Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

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

Raptiva

Efalizumab; a targeted T-cell modulator designed to selectively and reversibly block the activation, migration to the skin and trafficking of the T cells

Plaque psoriasis

An FDA panel recommended the approval of Raptiva (9/9)

CANCER

Antigenics
Inc.
(AGEN)

Oncophage

Personalized cancer vaccine

Metastatic melanoma and and renal cancer

FDA placed a partial clinical hold on two Phase III trials, citing insufficient product characterization data (9/3)

Dendreon Corp. (DNDN)

Provenge

Immunotherapy

Prostate cancer

FDA designated Provenge as a fast-track development program (9/4)

Genentech Inc. (NYSE:DNA)

Avastin

Bevacizumab; anti-EGFR antibody

Metastatic colorectal cancer

Company completed filing of BLA as part of first-line combination therapy; product has fast-track status (9/26)

Epeius Biotechnologies Corp.*

REXIN-G

Tumor-targeted gene therapy vector

Pancreatic cancer

FDA designated REXIN-G as an orphan drug (9/8)

Genta
Inc.
(GNTA)

Ganite

Gallium nitrate injection

Cancer-related hypercalcemia

FDA approved Ganite to treat hypercalcemia that is resistant to hydration (9/18)

Genta
Inc.
(GNTA) and Aventis SA (France)

Genasense

Antisense oncology compound

Malignant melanoma

Company began filing a rolling NDA based on Phase III data that demonstrated a 25% improvement in patients who finished the minimum follow-up of 12 months (9/10)

ILEX Oncology
Inc.
(ILXO)

Clofarabine

Purine nucleoside
antimetabolite

Acute lymphoblastic leukemia

FDA granted fast-track status for clofarabine to treat children (9/9)

Inex Pharmaceuticals Corp. (Canada; TSE:IEX)

Onco TCS

Vincristine encapsulated in Inex's TCS liposomal delivery technology

Relapsed, aggressive non-Hodgkin's lymphoma

Began rolling NDA submission by submitting first of three sections dealing with safety and pharmacokinetics (9/30)

Introgen Therapeutics Inc. (INGN)

Advexin

Supplies p53 protein

Squamous-cell carcinoma of the head and neck

FDA designated Advexin as a fast-track product (9/17)

PhotoCure ASA (the Netherlands; PHCUF)

Metvix

Methyl aminolevulinate

Skin cancer

An FDA panel said Mevix would not be recommended for approval (9/11)

Spectrum Pharmaceuticals Inc. (SPPI) and GPC Biotech AG (Germany; FSE GPC)

Satraplatin

Oral platinum compound

Hormone- refractory prostate cancer

FDA granted fast-track status (9/22)

Telik Inc. (TELK)

Telcyta

A small-molecule prodrug that is activated by GST P1-1

Ovarian cancer

FDA granted fast-track designation for Telcyta for third-line therapy in patients with platinum-refractory or -resistant ovarian cancer (9/3)

CARDIOVASCULAR

Nuvelo Inc.
(NUVO)

Alfimeprase

Thrombolytic agent

Acute peripheral arterial occlusion

Data safety monitoring board recommended the Phase II trial continue, following analysis from first 36 patients (9/25)

Xechem International Inc. (XKEM)

Niprisan

A phytopharmaceutical drug; a composition of four traditional plants

Sickle-cell disease

FDA granted orphan drug designation (9/2)

CENTRAL NERVOUS SYSTEM

Cephalon Inc. (CEPH)

Provigil (FDA-approved)

Modafinil tablets; oral formulation of compound

Sleepiness associated with sleep apnea

FDA advisory panel recommended approval (9/26)

Endo Pharmaceuticals Inc. (subsidiary of Endo Pharmaceuticals Holdings Inc.; ENDP)

DepoMorphine

Morphine sulfate sustained-release liposome injection; an analgesic

Post-operative pain

FDA accepted the NDA for DepoMorphine (9/22)

Neurobiological Technologies Inc. (NTII) and Forest Laboratories Inc.

Namenda

Memantine; NMDA receptor antagonist

Alzheimer's disease

FDA panel recommended approval of the product (9/25)

INFECTION

Cubist Pharmaceuticals Inc. (CBST)

Cubicin (formerly Cidecin)

Daptomycin for injection

Skin infections

FDA approved Cubicin for infections caused by Gram-positive bacteria (9/15)

Cubist Pharmaceuticals Inc. (CBST)

Cubicin (formerly Cidecin)

Daptomycin for injection

Infective endocartitis

Data monitoring board recommended continuation of Phase III trial, after review of first patient group (9/30)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Iseganan

Antimicobial peptide; a protegrin

To reduce the risk of pneumonia

FDA granted fast-track status for isegnanan in patients receiving mechanical ventilation to reduce the risk of pneumonia (9/5); reached agreement with FDA on special protocol assessment (9/22)

MISCELLANEOUS

Amgen Inc. (AMGN)

Cinacalcet

Cinacalcet hydrochrloride, a calcimimetic

Secondary hyperparathyroidism associated with chronic kidney disease

Company filed an NDA (9/9)

Idun Pharmaceuticals Inc.*

IDN-6556

Intended to protect livercells from apoptosis

Liver and other solid organ transplantations

FDA granted orphan drug status (9/24)

Inspire Pharmaceuticals Inc. (ISPH)

--

Diquafosol tetrasodium

ophthalmic solution

Dry eye

FDA accepted the NDA filing (9/9)

QLT Inc. (QLTI)

Visudyne

Light-activated therapy

Subfoveal choroidal neovascularization

FDA granted fast-track status to Visudyne therapy (9/18)


Notes:

* Privately held

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