Company* |
Product | Description |
Indication | Status |
CANCER | ||||
Rexahn Corp.* |
RX-0201 |
Signal inhibitor that blocks the protein kinase Akt |
Advanced cancer |
The FDA granted orphan designation to the drug in ovarian, renal-cell, stomach and pancreatic cancers, and glioblastoma (2/1) |
Vical Inc. |
Allovectin-7 | DNA plasmid/lipid complex containing the DNA sequences encoding HLA-7 and ß2 microglobulin |
Metastatic melanoma |
Reached agreement with FDA on SPA for Phase III trial in 375 patients with recurrent disease (2/10) |
Vion |
Cloretazine |
Sulfonyl hydrazine DNA alkylating agent |
Acute myelogenous leukemia |
Reached agreement with FDA on SPA for a Phase III trial with Ara- in 420 patients in first relapse (2/10) |
Viventia |
Proxinium |
Antibody fragment conjugated with a cancer-killing payload |
Head and neck cancer |
The FDA granted orphan designation to the product for treating advanced, recurrent disease (2/3) |
Xcyte Therapies |
Xcellerated T Cells |
T cells from patient stimulated to carry out immune functions |
Chronic lymphocytic leukemia trial |
The FDA requested a withdrawal of a planned Phase II/III trial to allow additional discussion of the design (2/2) |
CARDIOVASCULAR | ||||
AtheroGenics |
AGI-1067 |
Oral agent designed to inhibit the production of VCAM-1 and other molecules in the inflammatory process |
Atherosclerosis |
The FDA OK'd company's plan to increase enrollment in Phase III ARISE trial, to 6,000 patients from 4,000 (2/22) |
Inotek Pharmaceuticals Corp.* |
INO-1001 |
Inhibitor of the nuclear cell death enzyme poly (ADP-ibose) polymerase |
Aortic aneurysm repair |
The FDA granted orphan designation to the drug for preventing post-operative complications of aortic aneurysm repair (2/15) |
NitroMed |
BiDil |
Nitric oxide-enhancing oral agent; combination of isosorbide dinitrate and hydralazine |
Heart failure in African-Americans |
The FDA accepted the resubmission of the NDA; the PDUFA date is June 23 (2/3) |
CENTRAL NERVOUS SYSTEM | ||||
StemCells |
HuCNS-SC |
Human neural stem cells |
Batten disease |
The FDA had questions and suggestions on the company's IND, putting the proposed Phase I trial on hold (2/1) |
TheraQuest |
TQ-1017 |
Abuse-deterrent, once-daily, extended-release formulation of tramadol |
HIV-associated neuropathy |
The FDA granted orphan designation to the product in that indication (2/17) |
INFECTION | ||||
Aerogen Inc. |
-- |
Aerosolized formulation of amikacin |
Ventilator- associated pneumonia |
The FDA granted fast-track designation to the product, which is in Phase II trials (2/22) |
DVC LLC |
VIGIV |
Intravenous vaccinia immune globulin |
Side effects of smallpox vaccine |
The FDA approved the orphan product for treating adverse reactions to smallpox vaccination (2/22) |
Vicuron |
Dalbavancin |
Glycopeptide agent from the same class as vancomycin |
Complicated skin and soft-tissue infections |
NDA for the drug filed in December was granted priority-review status by the FDA (2/24) |
MISCELLANEOUS | ||||
BioBalance Corp. |
Probactrix |
Strain of E. coli in a BioBalance formulation |
Pouchitis |
The FDA had questions about the IND, putting the proposed trial on hold (2/4) |
BioMarin |
rhASB (Aryplase) |
Galsulfase; an enzyme-replacement therapy |
Mucopoly-saccharidosis-VI |
The FDA accepted for filing and assigned six-month review to the BLA, which was filed in November (2/1) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature infants |
The FDA had issues with the contract manufacturer of the product, setting back the review period; the NDA was filed in April 2004 (2/1); the FDA issued an approvable letter that did not call for additional trials, only resolution of manufacturing and labeling issues (2/14) |
Nastech |
Nascobal |
Nasally delivered formulation of cyanocobalamin |
Vitamin B-12 deficiency |
The FDA approved the product; Questcor Pharmaceuticals Inc. has worldwide marketing rights (2/1) |
Pharmaxis Inc. |
Bronchitol |
Mannitol formulation delivered via an inhalation device |
Bronchiectasis |
The FDA granted orphan designation to the product, which is in human trials in that indication (2/9) |
Tercica Inc. |
Increlex |
Mecasermin injection; recombinant human insulin-like growth factor-1 |
Short stature caused by IGF deficiency |
Filed NDA with FDA seeking approval for the long-term treatment of growth failure in children with a severe form of primary IGF-1 deficiency (2/28) |
| | ||||
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. | ||||
ASX = Australian Stock Exchange; OTC BB = Over-the-Counter Bublletin Board; TSE = Toronto Stock Exchange. | ||||
