Grifols Announces US Launch of Flebogamma(R) 10% DIF IVIGBy Grifols, PRNE
Sunday, November 21, 2010
Building on the safety record of its 5% concentration, the new 10% liquid, room temperature IVIG preparation establishes Grifols as the only producer offering both 5% and 10% IVIG concentrations to healthcare providers and patients in the US
LOS ANGELES, November 22, 2010 - Grifols today announced availability of its recently approved
Flebogamma(R) 10% DIF intravenous immune globulin. Grifols is a global
healthcare company specializing in bioscience medicines derived from human
plasma. Approval from the US Food and Drug Administration (FDA) for
Flebogamma(R) 10% DIF was obtained in July 2010 and final approval in Europe
is expected before the end of the year. Today's announcement signals
widespread product availability to the US market.
"We are excited about being able to meet a wider range of clinical needs
by providing healthcare providers and patients the additional treatment
option of Flebogamma(R) 10% DIF," said Gregory Rich, President of Grifols' US
operations. "Grifols understands that the clinical needs of patients are
unique and by offering a choice of IVIG concentrations we can better address
them," continued Mr. Rich.
The approval and launch of Flebogamma(R) 5% DIF in early 2007, ushered in
a new standard in IVIG treatment with the development of a dual inactivated,
nano-filtered (DIF) product. Like Flebogamma(R) 5% DIF, the new 10% solution
has two distinct pathogen inactivation processes (heat treatment and solvent
detergent) and a proprietary 20 nanometer filtration step. The manufacturing
process for Flebogamma(R) DIF is also very efficient at eliminating
extraneous proteins, resulting in a high purity IVIG solution (99.4% IgG).
Development of the DIF production process was the result of more than a
decade of research and the construction of dedicated, state-of-the-art IVIG
production facilities in Barcelona, Spain. A twin production facility has
been under construction in Los Angeles since 2008, and expected to be
completed in 2013. For the time being, Grifols' Flebogamma(R) 10% DIF will be
produced exclusively at its Barcelona facility.
"I commend Grifols on their commitment to the development of additional
treatment options," said Marcia Boyle, President and Founder of the Immune
Deficiency Foundation, the national patient organization for persons with
primary immune diseases. "New products help assure continued access to this
lifesaving medicine so that countless people who live with primary
immunodeficiencies, such as my son, can lead healthy and productive lives,"
continued Ms. Boyle.
Like all Grifols' products, each vial of Flebogamma(R) 10% DIF is laser
etched with a unique identification number to ensure product integrity. In
addition, the outer packaging is secured with a tamper evident holographic
overseal containing specialized printing to confirm authenticity. Grifols
also offers healthcare providers access to a proprietary web-based system
called PediGri(R) that provides full traceability for every plasma donation
used to produce an individual product vial.
Grifols has a wholly owned dedicated engineering division (Grifols
Engineering) that develops state-of-the-art manufacturing suites for the
biologics industry. The design concepts used in the Flebogamma(R) 5% DIF and
Flebogamma(R) 10% DIF production facility were developed exclusively by
Grifols Engineering and include such things as minimal exposure zones to
reduce manufacturing surface areas and the potential for microbial
contamination. Process enhancements achieved by the use of newer technologies
and Grifols' proprietary process design concepts result in an increase in the
amount of IVIG that can be obtained from each plasma donation.
Grifols S.A. is a Spain-based healthcare company engaged in the research,
development, manufacturing and marketing of plasma therapies, IV therapy
solutions, enteral and parenteral nutrition, diagnostic systems, pharmacy
automation, and medical materials and devices. Grifols plasma therapies are
produced from plasma obtained at over 80 donor centers across the US and are
used to treat a variety of rare and life-threatening diseases. Founded in
1940, Grifols currently operates in 90 countries with more than 6,000
employees and 23 subsidiaries. Grifols is listed on the Ibex-35 Madrid stock
For more information about Grifols, please visit www.grifols.com
or contact Chris Healey at +1-703-351-5004.
Chris Healey, +1-703-351-5004
Tags: california, Europe, Grifols, Los angeles, November 22