Baxter Reports Results of ADVATE Real-World Experience from Worldwide Post-Marketing Database of Hemophilia A Patients

  Baxter Reports Results of ADVATE Real-World Experience from Worldwide
  Post-Marketing Database of Hemophilia A Patients

Analyses Presented during ISTH Support ADVATE’s 10-year Real-world Experience

Business Wire

AMSTERDAM, Netherlands -- July 2, 2013

Baxter International Inc. (NYSE:BAX) today presented two comprehensive
analyses supporting the proven clinical and real-world results of ADVATE
[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] during the
24^th Annual Congress of the International Society on Thrombosis and
Haemostasis (ISTH) in Amsterdam, The Netherlands. The presentations include
two complementary studies of the ADVATE profile, including an analysis of
post-marketing data from approximately 1,200 hemophilia A patients across 15
countries as well as safety findings from a 10-year database of 12 clinical
trials.

A meta-analysis of post-authorization safety studies (PASS) (abstract# PO148)
presented at ISTH supports the overall product safety and effectiveness
profile, as well as low rate of inhibitor development with ADVATE, with only
one de-novo inhibitor in severe previously-treated patients (n=669) with more
than 150 prior exposure days.^1 The analysis assessed the effectiveness of
ADVATE treatment in non-controlled, real-world clinical practice, and found
that the median annual bleed rate (ABR) for patients on continuous prophylaxis
(twice a week or more, n=560) was 1.67, which supports the ABR reported in
controlled clinical studies.^2 The effectiveness result in the study captured
ADVATE efficacy in routine clinical practice (as opposed to efficacy, which
measures in a controlled, interventional trial setting). The meta-analysis
included patients from the United States, Australia, Japan, and 12 countries
in Europe, who were followed for more than one year with exposure to ADVATE
ranging between 85 and 103 mean exposure days across five studies.^1

''This meta-analysis of the post-market surveillance database, the largest
available in hemophilia today, demonstrates a global patient experience with
ADVATE that is consistent with the results reported in our highly controlled
clinical programs,'' said Bruce Ewenstein, M.D., Ph.D., vice president of
clinical affairs for Baxter. ''Given the broad range of patients and
hemophilia clinical practice around the world, it is significant that these
data continue to support the low inhibitor rate among patients using ADVATE as
well as the effectiveness of bleed prevention when on an ADVATE prophylaxis
regimen.''

Also presented at ISTH, a database of more than ten years of ADVATE clinical
data provided an integrated analysis of safety data from 12 clinical
interventional studies (abstract #812).^3 The studies included more than 400
patients with hemophilia A, with roughly 90 percent of patients receiving
prophylaxis treatment with ADVATE and a mean of 97 exposure days.

The integrated safety analysis confirmed previously demonstrated safety and
tolerability in children and adults with moderately severe or severe
hemophilia A in a wide variety of clinical settings, and revealed no new
safety signals. The overall incidence of FVIII inhibitors in
previously-treated patients, (PTPs, over 50 exposure days) was 0.4 percent.

Only one low-titer inhibitor was detected in PTP population who had at least
10 exposures to the product during their respective studies (n=276). In the
full safety analysis of 418 patients (both PTPs and previously-untreated
patients, or PUPs), there were no adverse events leading to study withdrawal,
no hypersensitivity and no anaphylaxis/anaphylactoid reactions.^3

''The ADVATE treatment data collected from 12 interventional clinical trials
over the past decade has allowed researchers to verify and confirm the
established safety and efficacy profile of this product,'' said Amy Shapiro,
M.D., medical director at the Indiana Hemophilia and Thrombosis Center and
lead investigator of the integrated analysis. ''The data we analyzed supports
the established safety record of ADVATE, and importantly, will give clinicians
continued confidence in prescribing ADVATE for their patients.''

About ADVATE

ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is
indicated for the control and prevention of bleeding episodes in adults and
children (0-16 years) with hemophilia A. ADVATE is also indicated for routine
prophylaxis to prevent or reduce the frequency of bleeding episodes in adults
and children (0-16 years) with hemophilia A. ADVATE is not indicated for the
treatment of von Willebrand disease.

ADVATE is a full-length (derived from the complete FVIII gene) recombinant
FVIII product that is processed without any blood-based additives. Because no
blood-derived components are added at any stage of the manufacturing process,
the potential risk of transmitting pathogens that may be carried in
blood-based additives is eliminated. There have been no confirmed reports of
transmission of HIV, HBV or HCV with rFVIII treatments.

ADVATE is approved in 58 countries worldwide, including the United States,
Canada, 27 countries in the European Union, Argentina, Australia, Brazil,
Chile, China, Colombia, Croatia, Hong Kong, Iceland, Iraq, Japan, Macau,
Malaysia, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South
Korea, Suriname, Switzerland, Taiwan, Uruguay and Venezuela.

Detailed Important Risk Information for ADVATE

ADVATE is contraindicated in patients with known anaphylaxis to mouse or
hamster protein or other constituents of the product.

Allergic-type hypersensitivity reactions, including anaphylaxis, are possible
and have been reported with ADVATE. Symptoms have manifested as dizziness,
paresthesia, rash, flushing, face swelling, urticaria, dyspnea, and pruritus.
Discontinue use if hypersensitivity symptoms occur and administer appropriate
emergency treatment.

