Navigation Links
Octapharma USA Announces FDA Approval of wilate(R) - the First Replacement Therapy Developed Specifically for von Willebrand Disease
Date:12/7/2009

HOBOKEN, N.J., Dec. 7 /PRNewswire/ -- Octapharma USA today announced the U.S. Food and Drug Administration has approved wilate® for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD). Wilate® is a newly developed, high-purity, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Concentrate (Human) that demonstrated efficacy for all types of VWD, including pediatric patients, in four prospective clinical trials utilizing both objective and subjective criteria.

Wilate® is indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.(1) Wilate® is the first double virus inactivated VWF/FVIII (von Willebrand Factor / Factor FVIII), high-purity concentrate, utilizing the solvent/detergent (S/D) process and a special terminal dry-heating (TDH) system. The selected purification processes isolates the VWF/FVIII complex under highly protein-protecting conditions, resulting in a 1:1 ratio of VWF:RCo (ristocetin cofactor) and FVIII activities that is similar to normal plasma. No albumin is added as a stabilizer. Wilate® is exclusively derived from large pools of human plasma collected in U.S. FDA approved plasma donation centers.

The FDA approval of wilate® marks the entrance of Octapharma USA into the U.S. blood coagulation market, with product availability scheduled for early 2010. Octapharma USA is the rapidly growing U.S. division of Octapharma AG, one of the largest plasma products manufacturers in the world.

VWD is the most common bleeding disorder, which is found in approximately 1% to 2% of the U.S. population, according to the Centers for Disease Control and Prevention.(2) The illness is a result of the body's inability to make von Willebrand Factor, the human protein that helps clot blood.

"The FDA approval of wilate® makes this the first and only replacement therapy developed and manufactured specifically for VWD. Its unique viral attenuation steps and it's close to 1:1 ratio of FVIII and VWF will provide a next generation treatment option for patients with von Willebrand disease," said Craig Kessler, M.D., Georgetown University Hospital, Professor of Medicine and Pathology and Director of the Division of Coagulation.

Four prospective clinical trials have demonstrated the safety, tolerability and hemostatic efficacy of wilate® in the treatment of acute bleeding episodes and prophylaxis in patients with various types of VWD. Using objective criteria, wilate® was observed in 1,068 bleeding episodes and determined to be successful between 84% and 93% of the time with results varying dependent on patient type.(3)

"Octapharma's worldwide commitment to coagulation disorders dates back to Octapharma Group's formation 25 years ago," said Octapharma USA President Flemming Nielsen. "We are thrilled that U.S. patients will now have access to wilate® following its significant success in Europe as a next generation therapy. Octapharma is committed to providing the U.S. market with life-enhancing therapies."

Since the mid-1980s, the requirements for the viral safety of plasma preparations have constantly been made increasingly stringent, requiring demonstrated virus elimination/inactivation.(4) (5) Several viral inactivation steps have enhanced the safety of coagulation products, but S/D inactivation is the current gold standard for safety from highly infectious enveloped viruses.(6) Octapharma was the first manufacturer to apply the S/D inactivation to a large-scale production of plasma derivatives. The wilate® manufacturing process provides two independent and effective virus inactivation procedures, namely S/D treatment in bulk and TDH treatment of the lyophilized product in final container. In addition, the ion-exchange chromatography step utilized during wilate® manufacturing contributes to the viral safety.

Plasma contains VWF and FVIII at very low concentration. The wilate® manufacturing process is designed to enrich the proportion of VWF/FVIII complex. Accompanying plasma proteins that may give rise to clinical side-effects, as well as proteases that could impair the stability of coagulation factors and degrade their natural structure and functionality, are efficiently removed during production.

Octapharma AG

Headquartered in Lachen, Switzerland, Octapharma is one of the largest plasma products manufacturers in the world and has been committed to patient care and medical innovation for over 25 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma's IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat disorders of the immune system, and Octapharma's Albumin (Human) is indicated for the restoration and maintenance of circulating blood volume. Octapharma employs over 3,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is headquartered in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration, providing the highest level of production flexibility and minimizing product shortages. For more information, please visit www.octapharma.com.

Forward-looking statements

This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.

