Company*
(Symbol)

Product

Description

Indication

Status (Date)


CANCER

Antigenics
Inc.
(AGEN)

Oncophage

Cancer vaccine

Renal cell carcinoma

FDA designated Oncophage a fast-track product (10/15)

AVAX
Technologies
Inc.
(AVXT)

M-Vax and O-Vax

Autologous cancer vaccines

Cancer

FDA recommended AVAX prepare and submit new IND applications in regard to the FDA's clinical hold on the vaccines (10/25)

Celgene Corp. (CELG)

Revimid

Immunomodulatory drug

Myeloma

FDA granted orphan drug designation (10/8)

Cell Path-
ways Inc.
(CLPA)

Aptosyn and Taxotere

Exisulind and weekly docetaxel

Non-small-cell lung cancer

Phase III enrollment is suspended while a Data and Safety Monitoring Board reviews the data and reports it to the FDA in November (10/5)

Peregrine
Pharmaceu-
ticals Inc.
(PPHM)

Cotara

Tumor necrosis therapy drug; radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out

Recurrent glioblastoma multiforme

FDA granted fast-track status (10/10)

PrimeCyte
Inc.*

PC4071

Identified by PrimeCyte's differential bioassay screening system, Cytection; selectively attacks soft tissue sarcomas and ovarian tumors

Soft tissue sarcomas

Company received orphan drug designation from the FDA (10/29)

CENTRAL NERVOUS SYSTEM

Serono SA
(Switzerland;
NYSE:SRA)

Rebif

A recombinant form of interferon beta-1a

Relapsing-remitting multiple sclerosis

Company submitted a supplemental BLA (10/8)

DIABETES

Advanced
Tissue Sciences
Inc.
(ATIS)

Dermagraft

Bioengineered, cryopreserved tissue that stimulates foot ulcers to heal

Diabetic foot ulcers

FDA approved Dermagraft (10/1)

Amylin Pharmaceu-
ticals
Inc.
(AMLN)

Symlin

Analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas

Type I and Type II diabetes

FDA issued an approvable letter, but called for some additional tests before clearing it for marketing (10/12)

INFECTION

Gilead Sciences
Inc.
(GILD)

Viread

Tenofovir disoproxil fumarate

HIV

FDA Antiviral Drugs Advisory Committee was split on the drug with nine members supporting a restricted label and seven members supporting a broad use (10/3); FDA approved the drug for all patients with the virus (10/29)

VaxGen Inc.
(VXGN)

AIDSVAX

Vaccine; made from a synthetic protein

AIDS

A Data Safety Monitoring Board found the vaccine continues to exhibit an excellent safety profile and recommended that the Phase III study continue until its planned conclusion at the end of 2002 (10/30)

ViroPharma
Inc.
(VPHM)

Picovir

Oral antiviral product that inhibits the function of the picornavirus capsid

Viral respiratory infection

FDA accepted the NDA (10/1)

MISCELLANEOUS

Biogen Inc.
(BGEN)

Amevive

Alefacept; novel immuno- modulatory agent that selectively targets the CD45RO+ subset of T cells

Psoriasis

FDA and European Agency for the Evaluation of Medicinal Products completed their initial reviews of the company's license application, and accepted it for filing (10/5)

Curis Inc.
(CRIS) and
Stryker Corp.

OP-1

An osteogenic protein

Long-bone nonunions

FDA approved OP-1, granting it device exemption status (10/18)

Genentech
Inc.
(NYSE:
DNA) and XOMA Ltd.
(XOMA)

Xanelim

Efalizumab

Moderate to severe psoriasis

Companies are delaying regulatory filing due to an FDA request for an additional study (10/5)

Genzyme
General
(GENZ)

Fabrazyme

Agalsidase beta enzyme replacement therapy

Fabry's disease

FDA requested more data for the company's BLA through its second complete response data (10/22)

Gliatech
Inc.
(GLIA)

Adcon-L

Gel to inhibit postsurgical scarring

Lumbar surgeries

A reread of magnetic resonance imaging data from a U.S. pivotal trial found no significant difference in the maximum scar scores between the treatment group and the untreated control group; the results bar Adcon-L from reentering the U.S. market on guidelines previously laid out by the FDA (10/15)

Orphan
Medical
Inc.
(ORPH)

Xyrem

Oral solution; sodium oxybate

Cataplexy associated with narcolepsy

Company submitted an NDA amendment responding to the FDA's approvable letter in July (10/9); FDA accepted the response (10/23)

SkyePharma
plc
(UK; LSE:
SKP) and Sanofi-Synthalabo
(France)*

UroXatral

Once-daily formulation of alfuzosin

Benign prostatic hyperplasia

Companies received an approvable letter from the FDA (10/10)


Notes:

* Privately held

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

LSE = London Stock Exchange; NYSE = New York Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application; IND = Investigational New Drug

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