Talecris Biotherapeutics Receives FDA Approval for Gamunex®-C

RESEARCH TRIANGLE PARK , N.C., Oct. 14 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics (Nasdaq: TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex®-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI). 

The newly approved Gamunex-C provides both the intravenous route of administration and a new subcutaneous route of administration. The intravenous delivery mode is approved to treat PI, chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP). The subcutaneous mode is approved to treat only PI.

The difference between Gamunex and Gamunex-C is the labeling and packaging information. Gamunex-C labeling describes both the intravenous and subcutaneous routes of administration, whereas Gamunex labeling describes only intravenous administration. Subcutaneous administration delivers the product under the skin into the subcutaneous tissue and intravenous administration is delivered through a vein.  

"The FDA approval of Gamunex-C is important because it provides another option for patients with primary immunodeficiency and their healthcare professionals when they are considering the various treatment modalities," said Fred Modell, Co-Founder of the Jeffrey Modell Foundation. "We consider it significant for patients to have multiple modes of delivery so they can select the option that best suits their individual needs."

Through its FDA approval, Gamunex-C becomes the first and only immunoglobulin therapy approved in the U.S. with both intravenous and subcutaneous routes of administration to treat PI. In clinical studies of Gamunex-C, the most common adverse reactions associated with subcutaneous administration were infusion site reactions, headache, fatigue, arthralgia and pyrexia.

"The approval of Gamunex-C is an exciting milestone in the treatment of primary immunodeficiency diseases, giving patients another choice to help manage their health," said Marcia Boyle, President and Founder, Immune Deficiency Foundation. "The Immune Deficiency Foundation applauds Talecris Biotherapeutics for its commitment to providing therapies for our community."

About PI

Primary immunodeficiency diseases are intrinsically or genetically-occurring defects of the immune system, and comprise a diverse group of illnesses.  Among the subcategories of PI are a group of disorders in which antibody production is reduced or absent.  Increased susceptibility to infection is common to all of the PI disorders.  More than 250,000 people in the United States are diagnosed with primary immunodeficiency (PI) diseases, and many more go undetected.

About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.

Talecris Biotherapeutics (Nasdaq: TLCR) is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology and hemostasis. (www.talecris.com)

Important Safety Information

Gamunex-C, Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.  Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.  Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gamunex-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer Gamunex-C at the minimum concentration available and the minimum infusion rate practicable.

Gamunex-C is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human).  It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

Gamunex-C is not approved for subcutaneous use in patients with ITP or CIDP. Due to the potential risk of hematoma formation, Gamunex-C should not be administered subcutaneously in patients with ITP.  

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization and/or known or suspected hyperviscosity.

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV.  The high dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

Gamunex-C is made from human plasma.  Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.

In clinical studies, the most common adverse reactions with Gamunex-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).  

The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Due to a potential risk of hematoma formation, Gamunex-C should not be administered subcutaneously in patients with ITP.  Subcutaneous administration of Gamunex-C in patients with ITP has not been studied.

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.

For additional information about Gamunex, please see www.gamunex.com for Full Prescribing Information.  The package insert is currently being revised to incorporate information regarding subcutaneous administration for treatment of primary immunodeficiency.

Cautionary statement regarding forward-looking statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, quotations from management in this press release, statements regarding strategic and operation plans, and statements regarding the development or commercialization of therapies.  Forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties. You are cautioned not to place undue reliance on forward-looking statements. Although Talecris believes that the forward-looking statements contained in this press release are reasonable, there is no assurance that expectations will be fulfilled. The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking statements: possible U.S. legislation or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare; our ability to procure adequate quantities of plasma and other materials which are acceptable for use in our manufacturing processes from our own plasma collection centers or from third-party vendors; our ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates through our research and development activities; and the timing of, and our ability to, obtain and/or maintain regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of our products.  Additional information about factors that could affect the business and financial results of Talecris is contained in its final Prospectus filed pursuant to Rule 424(b)(1) with the Securities and Exchange Commission on October 1, 2009. Talecris undertakes no duty to update any forward-looking statement.

SOURCE Talecris Biotherapeutics, Inc.