Sydney, Feb 21, 2006 AEST (ABN Newswire) - Life Therapeutics (ASX: LFE) has been granted an FDA license to collect hyperimmune plasma used to combat infection caused by the influenza virus. The FDA approval process, originally scheduled to take 12 months, was completed in 97 days, over seven months ahead of schedule.
"The first shipment of the Flu hyperimmune plasma was shipped directly after receiving the FDA approval," said Dr. Hari Nair, CEO and Managing Director of Life Therapeutics. Dr Nair added, "The Flu hyperimmune is also a product which can be sold with a high margin and joins a growing list of specialty plasmas that Life Therapeutics now collects and sells. We are consistently setting the standing for collection of this type of hyperimmune plasma"
Eight of Life Therapeutics' 13 plasma collection centers in the US are now collecting this new product that could be very beneficial to high risk personnel with serious flu symptoms. The US National Institute of Health states that over 200,000 influenza patients are admitted annually to US hospitals, and more than 36,000 deaths are associated with the influenza virus.
"This quick approval time is a testament to our successful submission track record with these types of immunization programs," said Wylen D. Won, Executive Vice President for Regulatory and Quality Affairs at Life Therapeutics. "We pride ourselves on submitting complete documentation and fully answering all possible questions for a program such as this and the rapid time in which we get FDA approvals."
Life Therapeutics is an international company with 444 employees, located in Australia and the United States with manufacturing operations in both countries and 13 plasma donor centers in eight American states. Life Therapeutics recently established its U.S. American Depositary Receipt (ADR) Level I program which enables trading in Life Therapeutics shares by U.S. based investors and is an important step toward the company's ultimate objective of achieving a full listing on NASDAQ stock exchange.
The company's four divisions are all headquartered in Atlanta, Georgia and include: Life Sera, Life Gels, Life Diagnostics, and Life Manufacturing.
Life Sera collects specialty plasma, including Anti-D and Hepatitis B from a donor base of more than 5,000 in thirteen U.S. collection centers. The plasma is then sold to blood fractionators who process it into hyperimmune therapeutic products.
Life Gels offers pre-cast gels for use in biological research and diagnostic testing, including a variety of electrophoresis systems. It also offers ultra-sensitive and rapid stains, molecular weight markers, and specially formulated buffers.
Life Diagnostics provides highly specific diagnostic tests for blood-clotting disorders and source plasma products for blood-borne diseases. Technologies include specialized blood coagulation tests to predict the risk of thrombosis and bleeding disorders. It also collects high-titer source plasma and serum used to make diagnostic kits.
Life Manufacturing incorporates the Gradiflow technology with the manufacture of therapeutic and diagnostic products. Gradiflow is a patented process that simultaneously purifies proteins and removes all viral pathogens, and infectious prion proteins.
Contact
USA
Jesse McCorvey
Vice President
Corporate Communications
TEL: +1 404-300-5030
Australia
Prakash Patel
Company Secretary
TEL: +61 2 8977 9000
www.life-therapeutics.com
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