References

(1) Mollison.P.L., Engelfriet C.P., Contreras M.: Some unfavourable effects of transfusion; in Klein H.G., Anstee D.J. (eds): Mollison's Blood Transfusion in Clinical Medicine. Blackwell Publishing, 2005, pp 666-700.

(2) Centers for Disease Control and Prevention. Bleeding disorders. Available at www.cdc.gov/ncbddd/hbd/hemophilia.htm. Accessed on November 22, 2009.

(3) Wilate® Approved Complete Prescribing Information, December 2009.

(4) Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses CPMP/BWP/268/95 February 1996.

(5) Note for guidance on plasma-derived products CPMP/BWP/269/95, rev.2. July 1998.

(6) Farrugia A . Guide for the assessment of clotting factor concentrates for the treatment of Hemophilia. 2003, WFH.

SOURCE Octapharma USA


'/>"/>
SOURCE Octapharma USA
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Octapharma Group and Fresenius Kabi Enter Into an Exclusive License, Development and Supply Agreement for a HESylated Recombinant Protein
2. Octapharma Targeting the Major Risk of Hemophilia Treatment - FVIII Antibodies
3. Octapharma Accepting Applications for Research Grants on Immunotherapy, Coagulation Disorders and Critical Care
4. Plasma Products Safe Despite Swine Influenza Outbreak, Assures International Biopharmaceutical Company Octapharma
5. Royalty Pharma Announces that Alexander von Perfall Joins Management Team
6. ThermoGenesis Announces Agreement for Adipose Tissue Clinical Program
7. Hill-Rom Announces Appointment of James R. Giertz to Board of Directors
8. CareFusion Announces Six New Pyxis(R) Technologies at the ASHP Midyear Clinical Meeting and Exhibition
9. Genoptix Announces Participation at Deutsche Bank 2009 MedTools Investor Conference
10. Suneva Medical Announces Corporate Developments Including Appointment of Philip Ranker as Chief Financial Officer
11. Axsun Technologies, A Wholly-Owned Subsidiary of Volcano Corporation, Announces Breakthrough Integrated Light Source Architecture for Optical Coherence Tomography (OCT) Imaging
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)...   , Study met ... and superiority in , Excellent plus ... of the ascending colon   , ... B.V. today announced new positive data from the phase III MORA ... standard 2 litre PEG with ascorbate. The study met both primary ...
(Date:5/24/2016)... Celsion Corporation (NASDAQ: CLSN ... an update on its ongoing OVATION study, a ... the Company,s DNA-based immunotherapy, with the standard of ... advanced ovarian cancer who will undergo neoadjuvant chemotherapy ... IL-12 DNA plasmid vector formulated as a nanoparticle ...
(Date:5/24/2016)... KONG , May 24, 2016 /PRNewswire/ ... COMBO ™ , la première ... des cathéters destinés à l,intervention portant sur ... (FAV)   OrbusNeich, entreprise mondiale ... permettant de changer la vie, a élargi ...
Breaking Medicine Technology:
(Date:5/24/2016)... ... 24, 2016 , ... The number of health insurance policies ... over last year, according to data in the forthcoming AIS’s Directory of Health ... with a slight decrease in risk-based groups and a slight increase in administrative-services-only/self-funded ...
(Date:5/24/2016)... ... May 24, 2016 , ... Bio-Logic Aqua® Research Water Life ... and a trainer for Ageless Grace ( http://www.agelessgrace.com ) to discuss healthier lifestyles, ... 16, 2016. , Formerly a Northwestern University Literature Professor, Kinst gravitated to her ...
(Date:5/24/2016)... ... ... WaterAid launched the #perioddrama campaign to mark Menstrual Hygiene Day on May 28 and ... who do not have access to a toilet, even when they’re on their periods. , ... The (sometimes hilarious) results help shine a light on the awkwardness that women face while ...
(Date:5/24/2016)... ... May 24, 2016 , ... In light of recent ... of the potential of contaminated well water throughout the Houston area. , Heavy floodwaters ... well water that’s exposed to contaminants. Residents may not even be aware of the ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... today announced a licensing relationship that will deliver a new series of Q&A ... will put the medical knowledge and expertise of Harvard Medical School faculty into ...
Breaking Medicine News(10 mins):