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Arginox Receives European and US Orphan Drug Designation for Cardiogenic Shock Medication.

MENLO PARK, California, October 13 /PRNewswire/ -- Arginox Pharmaceuticals, an emerging specialty pharmaceutical company today announced that the Committee for Orphan Medical Products (COMP), a division of the European Medicines Agency (EMEA), has recommended orphan drug designation in the European Union to Tilarginine Acetate Injection (TAI) for the treatment of cardiogenic shock (CS). This favorable opinion requires final ratification by the European Commission.

The OMP designation will result in reduced Marketing Authorization Application fees, free access to scientific advice from the EMEA, and other potential research and development incentives. If a product with OMP designation is the first to be given marketing authorization in Europe for its approved indication, the product receives 10-years of market exclusivity meaning that a similar drug is prevented from receiving authorization for the same indication during this period. TAI has already been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA). Under the US orphan drug approval, upon marketing authorization, the FDA does not accept or approve other applications to market the same medicinal product for the same therapeutic indication for a 7-year period.

"The Orphan Drug designation and the OMP decision promise to accelerate the development of TAI and to reduce our development costs. We are particularly pleased by receiving this designation in Europe because of the pioneering role European investigators are playing in the development of TAI for the management of cardiogenic shock," said Kenneth E. Drazan, M.D., Arginox's Chief Executive Officer.

CS is one of the most serious complications of a heart attack. Despite major advances in acute cardiac care that have led to dramatic improvements in heart attack survival overall, a similar benefit has not been realized for CS. Recent research and data from large-scale heart attack registries indicate that mortality from CS remains 40 percent to 50 percent under the best treatment conditions and is frequently much higher. The condition is characterized by circulatory collapse, leading to organ failure and death. Approximately 9% of myocardial infarction patients experience CS.

Commenting on current treatments for cardiogenic shock complicating acute myocardial infarction, Dr. Frans Van de Werf, chairman of the cardiology department of the University Hospital Gasthuisberg in Leuven, Belgium, stated, "We are committed to evaluating this novel therapeutic approach to the management of cardiogenic shock patients who have not had adequate treatment options to date, and we look forward to completing the enrollment of Phase 3 with a large contribution from Europe." Professor Van de Werf is a member of the Global Steering Committee for the Phase 3 trial evaluation of TAI.

Potential Role of TAI in Cardiogenic Shock

TAI is a first-in-class drug that inhibits the production of nitric oxide (NO), a chemical normally found in many cells of the body. A growing body of research suggests that overproduction of NO following a heart attack may play a critical role in the development of CS. By blocking the production of NO, TAI has the potential to interrupt the cycle of circulatory shutdown that can quickly lead to death. The TRIUMPH trial will study the effectiveness of TAI to improve survival in heart attack patients who develop CS.

About Arginox (

Arginox Pharmaceuticals is a privately held, emerging specialty pharmaceutical company focused on the discovery and development of breakthrough medicines to treat hospitalized patients. The company's initial area of research and development is directed at nitric oxide-mediated pathways, which have been shown in Nobel prize-winning research to play a role in a range of disease states. Arginox's lead compound, Tilarginine Acetate Injection, is in late-stage clinical evaluation for the treatment of cardiogenic shock.

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Grendel Burrell of Arginox Pharmaceuticals, Inc., +1-650-324-5160, or
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Publication:PR Newswire Europe
Date:Oct 13, 2005
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