Company
(Symbol)

Product

Description

Indication

Status (Date)


CANCER

GPC Bio-
tech AG
(Germany; FSE:GPC)

Bryostatin-1

Linked to the modulation of protein kinase C

Esophageal cancer

FDA granted orphan drug designation (12/12)

Guilford Pharm-
aceuticals
Inc. (GILD)

Gliadel Wafer

Carmustine

Malignant glioma

FDA's Oncologic Drugs Advisory Committee voted 8 to 5 in favor of using the Gliadel Wafer for newly diagnosed malignant glioma (12/6)

ImClone Systems
Inc.
(IMCL)

Erbitux
(IMC-
C225)

Monoclonal antibody designed to target and block the epidermal growth factor receptor

Colorectal cancer

FDA refused to accept the rolling BLA, delaying market launch by about six months; the FDA said the BLA contains insufficient data on response rates and eligibility requirements for patients entering the trial (12/31)

Praecis Pharma-
ceuticals
Inc. (PRCS)

Plenaxis

Abarelix for injectable suspension

Hormonally responsive advanced prostate cancer

FDA granted the company approval to proceed with additional clinical trials to support an NDA (12/3)

DIABETES

Amylin Pharma-
ceuticals
Inc. (AMLN)

Symlin

Pramlintide acetate

Type I and Type II diabetes

Company plans to conduct additional clinical trials requested by the FDA in its approvable letter, received in October (12/27)

MISCELLANEOUS

Avigen Inc.
(AVGN)

Coagulin-B

Gene therapy treatment; adeno-associated virus vector containing the Factor IX gene, Coagulin-B, via infusion into the hepatic artery

Hemophilia B

Company received notice from the FDA that it can continue clinical testing following a trial suspension in October after a trace amount of DNA from the gene therapy was detected in the seminal fluid of the first patient to participate (12/19)

Cellegy Pharma-
ceuticals
Inc. (CLGY)

Anogesic

Nitroglycerin ointment

Pain associated with chronic anal fissures

Company submitted a supplement to its NDA for Anogesic to include data from a recently completed confirmatory Phase III trial (12/3)


Notes:

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

FSE = Frankfurt Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application