Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Biogen Idec
Inc.
(BIIB) and Elan Corp. plc (Ireland)

Antegren (natalizumab)

Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class

Multiple sclerosis

The FDA accepted for filing the NDA on the drug, which already was designated for priority review (7/26)

CANCER

Cell Therapeutics Inc. (CTIC)

Pixantrone

Anthracycline agent designed to have improved properties

Non-Hodgkin's lymphoma

The FDA granted fast-track designation to the product in treating relapsed, aggresive NHL (7/12)

Corixa Corp.
(CRXA)

Bexxar
(FDA-approved)

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

Low-grade, follicular or transformed CD-20- ositive non-Hodgkin's lymphoma

Filed supplemental NDA seeking approval for use in patients with relapsed or refractory disease (7/6)

ILEX Oncology
Inc.
(ILXO)

Clofarabine

Second-generation purine nucleoside analogue

Refractory/ relapsed acute leukemia in children

The FDA will grant six months of extended market exclusivity to the product under the Best Pharmaceuticals for Children Act; the NDA is under review (7/21)

CARDIOVASCULAR

Alexion
Pharmaceuticals
Inc.
(ALXN)

Eculizumab

Humanized monoclonal antibody designed to block complement protein C5

Paroxysmal nocturnal hemoglobinuria

Agreed with FDA on special protocol assessment for pivotal Phase III program that will include the TRIUMPH and SHEPHERD trials (7/20)

CoTherix Inc.*

Ventavis

Iloprost solution for inhalation

Pulmonary arterial hypertension

Filed NDA seeking approval in PAH; the product is sold in Europe by Schering AG (7/1)

CV Therapeutics
Inc.
(CVTX)

Ranexa (ranolazine)

Partial inhibitor of fatty-acid oxidation

Chronic angina and acute coronary syndromes

Reached agremeent under FDA special protocol assessment on 5,500-patient MERLIN trial (7/29)

CENTRAL NERVOUS SYSTEM

Phytopharm plc (UK; LSE:PYM)

Myogane (PYM50018)

Product based on Asian plant extract believed to have neuroprotective effects

Amyotrophic lateral sclerosis

The FDA granted orphan designation to the product in ALS, for which a Phase I trial has been completed (7/26)

Sepracor
Inc.
(SEPR)

Estorra

Eszopiclone tablets

Insomnia

FDA accepted for filing NDA that was resubmitted in June; an approvable letter was issued in February (7/15)

Titan
Pharmaceuticals
Inc.
(AMEX:TTP)

Spheramine

Human retinal pigment epithelial cells adhered to spherical microscopic carriers

Parkinson's disease

The FDA granted fast-track designation to the product in treating advanced PD; the product is in a Phase IIb trial (7/12)

INFECTION

Bavarian Nordic
A/S
(Denmark;
CSE:BAVA)

Imvamune

Third-generation smallpox vaccine candidate

Smallpox infection

The FDA granted fast-track designation to the product in that indication (7/21)

Depomed
Inc.
(DEPO)

Proquin XR

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

Uncomplicated urinary tract infections

Filed NDA with FDA seeking approval in that indication (7/20)

MedImmune
Inc.
(MEDI)

Synagis (FDA-approved)

New liquid formulation of palivizumab; a humanized monoclonal antibody

Respiratory syncytial virus

The FDA approved the new liquid formulation of the product, which was first approved in 1998 (7/26)

MISCELLANEOUS

BioMarin Pharmaceutical Inc. (BMRN)

6R-BH4

Enzyme co-factor; the active ingredient in the company's investigational agent

Phenylketonuria

The product was granted orphan designation by the FDA (7/20)

BioMimetic Pharmaceuticals
Inc.*

GEM 21S

Synthetic bone matrix combined with a tissue growth factor

Periodontal diseases

FDA advisory panel recommended approval for treating bone defects of the jaw in patients with advanced periodontal diseases requiring surgery (7/15)

ISTA Pharmaceuticals Inc. (ISTA)

Xibrom

Bromfenac sodium solution; topical non-steroidal anti-inflammatory agent

Ocular inflammation following cataract surgery

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

Jerini AG*
(Germany)

Icatibant

Bradykinin B2 receptor antagonist

Hereditary angioedema

The FDA granted fast-track status to the product in that indication (7/22)

Jerini AG*
(Germany)

Icatibant

Bradykinin B2 receptor antagonist

Edema in severe burn patients

The FDA granted orphan status in that indication, for which a Phase II trial is being planned (7/7)

Neurochem
Inc.
(Canada;
NRMX)

Fibrillex

Glycosaminoglycan mimetic with anti-amyloid properties

Amyloid A amyloidosis

Product was selected for inclusion in FDA's Continous Marketing Applications Pilot 2 program (7/7)

Palatin
Technologies
Inc.
(AMEX:PTN)

NeutroSpec (formerly LeuTech)

Technetium-labeled anti-CD 15 monoclonal antibody that binds to neutrophils

Diagnosing appendicitis

The FDA approved NeutroSpec, which will be marketed by Mallinckrodt Imaging for diagnosing equivocal disease (7/6)

Transkaryotic
Therapies Inc.
(TKTX)

Iduronate-2-sulfatase

Enzyme replacement therapy

Hunter syndrome (MPS II)

The FDA granted fast-track designation to the product, which is being studied in a pivotal trial in that indication (7/15)


Notes:

* Privately held

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.

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