Company* |
Product | Description |
Indication | Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Biogen Idec |
Tysabri (formerly Antegren) |
Natalizumab; humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class |
Multiple sclerosis |
The FDA granted accelerated approval to the drug for treating relapsing forms of MS to reduce the frequency of clinical relapses (11/23) |
CANCER | ||||
Genzyme |
Thyrogen (FDA-approved) |
Thyrotropin alfa for injection; a recombinant human thyroid-stimulating hormone |
Ablation of remnant thyroid tissue |
Submitted an NDA supplement to the FDA seeking the additional indication; the product already is approved as a diagnostic tool (11/3) |
Marshall |
Phenoxodiol |
Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP |
Ovarian cancer |
The FDA granted fast-track status to the product for treating recurrent ovarian cancer (11/4) |
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Mantle-cell lymphoma |
The FDA granted the product fast- track status in treating relapsed and refractory MCL (11/2) |
OSI |
Tarceva |
Erlotinib HCl; small-molecule HER1/EGFR inhibitor |
Advanced non- small-cell lung cancer |
The FDA approved the drug for treating patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen (11/18) |
SuperGen |
Orathecin |
Rubitecan; topoisomerase- I inhibitor in capsule formulation |
Pancreatic cancer |
The FDA extended its review period 90 days, to Feb. 26, 2005, after additional data were submitted (11/29) |
SuperGen |
Paciltexel Injection |
Generic equivalent of the antineoplastic agent Taxol |
Various cancers |
The FDA approved the company's abbreviated NDA for the drug (11/15) |
SuperGen Inc. |
Dacogen |
Decitabine for injection; a hypomethylating agent |
Myelodysplastic syndromes |
The companies completed their NDA submission to the FDA; the first section was submitted in June (11/1) |
Threshold |
Glufosfamide |
Small molecule targeting abnormal glucose metabolism |
Metastatic pancreatic cancer |
The FDA granted fast-track status to the Phase III drug for treating unresectable, advanced disease previously treated with gemcitabine (11/15) |
YM BioSciences |
TheraCIM hR3 |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
Brain cancer |
The FDA granted orphan designation to the product in that indication (11/30) |
CARDIOVASCULAR | ||||
Encysive |
Thelin (sitaxsentan) |
Small molecule designed to block endothelin |
Pulmonary arterial hypertension |
The FDA granted orphan designation to the product, which is in Phase III trials (11/11) |
NitroMed |
BiDil |
Nitric oxide-enhancing oral agent |
Heart failure |
Submitted A-HeFT data set to the FDA, which the agency wanted before submission of an NDA amendment (11/1) |
CENTRAL NERVOUS SYSTEM | ||||
Neurocrine |
Indiplon |
Modified-release form of a non-benzodiazapine agent that targets the GABA-A receptor |
Insomnia |
Submitted an NDA with the FDA; an NDA for the immediate-release form of the drug was filed in October (11/22) |
Phytopharm |
Myogane (PYM50018) |
Product based on Asian plant extract believed to have neuroprotective effects |
Amyotrophic lateral sclerosis |
The FDA granted fast-track status to the product, which is in Phase I trials (11/9) |
MISCELLANEOUS | ||||
BioMarin |
Aryplase |
Galsulfase; an enzyme- replacement therapy |
Mucopoly- saccharidosis-VI |
The company submitted a BLA with the FDA, seeking approval to market the drug for MPS-VI (11/29) |
CuraGen |
CR002 |
Fully human monoclonal antibody that targets platelet-derived growth factor-D |
IgA nephropathy |
The FDA granted orphan designation for slowing the progression of IgA nephropathy and delaying kidney failure (11/11) |
ESP Pharma |
Terlipressin |
Analogue of vasopressin delivered intravenously |
Type I hepato-renal syndrome |
The FDA granted orphan designation to the drug in that indication (11/10) |
Nastech |
Nascobal |
Nasally delivered formulation of cyanocobalamin |
Vitamin B-12 deficiency |
The FDA issued an approvable letter saying only inspection of a manufacturing facility and finalization of labeling are needed prior to approval (11/1) |
Oragenics |
-- |
Replacement therapy using a genetically modified strain of S. mutans |
Dental caries |
The FDA lifted a clinical hold it had placed on the product; a Phase I trial is planned for early 2005 (11/30) |
| | ||||
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. | ||||
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