Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Aspreva
Pharmaceuticals
Corp.
(Canada;
ASPV) and
Hoffmann-La
Roche Inc.

CellCept

Mycophenolate mofetil; an immunosuppressant

Myasthenia gravis

The FDA granted orphan designation to the product in that indication, for which Phase III trials are ongoing (1/3)

Genelabs
Technologies
Inc.
(GNLB)

Prestara

Prasterone; synthetic equivalent of dehydro- epiandrosterone

Lupus

The FDA said an additional Phase III trial would be needed to support approval for treating signs and symptoms of lupus; Genelabs plans to conduct a trial; it is ending development for preventing loss of bone mineral density in lupus patients, however, after the FDA said another trial also would be needed in that indication (1/13)

CANCER

Favrille Inc.
(FVRL)

FavId

Patient-specific vaccine designed to stimulate immune responses

B-cell follicular non-Hodgkin's lymphoma

The FDA granted fast-track status in that indication, for which a pivotal trial is ongoing (1/12)

Genmab A/S
(Denmark; CSE:
GEN)

HuMax-GFr

Fully human antibody that targets the epidermal growth factor receptor

Reftractory head and neck cancer

The FDA granted fast-track status to the product in that indication (1/3)

CARDIOVASCULAR

CV
Therapeutics
Inc.
(CVTX)

Ranexa(ranolazine)

Partial inhibitor of fatty-acid oxidation

Chronic angina

The FDA approved the drug for treating chronic angina (1/27)

Nuvelo Inc.
(NUVO)

Alfimeprase

Modified fibrolase delivered via catheter; thrombolytic agent

Acute peripheral arterial occlusion

The FDA granted the drug fast- track designation in that indication, for which Phase III trials are ongoing (1/23)

CENTRAL NERVOUS SYSTEM

Adolor
Corp.
(ADLR)

ADL5859

Oral compound that targets the Delta opioid receptor

Pain

The FDA placed a hold on a proposed Phase I trial pending additional preclinical safety studies and other information (1/30)

Avanir
Pharmaceuticals
Inc.
(AMEX:AVN-R)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Pseudobulbar affect

Completed NDA submission seeking approval in that indication, which also is know as involuntary emotional expression disorder or emotional lability (1/30)

New River
Pharmaceuticals
Inc.
(NRPH) and
Shire plc (UK)

NRP104

Prodrug of amphetamine

Attention deficit/ hyperactivity disorder

The FDA accepted for review the NDA filing, which was made in December 2005 (1/27)

TheraQuest
Biosciences
LLC*

TQ-1018

High-concentration, topical Capsaicin

Postherpetic neuralgia

The FDA granted orphan designation to the product in that indication (1/31)

DIABETES

Nektar
Therapeutics
Inc.
(NKTR) and
Pfizer Inc.

Exubera

Dry-powder, inhaled insulin formulation that uses Nektar technology

Type I and II diabetes

The FDA granted marketing approval to Exubera, which will be marketed in the U.S. by Pfizer (1/27)

INFECTION

Acambis plc
(UK; ACAM)

ACAM2000

Second-generation vaccine

Smallpox infection

Submitted first portion of a BLA under a rolling application (1/18)

BioCryst
Pharmaceuticals
Inc.
(BCRX)

Peramivir

Influenza neuraminidase inhibitor

Influenza

The FDA granted fast-track status to the drug for treating influenza infections, including highly virulent, life-threatening strains (1/17)

Cangene Corp.
(Canada; TSE:CNJ)

VariZIG

Varicella immune globulin

Varicella zoster exposure

The FDA approved an expanded access program under which at- risk patients can receive VariZIG if exposed to the virus, which causes chickenpox (1/31)

Cangene Corp.
(Canada; TSE:CNJ)

HepaGam B

Hepatitis B immune globulin (human)

Exposure to hepatitis B virus

The FDA approved the product for treatment following acute exposure to hepatitis B virus (1/30)

Idenix
Pharmaceuticals
Inc.
(IDIX) and
Novartis
Pharmaceuticals
Corp.

Telbivudine

Selective, oral nucleoside analogue

Hepatitis B

They filed an NDA with the FDA seeking approval for treatment of chronic hepatitis B (1/3)

Medarex Inc.
(MEDX) and
PharmAthene
Inc.*

Valortim (MDX-1303)

Fully human antibody that targets the Bacillus anthracis protective antigen

Anthrax infection

The FDA granted fast-track designation to the product, which is in Phase I trials (1/9)

Oscient
Pharmaceuticals
Corp.
(OSCI)

Factive (FDA-approved)

Gemifloxacin mesylate; a fluoroquinolone antibiotic

Acute bacterial sinusitis and community- acquired pneumonia

The FDA accepted for review supplemental NDA in CAP but refused to accept the sNDA for treating ABS, citing an unacceptable risk- benefit profile (1/20)

Replidyne
Inc.*

Orapem

Ester, oral produg formulation of faropenem, an agent from the penem class

Multiple conditions

Replidyne filed an NDA seeking approval for acute bacterial sinusitis, community-acquired pneu- monia, acute exacerbations of bronchitis and uncomplicated skin and skin-structure infections (1/9)

Starpharma
Holdings Ltd.
(Australia;
ASX:SPL)

VivaGel

Vaginal microbicide gel

HIV prevention

The FDA granted fast-track status to the product (1/9)

MISCELLANEOUS

BioMarin
Pharmaceutical
Inc.
(BMRN)

Phenoptin

Sapropterin hydrochloride; form of the enzyme co-factor 6R-BH4

Phenylketonuria

The FDA granted fast-track designation to the product in that indication, for which Phase III trials are ongoing (1/25)

CepTor Corp.
(OTC BB:CEPO)

Myodur (C101)

Muscle cell-targeted product designed to inhibit calpain

Duchenne and Becker muscular dystrophies

The FDA granted orphan designation to the drug in both indications (1/25)

Discovery
Laboratories
Inc.
(DSCO)

Surfaxin

Engineered version of natural human lung surfactant

Broncho- pulmonary dysplasia

The FDA granted fast-track designation to the drug in BPD (also known as chronic lung disease) in premature infants (1/26)

Genzyme
Corp.
(GENZ)

Myozyme

Recombinant human acid alpha-lucosidase enzyme

Pompe disease

The FDA extended by 90 days its review period on the BLA; the new action date is April 28, 2006 (1/17)

Sucampo
Pharmaceuticals
Inc.*

Amitiza

Lubiprostone capsules; selective chloride channel activator

Chronic idiopathic constipation

The FDA approved the product, which will be jointly marketed with Takeda Pharmaceuticals America Inc. (1/31)


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; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.

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