Company** | Product | Description | Indication | Type Action (Date) |
Name | ||||
CANCER | ||||
Chiron Corp. | Proleukin | Recombinant human | Single-agent therapy | FDA's Oncologic Drugs |
(FDA- | interleukin-2 | for metastatic melanoma | Advisory Committee | |
approved) | in adults (Stage IV) | recommended approval | ||
(12/19) | ||||
CollaGenex | Metastat | Chemically modified | Inhibition of cancer | National Cancer Institute |
Pharmaceuticals | tetracycline (stripped of | metastasis | filed IND (12/5) | |
Inc. | antimicrobial proper- | |||
ties) that acts as a | ||||
matrix metalloprotein- | ||||
ase inhibitor | ||||
DepoTech Corp. | DepoCyt | Injectable, sustained- | Neoplastic meningitis | FDA's Oncologic Drugs |
and Chiron Corp. | release formulation of | arising from solid tumors | Advisory Committee | |
chemotherapeutic agent | declined to recommend | |||
cytarabine (uses Depo- | approval when it found | |||
Foam, lipid-based drug | no evidence that drug works | |||
delivery) | better than current thera- | |||
py (methotrexate) (12/18) | ||||
Genzyme Corp. | Thyrogen | Recombinant human | For use in diagnostic | Submitted NDA (12/17) |
thyroid stimulating | procedures (radio-iodine | |||
hormone | whole-body scanning) | |||
used to monitor patients | ||||
for recurrence of | ||||
thyroid cancer | ||||
Human Genome | MPF-1 | Human myeloid pro- | Protection of hemato- | Filed IND for Phase I |
Sciences Inc. | genitor inhibitory | poietic progenitor cells | trial (12/18) | |
factor-1 (genomics- | in human bone marrow | |||
derived) | from toxic effects of | |||
chemotherapy | ||||
NaPro | Paxene | Paclitaxel; compound | AIDS-related Kaposi's | FDA tentatively approved |
BioTherapeutics | extracted from needles | sarcoma (2nd-line | NDA, but because Bristol- | |
Inc. and Ivax Corp. | and limb stock of | therapy) | Myers Squibb Co.'s Tax- | |
(AMEX:IVX) | ornamental yew trees | ol was approved in 8/97 | ||
for this indication (and | ||||
has marketing exclusivity | ||||
for 7 years), NaPro/Ivax's | ||||
drug might not get final | ||||
approval until 8/4/04 (12/26) | ||||
NeoPharm Inc. | Neomark | Broxiuridine; a radio- | In vivo prognostic test | FDA's Oncologic Drugs |
sensitizer that is incor- | to measure tumor cell | Advisory Committee | ||
porated into DNA of | proliferation in breast | voted not to recommend | ||
tumor cells | cancer | for approval (12/19) | ||
Neoprobe Corp. | RIGScan | I-125-labeled mono- | Surgical detection and | FDA notified company |
CR49 | clonal antibody for use | management of primary | that approval of BLA | |
with hand-held isotope | and metastatic colorectal | cannot be considered | ||
detector for radioimmu- | cancer | without additional clinical | ||
noguided surgery | and manufacturing infor- | |||
mation (12/29) | ||||
Oncor Inc. | Inform | Genetic test designed to | Prediction of recurrence | Approved for marketing |
HER-2/neu | identify HER-2/neu | of breast cancer (identi- | (12/31) | |
gene amplification in | fies more aggressive | |||
breast cancer tissue | malignancies) | |||
Seragen Inc. (OTC | DAB389IL-2 | Denileukin diftitox; | Cutaneous T cell lymph- | Submitted BLA, request- |
Bulletin Board:SRGN) | interleukin-2 (IL-2) | oma that recurs or per- | ing expedited review | |
fusion protein consisting | sists after prior therapy | (12/8) | ||
of diphtheria toxin frag- | (i.e., as 2nd-line therapy) | |||
ment A-fragment B | ||||
genetically fused to | ||||
human IL-2 (targets high- | ||||
affinity IL-2 receptors | ||||
on activated T cells) | ||||
SuperGen Inc. | Nipent | Pentostatin for injection; | Hairy cell leukemia | FDA approved supple- |
(FDA- | chemotherapeutic drug | mental NDA for commer- | ||
