Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
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 | ||||
CARDIOVASCULAR | ||||
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 | |||
(albumin-free) | ||||
CENTRAL NERVOUS SYSTEM | ||||
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; | ||||
Germany) | ||||
DIABETES | ||||
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) | ||||
INFECTION | ||||
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) | ||
(NYSE:GLX; U.K.) | ||||
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) | ||||
MISCELLANEOUS | ||||
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) | |
disease | ||||
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) | ||||
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. | ||||
** 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. |