PROLASTIN® celebrates 25 years as leading augmentation therapy for treatment of alpha(1)-antitrypsin deficiency

RESEARCH TRIANGLE PARK, N.C., Feb. 5, 2013 /PRNewswire/ -- Grifols, a global healthcare company based in Barcelona, Spain, is commemorating the 25^th anniversary year of PROLASTIN^® (alpha₁-proteinase inhibitor [human]) and the 50th anniversary of the discovery of alpha₁-antitrypsin deficiency (Alpha1) with a series of events and programs around the world aimed at raising awareness and advancing research into the treatment of alpha1. This rare and life-threatening disease causes genetic emphysema due to low circulating levels of the alpha₁-antitrypsin protein.

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PROLASTIN was launched in the U.S. in February 1988 as the first and only FDA-approved therapy for the treatment of alpha1 by augmenting patients' levels of the alpha₁-antitrypsin protein. Twenty-five years later, the PROLASTIN brand of products remains the global market leader for the treatment of this debilitating lung disease, first identified by Swedish researchers Carl-Bertil Laurell and Sten Eriksson in 1963.

"For nearly 17 years, PROLASTIN was the only product available to patients with Alpha-1," said Dr. Sandy Sandhaus, Professor of Medicine and Director, Alpha₁-Antitrypsin Deficiency Program at National Jewish Health in Denver, CO. "Since the beginning, the makers of PROLASTIN have been remarkable partners with the patient community in helping to improve their health, educate patients about a little-known disease, and support scientific research to find better ways to detect and treat the disease."

"The level of patient support from the manufacturer of PROLASTIN helped many people change their lives," Sandhaus added.

To commemorate the 25^th anniversary of PROLASTIN and the 50^th anniversary of the discovery of the disease, Grifols is sponsoring a series of events, including the Alpha-1 Foundation's International Patient Congress in Barcelona and a National Education Conference in Washington, D.C. These events will promote dialogue and collaboration among patients, scientists, and healthcare providers. The goal is to increase diagnosis and promote research into a rare disease that remains vastly under-diagnosed, with an estimated five percent of affected individuals having been properly identified.

On the research front, Grifols continues to pursue initiatives with the goal of enhancing the understanding of alpha1 and devising better treatment options for patients. Toward that end, Grifols will initiate a multicenter clinical trial this summer to study the efficacy of multiple doses of PROLASTIN^®-C – a more purified and concentrated formulation of PROLASTIN approved in the U.S. in 2009 and in Canada in 2010. 

The development of PROLASTIN-C is one example of Grifols' ongoing commitment to devising novel therapeutic products and services. Additional initiatives include the distribution of free Alpha-1 diagnostic kits and the comprehensive disease-management program, PROLASTIN Direct^®.  

About Grifols

Grifols is a global healthcare company with a 70-year legacy of improving people's health and well-being through the development of life-saving plasma medicines, hospital pharmacy products, and diagnostic technology for clinical use. As the third largest global producer of plasma medicines, Grifols has a presence in more than 90 countries and is the world leader in plasma collection, with 150 plasma donation centers across the U.S.  Grifols is committed to increasing patient access to its life-saving plasma medicines through significant manufacturing expansions and the development of new therapeutic applications of plasma proteins. The company's class A shares are listed on the Spanish Stock Exchange, where they form part of the Ibex-35 (MCE:GRF).  Its non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). In 2011, Grifols' sales exceeded 2,300 million Euros. The company is headquartered in Barcelona, Spain, and employs more than 11,000 people worldwide. For more information visit www.grifols.com.

About Alpha₁-Antitrypsin Deficiency
Alpha₁-antitrypsin deficiency, also known as AAT deficiency or Alpha-1, is an inherited disorder that causes a significant reduction in the naturally occurring protein, alpha₁-proteinase inhibitor. While rare, Alpha-1 is the most common cause of genetic emphysema in adults and the most common cause of liver disease in children. Individuals suffering from Alpha-1 often develop severe chronic obstructive pulmonary disease (COPD) leading to disability and premature death. Alpha-1 is estimated to affect 200,000 people in North America and Europe combined, although greater than 90% of individuals remain undiagnosed.

About PROLASTIN^® and PROLASTIN^®-C

PROLASTIN-C and PROLASTIN are indicated for the treatment of alpha₁-antitrypsin (AAT) deficiency in patients with panacinar emphysema.  AAT deficiency is a genetic condition in which low levels of the alpha₁ protein can result in emphysema in adults and liver disease primarily in children. The active protein in PROLASTIN-C increases or augments protein levels in AAT-deficient patients. PROLASTIN-C is approved in the U.S. and Canada, while PROLASTIN is approved or registered in select countries in Europe and South America.

Important Safety Informationabout PROLASTIN^®-C

PROLASTIN-C, Alpha₁-Proteinase Inhibitor (Human) is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha₁-proteinase inhibitor (alpha₁-antitrypsin deficiency). The effect of augmentation therapy with any alpha₁-proteinase inhibitor (alpha₁-PI) on pulmonary exacerbations and on the progression of emphysema in alpha₁-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials. PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha₁-PI deficiency has not been established.

PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. PROLASTIN-C is contraindicated in patients with antibodies against IgA.

The most common drug related adverse reactions during clinical trials in ≥1% of subjects were chills, malaise, headache, rash, hot flush, and pruritus. The most serious adverse reaction observed during clinical studies with PROLASTIN-C was an abdominal and extremity rash in one subject.

PROLASTIN-C is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Please see full Prescribing Information at http://www.talecris-pi.info/inserts/Prolastin-C.pdf

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

CO11-0113

SOURCE Grifols