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TachoSil® to be marketed in the Unites States by Baxter

Nycomed grants Baxter International Inc. (NYSE: BAX) exclusive rights to market and distribute Nycomed’s TachoSil® patch in the United States. 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.

Baxter is allowed to distribute TachoSil® in the United States through 2022, while Nycomed will manufacture the product, hold the license and will be responsible for the regulatory filing expected later this year.

“We are delighted with this agreement,” says Dick Söderberg, Nycomed’s Executive Vice President International Marketing. “Our strategy in the United States is to work with the best available partners for marketing and commercialisation and we really couldn’t have found a better partner than Baxter that has such a depth of experience and expertise.”
“TachoSil® complements Baxter BioSurgery’s portfolio of surgical products offered in the United States as it is well-established in Europe and Japan as a device to help control bleeding and seal tissues in a variety of surgical procedures,” added Ron Lloyd, Vice-President and General Manager of Baxter’s BioSurgery business. “We look forward to bringing this product into the operating room in the United States through Baxter’s established sales force once it has been cleared by the FDA. Our sales representatives work with surgeons every day to offer them innovative biomaterials to help achieve hemostasis and achieve tissue sealing in surgical procedures. We see TachoSil® as an ideal addition to Baxter’s portfolio of TISSEEL, FloSeal and CoSeal products.”

TachoSil® is a patented Nycomed product, which is currently available in more than 50 markets outside of the United States including Europe and Japan. The product is a fixed combination of a collagen patch coated with human thrombin and fibrinogen. It is used in a variety of surgical procedures to seal tissue and control bleeding, requires little preparation and can be stored at room temperature. The currently approved indication in Europe is: “for supportive treatment in surgery for improvement of hemostasis where standard techniques are insufficient.” TachoSil® is not yet an approved product in the United States.

In accordance with generally accepted accounting principles, Baxter expects to record a special pre-tax charge of $10 million for in-process research and development associated with the transaction. The arrangement also includes potential additional payments in the future based on the successful achievement of specified development, regulatory and sales milestones.

About Baxter

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE:BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

About Nycomed

Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.

The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.

Privately owned, the combined group had annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results).

Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/tachosil-to-be-marketed-in-the-unites-states-by-baxter