Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Acorda
Therapeutics
Inc.*

Fampridine-SR

Selective neuronal potassium channel blocker

Multiple sclerosis

Reached agreement with FDA on SPA for Phase III trial that will measure improvement in walking (5/4)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Ulcerative colitis

Supplemental BLA filed with the FDA has been designated for priority review (5/31)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Psoriatic arthritis

The FDA approved the drug to reduce the signs and symptoms of active arthritis in patients with PA; it is the ninth FDA approval of the product (5/17)

La Jolla
Pharmaceutical
Co.
(LJPC)

Riquent

Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA

Lupus

The FDA designated fast-track status to Riquent for treating lupus renal disease (5/31)

CANCER

Amgen
Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa, a recombinant erythropoietic protein

Anemia

Submitted supplemental NDA seeking approval of extended dosing to treat chemotherapy-induced anemia in patients with non-myeloid malignancies (5/6)

Cell
Genesys
Inc.
(CEGE)

GVAX

Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF

Prostate cancer

Agreed to SPA with FDA for its second Phase III trial (VITAL-2) in prostate cancer; it will compare GVAX and Taxotere to Taxotere and prednisone (5/18)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

GTI-2040

Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase

Acute myeloid leukemia

The FDA awarded orphan status to the drug in that indication, for which Phase II trials are ongoing (5/4)

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

Sorafenib (BAY 43-9006)

RAF kinase and VEGF inhibitor

Metastatic kidney cancer

The product was accepted into the FDA's Pilot 1 Program for continuous marketing applications (5/4)

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

Tarceva (FDA-approved)

Erlotinib HCl; small- molecule HER1/EGFR inhibitor

Advanced pancreatic cancer

Submitted supplemental NDA for use of drug with gemcitabine for treating advanced, previously untreated patients (5/2)

Structural
Genomix Inc.*

Troxatyl

Troxacitabine; nucleoside analogue

Acute myelogenous leukemia

The FDA granted orphan designation to the drug, which is in Phase I/II trials in that indication (5/12)

CARDIOVASCULAR

Arginox
Pharmaceuticals*

Tilarginine Acetate Injection

Agent designed to inhibit the production of nitric oxide

Cardiogenic shock

The FDA granted orphan designation to the product in that indication, for which Phase III trials were starting (5/23)

Encysive
Pharmaceuticals
Inc.
(ENCY)

Thelin

Sitaxsentan; small molecule designed to block endothelin

Pulmonary arterial hypertension

Filed NDA with FDA seeking approval as a once-daily treatment for patients with PAH (5/25)

PR
Pharmaceuticals
Inc.*

PulmoLAR

2-methoxyestradiol (2ME), an endogenous non- estrogenic metabolite of estradiol

Pulmonary arterial hypertension

The FDA granted orphan designation to the drug; Phase I trials are expected to begin in 2005 (5/12)

CENTRAL NERVOUS SYSTEM

Alkermes Inc.
(ALKS)

Vivitrex

Long-acting, injectable form of naltrexone

Alcohol dependence

The FDA granted priority review to the NDA, which was filed in May, putting the review deadline at Sept. 30, 2005 (5/27)

Alkermes Inc.
(ALKS) and
Johnson &
Johnson

Risperdal Consta (FDA-approved)

Risperidone formulated in Alkermes' long-acting Medisorb technology

Psychosis of Alzheimer's disease

The FDA issued J&J a not-approvable letter on the supplemental NDA filing (5/26)

CytRx Corp.
(CYTR)

Arimoclomol

Small molecule designed to provide cellular protection by activating molecular chaperone proteins

Amyotrophic lateral sclerosis

The FDA granted orphan drug designation to the product in ALS (5/5)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

Tablet form of a non-benzodiazepine agent that targets the GABA-A receptor

Insomnia

The company has completed submission of an NDA with the FDA for treating insomnia in both adult and elderly patients (5/26)

INFECTION

Depomed Inc.
(DEPO)

Proquin XR

Once-daily, extended- release formulation of ciprofloxacin hydrochloride

Uncomplicated urinary tract infections

The FDA approved the product; Depomed was in late- stage negotiations with potential marketing partners (5/20)

Vicuron
Pharmaceuticals
Inc.
(MICU)

Anidulafungin

Broad-spectrum agent from the echinocandin class

Esophageal candidiasis

Filed amendment to existing NDA; amendment in invasive candidiasis/candidemia is expected in the third quarter (5/31)

Vicuron
Pharmaceuticals
Inc.
(MICU)

Dalbavancin

Glycopeptide agent from the same class as vancomycin

Complicated skin and soft-tissue infections

The FDA said it would extend its review date on the NDA for three months; action now is expected by Sept. 21, 2005 (5/11)

MISCELLANEOUS

Copernicus
Therapeutics
Inc.*

--

Drug based on DNA nanoparticle technology

Cystic fibrosis

The FDA granted orphan desig-nation to the drug in that indication (5/2)

Halozyme
Therapeutics
Inc.
(AMEX:HTI)

Hylenex (formerly Enhanze SC)

Formulation of recombinant human hyaluronidase

For use as a spreading agent

The FDA accepted the NDA for filing and review; it was filed in March (5/26)

InKine
Pharmaceutical
Co. Inc.
(INKP)

INKP-102

New-generation sodium phosphate purgative tablet

Bowel cleansing prior to colonoscopy

The company filed an NDA seeking approval of the product (5/3)

Tercica Inc.
(TRCA)

Increlex

Mecasermin injection; recombinant human insulin-like growth factor-1

Short stature caused by IGF deficiency

The FDA accepted for filing and granted priority review to the NDA, which was filed in February (5/2)


Notes:

* Privately held.

BLA = Biologics license 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.

AMEX = American Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange.

No Comments