Company** Product Description Indication Type Action/Date
Genzyme Corp. Thyrogen Recombinant human For use in diagnostic proce- FDA accepted NDA for
thyroid stimulating dures (radio-iodine whole- filing and granted it
hormone body scanning) used to priority review status
monitor patients for recur- (2/18)
rence of thyroid cancer
NeoPharm Inc. Neomark Broxiuridine; a radio- Prognostic test to Company will provide
sensitizer that is incor- measure tumor cell pro- FDA with additional
porated into DNA of liferation in breast information and analysis on
tumor cells cancer its product application (2/2)
Seragen Inc. (OTC DAB389IL-2 Denileukin diftitox; Recurrent or persistent FDA accepted BLA for
Bulletin Board:SRGN) interleukin-2 (IL-2) fusion cutaneous T cell lymph- filing and designated
protein consisting of oma in patients who application for priority
diphtheria toxin fragment have received prior review (2/4)
A-fragment B genetically therapy
fused to human IL-2 (targets
high-affinity IL-2 receptors
on activated T cells)
SuperGen Inc. MitoExtra Mitomycin reformulated Various cancers FDA accepted NDA for
with 'shielding' drug filing (2/24)
delivery technology
Diatide Inc. AccuTect Small molecule syn- In vivo imaging agent FDA's Medical Imaging
thetic peptide, designed for acute deep vein Advisory Committee
to adhere to GPIIb/IIIa thrombosis recommended approval
receptors on activated (7 to 4 vote, 1 abstension)
platelets, labeled with (2/9); FDA sent company
technetium-99m an approvable letter (2/23)
The Medicines Hirulog Synthetic thrombin Anticoagulant for use FDA accepted NDA for
Co.* inhibitor based on in patients with unstable filing (2/18)
hirudin (natural anti- angina undergoing per-
coagulant secreted by cutaneous transluminal
leeches) coronary angioplasty
Sonus Pharma- EchoGen Fluorocarbon-based Contrast radiography FDA requested additional
ceuticals Inc. Emulsion ultrasound contrast information in its review
agent of NDA, including a re-
analysis of some of animal
and clinical data (2/26)
Alexion Pharma- Apogen MP4 MP4 is recombinant Multiple sclerosis Filed IND (2/23)
ceuticals Inc. molecule designed to
eliminate T cells that target
nerves in the brain based
(on Apogen technology)
Anika Thera- Orthovisc Ultra-pure, high mole- Osteoarthritis of the FDA accepted PMA for
peutics Inc. cular-weight naturally knee filing and said it will not
derived hyaluronic acid require advisory panel
(intra-articular injection) review (2/24)
Bio-Technology BioLon 1% solution of sodium For use in ophthalmic FDA sent company an
General Corp. hyaluronate (visco- surgical procedures approvable letter (2/3)
elastic lubricant) (i.e., cataract removal)
Centocor Inc. Avakine Infliximab; chimeric Moderate-to-severe FDA accepted BLA for
(formerly cA2 monoclonal antibody Crohn's disease, includ- filing and designated
or Cen-TNF) to tumor necrosis ing fistulizing Crohn's application for priority
factor-alpha disease review (2/25)
Connetics Corp. Betametha- Foam formulation of Treatment of all steroid- FDA accepted NDA for
sone mousse corticosteroid beta- responsive dermatoses, filing (2/25)
methasone-17-alpha including scalp psoriasis
Metra Biosystems Pyrilinks-D Urine-based assay that Test to monitor anti- Cleared for marketing
Inc. Assay measures excretion of resorptive drugs (2/3)
(FDA- deoxypyridinoline cross- (including Fosamax)
approved) links (immunoassay; in treatment and pre-
biochemical indicator of vention of post-meno-
bone resorption) pausal osteoporosis
MGI Pharma Inc. Salagen Pilocarpine HCl Treatment of dry mouth Approved for marketing
Tablets caused by Sjogren's (2/17)
syndrome (autoimmune
Penederm Inc. Avita Gel Topical formulation of Treatment of acne Cleared for marketing
retinoic acid (tretinoin); (2/3)
employs TopiCare liquid
polymers for drug delivery
SangStat Medical Sang-35 Cyclosporine generic Prevention of graft FDA sent company an
Corp. drug (immunosuppres- rejection in organ action letter, citing minor
sive) transplantation deficiencies in AADA (2/12)
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. 14-15.