Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


CANCER

Chemokine
Therapeutics
Corp.
(Canada;
OTC BB:CHKT)

CTCE-9908

Drug targeting cancer via the CXCR4 receptor

Osteogenic sarcoma

The FDA granted orphan designation to the drug, which is in Phase I trials (7/19)

Onyx
Pharmaceuticals
Inc.
(ONXX)
and Bayer
Pharmaceuticals
Corp.

Sorafenib (BAY 43-9006)

RAF kinase and VEGF inhibitor

Advanced kidney cancer

They completed filing of an NDA for that indication (7/11)

OSI
Pharmaceuticals
Inc.
(OSIP) and
Genentech
Inc.
(NYSE:DNA)

Tarceva (FDA-approved)

Erlotinib HCl; small- molecule HER1/EGFR inhibitor

Advanced pancreatic cancer

The FDA accepted for review supplemental NDA for use with gemcitabine; the sNDA was filed in May (7/6)

Neose
Technologies
Inc.
(NTEC)

NE-180

Long-acting, glyco- PEGylated erythropoietin

Chemotherapy- induced anemia

The FDA placed proposed Phase I trial on hold pending additional manufacturing and preclinical information (7/19)

Sonus
Pharmaceuticals
Inc.
(SNUS)

Tocosol

Formulation of paclitaxel using Sonus' delivery system

Breast cancer

Reached agreement with FDA on SPA for pivotal Phase III trial that will compare drug to Taxol in 800 patients (7/7)

CARDIOVASCULAR

Biopure
Corp.
(BPUR)

Hemopure

Oxygen therapeutic consisting of bovine hemoglobin

Blood loss in trauma patients

The FDA put proposed RESUS trial by the Naval Medical Research Center on hold until certain issues are addressed (7/12)

CV
Therapeutics
Inc.
(CVTX)

Ranexa (ranolazine)

Partial inhibitor of fatty- acid oxidation

Chronic angina

Submitted amendment to the NDA, based on results of ERICA trial; an approvable letter was issued in October 2003 (7/27)

Encysive
Pharmaceuticals
Inc.
(ENCY)

Thelin

Sitaxsentan; small molecule designed to block endothelin

Pulmonary arterial hypertension

The FDA accepted the NDA filing and designated it for standard review; the NDA was filed in May (7/14)

CENTRAL NERVOUS SYSTEM

Neurobiological
Technologies
Inc.
(NTII)

Namenda
(FDA-approved)

Memantine; NMDA receptor antagonist

Alzheimer's disease

The FDA issued partner Forest Laboratories Inc. a non-approv- able letter on supplemental NDA to expand the label to include treatment of mild AD (7/25)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

Capsule formulation of a non- enzodiazepine agent that targets the GABA-A receptor

Insomnia

The FDA accepted for review the NDA for treatment of insomnia in both adult and elderly patients (7/26)

INFECTION

ID Biomedical
Corp.
(Canada;
IDBE)

Fluviral

Influenza virus vaccine

Influenza

The FDA granted fast-track designation to the vaccine (7/12)

Trimeris Inc.
(TRMS) and
Hoffmann-La
Roche Inc.

Fuzeon (FDA-approved)

HIV fusion inhibitor; enfuvirtide

HIV

The FDA accepted the filing of a supplemental NDA seeking to include the Biojector 2000 needle-free injection device in the labeling (7/18)

Vertex
Pharmaceuticals
Inc.
(VRTX)

640385 (VX-385)

HIV protease inhibitor

HIV

Partner GlaxoSmithKline plc was granted fast-track designation from the FDA; a Phase III trial was about to get under way (7/19)

MISCELLANEOUS

Adolor Corp.
(ADLR) and
GlaxoSmithKline
plc (UK)

Entereg

Alvimopan capsules; mu opioid antagonist

Post-operative
ileus

The FDA issued an approvable letter saying additional proof of efficacy was needed to support the NDA, which was filed in June 2004 (7/22)

Alizyme plc
(UK; LSE:AZM)

Renzapride

5-HT4 receptor agonist and an antagonist at 5-HT3 receptors

Irritable bowel syndrome

Reached agreement with the FDA under an SPA for pivotal Phase III trial in up to 1,700 women with constipation- redominant IBS (7/7)

BioDelivery
Sciences
International
Inc.
(BDSI)

Emezine

Formulation of the approved agent prochlorperazine

Nausea and vomiting

The FDA accepted for review the NDA, which was filed in April (7/20)

Chiron Corp.
(CHIR)

Pulminiq

Cyclosporine inhalation solution

For use in patients getting lung transplants

The FDA said the product was approvable but that an additional trial was needed to confirm efficacy (7/15)

Genentech
Inc.
(NYSE:DNA)

Nutropin and Nutropin AQ (both FDA- approved)

Somatropin for injection

Idiopathic short stature

The FDA approved supplemental applications for the long-term treatment of ISS (7/7)

Genzyme
Corp.
(GENZ)

Myozyme

Recombinant human acid alpha-lucosidase enzyme

Pompe disease

Submitted a BLA to the FDA, seeking approval of the product (7/29)

InKine
Pharmaceutical
Co. Inc.
(INKP)

INKP-102

New-generation sodium phosphate purgative tablet

Bowel cleansing prior to colonoscopy

The FDA accepted for filing the NDA, which was filed in May (7/26)

NPS
Pharmaceuticals
Inc.
(NPSP)

Preos

Recombinant human parathyroid hormone

Osteoporosis

The FDA accepted for review the NDA for treating osteoporosis in postmenopausal women; it was filed in May (7/11)

Santarus Inc.
(SNTS)

Zegerid

Tablet formulation of the proton pump inhibitor omeprazole

Gastrointestinal disorders

The FDA accepted for filing the NDA, which is seeking approval of the chewable tablet formulation for treating heartburn and symptoms of other conditions (7/26)


Notes:

* Privately held.

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration;

IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment.

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

LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board.

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