FDA Submissions, Approvals And Other Actions:
October 1998
Company** Product Description Indication Type Action (Date)
AltaRex Corp. BrevaRex Anti-idiotype induction Metastatic cancers that Filed IND for Phase I trial
(Canada) therapy; murine monoclon- express MUC1 antigen (10/13)
al antibody that is devel-
oped from, and specifically
binds to, MUC1 tumor-
associated antigen
DepoTech Corp. DepoCyt Injectable, sustained- Neoplastic meningitis DepoTech initiated submis-
and Chiron Corp. release formulation of arising from lymphomas sion of NDA (10/9)
chemotherapeutic agent
cytarabine (uses Depo-
Foam lipid-based drug
delivery system)
The Medicines Co.* Hirulog Synthetic thrombin Anticoagulant for use in FDA's Cardiovascular and
inhibitor based on patients with unstable Renal Drugs Advisory Com-
hirudin (natural anti- angina undergoing per- mittee voted 4-3 not to
coagulant secreted by cutaneous transluminal recommend approval (10/23)
leeches) coronary angioplasty
Advanced Tissue Dermagraft Human tissue-engi- Wound healing in FDA approved treatment
Sciences Inc. and neered replacement for diabetic foot ulcers investigational device exemp-
Smith & Nephew dermal layer of skin tion (IDE) (10/12)
plc (U.K.) (viable human dermal
fibroblasts, derived from
foreskins, cultured on
bioresorbable scaffold)
Generex Biotech- Oralgen Oral insulin (liquid; Types I and II diabetes Filed IND for Phase II and
nology Corp. administered with metered III trials (10/19)
(OTC Bulletin Board: dose aerosol applicator)
GNBT; Canada)
BioChem Pharma Epivir-HBV Nucleoside analogue Chronic hepatitis B FDA's Antiviral Drugs
Inc. (Canada) and (a.k.a. (oral dosage) virus infection in Advisory Committee recom-
Glaxo Wellcome plc lamivudine) adults mended approval (unani-
(NYSE:GLX; U.K.) mous vote) (10/6)
Biota Holdings Ltd. Relenza Zanamivir; neuraminidase Treatment and prevention Glaxo submitted NDA (10/27)
(ASX:BTA; Australia) inhibitor (designed and of influenza A and B
and Glaxo Wellcome synthesized based on
plc (NYSE:GLX; U.K.) crystal structure of surface
proteins of influenza virus);
inhaled in powder form
SunPharm Corp. DEHOP Diethylhomospermine; AIDS-related diarrhea FDA told company that it
analogue of naturally occur- needs to conduct another
ring essential intracellular Phase II trial before moving on
polyamine compound to pivotal trials (10/26)
Vertex Pharma- Agenerase Amprenavir; 2nd-genera- Combination therapy Glaxo submitted NDA (10/16)
ceuticals Inc. and tion HIV protease inhibitor; with antiretroviral drugs
Glaxo Wellcome plc twice-daily dosage for HIV and AIDS
Anika Thera- Orthovisc High-molecular weight Osteoarthritis of the FDA sent company a letter
peutics Inc. and naturally derived form knee stating that PMA is not
Zimmer Inc. (sub- of hyaluronic acid approvable; additional clin-
sidiary of Bristol- ical data required to show
Myers Squibb Co.; effectiveness (10/19)
CollaGenex Periostat Orally administered Adjunct to scaling and Approved for marketing
Pharmaceuticals drug consisting of root planing for treating (10/1)
Inc. subantibiotic dose of moderate to severe
doxycycline (inhibits pro- periodontitis in adults
duction of collagenase)
Cypress Prosorba Disposable filter that Moderate-to-severe FDA's Gastroenterology and
Bioscience Inc. Column uses Protein A to rheumatoid arthritis in Urology Device Advisory
(FDA- remove circulating patients who have failed Panel recommended approval
approved) immune complexes 2nd-line therapy (10 to 1 vote), with post-mar-
from patient's blood keting study required (10/29)
Discovery Surfaxin Sinapultide; lung sur- Acute respiratory FDA granted product fast-
Laboratories Inc. factant containing the distress syndrome from track status (10/15)
peptide KL4 (a 21- direct causes (i.e., non-
amino-acid peptide sepsis causes such as
modeled after the SP-B pneumonia)
protein in the human
surfactant system)
Surfaxin Sinapultide; lung sur- Meconium aspiration FDA granted product fast-
factant containing the syndrome (severe track status (10/21)
peptide KL4 (a 21- respiratory disease
amino-acid peptide in infants)
modeled after the SP-B
protein in the human
surfactant system)
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.
ASX = Australian Stock Exchange
* 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. 13-14.