LEXINGTON, Mass.–(BUSINESS WIRE)–July 1, 2008–EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced today that the New Drug Application (NDA) for its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist (gadofosveset trisodium) was resubmitted to the U.S. Food and Drug Administration (FDA) on June 30, 2008.
If approved, Vasovist will be the first contrast agent approved for marketing in the United States for use with MRA, a non-invasive modality for imaging blood vessels. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents.
We look forward to continuing to work with the FDA to bring Vasovist to market in the United States, said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. Throughout the appeal process for Vasovist, we worked closely with the FDA and the resubmission is a culmination of the work done by our team at EPIX. We remain hopeful that we will achieve approval for Vasovist by the end of 2008 and are focused on executing our strategy to monetize our interest in this valuable asset.
Vasovist is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). Vasovist has been approved for marketing in 33 countries, including all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, all Nordic countries, the United Kingdom and Switzerland.
Berlin, July 8, 2008 –The U.S. Food and Drug Administration (FDA) has approved Bayer Schering Pharma’s magnetic resonance imaging (MRI) contrast agent Primovist® (gadoxetate disodium) for the detection and characterization of liver lesions in adults with known or suspected focal liver disease. The product will be marketed in the United States under the name EOVIST®; it is currently marketed as Primovist outside the U.S. and as EOB Primovist in Japan. It is the first organ-specific MRI contrast agent to be approved in the U.S. for over a decade. Bayer plans to make EOVIST available to customers in the U.S. in the summer of 2008.
“Primovist not only offers the unique benefit of being able to simultaneously detect, locate and distinguish various types of liver lesions, but also helps to guide and follow-up on treatment decisions, as it enables radiologists to identify even tiny pathological liver lesions,” said Dr. Gunnar Riemann, Member of the Board of Management of Bayer Schering Pharma AG, responsible for the company’s Business Units. “Bayer is now in the unique position of offering Primovist for diagnosing patients with liver cancer and Nexavar for treating hepatocellular carcinoma – the most common form of liver cancer.”
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The Pathway PV™ Atherectomy system is designed to treat the entire spectrum of disease found in the PAD patient. Our system has expandable, rotating scraping blades with aspiration for preemptive removal of both hard and soft plaque. The Pathway PV™ Atherectomy system provides simple set-up and easy operation to maximize effectiveness and minimize procedure time.
The Pathway PV™ Atherectomy System is not yet approved for sale and is subject to FDA 510(k) clearance.
Pathway Medical Technologies said Tuesday that it has raised $24.5 million in venture capital from existing investors — money geared to help the firm launch its first commercial product later this year.
The latest cash influx brings the total raised by the Kirkland-based medical-device maker to about $80 million, Chief Executive Tom Clement said. The company’s newly padded war chest should last it until revenue starts coming in from sales of its system for clearing out arterial plaque.
“We shouldn’t need another round of investment in the next year and a half, if that,” Clement said.
Pathway seeks to market a device to treat peripheral-arterial disease by sending a catheter with rotating blades up an artery to bore through accumulated fat and vacuum the debris away.
The device, under review by the U.S. Food and Drug Administration, is to be used in patients’ legs to improve circulation and prevent amputations. It could be an alternative to surgery and other methods, which include widening blood vessels and costly laser catheters that burn plaque away.
Pathway’s main rival is Fox Hollow, of Redwood City, Calif., which sells the SilverHawk, a catheter to remove plaque from peripheral arteries.
Researchers led by Takahisa Furukawa, M.D. & Ph.D. of Japan’s Osaka Bioscience Institute have named a protein that they discovered after the Pikachu character from Nintendo‘s Pokémon game and anime franchise. The “Pikachurin” protein plays a role in the efficient transmission of kinetic vision information from the eyes to the brain, so the researchers named the protein after the Pokémon character known for its fast moves. The researchers expect that the discovery will help advance the treatments for retinitis pigmentosa, a major hereditary cause of blindness.
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