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Drug Information and Specification
T1, Predominantly positive enhancement
PHARMACOKINETIC
Intravascular, extracellular, renal excretion
DOSAGE
0.1 mmol/kg / 0.2mL/kg
PREPARATION
Finished product
INDICATION
Neuro/whole body
DEVELOPMENT STAGE
For sale
PRESENTATION
Vials of 5, 10, 15, 20mL Pre-filled syringes of 15 and 20 mL
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING
PACKAGE INSERT!
Distribution Information
TERRITORY
TRADE NAME
DEVELOPMENT STAGE
DISTRIBUTOR
France, Switzerland
Artirem®
for sale
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[This entry is marked for removal.]
(July 20, 2009 - EPIX Pharmaceuticals, Inc. announced today that, in light of the company's lack of capital and inability to obtain additional financing or consummate a strategic transaction, it has entered into an Assignment for the Benefit of Creditors, effective immediately, in accordance with Massachusetts law).
EPIX has been a specialty pharmaceutical firm developing targeted contrast agents to improve the capability of MRI as a diagnostic tool for a variety of diseases. Gadofosveset trisodium (formerly MS-325, Vasovist™, now ABLAVARt™), is an injectable intravascular contrast agents designed for multiple vascular imaging applications, including peripheral vascular disease and coronary artery disease.
EPIX conducted a pivotal Phase III trial for the detection of peripheral vascular disease, as well as a Phase II feasibility trial for coronary artery disease diagnosis.
To ensure rapid development and adoption of gadofosveset trisodium into clinical practice upon regulatory approval, EPIX pursued an aggressive product development plan and commercialization strategy. The Company established an exclusive, worldwide sales and marketing agreement with Bayer Schering Pharma AG. EPIX also established corporate collaborations with GE Healthcare, Philips Medical Systems and Siemens Medical Systems, the three leading MRI manufacturers, which together account for approximately 80 percent of the MRI machines installed worldwide.
EPIX had other MRI contrast agents under development, most significantly a novel prototype blood clot agent ( EP-2104R). Potential clinical applications for this type of agent include detection of deep venous thrombosis, pulmonary embolism and blood clots in the coronary and carotid arteries. Currently, there is no high resolution imaging technique to directly visualize blood clots in patients with suspected cardiovascular disease.
| |  | | • View the DATABASE results for 'EPIX Pharmaceuticals, Inc.' (7).
| | | • View the NEWS results for 'EPIX Pharmaceuticals, Inc.' (69).
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Eovist® (other brand name Primovist™) is a organ specific MRI contrast agent for the imaging, detection and characterization of liver conditions, including liver tumors, cysts, as well as other malignant and benign lesions. It is a water-soluble ethoxybenzyl derivative of Gd-DTPA. This compound is taken up by the hepatocytes (approximately 30% of the dose goes to the hepatocytes) and is equally excreted renal and biliary in humans. Excretion of Gd-EOB-DTPA in the bile may also permit visualization of both the gall bladder and the bile ducts.
Eovist® brightens the signal of T1 weighted MR images immediately after contrast administration.
Dynamic and accumulation phase imaging can also be performed after bolus injection of Eovist®. The hepatocytes uptake will increase the signal intensity of normal liver parenchyma at 10 to 20 minutes after injection. This results in improved lesion-to-liver contrast because malignant tumors (metastases, the majority of hepatocellular carcinomas) do not contain either hepatocytes or their functioning is hampered. WARNING:
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m 2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
See also Drug Development and Approval Process USA, Contrast Medium, Hepatobiliary Contrast Agents, Tumor Specific Agents and Molecular Imaging.
Drug Information and Specification
T1, Predominantly positive enhancement
PHARMACOKINETIC
50% hepatobiliary, 50% renal excretion
DOSAGE
12,5 - 25 µmol/kg
PREPARATION
Finished product
DEVELOPMENT STAGE
For sale
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING
PACKAGE INSERT!
| |  | | • View the DATABASE results for 'Eovist®' (4).
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| |  | | • View the DATABASE results for 'Extracellular Fluid Agents' (2).
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