Grifols Announces Launch of the SPIRIT Registry at the NHF Annual Meeting

Grifols Announces Launch of the SPIRIT Registry at the NHF Annual Meeting 
RESEARCH TRIANGLE PARK, N.C., Oct. 4, 2013 /CNW/ - Grifols Inc., a leading 
manufacturer of life-saving plasma protein therapies, today announced the 
launch of the SPIRIT (Study of Plasma-derived factor VIII/VWF in Immune 
toleRance Induction Therapy) registry for patients with hemophilia A at the 
National Hemophilia Foundation (NHF) annual meeting in Anaheim, Calif. The 
SPIRIT registry will enroll U.S. patients with hemophilia A and inhibitors 
being treated with Grifols' plasma-derived factor VIII/VWF product, 
ALPHANATE(®) (antihemophilic factor/von Willebrand factor complex [human]). 
(Logo: http://photos.prnewswire.com/prnh/20110304/PH59473LOGO ) 
According to the registry's lead investigator, Rebecca Kruse-Jarres, M.D., of 
Tulane University, this observational study fills an important void. 
"There is not a lot of prospective data to help us understand how patients 
with inhibitors respond to treatment, especially as it relates to adherence 
and quality of life. The data from the SPIRIT registry will give us more 
information to treat our patients and should complement the ongoing RESIST 
study." 
Dr. Kruse-Jarres will present a poster at the NHF meeting that outlines the 
registry design. 
"The SPIRIT registry is another example of Grifols' commitment to the 
hemophilia community," said Eva Bastida, Ph.D., Vice President of Scientific 
and Medical Affairs at Grifols. "We are happy to launch this initiative and 
further support efforts to provide information to hemophilia treaters." 
About ALPHANATE(® ) 
Indications  ALPHANATE(®) (antihemophilic factor/von Willebrand factor 
complex [human]) is indicated for: 


    --  Control and prevention of bleeding in patients with hemophilia
        A
    --  Surgical and/or invasive procedures in adult and pediatric
        patients with von Willebrand disease (VWD) in whom desmopressin
        (DDAVP) is either ineffective or contraindicated. It is not
        indicated for patients with severe VWD (Type 3) undergoing
        major surgery

Important Safety Information

ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is 
contraindicated in patients who have manifested life-threatening immediate 
hypersensitivity reactions, including anaphylaxis, to the product or its 
components.

Anaphylaxis and severe hypersensitivity reactions are possible. Should 
symptoms occur, treatment with ALPHANATE should be discontinued, and emergency 
treatment should be sought.

Development of activity-neutralizing antibodies has been detected in patients 
receiving FVIII containing products. Development of alloantibodies to VWF in 
Type 3 von Willebrand Disease (VWD) patients has been occasionally reported in 
the literature.

Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD 
patients, especially in the setting of known risk factors.

Intravascular hemolysis may be associated with infusion of massive doses of 
AHF/VWF Complex (Human).

Rapid administration of a FVIII concentrate may result in vasomotor reactions.

Plasma products carry a risk of transmitting infectious agents, such as 
viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite 
steps designed to reduce this risk.

The most frequent adverse events reported with ALPHANATE(®) (antihemophilic 
factor/von Willebrand factor complex [human]) in >5% of patients are 
respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, 
pain, fever, chills, joint pain, and fatigue.

About Grifols

Grifols is a global healthcare company with a 70-year legacy of improving 
people's health and well being through the development of life-saving plasma 
medicines, hospital pharmacy products and diagnostic technology for clinical 
use.

As a leading producer of plasma medicines, Grifols has a presence in more than 
100 countries and is the world leader in plasma collection, with 150 plasma 
donation centers across the U.S. Grifols is committed to increasing patient 
access to its life-saving plasma medicines through significant manufacturing 
expansions and the development of new therapeutic applications of plasma 
proteins. The company is headquartered in Barcelona, Spain and employs more 
than 11,000 people worldwide.

In 2012, Grifols' sales exceeded 2,620 million euros. The company's class A 
shares are listed on the Spanish Stock Exchange, where they are part of the 
Ibex-35 (MCE:GRF). Its non-voting class B shares are listed on the Mercado 
Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more 
information visit www.grifols.com



SOURCE  Grifols Inc. 
Punkaj Amin, Grifols - Director of Corporate Communications for North America, 
punkaj.amin@grifols.com, 919-316-6664 
http://www.grifols.com 
http://photos.prnewswire.com/prnh/20110304/PH59473LOGO 
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CO: Grifols Inc.
ST: California
NI: HEA MTC BTC SHOW NP  
-0- Oct/04/2013 12:45 GMT
 
 
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