approved) | that inhibits adenosine | cial scale manufacturing | ||
deaminase (blocks DNA | (12/29) | |||
synthesis) | ||||
Vion | Triapine | Ribonucleotide reduc- | Treatment of solid | Filed IND (12/12) |
Pharmaceuticals | tase inhibitor (inhibits | tumors | ||
Inc. | DNA synthesis) | |||
CARDIOVASCULAR | ||||
BioTime Inc. | Hextend | Blood plasma volume | Replacement of blood | Initiated submission of |
expander | volume during surgery | NDA (12/18) | ||
in which substantial | ||||
amounts of blood are lost | ||||
Collateral | Gene | Intra-arterial delivery of | Patients suffering from | Schering filed IND for |
Therapeutics Inc.* | therapy | gene that promotes | stable exertional angina | Phase I/II trial (12/23) |
and Schering AG | angiogenesis (gene not | due to atherosclerosis | ||
(Germany) | identified) via adeno- | (coronary artery disease) | ||
viral vector | ||||
Interneuron | CerAxon | Citicholine; membrane | Ischemic stroke | Submitted NDA (12/15) |
Pharmaceuticals | resynthesis facilitator; | |||
Inc. | organic molecule that | |||
consists of cytidine and | ||||
choline (components of | ||||
brain cell membranes) | ||||
Molecular | Optison | 2nd-generation ultra- | For use in patients with | Approved for marketing |
Biosystems Inc. and | sound contrast imaging | suboptimal echocardio- | (12/31) | |
Mallinckrodt Inc. | agent; contains perflu- | grams to improve imag- | ||
(NYSE:MKG) | orocarbon | ing of left ventricle of | ||
heart | ||||
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. | Provigil | Modafinil; oral formu- | Sleep disorders narco- | FDA sent company an |
lation of synthetic com- | lepsy and idiopathic | approvable letter (12/30) | ||
pound that is thought to | hypersomnia | |||
affect alpha-adrenergic | ||||
receptors in the brain | ||||
DIABETES | ||||
Chiron Corp. and | Regranex | Becaplermin; gel form | Wound healing in | Approved for marketing |
Johnson & | Gel | of recombinant human | diabetic foot ulcers | (12/17) |
Johnson (NYSE:JNJ) | platelet-derived growth | |||
factor-beta | ||||
INFECTION | ||||
Enzo Therapeutics | Gene | Use of StealthVector | To stop viral progression | Filed IND (12/18) |
Inc. (subsidiary of | therapy | gene delivery system | in HIV-infected patients | |
Enzo Biochem Inc.) | to treat patient's blood | |||
stem cells ex vivo (to | ||||
render them HIV-resis- | ||||
tant), then reinfuse cells | ||||
back into patient | ||||
Lidak | Lidakol | Long-chain fatty | Recurrent outbreaks of | Submitted NDA (12/23) |
Pharmaceuticals | (n-docosanol) | alcohol believed to | oral herpes (cold sores | |
Inc. | work by interfering | or fever blisters caused | ||
with viral entry into | by herpes simplex virus) | |||
cells (topical) | ||||
MedImmune Inc. | Synagis | Palivizumab; human- | Prevention of serious | Submitted BLA (12/19) |
(formerly | ized monoclonal anti- | RSV disease in certain | ||
MEDI-493) | body to respiratory | high-risk infants and | ||
syncytial virus (RSV); | young children (causes | |||
binds to fusion protein | pneumonia, bronchio- | |||
on viral surface | litis) | |||
PathoGenesis | TOBI | Tobramycin for | Chronic lung infections | Approved for marketing |
Corp. | inhalation | (Pseudomonas aerugi- | (12/23) | |
nosa) in patients with | ||||
cystic fibrosis | ||||
Penederm Inc. | Mentax | Butanefine HCl, 1% | 1-week dosing regi- | Approved for marketing |
(FDA- | cream (benzylamine, | men for treating Tinea | (label expansion) (12/3) | |
approved) | antifungal agent; topical) | pedis (athlete's foot) | ||
Schering-Plough | Intron A | Recombinant human | Combination therapy | Schering-Plough submit- |
Corp. (NYSE:SGP) | plus | interferon alfa-2b | for chronic hepatitis | ted NDA and requested |
