Navigation Links
Octapharma Aims to Expand U.S. Immune Globulin Therapy Portfolio
Date:9/23/2009

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 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.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... Newly ... technologies, services and solutions to the healthcare market. The company's primary focus is ... manufacturing, sales and marketing strategies that are necessary to help companies efficiently bring ...
(Date:6/24/2016)... 24, 2016 Epic Sciences unveiled a ... susceptible to PARP inhibitors by targeting homologous recombination ... The new test has already been incorporated into ... cancer types. Over 230 clinical trials ... pathways, including PARP, ATM, ATR, DNA-PK and WEE-1. ...
(Date:6/23/2016)... 23, 2016   Boston Biomedical , an ... designed to target cancer stemness pathways, announced that ... Orphan Drug Designation from the U.S. Food and ... cancer, including gastroesophageal junction (GEJ) cancer. Napabucasin is ... inhibit cancer stemness pathways by targeting STAT3, and ...
(Date:6/23/2016)... -- The Prostate Cancer Foundation (PCF) is pleased to announce 24 new ... prostate cancer. Members of the Class of 2016 were selected from a pool ... Read More About the Class of 2016 PCF Young Investigators ... ... ...
Breaking Biology Technology:
(Date:6/20/2016)... 2016 Securus Technologies, a leading provider ... public safety, investigation, corrections and monitoring announced that ... has secured the final acceptance by all three ... Access Systems (MAS) installed. Furthermore, Securus will have ... installed by October, 2016. MAS distinguishes between legitimate ...
(Date:6/7/2016)... June 7, 2016  Syngrafii Inc. and San ... relationship that includes integrating Syngrafii,s patented LongPen™ eSignature ... This collaboration will result in greater convenience for ... union, while maintaining existing document workflow and compliance ... ...
(Date:6/1/2016)... June 1, 2016 Favorable Government ... Administration and Criminal Identification to Boost Global Biometrics System ... released TechSci Research report, " Global Biometrics Market ... Forecast and Opportunities, 2011 - 2021", the global biometrics ... 2021, on account of growing security concerns across various ...
Breaking Biology News(10 mins):