Company*
(Symbol)

Product

Description

Indication

Status
(Date)


CANCER

Amgen Inc.
(AMGN) and Praecis Pharmaceuticals
Inc.
(PRCS)

Plenaxis

Prostate cancer drug

Prostate cancer

FDA issued a letter saying NDA data for the therapy is inadequate for approval (6/12)

Antisoma
Group
plc (UK;
LSE:ASM)

Pemtumomab

A yttrium-90 radiolabeled antibody formerly called Theragyn

Ovarian cancer

Company will increase the number of patients in its Phase III trial, per the FDA's request, extending the trial by 18 to 24 months (6/13**)

Guilford Pharmaceuticals Inc. (GILD)

Gliadel Wafer

Polifeprosan 20 with carmustine implant

Malignant glioma

FDA accepted for review the sNDA seeking to expand the indication to include first-line therapy in newly diagnosed patients (6/6)

ImClone
Systems Inc.
(IMCL)

IMC-C225

Used in combination with irinotecan; monoclonal antibody targeting and blocking epidermal growth factor receptor

Colorectal cancer

Company began filing a rolling BLA (6/28)

MGI Pharma
Inc.
(MOGN)

Irofulven

Used in combination with Gemzar (gemcitabine hydrochloride)

Pancreatic cancer

FDA granted fast-track status for irofulven (6/28)

Nycomed
Amersham
plc
(UK; NYSE:NYE)

EchoSeed

Uses ultrasound imaging for seed placement; a new generation of brachytherapy seed

Prostate cancer

FDA granted marketing clearance (6/4)

Wilex AG
(Germany)*

G250

Unconjugated chimeric G250 Ig G monoclonal antibody

Renal cell carcinoma

FDA granted orphan drug status (6/1)

CARDIOVASCULAR

Actelion Ltd. (Switzerland; SWX:ATLN)

Tracleer

Bosentan; endothelin receptor antagonist

Pulmonary arterial hypertension

FDA's Renal Drugs Advisory Committee will review the application for Tracleer on Aug. 9 (6/20)

CytRx Corp. (CYTR)

Flocor

Purified poloxamer 188

Acute chest syndrome associated with sickle cell disease

Flocor received fast-track designation from the FDA (6/14)

United
Therapeutics

Corp.
(UTHR)

Remodulin
(UT-15)

Prostacyclin analogue

Pulmonary arterial hypertension

FDA's Cardiovascular & Renal Drugs Advisory Committee will meet in August concerning Remodulin (6/28)

CENTRAL NERVOUS SYSTEM

Cellegy Pharmaceuticals Inc. (CLGY)

Anogesic

Nitroglycerin ointment

Pain associated with chronic anal fissures

Cellegy filed an NDA for Anogesic (6/26)

Orphan Medical Inc. (ORPH)

Xyrem

Gammahydroxybutyrate

Narcolepsy

Peripheral and Central Nervous System Advisory Committee voted that Xyrem was an effective treatment (6/6)

Protein Therapeutics Inc.*

¿

Oral human gammaglobulin

Juvenile rheumatoid arthritis

FDA granted orphan drug designation (6/14)

INFECTION

Aviron Inc. (AVIR)

FluMist

Intranasal vaccine

Influenza

Vaccines & Related Biological Products Advisory Committee will meet July 26-27 (6/28)

Visible Genetics Inc. (VGIN)

Trugene
HIV-1
Genotyping
Test and Open-Gene System

Designed to genetically
decode the highly mutagenic
HIV-1 from patient serum
and identify mutations

To identify genetic mutations in HIV

FDA found the product meets the requirements for clearance, but not as a 501(k) device; the company is asking the FDA to classify the product as a class II device (6/28)

MISCELLANEOUS

Biogen Inc. (BGEN)

Amevive

Novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells

Psoriasis

Company said it intends to file worldwide regulatory applications later this year (6/12)

Genelabs Technologies Inc. (GNLB)

Aslera

Orally administered, highly purified prasterone, the synthetic equivalent of dehydroepiandrosterone

Lupus erythematosus

Company received a not-approvable letter from the FDA (6/26)

Lilly ICOS LLC (joint venture of ICOS Corp. [ICOS] and Eli Lilly and Co.)

Cialis

A PDE5 inhibitor

Erectile dysfunction

Company filed an NDA (6/28)


Notes:

* Privately held; ** Denotes the date the item ran in BioWorld International.

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

LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX - Swiss Stock Exchange;

BLA = Biologics License Application; NDA = New Drug Application

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