and ICN Pharma- | Rebetol | (Intron-A) plus | C virus infection in | priority review status |
ceuticals Inc. | (both FDA- | oral form of ribaverin | patients 18 years of age | (12/9) |
approved) | (Rebetol; synthetic | or older with compen- | ||
nucleoside with | sated liver disease who | |||
broad-spectrum anti- | have relapsed following | |||
viral activity) | alpha-interferon therapy | |||
Siga | Strep throat | Vaccine uses vector | Strep throat (caused by | National Institutes of |
Pharmaceuticals | vaccine | system that presents | many strains of Group A | Health filed IND (12/18) |
Inc. | disease-associated | Streptococcus) | ||
antigens to body's | ||||
mucosal surfaces to | ||||
stimulate immune | ||||
system response | ||||
MISCELLANEOUS | ||||
Alexion | 5G1.1 | C5 complement inhib- | Rheumatoid arthritis | Filed IND (12/24) |
Pharmaceuticals | itor; humanized mono- | |||
Inc. | clonal antibody designed | |||
to inhibit complement | ||||
activation and reduce | ||||
inflammation over pro- | ||||
longed period of time | ||||
Alza Corp. | Testoderm | Testosterone trans- | Treatment of hypogo- | Approved for marketing |
dermal drug delivery | nadism (testosterone | (12/19) | ||
system | deficiency) in males | |||
Alza Corp. | Ditropan XL | Oxybutynin chloride | Urge urinary incon- | Alza submitted NDA |
and Crescendo | extended-release tablets | tinence | (12/22) | |
Pharmaceuticals | (via OROS osmotic drug | |||
Inc. | delivery technology) | |||
Anika | Orthovisc | Ultra-pure, high molecu- | Osteoarthritis of the | Submitted PMA (12/31) |
Therapeutics Inc. | lar-weight naturally | knee | ||
derived hyaluronic acid | ||||
(intra-articular injection) | ||||
Centocor Inc. | Avakine | Infliximab; chimeric | Moderate-to-severe | Submitted BLA (12/30) |
(formerly cA2 | monoclonal antibody | Crohn's disease, includ- | ||
or Cen-TNF) | to tumor necrosis factor- | ing fistulizing Crohn's | ||
alpha | disease | |||
Genentech Inc. | Nutropin | Powder (lyophilized) | Replacement of endo- | Approved for marketing |
(FDA- | formulation of recombi- | genous growth hormone | (expanded label) (12/17) | |
approved) | nant human growth | in adults with growth | ||
hormone | hormone deficiency | |||
Nutropin AQ | Aqueous formulation of | Replacement of endo- | Approved for marketing | |
(FDA- | recombinant human | genous growth hormone | (expanded label) (12/18) | |
approved) | growth hormone | in adults with growth | ||
hormone deficiency | ||||
Gliatech Inc. | Adcon-L | Anti-adhesion barrier | To inhibit postopera- | FDA's Orthopedic and |
gel (semisynthetic | tive peridural scars | Rehabilitation Devices | ||
carbohydrate polymer) | (following lumbar disc | Advisory Committee | ||
surgery) | voted 8 to 1 to recommend | |||
approval, with conditions | ||||
regarding labeling (12/12) | ||||
Eli Lilly and Co. | Evista | Raloxifene HCl; | Prevention of post- | Approved for marketing |
(NYSE:LLY) | selective estrogen | menopausal osteo- | (12/10) | |
receptor modulator | porosis | |||
MedImmune Inc. | MEDI-507 | Humanized monoclonal | Steroid-resistant | MedImmune filed IND |
and BioTransplant | antibody that binds to | graft-vs.-host disease | for Phase I/II trial (12/24) | |
Inc. | CD2 antigen receptor | |||
found on T cells and | ||||
natural killer cells | ||||
Protein Design | Zenapax | Daclizumab; human- | Prevention of organ | Approved for marketing |
Labs Inc. and | ized monoclonal anti- | rejection following | (12/11) | |
Hoffmann-La Roche | body (SMART Anti- | kidney transplantation | ||
Inc. | Tac) that binds to the | |||
interleukin-2 receptor | ||||
on activated T cells | ||||
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. 10-11. |