"We are pleased to collaborate with Catalent to ensure the safe, secure, sustainable supply of our life-saving and life-enhancing protein therapies throughout Europe," said Joel Abelson, Senior Vice President and General Manager, Portfolio Management and International Business, for Talecris, "and are confident that their expertise will support our continued global growth.”

Throughout this five-year contract, Talecris will ship products from its primary manufacturing facility in Clayton, N.C. to its European headquarters in Frankfurt, Germany. Products will then be sent to Catalent in Limoges, France for final testing, labeling and packaging. Finished products will be shipped back to Talecris in Frankfurt for final release to the market and distribution throughout Europe.

“We are pleased to partner with Talecris, and we are excited about the opportunity to employ our current portfolio of services to help support their global growth,” said Richard Yarwood, the Group President of Catalent’s Sterile Technologies segment.

About Gamunex
Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP).

Important Safety Information
Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer. 

There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain.

As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.

For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information.

About Prolastin
Prolastin is indicated for chronic augmentation therapy of individuals having congenital deficiency of alpha-1 proteinase inhibitor with clinically demonstrable panacinar emphysema. Individuals with selective IgA deficiencies who have known antibody against IgA should not receive Prolastin, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.

Important Safety Information
In clinical studies with Prolastin, reactions (none severe) were observed in 1.16% of infusions, the most common events being fever, lightheadedness and dizziness. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. For additional information on Prolastin, please see full prescribing information at www.prolastin.com.

About Alpha-1 Antitrypsin Deficiency
Alpha-1 antitrypsin Deficiency, also known as AAT Deficiency or alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein AAT. It is most common in the Caucasian population of northern Europe and North America. AAT Deficiency is also the most common cause of genetic liver disease in children, and genetic emphysema (shortness of breath) in adults. Individuals suffering from AAT Deficiency often develop severe obstructive pulmonary disease (COPD) causing disability and premature death. AAT Deficiency affects some 150,000 people in North America and Europe.