Company* |
Product |
Description |
Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Rheumatoid arthritis |
FDA approved label expansion to include improvement in physical function for adults with moderately to severely active RA (8/10) |
CANCER | ||||
Allos |
Efaproxyn (efaproxiral; RSR13) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
The FDA granted orphan status to the drug for use as an adjunct to whole-brain radiation therapy for brain metastases in patients with breast cancer (8/3) |
Aptamera Inc.* |
AGRO100 |
Anti-nucleolin aptamer |
Pancreatic cancer |
The FDA granted orphan designation to the product in that indication, for which a Phase II study is being planned (8/27) |
BioCryst |
Forodesine hydrochloride (BCX-1777) |
Purine nucleoside phosphorylase inhibitor; blocks T-cell synthesis |
Chronic lymphocytic leukemia and acute lymphoblastic leukemia |
The FDA granted orphan designation to the product in CLL and related leukemias, and in ALL; in February it got orphan status in T-cell non-Hodgkin's lymphoma (8/24) |
Genmab A/S |
HuMax-CD4 |
Human antibody that targets the CD4 receptor on T lymphocytes |
Mycosis fungoides |
The FDA granted the drug orphan designation in that indication, which affects 75% of patients with cutaneous T-cell lymphoma (8/23) |
ILEX Oncology Inc. (ILXO) |
Clofarabine |
Second-generation purine nucleoside analogue |
Refractory/relapsed acute leukemia in children |
Company provided FDA with new patient data to support the NDA, which was filed in March; the fil- ing moved the FDA action date back to Dec. 30 (8/24) |
Medarex Inc. |
MDX-010 |
Fully human anti-CTLA-4 antibody; gp100 melanoma peptide vaccine |
Metastatic melanoma |
Reached agreement with FDA on a special protocol assessment for a pivotal Phase III trial of the drug combination in patients who have failed first-line therapy (8/23) |
OSI |
Tarceva |
Erlotinib HCl; small-molecule HER1/EGFR inhibitor |
Non-small-cell lung cancer |
The companies completed their NDA submission, seeking approval in advanced patients for whom chemotherapy has failed (8/2) |
Seattle Genetics |
SGN-40 |
Humanized monoclonal antibody that targets the CD40 antigen |
Multiple myeloma |
The FDA granted orphan status in that indication, for which the drug is in a Phase I trial (8/24) |
CARDIOVASCULAR | ||||
Medicure Inc. | MC-4232 |
A combination MC-1 and and ACE inhibitor | Hypertension |
Began Phase II trial in Canada to assess effects on 120 patients with co-existing diabetes and hypertension (8/11) |
Myogen Inc. |
Ambrisentan |
Type-A selective endothelin receptor antagonist |
Pulmonary arterial hypertension |
The FDA granted orphan designation to the drug in PAH, in which it is in two pivotal trials (8/3) |
CENTRAL NERVOUS SYSTEM | ||||
Corcept |
Corlux (mifepristone) |
Oral GR-II antagonist with potential mitigating effects on cortisol |
Psychotic major depression |
Reached agreement with FDA on special protocol assessment for two pivotal trials; the first trial, Corcept 07, began immediately and will enroll up to 280 patients; the second trial, Corcept 06 to start in 4Q:04, will enroll about 440 patients (8/30) |
New River |
NRP104 |
Prodrug of amphetamine |
Cocaine dependence |
The preclinical product was granted fast-track status by the FDA (8/31) |
Pharmos |
Dexanabinol |
A tricyclic dextro-cannabinoid; synthetic analogue of marijuana |
Severe traumatic brain injury |
The FDA granted the drug orphan designation in that indication, for which Phase III results are expected in 4Q:04 (8/12) |
INFECTION | ||||
Gilead Sciences Inc. (GILD) |
Truvada |
Fixed-dose combination of Gilead's approved HIV drugs Emtriva and Viread |
HIV |
The FDA granted accelerated approval of Truvada for use once daily in combination with other antiretroviral agents (8/2) |
MISCELLANEOUS | ||||
Eyetech |
Macugen |
Pegaptanib sodium injection; pegylated anti-VEGF aptamer |
Age-related macular degeneration |
FDA accepted for review the NDA on the drug, the filing on which was completed in June (8/17); FDA panel discussed application but did not conduct a formal vote (8/27) |
ISTA |
Vitrase (FDA-approved) |
Ovine hyaluronidase formulation |
Use as a spreading agent |
ISTA filed a supplemental NDA seeking approval for a smaller vial size (8/2) |
Vital |
-- |
Immortalized human liver cells |
Acute liver failure |
The FDA granted the product orphan designation in that indication (8/20) |
| | ||||
Notes: | ||||
* Privately held | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. | ||||
