Company* |
Product | Description |
Indication | Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Immunomedics |
Epratuzumab |
Humanized anti-CD22 antibody labeled with yttrium-90 |
Lupus |
The FDA granted fast-track status to the drug for treating moderate to severe disease (1/5) |
CANCER | ||||
American |
Abraxane |
Paclitaxel protein-bound particles for injection; albumin-bound |
Metastatic breast cancer |
The FDA approved the drug for use after failure of chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy (1/8) |
Gemin X |
GX15-070 |
Small-molecule inhibitor of bcl-2 proteins |
Chronic lymphocytic leukemia |
The FDA granted orphan status to the drug in that indication (1/6) |
Inex |
Marqibo (Onco TCS) |
Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology |
Non-Hodgkin's lymphoma |
The FDA said the product was not approvable; the move followed an FDA panel's recommendation against approval in December (1/19) |
Marshall |
Phenoxodiol |
Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP |
Prostate cancer |
The FDA granted fast-track status to the product for treating hormone-refractory prostate cancer (1/26) |
Maxim |
Ceplene |
Histamine dihydrochloride in combination with interleukin-2 |
Acute myeloid leukemia |
FDA said another Phase III trial would be necessary before Maxim could apply for regulatory approval (1/18) |
MGI Pharma |
Dacogen |
Decitabine for injection; a hypomethylating agent |
Myelodysplastic syndromes |
The FDA accepted for filing the NDA, which was filed in November (1/3) |
Savient |
Soltamox |
Tamoxifen oral liquid solution |
Hormonally sensitive breast cancer |
Filed NDA with the FDA; the drug is a product of Savient subsidiary Rosemont Pharmaceuticals Ltd. (1/6) |
Sonus |
Tocosol |
Formulation of paclitaxel |
Non-superficial urothelial cancer |
The FDA granted orphan status to the drug for that indication, which includes bladder cancer (1/27) |
SuperGen |
Orathecin |
Rubitecan; topoisomerase-I inhibitor in capsule formulation |
Pancreatic cancer |
SuperGen withdrew NDA filing after learning package would not be sufficient to gain approval (1/3) |
CARDIOVASCULAR | ||||
Neurobiological |
Viprinex (ancrod) |
Thrombin-like enzyme highly specific to fibrinogen that is derived from venom of the Malayan pit viper |
Ischemic stroke |
The FDA granted fast-track status to the product for treating ischemic stroke (1/28) |
CENTRAL NERVOUS SYSTEM | ||||
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Diabetic neuropathy |
Reached agreement with FDA on an SPA for Phase III trials, expected to start in IH:05 (1/12) |
Neurocrine |
Indiplon |
Modified-release form of a non-benzodiazapine agent that targets the GABA-A receptor |
Insomnia |
Will resubmit NDA filed in November after it was not accepted by the FDA due to difficulties in navigating the filing in the electronic common technical document format (1/11) |
Orphan |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Narcolepsy |
Filed supplemental NDA seeking approval for treating other primary symptoms of narcolepsy, including excessive sleepiness (1/18) |
INFECTION | ||||
Acambis plc |
ACAM2000 |
Second-generation vaccine |
Smallpox |
The FDA granted fast-track status to the vaccine, for which a BLA filing is being worked on (1/5) |
Panacos |
PA-457 |
Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein |
HIV |
The FDA granted fast-track status to the product in that indication, for which Phase IIa trials are ongoing (1/6) |
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg |
Alvimopan capsules; mu opioid antagonist |
Post-operative ileus |
The FDA requested information from a Phase III trial in Europe, which failed to meet its primary endpoint, as part of its NDA review (1/10) |
Genaera |
Squalamine |
Anti-angiogenesis agent; vascular endothelial growth factor inhibitor |
Wet age-related macular degeneration |
The Phase II product was selected for participation in the FDA CMA Pilot 2 program (1/4) |
Insmed Inc. |
SomatoKine |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Growth hormone insensitivity syndrome |
Company submitted NDA for that indication, for which the product has orphan status (1/3) |
Kamada Ltd.* |
-- |
Aerosolized version of its alpha-1 proteinase inhibitor product |
Congenital emphysema |
The FDA granted orphan status to the drug (1/5) |
Osiris |
Prochymal |
Formulation of a specific type of adult stem cell that has the ability to modulate the immune system |
Graft-vs.-host disease |
The FDA granted fast-track status to the product, which is entering Phase II trials (1/31) |
PTC |
PTC124 |
Oral agent that targets nonsense mutations |
Duchenne's muscular dystrophy |
The FDA granted orphan status to the drug for treating DMD due to a nonsense mutation in the dys- trophin gene (1/27) |
| | ||||
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; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; TSE = Toronto Stock Exchange. | ||||
