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Company** Product Description Indication Type Action (Date)
Name
CANCER
Anthra AD32 Lipophilic anthra- Superficial bladder can- Filed NDA (1/9)
Pharmaceuticals cycline analogue cer in patients who have
Inc.* failed 1st-line therapy
Chiron Corp. Proleukin Recombinant human Single-agent therapy Approved for marketing
(FDA- interleukin-2 for metastatic melanoma (1/12)
approved) in adults (Stage IV)
QLT PhotoThera- Photofrin Photosensitive drug Treatment of microinva- Approved for marketing
peutics Inc. (Canada) (FDA- (produces toxic oxygen sive endobronchial non- (1/9)
and Sanofi Pharma- approved) compound when light- small cell lung cancer
ceuticals Inc. (unit activated) (early-stage) in patients
of Sanofi SA; France) who are not indicated for
surgery and radiotherapy
CARDIOVASCULAR
Cor Therapeutics Integrilin Small molecule syn- To reduce death, heart FDA's Cardiovascular
Inc. and Schering- thetic compound attack and other compli- and Renal Drugs Adviso-
Plough Corp. (derived from rattle- cations of percutaneous ry Committee recom-
(NYSE:SGP) snake venom) that transluminal coronary mended approval in
inhibits GPIIb/IIIa angioplasty as well as in angioplasty setting but
receptor that mediates acute coronary condi- recommended against
platelet aggregation tions (unstable angina approval in acute syn-
and non-Q-wave myo- dromes (angina and non-
cardial infarction [MI]) Q-wave MI), stating that
1 trial was not a suffi-
cient basis for approval in
the latter setting (1/28)
Texas Novastan Synthetic small mole- Anticoagulant therapy in FDA has extended its
Biotechnology cule (argatroban) deri- patients with heparin- review of NDA for up to
Corp. ved from arginine; acts induced thrombocyto- 90 days in order to con-
as direct inhibitor of penia sider new data from a
thrombin follow-on study (1/23)
DIABETES
Advanced Tissue Dermagraft Human tissue-engi- Wound healing in FDA's General and
Sciences Inc. and neered replacement for diabetic foot ulcers Plastic Surgery Devices
Smith & Nephew dermal layer of skin Advisory Committee
plc (U.K.) (viable human dermal recommended approval
fibroblasts cultured on with condition that com-
bioresorbable scaffold) pany perform postmar-
keting study and develop
physician training pro-
gram (7 to 2 vote) (1/29)
INFECTION
Unimed NTZ Nitazoxanide; a nitro- Cryptosporidiosis in Submitted NDA and
Pharmaceuticals thiazole compound with AIDS patients (caused requested priority review
Inc. (NASDAQ:UMED) activity against many by Cryptosporidium (1/15)
protozoan and helmin- parvum)
thic pathogens
MISCELLANEOUS
Alexion 5G1.1 C5 complement inhib- Systemic lupus Filed IND (1/12)
Pharmaceuticals itor; humanized mono- erythematosus
Inc. clonal antibody designed
to inhibit complement
activation and reduce
inflammation over pro-
longed period of time
Bio-Technology Androtab-SL Sublingual delivery Treatment of hypo- FDA notified company
General Corp. (a.k.a. Andro- system for testosterone gonadism (testosterone that data submitted with
test-SL) (produces pulse-like deficiency) in males NDA are inadequate for
increases in levels of approval (1/28)
hormone in blood)
CollaGenex Periostat Orally administered Treatment of FDA sent company a 2nd
Pharmaceuticals drug consisting of periodontitis action letter regarding
Inc. sub-antibiotic dose of NDA, stating that addi-
doxycycline (inhibits tional issues still need to
production of be addressed (1/28)
collagenase)
Connetics Corp. Betametha- Foam formulation of Treatment of all steroid- Submitted NDA (1/6)
sone mousse corticosteroid betametha- responsive dermatoses,
sone-17-alpha valerate including scalp psoriasis
Epitope Inc. and Cocaine Enzyme immunoassay Testing for drugs of Cleared for marketing
STC Technologies metabolite kit that detects cocaine abuse (1/15)
Inc.* EIA and cocaine metabolites
in oral fluids (collected
with Epitope's OraSure
oral specimen collection
device)
GelTex RenaGel Non-absorbed polymer- Control of elevated FDA accepted NDA for
Pharmaceuticals based compound that phosphorus levels in filing (1/5)
Inc. and binds to and eliminates chronic kidney failure
Genzyme Corp. target substances from (administered in con-
the intestinal tract junction with dietary
calcium supplement)
Organogenesis Apligraf Living human-skin Treatment of venous FDA's General and Plas-
Inc. and Novartis (a.k.a. equivalent, composed of leg ulcers tic Surgery Devices Ad-
Pharma AG Graftskin) living human keratino- visory Committee recom-
(Switzerland) cytes and fibroblasts mended approval (5 to 4
(epidermis and dermis) vote) (1/29)
cultured in a 3-dimen-
sional culture system
SangStat Medical Thymo- Rabbit anti-human Treatment and preven- FDA sent companies a
Corp. and the Imtix globulin thymocyte polyclonal tion of acute graft rejec- "complete review" letter
division of Pasteur antibody tion episodes in kidney regarding the PLA (1/28)
Merieux Connaught transplant patients
(member of the Rhone-
Poulenc Group; France)
Sheffield — Albuterol sulfate Asthma Filed IND (1/6)
Pharmaceuticals delivered via Metered
Inc. Solution Inhaler
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.