Grifols Study Suggests Repeated Plasmapheresis May Reduce "Bad" LDL Cholesterol Levels While Increasing "Good" HDL Cholesterol Levels in Some Individuals

MADRID, March 14, 2012 /PRNewswire/ -- Grifols, (MCE:GRF, MCE:GRF.P andNASDAQ:GRFS), a global healthcare company that specializes in the production of biological medicines derived from human plasma, presented study results today suggesting that the plasmapheresis process may reduce levels of low-density lipoprotein (LDL) or "bad" cholesterol as well as total cholesterol in individuals who have high baseline levels.  The study also suggests that plasmapheresis could increase levels of "good" (HDL) cholesterol among individuals with low baseline levels.

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The study, involving 663 adults and 9,153 plasma samples, was designed to assess the impact of plasmapheresis on cholesterol levels in the blood.  Plasmapheresis is a technique widely used to obtain blood plasma from individuals while returning their remaining blood components.  Plasma obtained during plasmapheresis is used to produce life-saving medicines for patients who have rare, genetic and life-threatening illnesses.

"The results of our study suggest that plasmapheresis may reduce the levels of cholesterol, although the magnitude of the effect observed depends on the baseline levels of cholesterol and the time intervals between plasmapheresis procedures," said Dr. Marilyn Rosa-Bray, Chief Medical Officer of the Grifols Plasma Operations.  "While the results are preliminary and the study should be replicated in larger populations, our data suggest that plasmapheresis might particularly benefit people with either high LDL or total cholesterol levels," said Dr. Rosa-Bray.  Dr. Rosa-Bray presented the study today at the International Plasma Protein Conference (IPPC) meeting in Madrid, Spain. 

Study Results
Using a statistical model known as multi-variable regression to analyze the study data, the researchers estimated that plasmapheresis could reduce the levels of low density lipoproteins (LDL) or "bad" cholesterol by more than 30 mg/dL among individuals with high levels (> 160 mg/dL) or higher than desirable levels (>130 mg/dL), when plasmapheresis procedures are performed two to four days apart.  This effect was more significant in women, in whom cholesterol could be reduced by up to 35 mg/dL.  A similar reduction pattern is estimated to occur in individuals with high total cholesterol levels (>240mg/dL) or higher than desirable levels (>200mg/dL), with the reductions in these cases potentially reaching 45mg/dL and 32 mg/dL, respectively. 

The cholesterol-lowering effects of plasmapheresis appeared to last only as long as the procedure continued at regular intervals, with cholesterol levels gradually returning to baseline following long periods without plasmapheresis.  The same pattern of reductions could be seen, although to a lesser degree, when subsequent plasmapheresis procedures were performed more than 10 days apart.  Among individuals with normal baseline cholesterol levels, the study results suggested that plasmapheresis would not cause significant changes.  The study results also suggest that plasmapheresis could increase the levels of high-density lipoproteins (HDL) or "good" cholesterol in individuals who presented low baseline levels of HDL cholesterol.  

Study Design
The multi-center longitudinal study was conducted in 9 plasma donor centers in the U.S., with blood analyses performed prior to plasma donations to measure initial levels of total cholesterol, HDL (high density lipoproteins), and LDL (low density lipoproteins).  Plasma was collected from first-time donors or from donors who had not donated plasma for at least six months.  Participants were closely monitored throughout the process and no significant adverse events were observed.

Significant variables in the study included age, gender, weight, and race; the recommended base levels of cholesterol per the American Heart Association (totals of LDL and HDL); the time interval between donations; the number of donations made by each donor, and; potential changes in lifestyle (reviewed at the time of each donation using prior questionnaires).

About plasmapheresis
Plasmapheresis is a technique used to separate plasma from the remaining blood components such as red blood cells, platelets and other cells, which are immediately injected back into the donor at the time of the donation.  Returning the remaining blood components to the donor facilitates a more rapid recovery and replenishment of the blood when compared to whole blood donations.  The plasmapheresis method was first reported in the scientific literature by Dr. J. A. Grifols Lucas, who presented his findings at the International Transfusion Congress held in Lisbon in 1951.

Today plasmapheresis is performed at Grifols' 147 plasma donor centers across the U.S.  Operated under names BiomatUSA, PlasmaCare and Talecris Plasma Resources, thousands of qualified donors make more than 6.6 million donations per year – equivalent to 24,000 donations per day.  Every donation is analyzed using FDA-licensed protocols to maximize the quality and safety of the plasma for use as the starting material in the production of plasma-derived therapies.  Testing and analysis also enables Grifols to obtain and study important clinical and biochemical data with the donors' consent.

About Grifols
Grifols is a global healthcare company that specializes in the pharmaceutical and hospital sectors.  Headquartered in Spain, Grifols has a presence in more than 100 countries.  Since 2006, the ordinary shares of Grifols (class A) have been quoted on the Mercado Continuo Espanol and since 2008 they have been on the Ibex-35 (GRF).  Starting in June 2011, the non-voting shares of Grifols (class B) were also quoted on the Mercado Continuo (GRF.P) and on the U.S. NASDAQ (GRFS) through ADRs (American Depository Receipts).

Today Grifols is the third largest producer of plasma-derived therapies in the world and is the leading European company in the market sector, with a balanced and diversified range of products.  A vertically integrated company, Grifols is the world leader in plasma collection, with 147 plasma donation centers across the United States.  Grifols owns and operates three state-of-the-art manufacturing facilities in Spain and the U.S., allowing the company to respond to the growing market demand for plasma-derived therapies.

Geographical diversification is one of the principal growth strategies of Grifols, which has a significant presence in the United States, Canada and Europe and a firm commitment to research and development, for which it invests approximately 5% of its sales.  Grifols holds a large number of patents and has research projects underway, of which more than ten have advanced to the preclinical development phase.

LEGAL NOTICE
The facts and/or figures contained in the present report that do not refer to historic data are "projections and considerations for the future."  The expressions "it is believed," "it is expected," "it is anticipated," "it is foreseen," "it is intended," "there is the intention," "should," "it is being attempted to achieve," "it is estimated," "future" and similar expressions, to the extent that they are related with the Grifols group, are used to identify projections and considerations for the future.  These expressions reflect the assumptions, hypotheses, expectations and forecasts of the management team as of the date when this report was drawn up, which are subject to a number of factors that may cause the actual results to be materially different.  The future results of the Grifols group might be affected by events related with its own activity, such as the lack of supplies of raw materials for the manufacture of its products, the appearance of competing products on the market or changes in the regulations that govern the markets where it operates, among others.  As of the date when this report was drawn up, the Grifols group has adopted the measures necessary to remedy the possible effects deriving from these events.  Grifols, S.A. does not assume any obligation to publicly report, revise or update projections and considerations for the future to adapt them to facts or circumstances subsequent to the date of the formulation of this report, except in the cases expressly required by the applicable laws.  The information, opinions, statements in this document concerning pro-forma figures have not been audited or verified by independent third parties; therefore the company in no case guarantees the impartiality, accuracy, completeness or correctness of these figures, information, opinions and statements.  This document does not constitute an offer or invitation to purchase or underwrite shares in accordance with the provisions of Law 24/1988 of 28 July, on the Securities Market, Royal Decree 5/2005 of 11 March and/or Royal Decree 1310/2005 of 4 November and its development standards.

SOURCE Grifols