Grifols Announces FDA Approval of Alphanate to Treat von Willebrand Disease

Delivering on a promise to the bleeding disorders community, Grifols offers the only dual inactivated and US manufactured, antihemophilic factor/von Willebrand factor complex.

LOS ANGELES, February 01, 2007 /PRNewswire/ -- Grifols S.A., a global healthcare company specializing in the research, development and production of biologic therapies derived from human plasma, today announced that it has received approval from the US Food and Drug Administration (FDA) to market Alphanate(R) for the treatment of congenital von Willebrand Disease (VWD) in connection with surgery or other invasive procedures. Alphanate(R) is the first and only dual inactivated (solvent detergent and heat treatment) and affinity chromatography purified antihemophilic factor/von Willebrand factor complex that is FDA approved for the treatment of VWD. Dual inactivated Alphanate(R) has been proven safe and effective for the treatment of hemophilia A through more than a decade of use.

"Realizing the full therapeutic potential of our products is part of our commitment to the bleeding disorders community," said Javier Jorba, MD, President and CEO of Instituto Grifols, a wholly owned subsidiary of Grifols S.A. "Obtaining the VWD indication for Alphanate(R) addresses that commitment and offers the community a new treatment choice with the benefit of a trusted product," continued Dr. Jorba.

"NHF recognizes the value of having multiple treatment options for patients. We applaud Grifols for pursuing FDA approval of the VWD indication," said Dr. Alan Kinniburgh, CEO of the National Hemophilia Foundation. Grifols obtained FDA approval for the use of Alphanate(R) in the treatment of VWD on the basis of prospective and retrospective clinical data to evaluate the safety and efficacy of the therapy in treating VWD patients undergoing invasive procedures and/or surgery. Clinical data from 76 patients was submitted in support of the VWD indication for Alphanate(R), including both pediatric and female patients who underwent surgery and/or invasive procedures. The Company has committed to conducting post-market studies to collect additional clinical data on the safety and efficacy in treating severe VWD.

Grifols acquired the product license for Alphanate(R) in 2003 from AlphaTherapeutic Corporation along with other assets and manufacturing facilities. "Today, Alphanate(R) is manufactured in accordance with the quality and safety standards that Grifols is recognized for around the world," said Willie Zuniga, head of the Grifols US manufacturing division. "From the collection of plasma at our 72 dedicated plasma collection centers across the US, to product filling and packaging, Grifols is committed to quality and safety," added Mr. Zuniga.

Additionally, the Company is in the process of validating a new state-of- the-art bulk processing and aseptic filling facility at its US manufacturing complex in Los Angeles, California. The new facility uses proprietary equipment and process flow designs pioneered by Grifols Engineering S.A., a wholly owned subsidiary of Grifols S.A. When fully validated and FDA approved, the new facility will be used for final container filling of Alphanate(R) and other Grifols products.

About von Willebrand Disease

Von Willebrand disease is a bleeding disorder caused by a defect or deficiency of a blood clotting protein called von Willebrand factor. Von Willebrand factor is a protein necessary in the initial stages of blood clotting. VWD is the most common bleeding disorder, estimated to occur in 1 to 2 percent of the population. It is a genetic disease that can be inherited from either parent and equally affects both males and females.

There are several classifications of the disease ranging from Type 1 (the most common and mildest form) to Type 3 (the most severe). People with VWD tend to bruise easily, have recurrent nosebleeds, or bleed after surgery. Women can have increased menstrual bleeding. There are several treatment options depending on whether the VWD is mild or severe such as treating the milder form with desmopressin acetate, a nasal spray used to boost Factor VIII and von Willebrand levels. For other types of bleeding, infusions of a factor VIII concentrate rich in von Willebrand factor, such as Alphanate(R) may be required.

About Alphanate(R)

Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate(R), is indicated for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency. Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate(R), is also indicated for surgical and/or invasive procedures in patients with von Willebrand Disease (VWD), except Type 3 patients undergoing major surgery, in whom desmopressin (DDAVP(R)) is either ineffective or contraindicated. Antihemophilic factor potency (Factor VIII:C activity) is expressed in International Units (IU) on the product label. Additionally, each vial of Alphanate(R) also contains VWF:RCof activity in IU for the treatment of VWD.

Thromboembolic events have been reported in von Willebrand Disease patients receiving Antihemophilic Factor/von Willebrand Factor Complex replacement therapy, especially in the setting of known risk factors for thrombosis. Because Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate(R) is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

About Grifols

Grifols has been present in healthcare since 1940, creating innovative products and services based on the values of ethics and responsibility. Grifols' activities focus on fulfilling the needs of healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 60 years, Grifols has developed, manufactured and marketed products of proven efficacy, quality and safety contributing to improve human health, life expectancy and quality of life. More information about Grifols can be found at http://www.grifols.com.

CONTACT: Chris Healey of Grifols, +1-703-351-5004, Fax: +1-703-276-9052, Chris.Healey@grifols.com

Web site: http://www.grifols.com/

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Posted: February 2007


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