Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

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

Tysabri

Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells

Multiple sclerosis

The FDA lifted a hold it had placed on clinical dosing; an open-label trial was planned (2/15)

Genentech
Inc.
(NYSE:DNA)
and Biogen
Idec Inc.
(BIIB)

Rituxan (FDA-approved)

Rituximab; antibody that targets and selectively depletes CD20-positive B cells

Rheumatoid arthritis

The FDA approved the drug for use with methotrexate to reduce signs and symptoms of moderately to severely active RA in patients who have inadequately responded to TNF antagonist therapies (2/28)

CANCER

Cell
Therapeutics
Inc.
(CTIC)

Xyotax

Paclitaxel linked to a biodegradable polyglutamate polymer

Advanced non- small-cell lung cancer

The FDA granted the drug fast- track status for treating poor-performance-status women with first-line advanced NSCLC(2/8)

Genentech
Inc.
(NYSE:DNA)

Herceptin (FDA-approved)

Trastuzumab; monoclonal antibody against the HER2/neu protein

Early stage breast cancer

Completed submission of sBLA with FDA seeking approval for treating early stage, HER2-positive breast cancer (2/15)

Genentech
Inc.
(NYSE:DNA)
and Biogen
Idec Inc.
(BIIB)

Rituxan (FDA-approved)

Rituximab; antibody that targets and selectively depletes CD20-positive B cells

Non-Hodgkin's lymphoma

The FDA approved supplemental BLA, approving drug for use in the first-line treatment of diffuse large B-cell, CD20- ositive, NHL in combination with anthracycline-based chemotherapy regimens (2/10)

Molecular
Insight
Pharmaceuticals
Inc.*

Ultratrace MIBG

Radiopharmaceutical designed to maximize delivery of radiolabeled MIBG molecules

Neuroendocrine tumors

The FDA granted the product orphan designation in that indication (2/8)

Therion
Biologics
Corp.*

Panvac-VF

Vaccine designed to stimulate the immune system to destroy cells expressing CEA and mucin-1

Metastatic pancreatic cancer

The FDA granted the drug orphan designation in that indication, for which Phase III trials are ongoing (2/10)

YM
BioSciences
Inc.
(Canada;
TSE:YM)

Tesmilifene (DPEE)

Small molecule designed to augment the activity of chemotherapy agents

Advanced breast cancer

The FDA granted fast-track status to the drug for use in combination with an anthracycline agent for that indication (2/13)

CARDIOVASCULAR

ActivBiotics
Inc.*

Rifalazil

Bactericidal anti-chlamydial agent

Peripheral arterial disease

The FDA granted fast-track status to the product in that indication, for which Phase III trials are ongoing (2/1)

DIABETES

TolerRx Inc.*

TRX4

Monoclonal antibody that binds to the CD3 receptor on T cells

Type I diabetes

The FDA granted orphan designation to the product in that indication (2/15)

INFECTION

Amarillo
Biosciences Inc.
(OTC BB:AMAR)

Oral interferon

Various diseases

The FDA granted orphan drug designation to the product for treatment of oral warts in HIV patients, Behcet's disease and polycythemia vera (2/14)

Nabi Bio-
pharmaceuticals
(NABI)

Civacir

Hepatitis C immune globulin (human)

Hepatitis C

The FDA granted fast-track status to the product for preventing HCV re-infection in liver transplants (2/1)

Nektar
Therapeutics
Inc.
(NKTR)

Amphotericin B inhalation powder

Fungal infections

The FDA granted orphan status to the product for preventing pulmonary infections in patients at risk for aspergillosis due to immuno- suppressive therapy (2/14)

Progenics
Pharmaceuticals
Inc.
(PGNX)

PRO 140

Humanized monoclonal antibody that binds CCR5; viral entry inhibitor

HIV

The FDA granted fast-track status to the drug; it is in Phase Ib trials in HIV (2/22)

Replidyne
Inc.*
and Forest
Laboratories Inc.

Faropenem medoxomil

Ester prodrug derivative of the beta- lactam antibiotic faropenem

Multiple conditions

The FDA accepted for review NDA seeking approval for treating acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin-structure infections (2/23)

ViroPharma
Inc.
(VPHM)

Maribavir

Benzimidazole compound; oral inhibitor of cytomeg-alovirus

Prevention of CMV infection

The FDA granted fast-track status to the drug for preventing CMV infection in allogeneic bone mar- row and solid organ transplant patients (2/7)

MISCELLANEOUS

Amicus
Therapeutics
Inc.*

AT2101

Agent that acts as a pharmacological chaperone that binds to gluco- cerebrosidase

Gaucher's disease

The FDA granted orphan designation to the preclinical product in that indication (2/15)

Apoxis SA*
(Switzerland)

APO200

Protein therapeutic based on Apoxis' multimerization technology

X-linked hypohidrotic ectodermal dysplasia

The FDA granted the product orphan designation in that indication, a rare genetic disease (2/2)

BioSante
Pharmaceuticals
Inc.
(AMEX:BPA)

Bio-E-Gel

Estradiol transdermal gel

Hot flashes

Company filed NDA with the FDA seeking approval to treat moderate to severe hot flashes in menopausal women (2/16)

Genentech Inc. (NYSE:DNA)

Lucentis

Ranibizumab; humanized antibody fragment designed to bind and inhibit VEGF-A

Wet age-related macular degeneration

The FDA accepted for review the BLA that was filed in December and granted it priority review (2/28)

Neurochem
Inc. (Canada; NRMX)

Fibrillex

Glycosaminoglycan mimetic with anti- amyloid properties

Amyloid A amyloidosis

Company submitted to the FDA the final modules of its NDA; it began the rolling NDA in August 2005 (2/13)

Santarus Inc.
(SNTS)

Zegerid

Capsule formulation of the proton pump inhibitor omeprazole

Heartburn

The FDA approved the product for treating heartburn and other symptoms associated with gastroesophageal reflux disease, as well as for esophagitis and ulcer indications (2/27)

Sepracor Inc.
(SEPR)

Arformoterol

Long-acting beta-agonist formulated for inhalation; single isomer of formoterol

Chronic obstructive pulmonary disease

NDA filed with the FDA in December was accepted for review (2/13)


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; OTC BB = Over-the-Counter Bulletin Board; NYSE = New York Stock Exchange.

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