Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Amgen Inc.
(AMGN) and
Wyeth

Enbrel (FDA-approved)

Etanercept; anti- tumor necrosis factor-alpha antibody

Rheumatoid arthritis

FDA approved an indication to induce a major clinical response in RA patients (9/28)

Centocor Inc.
(unit of Johnson-
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Rheumatoid arthritis

The FDA approved an expanded label as a first-line treatment, in combination with methotrexate, to treat moderate to severe RA (9/30)

CANCER

Biomira Inc.
(Canada; BIOM)
and Merck KGaA
(Germany)

BLP25

Therapeutic vaccine encapsulating a sequence of the MUC1 cancer mucin in a liposomal delivery system

Non-small-cell lung cancer

The FDA granted fast-track status to the product for treating late-stage NSCLC patients (9/29)

Burzynski
Research
Institute
(OTC BB:BZYR)

Anti-neoplastons A10 and AS2-1

Compounds composed of growth-inhibiting peptides, amino acid derivatives and organic acids

Brain stem glioma

The FDA granted orphan designation to the products in that indication (9/7)

Corixa Corp.
(CRXA)

Bexxar (FDA-approved)

Radiolabeled antibody combining tositumomab and iodine-131; targets CD20 antigen on B cells lymphoma

Low-grade, follicular or transformed CD20-positive non-Hodgkin's lymphoma

The FDA accepted for review the supplemental BLA, which was filed in July; the FDA also granted priority- review status to the filing (9/20)

Guilford
Pharmaceuticals
Inc.
(GLFD)

Gliadel Wafer (FDA-approved)

Wafer comprised of a biodegradable polymer incorporating carmustine

Malignant glioma

FDA granted orphan designation to the product in malignant glioma patients undergoing primary surgical resection (9/27)

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

Tarceva

Erlotinib HCl; small-molecule HER1/EGFR inhibitor

Non-small-cell lung cancer

The FDA accepted for review the NDA, which was filed in August for treating advanced patients for whom chemotherapy has failed (9/30)

CARDIOVASCULAR

CoTherix Inc.*

Ventavis

Inhaled formulation of iloprost, a prostacyclin analogue

Pulmonary arterial hypertension

The FDA accepted for review the NDA, which was filed in July; the product also was granted priority review and received orphan designation; it is sold in Europe by Schering AG (9/8)

KAI
Pharmaceuticals
Inc.*

KAI-9803

Protein kinase C inhibitor; targets the delta-PKC isozyme

Acute myocardial infarction

The FDA granted orphan designation to the product in that indication (9/28)

NovaDel
Pharma Inc.
(AMEX:NVD)

--

Aerosol nitroglycerin lingual spray

Angina

The FDA acecpted for review the NDA, which seeks approval for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease (9/29)

CENTRAL NERVOUS SYSTEM

Boston Life
Sciences Inc.
(BLSI)

Axosine

Small-molecule axonal growth factor

Motor function recovery after a stroke

The FDA placed a hold on a Phase I trial pending the submission of additional pharmacology/toxicology data (9/14)

Prestwick
Pharmaceuticals
Inc.*

Tetrabenazine

Dopamine depletor that works by selectively blocking the VMAT2 transporter

Chorea associated with Huntington's disease

The FDA designated fast-track and orphan status to the drug, which is on the market in Europe and Canada (9/16)

Proneuron
Biotechnologies
Inc.*

ProCord

Autologous incubated macrophage therapy

Acute spinal cord injury

The FDA granted orphan designation to the Phase II product for improving motor and sensory neurological outcomes (9/13)

DIABETES

Amylin
Pharmaceuticals
Inc.
(AMLN) and
Eli Lilly and Co.

Exenatide

Incretin mimetic; synthetic exendin-4

Type II diabetes

The FDA accepted for review the NDA on the drug, which was filed in June (9/1)

INFECTION

Acambis plc
(UK; ACAM)
and Baxter
Healthcare

--

Modified vaccinia Ankara vaccine

Smallpox infection

The FDA granted fast-track status to the vaccine, which is being developed under a contract from the NIH (9/24)

Acambis plc
(UK; ACAM)

ACAM2000

Second-generation vaccine

Smallpox

The FDA lifted the clinical hold it had placed on Phase III trial, and agreed that the current enrollment was sufficient to complete data analysis (9/20)

Access
Pharmaceuticals
Inc.
(AMEX:AKC)

OraDisc A

Amlexanox delivered via a mucoadhesive patch

Canker sores

The FDA approved the product for treating aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system (9/30)

Depomed
Inc.
(DEPO)

Proquin XR

Once-daily, extended-release formulation of the antibiotic ciprofloxacin

Uncomplicated urinary tract infections

The FDA accepted for review the NDA, which was filed in July (9/20)

Inhibitex
Inc.
(INHX)

Aurexus

Humanized monoclonal antibody that targets the ClfA protein on the surface of S. aureus

S. aureus infections

The FDA designated fast-track status to the Phase II product (9/21)

Vicuron
Pharmaceuticals
Inc.
(MICU)

Anidulafungin

Broad-spectrum agent from the echinocandin class

Esophageal candidiasis; invasive candidiasis/ candidemia

Following FDA approvable letter in May, company said it expected to file NDA supplement in 2Q:05 for esophageal candidiasis; in invasive disease, filing is planned for 3Q:05 using integrated data (9/21)

MISCELLANEOUS

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

Entereg (alvimopan)

Mu opioid antagonist

Postoperative ileus

The FDA accepted for review the NDA, which was filed in June, and designated it for standard review (9/8)

Atrix
Laboratories
Inc.
(ATRX) and
Fujisawa
Healthcare Inc.

Aczone (Atrisone)

Dapsone gel formulated with Atrix's SMP technology

Acne

Companies submitted an NDA with the FDA (9/1)

Altus
Pharmaceuticals
Inc.*

TheraCLEC

Oral enzyme-replacement
therapy designed to
replace digestive enzymes

Pancreatic
insufficiency

The FDA selected the product for participation in the Continuous Marketing Application Pilot 2 pro- gram (9/10)

Cellegy
Pharmaceuticals
Inc.
(CLGY)

Cellegesic

Nitroglycerin ointment

Pain from anal fissures

The FDA accepted for review the NDA on the product, which was filed in June (9/1)

Halozyme
Therapeutics
Inc.
(OTC
BB:HZYM)

Cumulase

Ex vivo formulation of recombinant human PH20 hyaluronidase

Treatment of oocytes

Submitted a 510(k) application to the FDA for treating oocytes to facilitate certain in vitro fertilizations (9/14)

ISTA
Pharmaceuticals
Inc.
(ISTA)

Vitrase (FDA-approved)

Ovine hyaluronidase formulation

For use as a spreading agent

The FDA granted three years of market exclusivity to the product, which was approved in May (9/21)

Miravant
Medical
Technologies
Inc.
(OTC BB:MRVT)

SnET2

Photodynamic therapy that uses a light-activated drug to destroy abnormal blood vessels

Age-related macular degeneration

The FDA issued an approvable letter that calls for an additional trial before approval can be gained (9/30)


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; OTC BB = Over-the-Counter Bulletin Board.

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