Company* |
Product | Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Biogen Idec |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
— |
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- |
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 |
— |
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 |
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 |
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 |
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 |
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* |
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 |
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 |
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. |
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. |
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. | ||||
