors information (6/17)
on activated T cells)
Vysis Inc. PathVysion Assay based on fluores- Diagnostic test to detect Submitted PMA (6/18)
HER-2 DNA cent in situ hybridization and quantify HER-2
Probe Kit technology (FISH); uses gene in breast cancer
locus-specific, direct- patients
label DNA probe that
binds to HER-2 gene in
tissue biopsy
Bayer Corp. Kogenate SF 2nd generation recom- Hemophilia A Submitted amendment to
(member of Bayer binant Factor VIII; BLA (6/11)
Group; Germany) sucrose-formulated
Chiron Corp. and Betaseron Recombinant human Secondary progressive Submitted supplement to
Berlex Laborato- (FDA- interferon beta-1b multiple sclerosis BLA (6/30)
ries Inc. (subsid- approved) (injection)
iary of Schering AG;
Advanced Tissue Dermagraft Human tissue-engi- Wound healing in FDA notified companies
Sciences Inc. and neered replacement for diabetic foot ulcers PMA not approvable
Smith & Nephew dermal layer of skin without supportive data
plc (U.K.) (viable human dermal from additional controlled
fibroblasts cultured on clinical trial; FDA also
bioresorbable scaffold) suggested companies
submit a treatment inves-
tigational device exemp-
tion (6/11)
BioChem Pharma Epivir-HBV Nucleoside analogue Chronic hepatitis B Glaxo Wellcome com-
Inc. and Glaxo (a.k.a. (oral dosage) virus infection pleted submission of
Wellcome plc lamivudine) NDA (6/25)
Calypte Bio- Urine HIV Urine HIV-1 Western Assay for HIV infection Cleared for marketing
medical Corp. Test blot confirmatory test (6/1)
for antibodies to HIV-1
Cortecs plc (U.K.) Link2 One-step assay for Diagnostic for H. pylori Cleared for marketing
H. pylori Helicobacter pylori infection (causes peptic (6/12)
Rapid Test ulcer disease)
The DuPont Merck Sustiva Efavirenz; non-nucleo- HIV infection and AIDS Submitted NDA; com-
Pharmaceutical Co. side reverse trans- in children and adults pany requested acceler-
criptase inhibitor (once- ated approval and FDA
daily dosage) granted product fast-
track status (6/11)
Glaxo Wellcome Ziagen Abacavir; nucleoside HIV infection and AIDS Submitted 2 NDAs; FDA
plc (NYSE:GLX; U.K.) (formerly analogue reverse trans- in children and adults granted product fast-
1592) criptase inhibitor (oral; (combination therapy track status (6/25)
tablet and liquid) with Epivir and Retrovir)
MedImmune Inc. Synagis Palivizumab; human- Prevention of serious Approved for marketing
(formerly ized monoclonal anti- RSV disease in certain (6/19)
MEDI 493) body to respiratory high-risk infants and
syncytial virus (RSV); young children (causes
binds to fusion protein pneumonia, bronchio-
on viral surface (intra- litis)
muscular injection)
Roche Molecular Amplicor Ultrasensitive assay; Measurement of viral Filed 510(k); requested
Systems Inc. (unit HIV-1 quantitates HIV-1 load (circulating virus) expedited review status
of Roche Holding Monitor RNA levels down to in HIV-infected patients (6/26)
AG; Switzerland) 50 copies per milli- (used to prove efficacy
liter of plasma (uses of antiretroviral drug
PCR amplification) therapies)
Schering-Plough Rebetron Combination of Combination therapy Approved for marketing
Corp. (NYSE:SGP) Intron A (recombi- for treating chronic (6/3)
and ICN Pharma- nant human interferon hepatitis C virus
ceuticals Inc. alfa-2b; injection) and infection in patients
(NYSE:ICN) Rebotol (ribavirin; with compensated liver
synthetic nucleoside disease who have re-
with antiviral activity; lapsed following alpha-
oral) (each product interferon therapy
separately approved
by FDA for other uses)
Rebetron Combination of Combination therapy Submitted supplemental
Intron A (recombi- for treating chronic NDA and requested
nant human interferon hepatitis C virus priority review status
alfa-2b; injection) and infection in patients (6/16)
Rebotol (ribavirin; with compensated liver
synthetic nucleoside disease who have not
with antiviral activity; received previous alpha-
oral) (each product interferon therapy
separately approved (treatment-naive)
by FDA for other uses)
Axsys APC-366 Tryptase inhibitor Asthma Filed IND for Phase IIb
Pharmaceuticals (synthetic small trial (6/2)
Inc. molecule); dry powder
inhaler formulation
Centocor Inc. Infliximab Chimeric monoclonal Moderate-to-severe FDA sent company a
(formerly antibody to tumor Crohn's disease, includ- "complete review" letter
Avakine) necrosis factor-alpha ing fistulizing Crohn's (6/30)
Cypress Prosorba Disposable filter that Severe rheumatoid Company completed 2 of
Bioscience Inc. Column uses Protein A to arthritis 3 PMA rolling submis-
(FDA- remove circulating sions for expanded label
approved) immune complexes (6/23)
from patient's blood
Dusa Levulan Photodynamic therapy; Multiple actinic kera- Submitted NDA (combi-
Pharmaceuticals 20% solution of amino- toses of the face and nation drug/device;
Inc. (Canada) levulinic acid HCl scalp (sun-induced pre- includes applicator and
(topical) cancerous skin lesions) light source) (6/30)
Immunex Corp. Enbrel Recombinant, soluble Active rheumatoid FDA accepted BLA for
p75 tumor necrosis arthritis filing and assigned it
factor receptor (TNFr) priority review status
linked to the Fc portion (6/22)
of human IgG1
Lifecore Intergel Hyaluronate gel Prevention of adhesion Initiated PMA application
Biomedical Inc. formation following process (modular) (6/30)
abdominal surgical
procedures performed
by laparotomy
Metra Alkphase-B Serum-based test that Assay to monitor effects Cleared for marketing
Biosystems Inc. measures bone-specific of drugs used for treat- (6/8)
alkaline phosphatase ing or preventing osteo-
levels (marker for porosis
bone formation)
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.
** 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. 19-20.