Baxter and Nycomed Announce FDA Approval of TachoSil®

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Tue Apr 6, 2010 8:59am EDT

TachoSil indicated for use as an adjunct to hemostasis in cardiovascular surgery
DEERFIELD, Ill.--(Business Wire)--
Baxter International Inc. (NYSE: BAX) and Nycomed today announced the U.S. Food
and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant
Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil
is the first and only adjunctive hemostatic agent available in the U.S. that
combines a collagen patch with a coating of human coagulation factors. This
ready-to-use patch can be applied directly to the bleeding area either dry or
wet. In the presence of saline, blood or other bodily fluids, the coagulation
factors dissolve to form a fibrin clot, which adheres the TachoSil patch to the
bleeding surface and achieves hemostasis. 

"Controlling bleeding has always been a challenge in cardiovascular surgery, and
we are constantly looking for new ways to achieve hemostasis effectively," said
Dr. Yoshiya Toyoda, M.D., Ph.D., Head of Cardiothoracic Transplantation at the
Heart, Lung and Esophageal Surgery Institute at the University of Pittsburgh
Medical Center (UPMC). "As a ready-to-use patch, TachoSil represents a new and
different option, which I believe will be a welcomed addition to the
armamentarium of adjunctive hemostasis products used in cardiovascular surgery
today." 

TachoSil is a patented Nycomed product that is currently available in more than
50 markets outside of the U.S. Baxter holds exclusive rights to market and
distribute TachoSil in the U.S. Nycomed will manufacture the product and holds
the license with the FDA. Baxter plans to launch TachoSil during the second half
of 2010. 

"TachoSil is the first and only product of its kind approved by the FDA, and an
important addition to our BioSurgery line of products," said Ron Lloyd, vice
president and general manager of Baxter`s Regenerative Medicine business. "The
approval of TachoSil and our recently announced acquisition in the
orthobiologics space underscore Baxter`s commitment to continued growth and
leadership across all facets of our BioSurgery business." 

Important Risk Information

TachoSil is indicated as an adjunct to hemostasis for use in cardiovascular
surgery when control of bleeding by standard surgical techniques (such as
suture, ligature or cautery) is ineffective or impractical. 

Do not use TachoSil in renal pelvis or ureter procedures, neurosurgical
procedures, or in the closure of skin incisions. 

Apply on the surface of tissue only. Do not apply TachoSil intravascularly.
Intravascular application may result in life-threatening thromboembolic events.
Do not use TachoSil in individuals known to have anaphylactic or severe systemic
reaction to human blood products or horse proteins. 

Do not use TachoSil for the treatment of severe or brisk arterial bleeding. Do
not use TachoSil as the primarymode to control hemostasis. TachoSil is not
intended as a substitute for meticulous surgical technique and the proper
application of suture, ligature or other conventional procedures for hemostasis.


Hypersensitivity or allergic/anaphylactoid reactions may occur with TachoSil.
Symptoms associated with allergic anaphylactic reactions include: flush,
urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia,
dyspnea, severe hypotension and anaphylactic shock. These reactions may occur in
patients receiving TachoSil for the first time or may increase with repetitive
applications of TachoSil. In the event of hypersensitivity reactions,
discontinue administration of TachoSil. Do not leave TachoSil in an infected or
contaminated space. 

When placing TachoSil into cavities or closed spaces, avoid overpacking. Use
only the minimum amount of TachoSil patches necessary to achieve hemostasis. The
active substances of TachoSil are made from human plasma. Products made from
human plasma may contain infectious agents, such as viruses, that can cause
disease. 

In the cardiovascular study the most frequently reported adverse reactions were
atrial fibrillation (18 patients [29.0%] in the TachoSil group and 14 patients
[24.6%] in the comparator group) and pleural effusion (14 patients [22.6%] in
the TachoSil group and 11 patients [19.3%] in the comparator group). 

About Nycomed

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 U.S. 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. 

About Baxter

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. 

This release includes forward-looking statements concerning expectations with
respect to the launch of TachoSil. The statements are based on assumptions about
many important factors, including the following, which could cause actual
results to differ materially from those in the forward-looking statements:
completion of final steps in product development, including scaling up
production and satisfactory quality and regulatory work; and other risks
identified in Baxter`s most recent filing on Form 10-K and other SEC filings,
all of which are available on Baxter`s web site. Baxter does not undertake to
update its forward-looking statements.

Baxter International Inc.
Media Contacts
Andrew Lewis, 847-948-2815
Laura Jacobs, 847-948-3026
or
Investor Contacts
Mary Kay Ladone, 847-948-3371
Clare Trachtman, 847-948-3085 



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