Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Pediatric Crohn's disease

The FDA approved the drug for use in pediatric patients with moderately to severely active disease who have inadequately responded to conventional therapy (5/19)

CANCER

Accentia Bio-
pharmaceuticals
Inc.
(ABPI)

BiovaxID

Personalized vaccine; tumor antigen conjugated to KLH administered with GM-CSF

Follicular non- Hodgkin'slymphoma

Accentia's majority-owned sub- sidiary, Biovest International Inc., was granted fast-track status for the product by the FDA (5/11)

Adventrx
Pharmaceuticals
Inc.
(AMEX:ANX)

CoFactor

Form of folic acid designed to enhance the effects of 5-FU

Metastatic colorectal cancer

Reached agreement on SPA with FDA for Phase III trial to compare drug to leucovorin as part of first- line regimens (5/22)

Bioniche Life
Sciences Inc.
(Canada; TSE:BNC)

Urocidin

Mycobacterial cell wall- DNA complex

Bladder cancer

The FDA granted fast-track designation to the product for treating non-muscle invasive bladder cancer in BCG-refractory patients (5/4)

Celgene
Corp.
(CELG)

Thalomid (FDA-approved)

Thalidomide

Multiple myeloma

The FDA granted accelerated approval to sNDA for use with dex- amethasone for treating newly diagnosed MM (5/25)

Cell Genesys
Inc.
(CEGE)

GVAX

Vaccine comprising non- patient-specific tumor cells modified to secrete GM-CSF; an immunotherapy

Prostate cancer

The FDA granted fast-track designation in that indication, for which Phase III trials are ongoing (5/10)

Genentech
Inc.
(NYSE:DNA)

Avastin
(FDA-approved)

Bevacizumab; antibody designed to inhibit vascular endothelial growth factor

Advanced breast cancer

Submitted supplemental BLA with FDA seeking approval for use with taxane chemotherapy in first-line metastatic disease (5/25)

Hana
Biosciences
Inc.
(HNAB)

Talotrexin (PT-523)

Non-classical antifolate; analogue of aminopterin

Acute lymphoblastic leukemia

The FDA granted orphan designation to the product in that indication (5/22)

Marshall
Edwards Inc.
(MSHL)

Phenoxodiol

Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP

Advanced ovarian cancer

Reached agreement with FDA on pivotal Phase III OVATURE trial that will assess restoration of sensitivity to carboplatin (5/16)

MGI Pharma
Inc.
(MOGN)
and SuperGen
Inc.
(SUPG)

Dacogen

Decitabine for injection; a hypomethylating agent

Myelodysplastic syndromes

The FDA approved the product and gave it a broad label for treating MDS; MGI will market the drug (5/3)

Novelos
Therapeutics
Inc.
(OTC BB:NVLT)

NOV-002

Oxidized glutathione- based compound; chemo- protectant and immuno-modulator

Advanced non-small- cell lung cancer

Reached agreement with FDA on SPA for pivotal Phase III trial to evaluate drug in first-line chemo- therapy regimen (5/30)

Oxford
BioMedica plc
(UK; LSE:OXB)

TroVax

Vaccine that delivers an antigen (5T4) using a poxvirus vector

Renal cell carcinoma

Reached agreement on SPA with FDA for Phase III TRIST trial, which will evaluate vaccine with first-line standard therapy (5/12)

OxiGene Inc.
(OXGN)

Combrestatin A4 Prodrug

Vascular-targeting agent designed to block the flow of blood to a tumor

Ovarian cancer

The FDA granted orphan designation to the product in that indication (5/15)

CARDIOVASCULAR

Cardiome
Pharma Corp.
(Canada; CRME)

RSD1235

Intravenous formulation of drug designed to selectively block ion channels in the heart

Atrial fibrillation

The FDA issued a refusal to file response to NDA that was filed in March by Cardiome partner Astellas Pharma US Inc. (5/31)

