Company* |
Product |
Description |
Indication |
Status (Date) |
AUTOIMMUNE | ||||
Biogen Idec |
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. |
Bexxar |
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 |
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 |
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 |
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 |
Estorra |
Eszopiclone tablets |
Insomnia |
FDA accepted for filing NDA that was resubmitted in June; an approvable letter was issued in February (7/15) |
Titan |
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 |
Imvamune |
Third-generation smallpox vaccine candidate |
Smallpox infection |
The FDA granted fast-track designation to the product in that indication (7/21) |
Depomed |
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 |
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 |
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* |
Icatibant |
Bradykinin B2 receptor antagonist |
Hereditary angioedema |
The FDA granted fast-track status to the product in that indication (7/22) |
Jerini AG* |
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 |
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 |
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 |
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. | ||||