Carefully monitor patients treated with AHF products for the development of
FVIII inhibitors by appropriate clinical observations and laboratory tests.
Inhibitors have been reported following administration of ADVATE predominantly
in previously untreated patients (PUPs) and previously minimally treated
patients (MTPs).

If expected plasma FVIII levels are not attained, or if bleeding is not
controlled with an expected dose, perform an assay that measures FVIII
inhibitor concentration.

The serious adverse reactions seen with ADVATE are hypersensitivity reactions
and the development of high-titer inhibitors necessitating alternative
treatments to FVIII.

The most common adverse reactions observed in clinical trials (frequency
greater than or equal to 10 percent of subjects) were pyrexia, headache,
cough, nasopharyngitis, vomiting, arthralgia, and limb injury.

Please see full prescribing information for ADVATE at:
http://www.baxter.com/downloads/healthcare_professionals/products/ADVATE_PI.pdf

About Hemophilia A

Hemophilia is a rare genetic^4 blood clotting disorder and the most severe
forms of the disease primarily affect males.^5 People living with hemophilia
do not have enough of, or are missing, one of the blood clotting proteins
naturally found in blood.^6 Two of the most common forms of hemophilia are A
and B. In people with hemophilia A, clotting factor VIII is not present in
sufficient amounts or is absent.^6 Without enough FVIII, people with
hemophilia can experience spontaneous, uncontrolled internal bleeding that is
painful, debilitating, damaging to joints and potentially fatal.^5,7 According
to the World Federation of Hemophilia, it is estimated that more than 400,000
people in the world have hemophilia. ^ 8 All races and economic groups are
affected equally.^9

About Inhibitors

As many as one-third of patients with severe or moderately severe hemophilia A
are at risk for developing inhibitors,^10 which are antibodies produced by the
body's immune system in response to factor replacement therapy.^11 Inhibitors
cause the body to work against the factor replacement therapy, neutralizing
its effect and preventing an individual's blood from clotting.^10 Individuals
who have inhibitors have a form of hemophilia that is more difficult to
control, with an increased risk of uncontrolled bleeding, compared to patients
without inhibitors. Inhibitor development is considered one of the most
serious complications associated with hemophilia treatment, and may include
other associated complications such as impaired movement, increased need for
surgery and greater complexity or risk associated with surgery.^10

About Baxter in Hemophilia

Baxter has more than 60 years’ experience in hemophilia and has introduced a
number of therapeutic firsts for hemophilia patients. Baxter has the broadest
portfolio of hemophilia treatments in the industry and is able to meet
individual therapy choices, providing a range of options at each treatment
stage. The company’s work is focused on optimizing hemophilia care and
improving the lives of people living with hemophilia A and B worldwide.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures
and markets products that save and sustain the lives of people with
hemophilia, immune disorders, cancer, 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.

^1 2013 ISTH Congress. E-poster presentation. Meta-analysis of Post
Authorization Safety Studies (PASS): Worldwide postmarketing surveillance of
hemophilia A patients treated with antihemophilic factor recombinant
plasma/albumin-free method rAHF-PFM.

^2 Valentino LA, Mamonov V, Hellmann A, Quon DV, Chybicka A, Schroth P,
Patrone L, Wong W-Y for the Prophylaxis Study Group. A randomized comparison
of two prophylaxis regimens and a paired comparison of on-demand and
prophylaxis treatments in hemophilia A management. J Thromb Haemost 2012; 10:
359–67.

^3 2013 ISTH Congress. E-poster presentation. Integrated Analysis of Safety
Data from 12 clinical interventional studies of a Plasma- and Albumin-free
Recombinant Factor VIII (rAHF-PFM) in Persons with Hemophilia A.

^4 How do you get hemophilia? World Federation of Hemophilia. Accessed on:
June 3, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=644

^5 Frequently Asked Questions About Hemophilia. World Federation of
Hemophilia. Accessed on: June 3, 2013. Available at:
http://www.wfh.org/en/page.aspx?pid=637

^6 What is Hemophilia? World Federation of Hemophilia. Accessed on: June 3,
2013. Available at: http://www.wfh.org/en/page.aspx?pid=646

^7 Lee, C. A. Hemophilia Care in the Modern World, in Current and Future
Issues in Hemophilia Care (eds E.-C. Rodríguez-Merchán and L. A. Valentino),
2011.

^8 Treatment. World Federation of Hemophilia. Accessed on June 3, 2013.
Available at: http://www.wfh.org/en/page.aspx?pid=642

^9 What is Hemophilia? Hemophilia Federation of America. Accessed on June 3,
2013. Available at:
http://www.hemophiliafed.org/bleeding-disorders/hemophilia/

^10 Leissinger, Cindy A. Prevention of Bleeds in Hemophilia Patients With
Inhibitors: Emerging Data and Clinical Direction. American Journal of
Hematology. 2004.

^11 What are Inhibitors? World Federation of Hemophilia. Accessed on June 3,
2013. Available at:http://www.wfh.org/en/page.aspx?pid=651

Contact:

Baxter International Inc.
Media Contacts
Brian Kyhos or Deborah Spak
(224) 948-5353
media@baxter.com
Investor Contacts
Mary Kay Ladone, (224) 948-3371
Clare Trachtman, (224) 948-3085
 
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