Kedrion’s product development and distribution capabilities will be most valuable to Entegrion’s mission of making blood-derived products safer and more readily available.
ResearchTriangle Park, NC (PRWEB) March 19, 2013
Entegrion announced today it has entered into a collaboration and exclusive license agreement with Kedrion Melville, Inc. for clinical development and commercialization of Entegrion’s dehydrated pathogen-inactivated plasma product, Resusix™. In the collaboration, Entegrion and Kedrion will jointly advance the clinical development of Resusix™, and Kedrion will have exclusive worldwide commercialization rights to the product. Entegrion will begin human clinical trials with Resusix™ during 2013, with funding provided primarily through contracts with the U.S. Department of Defense. The collaboration additionally entails an equity investment by Kedrion in the Series C Preferred Stock of Entegrion, which will occur incrementally throughout 2013.
Entegrion Executive Chairman John B. Mowell said, “We are extremely pleased to expand our existing relationship with Kedrion, an international leader in providing plasma-derived products, to continue development of this important resuscitation therapy. Kedrion’s product development and distribution capabilities will be most valuable to Entegrion’s mission of making blood-derived products safer and more readily available.” Mowell added, “The Entegrion Board of Directors is proud to welcome Kedrion as a strategic investor in Entegrion, bringing into close alignment the objectives of the two companies.”
"Kedrion strongly believes in the potential of Resusix™ and is committed to its development,” stated Paolo Marcucci, CEO of Kedrion. “This product is a strong strategic fit with Kedrion's existing product portfolio and will further increase our presence in a number of key markets, including the U.S. Furthermore, I am pleased to reinforce our partnership with Entegrion, with whom we have been working successfully for a number of years in the early phases of development of Resusix™."
Michael Galiger, Entegrion’s Vice President of Operations, added, “Formalizing this relationship focuses our companies’ combined technical resources on delivering Resusix™ to the Department of Defense and the commercial market.”
The development of Resusix™ began with support from The Office of Naval Research (ONR), which provided the challenge to develop a safe and effective dehydrated blood plasma for combat casualty care, and continues with support from the Office of the Secretary of Defense. ONR’s continued funding as critical milestones were achieved, combined with Entegrion’s resources, led to a successful early development program and a transition to advanced development in 2013. The program will be managed by the U.S. Army combat casualty care directorate.
Entegrion’s Executive Vice President Richard Martin noted, “Kedrion’s experience in the plasma products market will be essential to the success of this product, and we are pleased that Kedrion will participate in its development.”
Fresh frozen plasma (FFP) is the standard of care for resuscitation of patients having experienced acute blood loss, with over 5 million units of FFP being administered annually in the U.S. alone. However, disadvantages associated with FFP as a resuscitation therapy include its need for storage in a frozen state, as well as serious and sometimes fatal reactions to transfusions. Entegrion’s Resusix™ offers a valuable advantage in remote and austere military and civilian settings. Derived from pathogen inactivated plasma manufactured by Kedrion, and spray dried to provide an extended shelf life, Resusix™ is a highly portable resuscitation fluid that is rehydrated for infusion when needed. With an extended shelf life, Resusix™ not only breaks the cold chain restrictions of FFP, which is the current standard of care, but it provides a safer alternative to FFP because it is free of micro particles and cell fragments commonly found in FFP.
Entegrion, Inc.is a life sciences product development company that is focused on improving the safety and availability of the world’s blood supply. Based in North Carolina’s Research Triangle Park, Entegrion offers patented technologies designed to overcome limitations in storage, safety, and availability of blood-derived products while preserving their functionality. Many of Entegrion’s advances in biologics are based on close collaborations with leading medical research institutions. Visit http://www.entegrion.com for more information.
Kedrion is a biopharmaceutical company specialized in the development, production and distribution of plasma-derived products. In Italy, Kedrion is the partner of the National Health Service for the achievement of nationwide self-sufficiency. Created in 2001 as a result of the rationalization and upgrading of other companies that had been working in the industry, Kedrion acquired a heritage of expertise that secures it a prominent role in Italy, in Europe and in the world. With its headquarters in Italy, companies in Europe, Mexico and the United States, Kedrion sells its products in 60 countries worldwide. The production is concentrated in Italy in the plants situated in Bolognana, near Lucca, and in Sant’Antimo, near Naples, and in a third facility in Gödöllő, Hungary, near Budapest. In 2011, Kedrion further consolidated its presence in the United States with the acquisition of a fractionation plant located in Melville, New York. Its state-of-the-art production facilities certified according to GMPs (Good Manufacturing Practices) and based on U.S. FDA (Food and Drug Administration) requirements, its wide range of products and its constant commitment to research and development represent the key factors of Kedrion’s success. Recently the company has acquired worldwide rights for the sales of a human anti-D immunoglobulin leader in the United States, an effective product for the prevention of the “haemolytic disease of the newborn” (HDN). http://www.kedrion.com