CENTRAL NERVOUS SYSTEM

Cephalon
Inc.
(CEPH)

Nuvigil

Armodafinil; single-isomer formulation of the active ingredient in Provigil (modafinil)

Excessive sleepiness

FDA issued approvable letter for treating sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder; approval is contigent only on product labeling (5/1)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

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

Insomnia

The FDA said the 5-mg and 10-mg capsule formulations of the drug were approvable; a re-analysis of data was requested (5/16)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

Extended-release tablet formulation of a non- enzodiazepine agent that targets the GABA-A receptor

Insomnia

The FDA said the agent was not approvable; it asked for a re-analysis of certain safety and efficacy data, likely requiring additional clinical data (5/16)

NeuroHealing
Pharmaceuticals
Inc.*

NH001

Dopaminergic agonist

Brain injury

The FDA granted orphan designation to the product for treating patients in a vegetative or minimally conscious state (5/25)

INFECTION

Caprion
Pharmaceuticals
Inc.*
(Canada)

Shigamabs

Intravenous agent consisting of the monoclonal antibodies caStx1 and caStx2

Shigatoxin- producing bacterial infections

The FDA granted fast-track designation to the product in that indication, for which a pivotal trial is being planned (5/10)

Coley
Pharmaceutical
Group Inc.
(COLY)

Actilon (CPG 10101)

Agent designed to target and stimulate Toll-like receptor 9

Hepatitis C

The FDA granted fast-track status to the product for treating refractory patients chronically infected with HCV (5/17)

Cubist
Pharmaceuticals
Inc.
(CBST)

Cubicin (FDA-approved)

Daptomycin for injection; a bactericidal antibiotic

S. aureus bacteremia and endocarditis

The FDA approved supplemental application for the new indication of treating bloodstream infections (5/25)

Nektar
Therapeutics
Inc.
(NKTR)

ABIP

Amphotericin B inhalation powder

Pulmonary fungal infections

The FDA granted fast-track status to the product for prevention of funal infections in patients at risk for aspergillosis (5/22)

MISCELLANEOUS

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

Entereg

Alvimopan capsules; mu opioid antagonist

Post-operative ileus

The FDA accepted as complete the response to the July 2005 NDA approvable letter; the PDUFA date is Nov. 9(5/31)

Aradigm
Corp.
(ARDM)

--

Aerosolized, liposomal formulation of ciprofloxacin

Cystic fibrosis

The FDA granted orphan designation to the product in that indication (5/9)

CollaGenex
Pharmaceuticals
Inc.
(CGPI)

Oracea

Capsule formulation of doxycycline

Rosacea

The FDA approved the drug for treating inflammatory lesions of rosacea in adult patients (5/30)

Dyax Corp.
(DYAX) and
Genzyme
Corp.
(GENZ)

DX-88

Recombinant small protein designed to inhibit human plasma kallikrein

Hereditary angioedema

The FDA said more clinical data would be needed than was planned, likely setting back the development timeline (5/15)

NPS
Pharmaceuticals
Inc.
(NPSP)

Preos

Recombinant human parathyroid hormone

Osteoporosis

The FDA said NPS should conduct another clinical trial to address the hypercalcemia issue raised in March 2006 approvable letter (5/2)

Regeneron
Pharmaceuticals
Inc.
(REGN)

IL-1 Trap

Agent designed to attach to and neutralize interleukin-1

CIAS1-associated periodic syndromes

The FDA granted fast-track designation to the product for treating chronic inflammation in patients with CAPS, a spectrum of rare genetic disorders (5/31)

Threshold
Pharmaceuticals
Inc.
(THLD)

TH-070

lonidamine; an indazole-3-carboxylic acid

Benign prostatic hyperplasia

The FDA placed a hold on Phase II program due to abnormalities seen in liver enzyme levels; the company must provide additional information to the FDA (5/11)


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; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.

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

AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange.

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