Nycomed and Baxter receive FDA approval
for TachoSil®, an adjunct to haemostasis in cardiovascular
US Food and Drug Administration (FDA) has granted approval for the surgical patch TachoSil® in cardiovascular surgery
April 6, 2010 -- Today Nycomed and its partner Baxter International Inc. (NYSE: BAX) received the approval for TachoSil®, a surgical patch, from the US Food and Drug Administration (FDA). TachoSil has been approved as an adjunct to haemostasis (control of bleeding) in cardiovascular surgery.
TachoSil is the key product in Nycomed's tissue management portfolio and fulfils the market need for a ready-to-use surgical patch, developed to assist surgeons in achieving fast and reliable bleeding control. With the US approval, Nycomed and its partner Baxter can offer the surgical patch for use as an adjunct to haemostasis in cardiovascular surgery.
In the United States, the product will be distributed and marketed by Baxter, which plans to launch TachoSil during the second half of 2010. Nycomed will manufacture the product and holds the licence with the FDA. The agreement is part of Nycomed's strategy to seek marketing and commercialisation partnerships for the US market instead of operating its own sales force.
TachoSil was filed with the FDA in 2009, based on international clinical trial results on cardiovascular surgery.
Guido Oelkers, Nycomed's Executive Vice President, Commercial Operations, said: "TachoSil has been a success in Europe and we have great expectations for the surgical patch in the US. With Baxter, we have an experienced partner to market and distribute the product successfully in the US market and TachoSil perfectly complements Baxter BioSurgery's portfolio of surgical products."
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.
Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.
Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion.
For more information visit www.nycomed.com
For further information
General phone: +41 44 555 15 10
Beatrix Benz, phone: +41 44 555 15 08
Tobias Cottmann, phone: +41 44 555 15 01
Christian B. Seidelin, phone: +41 44 555 11 04