LOS ANGELES, February 1 /PRNewswire/ --
- Delivering on a promise to the bleeding disorders community, Grifols offers the only dual inactivated and US manufactured, antihemophilic factor/von Willebrand factor complex
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 DrugAdministration (FDA) to market Alphanate(R) for the treatment of congenitalvon Willebrand Disease (VWD) in connection with surgery or other invasiveprocedures. Alphanate(R) is the first and only dual inactivated (solventdetergent and heat treatment) and affinity chromatography purifiedantihemophilic factor/von Willebrand factor complex that is FDA approved forthe treatment of VWD. Dual inactivated Alphanate(R) has been proven safe andeffective for the treatment of hemophilia A through more than a decade ofuse.
"Realizing the full therapeutic potential of our products is part of ourcommitment to the bleeding disorders community," said Javier Jorba, MD,President and CEO of Instituto Grifols, a wholly owned subsidiary of GrifolsS.A. "Obtaining the VWD indication for Alphanate(R) addresses that commitmentand offers the community a new treatment choice with the benefit of a trustedproduct," continued Dr. Jorba.
"NHF recognizes the value of having multiple treatment options forpatients. We applaud Grifols for pursuing FDA approval of the VWDindication," said Dr. Alan Kinniburgh, CEO of the National HemophiliaFoundation. Grifols obtained FDA approval for the use of Alphanate(R) in thetreatment of VWD on the basis of prospective and retrospective clinical datato evaluate the safety and efficacy of the therapy in treating VWD patientsundergoing invasive procedures and/or surgery. Clinical data from 76 patientswas submitted in support of the VWD indication for Alphanate(R), includingboth pediatric and female patients who underwent surgery and/or invasiveprocedures. The Company has committed to conducting post-market studies tocollect additional clinical data on the safety and efficacy in treatingsevere VWD.
Grifols acquired the product license for Alphanate(R) in 2003 fromAlphaTherapeutic Corporation along with other assets and manufacturingfacilities. "Today, Alphanate(R) is manufactured in accordance with thequality and safety standards that Grifols is recognized for around theworld," said Willie Zuniga, head of the Grifols US manufacturing division."From the collection of plasma at our 72 dedicated plasma collection centersacross the US, to product filling and packaging, Grifols is committed toquality and safety," added Mr. Zuniga.
Additionally, the Company is in the process of validating a newstate-of-the-art bulk processing and aseptic filling facility at its USmanufacturing complex in Los Angeles, California. The new facility usesproprietary equipment and process flow designs pioneered by GrifolsEngineering S.A., a wholly owned subsidiary of Grifols S.A. When fullyvalidated and FDA approved, the new facility will be used for final containerfilling of Alphanate(R) and other Grifols products.
About von Willebrand Disease
Von Willebrand disease is a bleeding disorder caused by a defect ordeficiency of a blood clotting protein called von Willebrand factor. VonWillebrand factor is a protein necessary in the initial stages of bloodclotting. VWD is the most common bleeding disorder, estimated to occur in 1to 2 percent of the population. It is a genetic disease that can be inheritedfrom either parent and equally affects both males and females.
There are several classifications of the disease ranging from Type 1 (themost common and mildest form) to Type 3 (the most severe). People with VWDtend to bruise easily, have recurrent nosebleeds, or bleed after surgery.Women can have increased menstrual bleeding. There are several treatmentoptions depending on whether the VWD is mild or severe such as treating themilder form with desmopressin acetate, a nasal spray used to boost FactorVIII and von Willebrand levels. For other types of bleeding, infusions of afactor 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 inpatients with Factor VIII deficiency due to hemophilia A or acquired FactorVIII deficiency. Antihemophilic Factor/von Willebrand Factor Complex (Human),Alphanate(R), is also indicated for surgical and/or invasive procedures inpatients with von Willebrand Disease (VWD), except Type 3 patients undergoingmajor surgery, in whom desmopressin (DDAVP(R)) is either ineffective orcontraindicated. Antihemophilic factor potency (Factor VIII:C activity) isexpressed in International Units (IU) on the product label. Additionally,each vial of Alphanate(R) also contains VWF:RCof activity in IU for thetreatment of VWD.
Thromboembolic events have been reported in von Willebrand Diseasepatients receiving Antihemophilic Factor/von Willebrand Factor Complexreplacement therapy, especially in the setting of known risk factors forthrombosis. Because Antihemophilic Factor/von Willebrand Factor Complex(Human), Alphanate(R) is made from pooled human plasma, it may carry a riskof transmitting infectious agents, e.g., viruses, and theoretically, theCreutzfeldt-Jakob disease (CJD) agent.
About Grifols
Grifols has been present in healthcare since 1940, creating innovativeproducts and services based on the values of ethics and responsibility.Grifols' activities focus on fulfilling the needs of healthcare professionalsworking in therapeutics, pharmacy, diagnostics and blood banking. For morethan 60 years, Grifols has developed, manufactured and marketed products ofproven efficacy, quality and safety contributing to improve human health,life expectancy and quality of life. More information about Grifols can befound at http://www.grifols.com.
Web site: http://www.grifols.com
Grifols, Inc.
Chris Healey of Grifols, +1-703-351-5004, Fax: +1-703-276-9052, Chris.Healey@grifols.com
