Navigation Links
Octapharma Aims to Expand U.S. Immune Globulin Therapy Portfolio

LACHEN, SWITZERLAND and HOBOKEN, N.J., Sept. 23 /PRNewswire/ -- Octapharma AG recently submitted its Biological License Application for octagam(R) 10% (human normal intravenous immunoglobulin, liquid) to the U.S. Food and Drug Administration (FDA) with the goal of expanding the biopharmaceutical company's U.S. immune globulin therapy portfolio by early 2010. The application was submitted for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a blood-clotting disorder that can result in excessive bruising and bleeding.

"We are extremely pleased with the BLA submission for octagam 10% and look forward to advancing Octapharma's firm commitment to providing immune globulin therapy in the U.S. marketplace," said Octapharma USA President Flemming Nielsen. "The expected introduction of octagam 10% will provide yet another immune globulin intravenous (IGIV) product option for patients that further builds on the success already achieved with the octagam product line both globally and in the U.S."

In 2004, Octapharma, one of the largest plasma products manufacturers in the world, gained U.S. approval from the FDA for its IGIV product, octagam(R) (immune globulin intravenous [human] 5%). The therapy, which treats disorders of the immune system, has already gained over 10% of the U.S. market despite entrenched competition.

"No market is more important to Octapharma than the U.S.," said Nielsen. "Octapharma has been committed to patient care and medical innovation since its founding over 25 years ago and our vision of providing patients with the safest, highest quality products available is stronger than ever. We look forward to a rapid expansion of our U.S. product portfolio. Octapharma is committed to providing life saving products as well as ensuring reliable supply and fair pricing."

Octapharma also recently submitted an Investigational New Drug (IND) application for a next generation IGIV product for the treatment of ITP and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder that progressively impairs leg and arm function.

The IND for this next generation IGIV is just one part of Octapharma's extensive global Research and Development program. Octapharma also is evaluating the efficacy of immune globulin as a treatment in new and existing conditions. Octagam is currently being investigated in clinical trials studying the efficacy of treatment for CIDP, ITP, multiple sclerosis, Alzheimer's disease and primary immune deficiency. In February, Octapharma started phase II clinical trials following FDA review of its IND for octagam 10% in mild-to-moderate Alzheimer's disease.

Octapharma AG

Headquartered in Lachen, Switzerland, Octapharma is the third largest plasma products manufacturer 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(R) (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

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.

SOURCE Octapharma AG
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Octapharma Names Dennis D. Curtin To Lead U.S. Plasma Operations
2. Octapharma USA Retains Yankee Public Relations as its Agency of Record
3. ProMetic announces Octapharma publication of PRDTS prion removal resin in Octaplas(R) manufacturing process at 30th International Congress of the International Society for Blood Transfusion meeting in Macao SAR, China
4. Haemonetics and Octapharma AG Announce Plasma Collection Technology Contract
5. Octapharma Joins Biotechnology Industry Organization
6. Haemonetics Becomes Preferred Provider of Plasma Collection Products to Octapharma Europe
7. DIA/FDA/PhRMA Conference To Expand The Role Of Modeling And Simulation In Clinical Drug Development
8. Medelis Expands CRO Services to Medical Devices, Appoints Dr. Inder Makin as VP
9. PA Helping Life Science Companies Secure Venture Capital Needed to Expand, Gov. Rendell Says
10. Toshos Satisfaction With Health Robotics Steers the Japanese Pharmacy Automation Leader to Renew and to Expand its I.V. Automation Strategic Partnership
11. OmniComm Systems Inc. Expands Its Successful CRO Preferred Program(TM) By Signing On Three New CRO Partners
Post Your Comments:
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... Sciences today announced the three Winners and six Finalists of the 2017 Blavatnik ... annually by the Blavatnik Family Foundation and administered by the New York Academy ...
(Date:10/12/2017)... CA (PRWEB) , ... October ... ... ( ) has launched Rosalind™, the first-ever genomics analysis platform specifically designed ... bioinformatics complexity. Named in honor of pioneering researcher Rosalind Franklin, who made ...
(Date:10/11/2017)... Md. (PRWEB) , ... October 11, 2017 , ... ... digital pathology, announced today it will be hosting a Webinar titled, “Pathology is ... Advanced Pathology Associates , on digital pathology adoption best practices and how Proscia ...
(Date:10/11/2017)... (PRWEB) , ... October 11, 2017 , ... ... Administration (FDA) has granted orphan drug designation to SBT-100, its novel anti-STAT3 (Signal ... the treatment of osteosarcoma. SBT-100 is able to cross the cell membrane and ...
Breaking Biology Technology:
(Date:7/20/2017)... July 20, 2017 Delta (NYSE: DAL ) customers ... Delta aircraft at Reagan Washington National Airport (DCA). ... Delta launches biometrics to board aircraft ... Delta,s biometric boarding pass ... is now integrated into the boarding process to allow eligible Delta ...
(Date:6/23/2017)... and ITHACA, N.Y. , June 23, ... University, a leader in dairy research, today announced a ... to help reduce the chances that the global milk ... of this dairy project, Cornell University has become the ... the Food Supply Chain, a food safety initiative that ...
(Date:5/23/2017)... GENOA, Italy , May 23, 2017  Hunova, the first robotic ... and trunk, has been officially launched in Genoa, Italy ... Europe and the USA . The ... launched on the market by the IIT spin-off Movendo Technology thanks to ... view the Multimedia News Release, please click: ...
Breaking Biology News(10 mins):